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Evaluation of an Anti-cancer Immunotherapy Combined With Standard Neoadjuvant Treatment in Patients With WT1-positive Primary Invasive Breast Cancer (INDUCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01220128
Recruitment Status : Terminated (Study termination due to negative Ph III of another study product from same technology platform.)
First Posted : October 13, 2010
Results First Posted : May 25, 2017
Last Update Posted : May 25, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Neoplasms, Breast
Interventions Biological: GSK Biologicals' recombinant WT1 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK2302024A
Drug: Placebo
Drug: Aromatase inhibitor
Drug: 5-Fluorouracil
Drug: Carboplatin AUC
Drug: Cyclophosphamide
Drug: Docetaxel
Drug: Doxorubicin
Drug: Epirubicin
Drug: Paclitaxel
Drug: Trastuzumab
Enrollment 66
Recruitment Details Out of the 66 enrolled patients, 6 patients did not receive study product doses and were hence excluded prior to study start.
Pre-assignment Details During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Arm/Group Title Cohort A-GSK2302024A Group Cohort A-Placebo Group Cohort B-GSK2302024A Group Cohort B-Placebo Group Cohort C-GSK2302024A Group Cohort C-Placebo Group Cohort D-GSK2302024A-D14 Group
Hide Arm/Group Description This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule. This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule. This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy. This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule. This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule. This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Period Title: Overall Study
Started 15 7 9 6 11 4 8
Completed 11 6 6 6 11 4 3
Not Completed 4 1 3 0 0 0 5
Reason Not Completed
Progressive disease             0             0             2             0             0             0             0
Sponsor study termination             0             1             0             0             0             0             1
Adverse event, serious fatal             2             0             0             0             0             0             1
Adverse event, non-fatal             1             0             0             0             0             0             3
Other             0             0             1             0             0             0             0
Consent withdrawn by subject             1             0             0             0             0             0             0
Arm/Group Title Cohort A-GSK2302024A Group Cohort A-Placebo Group Cohort B-GSK2302024A Group Cohort B-Placebo Group Cohort C-GSK2302024A Group Cohort C-Placebo Group Cohort D-GSK2302024A-D14 Group Total
Hide Arm/Group Description This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule. This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule. This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy. This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule. This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule. This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule. Total of all reporting groups
Overall Number of Baseline Participants 15 7 9 6 11 4 8 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 7 participants 9 participants 6 participants 11 participants 4 participants 8 participants 60 participants
69.3  (10.4) 70.9  (7.1) 49.3  (15.6) 60.7  (9.8) 52.9  (10.6) 53.3  (6.2) 49.6  (8.7) 58.9  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 7 participants 9 participants 6 participants 11 participants 4 participants 8 participants 60 participants
Female
15
 100.0%
7
 100.0%
9
 100.0%
6
 100.0%
11
 100.0%
4
 100.0%
8
 100.0%
60
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Subjects With Severe Toxicities
Hide Description

Severe toxicity was defined as follows:

  • A Grade 3 or higher toxicity that is related or possibly related to the combined administration of standard treatment and GSK2302024A/placebo
  • A decrease in Left Ventricular Ejection Fraction (LVEF) from baseline with ≥ 10 points and at < 50% that is related or possibly related to the combined administration of treatment and that is confirmed by a second LVEF assessment within approximately 3 weeks.
  • A Grade 2 or higher cardiac ischemia/infarction that is related or possibly related to the combined administration of standard treatment and GSK2302024A /placebo.
  • A Grade 2 or higher allergic reaction occurring within 24 hours following the administration.
  • A Grade 3 or higher blood/bone marrow toxicity that was considered as related or possibly related to the combined Administration.
  • A decrease in renal function at the time of administration that was considered as related or possibly related.
Time Frame During the whole study period, up to Year 3
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.
Arm/Group Title Cohort A-GSK2302024A Group Cohort A-Placebo Group Cohort B-GSK2302024A Group Cohort B-Placebo Group Cohort C-GSK2302024A Group Cohort C-Placebo Group Cohort D-GSK2302024A-D14 Group
Hide Arm/Group Description:
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Overall Number of Participants Analyzed 15 7 9 6 11 4 8
Measure Type: Number
Unit of Measure: Subjects
0 0 1 0 1 0 0
2.Primary Outcome
Title Number of Patients With an Anti-Wilm's Tumor Gene (Anti-WT1) Humoral Response
Hide Description At post-GSK2302024A/placebo Dose 4 (Week 13)
Time Frame For initially seronegative patients: post-administration antibody concentration ≥ 9 EU/mL For initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-vaccination antibody concentration. The main analysis for the Phase
Hide Outcome Measure Data
Hide Analysis Population Description
According-to-Protocol (ATP) Population for immunogenicity included all eligible patients who did not report major protocol deviation, who had at least received the first 4 doses of study product and provided a valid result for immunogenicity measurement within the 4 weeks following Dose 4.
Arm/Group Title Cohort A-GSK2302024A Group Cohort A-Placebo Group Cohort B-GSK2302024A Group Cohort B-Placebo Group Cohort C-GSK2302024A Group Cohort C-Placebo Group Cohort D-GSK2302024A-D14 Group
Hide Arm/Group Description:
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Overall Number of Participants Analyzed 10 4 8 6 11 3 3
Measure Type: Number
Unit of Measure: Subjects
10 0 0 0 6 0 2
3.Primary Outcome
Title Number of Patients With Adverse Events (AEs)
Hide Description An AE is any untoward medical occurrence in a clinical investigation patient, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse.
Time Frame During the 31-day (Days 0-30) following vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.
Arm/Group Title Cohort A-GSK2302024A Group Cohort A-Placebo Group Cohort B-GSK2302024A Group Cohort B-Placebo Group Cohort C-GSK2302024A Group Cohort C-Placebo Group Cohort D-GSK2302024A-D14 Group
Hide Arm/Group Description:
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included breast cancer patients who received GSK2302024AI and intravenous chemotherapy.
This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Overall Number of Participants Analyzed 15 7 9 6 11 4 8
Measure Type: Number
Unit of Measure: Subjects
15 5 9 6 11 4 7
4.Primary Outcome
Title Number of Subjects With Serious Adverse Events SAE(s)
Hide Description A serious adverse event (SAE) is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of hospitalization, causes disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study patient. In this study, an event which was part of the natural course of the disease under study (i.e., disease progression/recurrence) was captured in the study/as an efficacy measure. Therefore it was not reported as an SAE. Progression/recurrence of the tumor was recorded in the clinical assessments in the electronic case report form (eCRF). Death due to progressive disease was recorded on a specific form in the eCRF but not as an SAE.
Time Frame From Week 0 to Week 26/32
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.
Arm/Group Title Cohort A-GSK2302024A Group Cohort A-Placebo Group Cohort B-GSK2302024A Group Cohort B-Placebo Group Cohort C-GSK2302024A Group Cohort C-Placebo Group Cohort D-GSK2302024A-D14 Group
Hide Arm/Group Description:
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included breast cancer patients who received GSK2302024AI and intravenous chemotherapy.
This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Overall Number of Participants Analyzed 15 7 9 6 11 4 8
Measure Type: Number
Unit of Measure: Subjects
3 0 4 2 5 1 5
5.Primary Outcome
Title Number of Subjects With Alanine Aminotransferase Increased Abnormality, by Common Terminology Criteria for Adverse Events (CTCAE) Maximum Grade
Hide Description [Not Specified]
Time Frame During the treatment period and up to 30 days post last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.
Arm/Group Title Cohort A-GSK2302024A Group Cohort A-Placebo Group Cohort B-GSK2302024A Group Cohort B-Placebo Group Cohort C-GSK2302024A Group Cohort C-Placebo Group Cohort D-GSK2302024A-D14 Group
Hide Arm/Group Description:
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Overall Number of Participants Analyzed 15 7 9 6 11 4 8
Measure Type: Number
Unit of Measure: Subjects
Grade 0 12 5 8 4 6 2 1
Grade 1 2 1 1 2 5 2 2
Grade 2 0 0 0 0 0 0 0
Grade 3 0 0 0 0 0 0 0
Grade 4 0 0 0 0 0 0 0
Grade Unknown 1 1 0 0 0 0 5
6.Primary Outcome
Title Number of Subjects With Alkaline Phosphatase Increased Abnormality, by CTCAE Maximum Grade
Hide Description [Not Specified]
Time Frame During the treatment period and up to 30 days post last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.
Arm/Group Title Cohort A-GSK2302024A Group Cohort A-Placebo Group Cohort B-GSK2302024A Group Cohort B-Placebo Group Cohort C-GSK2302024A Group Cohort C-Placebo Group Cohort D-GSK2302024A-D14 Group
Hide Arm/Group Description:
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Overall Number of Participants Analyzed 15 7 9 6 11 4 8
Measure Type: Number
Unit of Measure: Subjects
Grade 0 10 5 8 6 7 3 1
Grade 1 5 1 1 0 4 1 2
Grade 2 0 0 0 0 0 0 0
Grade 3 0 0 0 0 0 0 0
Grade 4 0 0 0 0 0 0 0
Grade Unknown 0 1 0 0 0 0 5
7.Primary Outcome
Title Number of Subjects With Anemia, by CTCAE Maximum Grade
Hide Description [Not Specified]
Time Frame During the treatment period and up to 30 days post last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.
Arm/Group Title Cohort A-GSK2302024A Group Cohort A-Placebo Group Cohort B-GSK2302024A Group Cohort B-Placebo Group Cohort C-GSK2302024A Group Cohort C-Placebo Group Cohort D-GSK2302024A-D14 Group
Hide Arm/Group Description:
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Overall Number of Participants Analyzed 15 7 9 6 11 4 8
Measure Type: Number
Unit of Measure: Subjects
Grade 0 12 7 1 0 0 0 2
Grade 1 2 0 7 4 7 3 2
Grade 2 1 0 0 0 4 1 0
Grade 3 0 0 1 0 0 0 0
Grade 4 0 0 0 0 0 0 0
Grade Unknown 0 0 0 0 0 0 4
8.Primary Outcome
Title Number of Subjects With Aspartate Aminotransferase Increased Abnormality, by CTCAE Maximum Grade
Hide Description [Not Specified]
Time Frame During the treatment period and up to 30 days post last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.
Arm/Group Title Cohort A-GSK2302024A Group Cohort A-Placebo Group Cohort B-GSK2302024A Group Cohort B-Placebo Group Cohort C-GSK2302024A Group Cohort C-Placebo Group Cohort D-GSK2302024A-D14 Group
Hide Arm/Group Description:
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Overall Number of Participants Analyzed 15 7 9 6 11 4 8
Measure Type: Number
Unit of Measure: Subjects
Grade 0 12 4 8 6 7 1 2
Grade 1 3 2 1 0 4 3 1
Grade 2 1 0 0 0 0 0 0
Grade 3 0 0 0 0 0 0 0
Grade 4 0 0 0 0 0 0 0
Grade Unknown 0 1 0 0 0 0 5
9.Primary Outcome
Title Number of Subjects With Blood Bilirubin Increased Abnormality, by CTCAE Maximum Grade
Hide Description [Not Specified]
Time Frame During the treatment period and up to 30 days post last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.
Arm/Group Title Cohort A-GSK2302024A Group Cohort A-Placebo Group Cohort B-GSK2302024A Group Cohort B-Placebo Group Cohort C-GSK2302024A Group Cohort C-Placebo Group Cohort D-GSK2302024A-D14 Group
Hide Arm/Group Description:
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Overall Number of Participants Analyzed 15 7 9 6 11 4 8
Measure Type: Number
Unit of Measure: Subjects
Grade 0 15 5 9 6 11 2 3
Grade 1 0 1 0 0 0 0 0
Grade 2 0 0 0 0 0 1 0
Grade 3 0 0 0 0 0 1 0
Grade 4 0 0 0 0 0 0 0
Grade Unknown 0 1 0 0 0 0 5
10.Primary Outcome
Title Number of Subjects With Creatine Increased Abnormality, by CTCAE Maximum Grade
Hide Description [Not Specified]
Time Frame During the treatment period and up to 30 days post last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.
Arm/Group Title Cohort A-GSK2302024A Group Cohort A-Placebo Group Cohort B-GSK2302024A Group Cohort B-Placebo Group Cohort C-GSK2302024A Group Cohort C-Placebo Group Cohort D-GSK2302024A-D14 Group
Hide Arm/Group Description:
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Overall Number of Participants Analyzed 15 7 9 6 11 4 8
Measure Type: Number
Unit of Measure: Subjects
Grade 0 11 4 8 5 10 3 3
Grade 1 4 2 1 1 1 1 0
Grade 2 0 0 0 0 0 0 0
Grade 3 0 0 0 0 0 0 0
Grade 4 0 0 0 0 0 0 0
Grade Unknown 4 1 0 0 0 0 5
11.Primary Outcome
Title Number of Subjects With Hemoglobin Increased Abnormality, by CTCAE Maximum Grade
Hide Description [Not Specified]
Time Frame During the treatment period and up to 30 days post last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.
Arm/Group Title Cohort A-GSK2302024A Group Cohort A-Placebo Group Cohort B-GSK2302024A Group Cohort B-Placebo Group Cohort C-GSK2302024A Group Cohort C-Placebo Group Cohort D-GSK2302024A-D14 Group
Hide Arm/Group Description:
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Overall Number of Participants Analyzed 15 7 9 6 11 4 8
Measure Type: Number
Unit of Measure: Subjects
Grade 0 15 6 9 6 11 4 4
Grade 1 0 1 0 0 0 0 0
Grade 2 0 0 0 0 0 0 0
Grade 3 0 0 0 0 0 0 0
Grade 4 0 0 0 0 0 0 0
Grade Unknown 0 0 0 0 0 0 4
12.Primary Outcome
Title Number of Subjects With Hypercalcemia Abnormality, by CTCAE Maximum Grade
Hide Description [Not Specified]
Time Frame During the treatment period and up to 30 days post last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.
Arm/Group Title Cohort A-GSK2302024A Group Cohort A-Placebo Group Cohort B-GSK2302024A Group Cohort B-Placebo Group Cohort C-GSK2302024A Group Cohort C-Placebo Group Cohort D-GSK2302024A-D14 Group
Hide Arm/Group Description:
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Overall Number of Participants Analyzed 15 7 9 6 11 4 8
Measure Type: Number
Unit of Measure: Subjects
Grade 0 14 3 8 6 11 4 3
Grade 1 1 3 1 0 0 0 0
Grade 2 0 0 0 0 0 0 0
Grade 3 0 0 0 0 0 0 0
Grade 4 0 0 0 0 0 0 0
Grade Unknown 3 1 0 0 0 0 5
13.Primary Outcome
Title Number of Subjects With Hyperkalemia Abnormality, by CTCAE Maximum Grade
Hide Description [Not Specified]
Time Frame During the treatment period and up to 30 days post last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.
Arm/Group Title Cohort A-GSK2302024A Group Cohort A-Placebo Group Cohort B-GSK2302024A Group Cohort B-Placebo Group Cohort C-GSK2302024A Group Cohort C-Placebo Group Cohort D-GSK2302024A-D14 Group
Hide Arm/Group Description:
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Overall Number of Participants Analyzed 15 7 9 6 11 4 8
Measure Type: Number
Unit of Measure: Subjects
Grade 0 15 5 7 6 10 4 3
Grade 1 0 1 1 0 1 0 0
Grade 2 0 0 1 0 0 0 0
Grade 3 0 0 0 0 0 0 0
Grade 4 0 0 0 0 0 0 0
Grade Unknown 0 1 0 0 0 0 5
14.Primary Outcome
Title Number of Subjects With Hypernatremia Abnormality, by CTCAE Maximum Grade
Hide Description [Not Specified]
Time Frame During the treatment period and up to 30 days post last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.
Arm/Group Title Cohort A-GSK2302024A Group Cohort A-Placebo Group Cohort B-GSK2302024A Group Cohort B-Placebo Group Cohort C-GSK2302024A Group Cohort C-Placebo Group Cohort D-GSK2302024A-D14 Group
Hide Arm/Group Description:
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Overall Number of Participants Analyzed 15 7 9 6 11 4 8
Measure Type: Number
Unit of Measure: Subjects
Grade 0 14 4 9 6 10 4 3
Grade 1 1 2 0 0 0 0 0
Grade 2 0 0 0 0 1 0 0
Grade 3 0 0 0 0 0 0 0
Grade 4 0 0 0 0 0 0 0
Grade Unknown 0 1 0 0 0 0 5
15.Primary Outcome
Title Number of Subjects With Hypoalbuminemia Abnormality, by CTCAE Maximum Grade
Hide Description [Not Specified]
Time Frame During the treatment period and up to 30 days post last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.
Arm/Group Title Cohort A-GSK2302024A Group Cohort A-Placebo Group Cohort B-GSK2302024A Group Cohort B-Placebo Group Cohort C-GSK2302024A Group Cohort C-Placebo Group Cohort D-GSK2302024A-D14 Group
Hide Arm/Group Description:
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Overall Number of Participants Analyzed 15 7 9 6 11 4 8
Measure Type: Number
Unit of Measure: Subjects
Grade 0 13 6 9 5 9 3 3
Grade 1 1 0 0 1 2 1 0
Grade 2 1 0 0 0 0 0 0
Grade 3 0 0 0 0 0 0 0
Grade 4 0 0 0 0 0 0 0
Grade Unknown 0 1 0 0 0 0 5
16.Primary Outcome
Title Number of Subjects With Hypocalcemia Abnormality, by CTCAE Maximum Grade
Hide Description [Not Specified]
Time Frame During the treatment period and up to 30 days post last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.
Arm/Group Title Cohort A-GSK2302024A Group Cohort A-Placebo Group Cohort B-GSK2302024A Group Cohort B-Placebo Group Cohort C-GSK2302024A Group Cohort C-Placebo Group Cohort D-GSK2302024A-D14 Group
Hide Arm/Group Description:
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Overall Number of Participants Analyzed 15 7 9 6 11 4 8
Measure Type: Number
Unit of Measure: Subjects
Grade 0 12 6 5 4 10 3 3
Grade 1 3 0 3 1 1 1 0
Grade 2 0 0 1 1 0 0 0
Grade 3 0 0 0 0 0 0 0
Grade 4 0 0 0 0 0 0 0
Grade Unknown 0 1 0 0 0 0 5
17.Primary Outcome
Title Number of Subjects With Hypokalemia Abnormality, by CTCAE Maximum Grade
Hide Description [Not Specified]
Time Frame During the treatment period and up to 30 days post last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.
Arm/Group Title Cohort A-GSK2302024A Group Cohort A-Placebo Group Cohort B-GSK2302024A Group Cohort B-Placebo Group Cohort C-GSK2302024A Group Cohort C-Placebo Group Cohort D-GSK2302024A-D14 Group
Hide Arm/Group Description:
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Overall Number of Participants Analyzed 15 7 9 6 11 4 8
Measure Type: Number
Unit of Measure: Subjects
Grade 0 15 6 9 6 10 4 3
Grade 1 0 0 0 0 1 0 0
Grade 2 0 0 1 0 0 0 0
Grade 3 0 0 0 0 0 0 0
Grade 4 0 0 0 0 0 0 0
Grade Unknown 0 1 0 0 0 0 5
18.Primary Outcome
Title Number of Subjects With Hyponatremia Abnormality, by CTCAE Maximum Grade
Hide Description [Not Specified]
Time Frame During the treatment period and post 30 days post last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.
Arm/Group Title Cohort A-GSK2302024A Group Cohort A-Placebo Group Cohort B-GSK2302024A Group Cohort B-Placebo Group Cohort C-GSK2302024A Group Cohort C-Placebo Group Cohort D-GSK2302024A-D14 Group
Hide Arm/Group Description:
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Overall Number of Participants Analyzed 15 7 9 6 11 4 8
Measure Type: Number
Unit of Measure: Subjects
Grade 0 15 6 5 6 11 4 3
Grade 1 0 0 4 0 0 0 0
Grade 2 0 0 0 0 0 0 0
Grade 3 0 0 0 0 0 0 0
Grade 4 0 0 0 0 0 0 0
Grade Unknown 0 1 0 0 0 0 5
19.Primary Outcome
Title Number of Subjects With Lymphocyte Count Decreased Abnormality, by CTCAE Maximum Grade
Hide Description [Not Specified]
Time Frame During the treatment period and up to 30 days post last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.
Arm/Group Title Cohort A-GSK2302024A Group Cohort A-Placebo Group Cohort B-GSK2302024A Group Cohort B-Placebo Group Cohort C-GSK2302024A Group Cohort C-Placebo Group Cohort D-GSK2302024A-D14 Group
Hide Arm/Group Description:
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Overall Number of Participants Analyzed 15 7 9 6 11 4 8
Measure Type: Number
Unit of Measure: Subjects
Grade 0 9 4 0 0 2 1 1
Grade 1 5 2 3 2 3 1 1
Grade 2 1 1 5 2 5 1 2
Grade 3 0 0 1 2 1 1 0
Grade 4 0 0 0 0 0 0 0
Grade Unknown 0 0 0 0 0 0 4
20.Primary Outcome
Title Number of Subjects With Lymphocyte Count Increased Abnormality, by CTCAE Maximum Grade
Hide Description [Not Specified]
Time Frame During the treatment period and up to 30 days post last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.
Arm/Group Title Cohort A-GSK2302024A Group Cohort A-Placebo Group Cohort B-GSK2302024A Group Cohort B-Placebo Group Cohort C-GSK2302024A Group Cohort C-Placebo Group Cohort D-GSK2302024A-D14 Group
Hide Arm/Group Description:
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Overall Number of Participants Analyzed 15 7 9 6 11 4 8
Measure Type: Number
Unit of Measure: Subjects
Grade 0 15 7 9 6 11 4 4
Grade 1 0 0 0 0 0 0 0
Grade 2 0 0 0 0 0 0 0
Grade 3 0 0 0 0 0 0 0
Grade 4 0 0 0 0 0 0 0
Grade Unknown 0 0 0 0 0 0 4
21.Primary Outcome
Title Number of Patients With Adverse Events (AEs), by CTCAE Maximum Grade Reported
Hide Description [Not Specified]
Time Frame During the treatment period and up to 30 days post last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.
Arm/Group Title Cohort A-GSK2302024A Group Cohort A-Placebo Group Cohort B-GSK2302024A Group Cohort B-Placebo Group Cohort C-GSK2302024A Group Cohort C-Placebo Group Cohort D-GSK2302024A-D14 Group
Hide Arm/Group Description:
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Overall Number of Participants Analyzed 15 7 9 6 11 4 8
Measure Type: Number
Unit of Measure: Subjects
Any AE(s) Grade 1 6 1 0 0 0 0 0
Any AE(s) Grade 2 6 4 6 0 4 3 2
Any AE(s) Grade 3 3 0 0 5 3 0 1
Any AE(s) Grade 4 0 0 2 1 4 1 4
Any AE(s) Grade 5 0 0 1 0 0 0 0
Any AE(s) 15 5 9 6 11 4 7
22.Primary Outcome
Title Number of Subjects With Platelet Count Decreased Abnormality, by CTCAE Maximum Grade
Hide Description [Not Specified]
Time Frame During the treatment period and up to 30 days post last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.
Arm/Group Title Cohort A-GSK2302024A Group Cohort A-Placebo Group Cohort B-GSK2302024A Group Cohort B-Placebo Group Cohort C-GSK2302024A Group Cohort C-Placebo Group Cohort D-GSK2302024A-D14 Group
Hide Arm/Group Description:
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Overall Number of Participants Analyzed 15 7 9 6 11 4 8
Measure Type: Number
Unit of Measure: Subjects
Grade 0 14 6 8 5 5 2 2
Grade 1 1 1 1 1 5 2 2
Grade 2 0 0 0 0 1 0 0
Grade 3 0 0 0 0 0 0 0
Grade 4 0 0 0 0 0 0 0
Grade Unknown 0 0 0 0 0 0 4
23.Primary Outcome
Title Number of Subjects With White Blood Cell Decreased Abnormality, by CTCAE Maximum Grade
Hide Description [Not Specified]
Time Frame During the treatment period and up to 30 days post last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.
Arm/Group Title Cohort A-GSK2302024A Group Cohort A-Placebo Group Cohort B-GSK2302024A Group Cohort B-Placebo Group Cohort C-GSK2302024A Group Cohort C-Placebo Group Cohort D-GSK2302024A-D14 Group
Hide Arm/Group Description:
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Overall Number of Participants Analyzed 13 7 6 3 7 4 8
Measure Type: Number
Unit of Measure: Subjects
Grade 0 13 7 6 3 7 2 0
Grade 1 2 0 2 2 4 1 1
Grade 2 0 0 1 1 0 1 0
Grade 3 0 0 0 0 0 0 3
Grade 4 0 0 0 0 0 0 0
Grade Unknown 0 0 0 0 0 0 4
24.Primary Outcome
Title Number of Subjects With Neutrophil Count Decreased Abnormality, by CTCAE Maximum Grade
Hide Description [Not Specified]
Time Frame During the treatment period and up to 30 days post last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.
Arm/Group Title Cohort A-GSK2302024A Group Cohort A-Placebo Group Cohort B-GSK2302024A Group Cohort B-Placebo Group Cohort C-GSK2302024A Group Cohort C-Placebo Group Cohort D-GSK2302024A-D14 Group
Hide Arm/Group Description:
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Overall Number of Participants Analyzed 15 7 9 6 11 4 8
Measure Type: Number
Unit of Measure: Subjects
Grade 0 12 6 7 5 10 3 0
Grade 1 3 0 1 1 1 0 0
Grade 2 0 1 1 0 0 0 1
Grade 3 0 0 0 0 0 1 0
Grade 4 0 0 0 0 0 0 3
Grade Unknown 0 0 0 0 0 0 4
25.Primary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs), by CTCAE Maximum Grade Reported
Hide Description [Not Specified]
Time Frame During the treatment period and up to 30 days post last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.
Arm/Group Title Cohort A-GSK2302024A Group Cohort A-Placebo Group Cohort B-GSK2302024A Group Cohort B-Placebo Group Cohort C-GSK2302024A Group Cohort C-Placebo Group Cohort D-GSK2302024A-D14 Group
Hide Arm/Group Description:
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Overall Number of Participants Analyzed 15 7 9 6 11 4 8
Measure Type: Number
Unit of Measure: Subjects
Any SAE(s) Grade 1 0 0 0 0 0 0 0
Any SAE(s) Grade 2 1 0 1 0 0 0 0
Any SAE(s) Grade 3 2 0 0 1 1 0 1
Any SAE(s) Grade 4 0 0 2 1 4 1 4
Any SAE(s) Grade 5 0 0 1 0 0 0 0
Any SAE(s) 3 0 4 2 5 1 5
26.Primary Outcome
Title Number of Subjects With Adverse Events (AEs) Assessed by the Investigators as Causally Related to GSK2302024A Treatment, by CTCAE Maximum Grade Reported
Hide Description [Not Specified]
Time Frame During the treatment period and up to 30 days post last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.
Arm/Group Title Cohort A-GSK2302024A Group Cohort A-Placebo Group Cohort B-GSK2302024A Group Cohort B-Placebo Group Cohort C-GSK2302024A Group Cohort C-Placebo Group Cohort D-GSK2302024A-D14 Group
Hide Arm/Group Description:
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Overall Number of Participants Analyzed 15 7 9 6 11 4 8
Measure Type: Number
Unit of Measure: Subjects
Any related AE(s) Grade 1 7 2 0 0 5 0 2
Any related AE(s) Grade 2 4 0 3 0 1 1 4
Any related AE(s) Grade 3 1 0 0 0 1 0 0
Any related AE(s) Grade 4 0 0 0 0 0 0 0
Any related AE(s) Grade 5 0 0 0 0 0 0 0
Any related AE(s) 12 2 3 0 7 1 6
27.Primary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs), Assessed by the Investigators as Causally Related to GSK2302024A Treatment, by CTCAE Maximum Grade Reported
Hide Description [Not Specified]
Time Frame During the treatment period and up to 30 days post last vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.
Arm/Group Title Cohort A-GSK2302024A Group Cohort A-Placebo Group Cohort B-GSK2302024A Group Cohort B-Placebo Group Cohort C-GSK2302024A Group Cohort C-Placebo Group Cohort D-GSK2302024A-D14 Group
Hide Arm/Group Description:
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Overall Number of Participants Analyzed 15 7 9 6 11 4 8
Measure Type: Number
Unit of Measure: Subjects
Any related SAE(s) Grade 1 0 0 0 0 0 0 0
Any related SAE(s) Grade 2 1 0 0 0 0 0 0
Any related SAE(s) Grade 3 0 0 0 0 1 0 0
Any related SAE(s) Grade 4 0 0 0 0 0 0 0
Any related SAE(s) Grade 5 0 0 0 0 0 0 0
Any related SAE(s) 1 0 0 0 1 0 0
28.Primary Outcome
Title Number of Subjects With Breast Cancer Pathological Response
Hide Description The pathological response in lymph nodes was evaluated by presence or absence of tumor cells by histopathological examination. Partial responses mark the disappearance of tumor cells, with only small clusters or dispersed cells remaining (more than 90% loss) while complete response indicate no identifiable malignant cells. However, ductal carcinoma in situ may be present.
Time Frame During Phase II of the study period, up to Year 3
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated Population included all patients who have received at least one dose of GSK2302024A study product or placebo.
Arm/Group Title Cohort A-GSK2302024A Group Cohort A-Placebo Group Cohort B-GSK2302024A Group Cohort B-Placebo Group Cohort C-GSK2302024A Group Cohort C-Placebo Group Cohort D-GSK2302024A-D14 Group
Hide Arm/Group Description:
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
Overall Number of Participants Analyzed 13 6 9 6 11 4 4
Measure Type: Number
Unit of Measure: Subjects
Partial respose 4 3 5 3 3 1 3
Complete response 0 0 0 2 6 3 1
Time Frame AEs were reported during the 31-day period (Days 0-30). SAEs during the entire study period (Week 0 to Week 26/32).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort A-GSK2302024A Group Cohort A-Placebo Group Cohort B-GSK2302024A Group Cohort B-Placebo Group Cohort C-GSK2302024A Group Cohort C-Placebo Group Cohort D-GSK2302024A-D14 Group
Hide Arm/Group Description This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule. This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule. This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy. This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule. This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule. This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
All-Cause Mortality
Cohort A-GSK2302024A Group Cohort A-Placebo Group Cohort B-GSK2302024A Group Cohort B-Placebo Group Cohort C-GSK2302024A Group Cohort C-Placebo Group Cohort D-GSK2302024A-D14 Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cohort A-GSK2302024A Group Cohort A-Placebo Group Cohort B-GSK2302024A Group Cohort B-Placebo Group Cohort C-GSK2302024A Group Cohort C-Placebo Group Cohort D-GSK2302024A-D14 Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/15 (20.00%)      0/7 (0.00%)      4/9 (44.44%)      2/6 (33.33%)      5/11 (45.45%)      1/4 (25.00%)      5/8 (62.50%)    
Blood and lymphatic system disorders               
Neutropenia * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  1 1/6 (16.67%)  1 4/11 (36.36%)  4 0/4 (0.00%)  0 3/8 (37.50%)  3
Febrile neutropenia * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  1 1/6 (16.67%)  1 1/11 (9.09%)  1 1/4 (25.00%)  1 2/8 (25.00%)  2
Leukopenia * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  1 0/6 (0.00%)  0 1/11 (9.09%)  1 0/4 (0.00%)  0 1/8 (12.50%)  1
Ear and labyrinth disorders               
Vestibular disorder * 1  1/15 (6.67%)  1 0/7 (0.00%)  0 0/9 (0.00%)  0 0/6 (0.00%)  0 0/11 (0.00%)  0 0/4 (0.00%)  0 0/8 (0.00%)  0
Gastrointestinal disorders               
Diarrhoea * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/6 (0.00%)  0 2/11 (18.18%)  2 0/4 (0.00%)  0 0/8 (0.00%)  0
Haemorrhoidal haemorrhage * 1  1/15 (6.67%)  1 0/7 (0.00%)  0 0/9 (0.00%)  0 0/6 (0.00%)  0 0/11 (0.00%)  0 0/4 (0.00%)  0 0/8 (0.00%)  0
Nausea * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/6 (0.00%)  0 1/11 (9.09%)  1 0/4 (0.00%)  0 0/8 (0.00%)  0
Stomatitis * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/6 (0.00%)  0 0/11 (0.00%)  0 0/4 (0.00%)  0 1/8 (12.50%)  1
Vomiting * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/6 (0.00%)  0 1/11 (9.09%)  1 0/4 (0.00%)  0 0/8 (0.00%)  0
General disorders               
Death * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  1 0/6 (0.00%)  0 0/11 (0.00%)  0 0/4 (0.00%)  0 0/8 (0.00%)  0
Hepatobiliary disorders               
Cholecystitis * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  1 0/6 (0.00%)  0 0/11 (0.00%)  0 0/4 (0.00%)  0 0/8 (0.00%)  0
Metabolism and nutrition disorders               
Dehydration * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/6 (0.00%)  0 1/11 (9.09%)  1 0/4 (0.00%)  0 0/8 (0.00%)  0
Hyponatraemia * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 1/9 (11.11%)  1 0/6 (0.00%)  0 0/11 (0.00%)  0 0/4 (0.00%)  0 0/8 (0.00%)  0
Musculoskeletal and connective tissue disorders               
Myalgia * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/6 (0.00%)  0 0/11 (0.00%)  0 0/4 (0.00%)  0 1/8 (12.50%)  1
Polymyalgia rheumatica * 1  1/15 (6.67%)  1 0/7 (0.00%)  0 0/9 (0.00%)  0 0/6 (0.00%)  0 0/11 (0.00%)  0 0/4 (0.00%)  0 0/8 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Renal cancer * 1  1/15 (6.67%)  1 0/7 (0.00%)  0 0/9 (0.00%)  0 0/6 (0.00%)  0 0/11 (0.00%)  0 0/4 (0.00%)  0 0/8 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort A-GSK2302024A Group Cohort A-Placebo Group Cohort B-GSK2302024A Group Cohort B-Placebo Group Cohort C-GSK2302024A Group Cohort C-Placebo Group Cohort D-GSK2302024A-D14 Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/15 (100.00%)      5/7 (71.43%)      9/9 (100.00%)      6/6 (100.00%)      11/11 (100.00%)      4/4 (100.00%)      7/8 (87.50%)    
Blood and lymphatic system disorders               
Neutropenia * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 2/6 (33.33%)  2 4/11 (36.36%)  4 0/4 (0.00%)  0 3/8 (37.50%)  3
Anaemia * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 2/6 (33.33%)  2 4/11 (36.36%)  4 0/4 (0.00%)  0 0/8 (0.00%)  0
Leukopenia * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 3/6 (50.00%)  3 0/11 (0.00%)  0 0/4 (0.00%)  0 2/8 (25.00%)  2
Febrile neutropenia * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/6 (0.00%)  0 0/11 (0.00%)  0 0/4 (0.00%)  0 2/8 (25.00%)  2
Thrombocytopenia * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/6 (0.00%)  0 2/11 (18.18%)  2 0/4 (0.00%)  0 0/8 (0.00%)  0
Cardiac disorders               
Palpitations * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/6 (0.00%)  0 2/11 (18.18%)  2 0/4 (0.00%)  0 0/8 (0.00%)  0
Sinus tachycardia * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 2/9 (22.22%)  2 0/6 (0.00%)  0 0/11 (0.00%)  0 0/4 (0.00%)  0 0/8 (0.00%)  0
Gastrointestinal disorders               
Nausea * 1  2/15 (13.33%)  2 0/7 (0.00%)  0 6/9 (66.67%)  6 0/6 (0.00%)  0 8/11 (72.73%)  8 2/4 (50.00%)  2 3/8 (37.50%)  3
Diarrhoea * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 3/9 (33.33%)  3 0/6 (0.00%)  0 3/11 (27.27%)  3 0/4 (0.00%)  0 2/8 (25.00%)  2
Stomatitis * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 2/9 (22.22%)  2 2/6 (33.33%)  2 2/11 (18.18%)  2 0/4 (0.00%)  0 2/8 (25.00%)  2
Constipation * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 2/9 (22.22%)  2 0/6 (0.00%)  0 4/11 (36.36%)  4 0/4 (0.00%)  0 0/8 (0.00%)  0
Vomiting * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 3/9 (33.33%)  3 2/6 (33.33%)  2 0/11 (0.00%)  0 0/4 (0.00%)  0 0/8 (0.00%)  0
Abdominal pain upper * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 4/9 (44.44%)  4 0/6 (0.00%)  0 0/11 (0.00%)  0 0/4 (0.00%)  0 0/8 (0.00%)  0
Gastrooesophageal reflux disease * 1  0/15 (0.00%)  0 1/7 (14.29%)  1 0/9 (0.00%)  0 0/6 (0.00%)  0 0/11 (0.00%)  0 0/4 (0.00%)  0 0/8 (0.00%)  0
General disorders               
Fatigue  1  3/15 (20.00%)  3 1/7 (14.29%)  1 8/9 (88.89%)  8 4/6 (66.67%)  4 7/11 (63.64%)  7 4/4 (100.00%)  4 2/8 (25.00%)  2
Injection site pain * 1  4/15 (26.67%)  4 0/7 (0.00%)  0 0/9 (0.00%)  0 0/6 (0.00%)  0 4/11 (36.36%)  4 0/4 (0.00%)  0 4/8 (50.00%)  4
Injection site erythema * 1  5/15 (33.33%)  5 1/7 (14.29%)  1 0/9 (0.00%)  0 0/6 (0.00%)  0 3/11 (27.27%)  3 0/4 (0.00%)  0 0/8 (0.00%)  0
Mucosal inflammation * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 3/9 (33.33%)  3 0/6 (0.00%)  0 3/11 (27.27%)  3 2/4 (50.00%)  2 0/8 (0.00%)  0
Injection site reaction * 1  2/15 (13.33%)  2 0/7 (0.00%)  0 2/9 (22.22%)  2 0/6 (0.00%)  0 0/11 (0.00%)  0 0/4 (0.00%)  0 0/8 (0.00%)  0
Injection site swelling * 1  2/15 (13.33%)  2 0/7 (0.00%)  0 0/9 (0.00%)  0 0/6 (0.00%)  0 2/11 (18.18%)  2 0/4 (0.00%)  0 0/8 (0.00%)  0
Oedema peripheral * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 3/9 (33.33%)  3 0/6 (0.00%)  0 0/11 (0.00%)  0 0/4 (0.00%)  0 0/8 (0.00%)  0
Chills * 1  2/15 (13.33%)  2 0/7 (0.00%)  0 0/9 (0.00%)  0 0/6 (0.00%)  0 0/11 (0.00%)  0 0/4 (0.00%)  0 0/8 (0.00%)  0
Injection site discomfort * 1  2/15 (13.33%)  2 0/7 (0.00%)  0 0/9 (0.00%)  0 0/6 (0.00%)  0 0/11 (0.00%)  0 0/4 (0.00%)  0 0/8 (0.00%)  0
Injection site haematoma * 1  0/15 (0.00%)  0 1/7 (14.29%)  1 0/9 (0.00%)  0 0/6 (0.00%)  0 0/11 (0.00%)  0 0/4 (0.00%)  0 0/8 (0.00%)  0
Infections and infestations               
Conjunctivitis * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/6 (0.00%)  0 2/11 (18.18%)  2 0/4 (0.00%)  0 0/8 (0.00%)  0
Gingivitis * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 2/9 (22.22%)  2 0/6 (0.00%)  0 0/11 (0.00%)  0 0/4 (0.00%)  0 0/8 (0.00%)  0
Nasopharyngitis * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 2/6 (33.33%)  2 0/11 (0.00%)  0 0/4 (0.00%)  0 0/8 (0.00%)  0
Pharyngitis * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/6 (0.00%)  0 2/11 (18.18%)  2 0/4 (0.00%)  0 0/8 (0.00%)  0
Influenza * 1  0/15 (0.00%)  0 1/7 (14.29%)  1 0/9 (0.00%)  0 0/6 (0.00%)  0 0/11 (0.00%)  0 0/4 (0.00%)  0 0/8 (0.00%)  0
Injury, poisoning and procedural complications               
Procedural pain * 1  0/15 (0.00%)  0 1/7 (14.29%)  1 0/9 (0.00%)  0 0/6 (0.00%)  0 0/11 (0.00%)  0 0/4 (0.00%)  0 1/8 (12.50%)  1
Investigations               
Weight decreased * 1  2/15 (13.33%)  2 0/7 (0.00%)  0 0/9 (0.00%)  0 0/6 (0.00%)  0 0/11 (0.00%)  0 0/4 (0.00%)  0 0/8 (0.00%)  0
Metabolism and nutrition disorders               
Decreased appetite * 1  2/15 (13.33%)  2 0/7 (0.00%)  0 0/9 (0.00%)  0 0/6 (0.00%)  0 0/11 (0.00%)  0 0/4 (0.00%)  0 0/8 (0.00%)  0
Musculoskeletal and connective tissue disorders               
Arthralgia * 1  3/15 (20.00%)  3 2/7 (28.57%)  2 2/9 (22.22%)  2 0/6 (0.00%)  0 3/11 (27.27%)  3 2/4 (50.00%)  2 0/8 (0.00%)  0
Myalgia * 1  4/15 (26.67%)  4 0/7 (0.00%)  0 4/9 (44.44%)  4 0/6 (0.00%)  0 2/11 (18.18%)  2 0/4 (0.00%)  0 2/8 (25.00%)  2
Bone pain * 1  2/15 (13.33%)  2 0/7 (0.00%)  0 3/9 (33.33%)  3 0/6 (0.00%)  0 2/11 (18.18%)  2 0/4 (0.00%)  0 0/8 (0.00%)  0
Back pain * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 2/9 (22.22%)  2 2/6 (33.33%)  2 0/11 (0.00%)  0 0/4 (0.00%)  0 0/8 (0.00%)  0
Pain in extremity * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/6 (0.00%)  0 3/11 (27.27%)  0/4 (0.00%)  0 0/8 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Bowen’s disease * 1  0/15 (0.00%)  0 1/7 (14.29%)  1 0/9 (0.00%)  0 0/6 (0.00%)  0 0/11 (0.00%)  0 0/4 (0.00%)  0 0/8 (0.00%)  0
Nervous system disorders               
Headache * 1  5/15 (33.33%)  5 1/7 (14.29%)  1 0/9 (0.00%)  0 0/6 (0.00%)  0 3/11 (27.27%)  3 0/4 (0.00%)  0 2/8 (25.00%)  2
Peripheral sensory neuropathy * 1  0/15 (0.00%)  0 1/7 (14.29%)  1 2/9 (22.22%)  2 0/6 (0.00%)  0 5/11 (45.45%)  5 2/4 (50.00%)  2 0/8 (0.00%)  0
Dysgeusia * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 2/9 (22.22%)  2 3/6 (50.00%)  3 0/11 (0.00%)  0 0/4 (0.00%)  0 2/8 (25.00%)  2
Paraesthesia * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 2/9 (22.22%)  2 0/6 (0.00%)  0 2/11 (18.18%)  2 0/4 (0.00%)  0 0/8 (0.00%)  0
Neuropathy peripheral * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/6 (0.00%)  0 2/11 (18.18%)  2 0/4 (0.00%)  0 0/8 (0.00%)  0
Psychiatric disorders               
Insomnia * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 2/6 (33.33%)  2 2/11 (18.18%)  2 0/4 (0.00%)  0 0/8 (0.00%)  0
Renal and urinary disorders               
Pollakiuria * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 2/6 (33.33%)  2 0/11 (0.00%)  0 0/4 (0.00%)  0 0/8 (0.00%)  0
Respiratory, thoracic and mediastinal disorders               
Cough * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 3/9 (33.33%)  3 0/6 (0.00%)  0 2/11 (18.18%)  2 0/4 (0.00%)  0 0/8 (0.00%)  0
Epistaxis * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/6 (0.00%)  0 2/11 (18.18%)  2 0/4 (0.00%)  0 0/8 (0.00%)  0
Skin and subcutaneous tissue disorders               
Alopecia * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 9/9 (100.00%)  9 5/6 (83.33%)  5 8/11 (72.73%)  8 3/4 (75.00%)  3 3/8 (37.50%)  3
Dry skin * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/6 (0.00%)  0 2/11 (18.18%)  2 0/4 (0.00%)  0 0/8 (0.00%)  0
Palmar-plantar erythrodysaesthesia syndrome * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/6 (0.00%)  0 2/11 (18.18%)  2 0/4 (0.00%)  0 0/8 (0.00%)  0
Pruritus * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 0/9 (0.00%)  0 0/6 (0.00%)  0 0/11 (0.00%)  0 2/4 (50.00%)  2 0/8 (0.00%)  0
Vascular disorders               
Hot flush * 1  2/15 (13.33%)  2 0/7 (0.00%)  0 2/9 (22.22%)  2 0/6 (0.00%)  0 0/11 (0.00%)  0 0/4 (0.00%)  0 2/8 (25.00%)  2
Flushing * 1  0/15 (0.00%)  0 0/7 (0.00%)  0 2/9 (22.22%)  2 0/6 (0.00%)  0 0/11 (0.00%)  0 0/4 (0.00%)  0 0/8 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01220128     History of Changes
Other Study ID Numbers: 113172
2010-019909-42 ( EudraCT Number )
First Submitted: October 7, 2010
First Posted: October 13, 2010
Results First Submitted: November 28, 2016
Results First Posted: May 25, 2017
Last Update Posted: May 25, 2017