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Cisplatin and Paclitaxel With or Without Everolimus in Treating Patients With Stage II or Stage III Breast Cancer

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ClinicalTrials.gov Identifier: NCT00930930
Recruitment Status : Completed
First Posted : July 2, 2009
Results First Posted : May 7, 2015
Last Update Posted : May 7, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Ingrid Mayer, MD, Vanderbilt-Ingram Cancer Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: cisplatin
Drug: everolimus
Drug: paclitaxel
Other: placebo
Procedure: Venous blood draw
Enrollment 145

Recruitment Details This Vanderbilt-Ingram Cancer Center, multi-site intervention study included 7 additional cancer centers. It opened to enrollment in June 2009 and ran through May 2013.
Pre-assignment Details One hundred forty-seven patients enrolled in this study. Two patients were not eligible to participate.
Arm/Group Title Arm I Arm II
Hide Arm/Group Description

Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks

cisplatin: Given IV

everolimus: Given orally

paclitaxel: Given IV

Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment

Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks

cisplatin: Given IV

paclitaxel: Given IV

placebo: Given orally

Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment

Period Title: Overall Study
Started 96 49
Completed 75 40
Not Completed 21 9
Reason Not Completed
Death             1             0
Physician Decision             1             0
Adverse Event             13             3
Withdrawal by Subject             3             1
Disease progression             2             3
excessive lapse btw txs, not eligible             0             1
patients not compliant             1             1
Arm/Group Title Arm I Arm II Total
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Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks

cisplatin: Given IV

everolimus: Given orally

paclitaxel: Given IV

Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment

Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks

cisplatin: Given IV

paclitaxel: Given IV

placebo: Given orally

Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment

Total of all reporting groups
Overall Number of Baseline Participants 96 49 145
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 96 participants 49 participants 145 participants
52
(42.8 to 57.2)
52
(43 to 58)
52
(43 to 58)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 49 participants 145 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
87
  90.6%
46
  93.9%
133
  91.7%
>=65 years
9
   9.4%
3
   6.1%
12
   8.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 49 participants 145 participants
Female
96
 100.0%
49
 100.0%
145
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 96 participants 49 participants 145 participants
96 49 145
1.Primary Outcome
Title Number of Patients With Pathological Complete Response
Hide Description Pathological complete response is defined as no residual tumor on histopathological analysis of both breast and axillary contents.
Time Frame at time of surgery, week 15-18
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of patients that had complete response. Specimens containing only non-invasive disease will be classified as complete pathologic responders
Arm/Group Title Cisplatin and Paclitaxel + RAD001 Cisplatin and Paclitaxel + Placebo
Hide Arm/Group Description:

Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks

cisplatin: Given IV

everolimus: Given orally

paclitaxel: Given IV

Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment

Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks

cisplatin: Given IV

paclitaxel: Given IV

placebo: Given orally

Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment

Overall Number of Participants Analyzed 88 44
Measure Type: Number
Unit of Measure: participants
34 17
2.Secondary Outcome
Title Number of Patients That Underwent Breast Conservation Surgery
Hide Description Defined as patients that did not undergo complete removal of a cancerous breast (mastectomy).
Time Frame at the time of surgery, week 15-18
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
participants that had breast conservation surgery
Arm/Group Title Cisplatin and Paclitaxel + RAD001 Cisplatin and Paclitaxel + Placebo
Hide Arm/Group Description:

Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks

cisplatin: Given IV

everolimus: Given orally

paclitaxel: Given IV

Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment

Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks

cisplatin: Given IV

paclitaxel: Given IV

placebo: Given orally

Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment

Overall Number of Participants Analyzed 96 49
Measure Type: Number
Unit of Measure: participants
38 19
3.Secondary Outcome
Title Clinical Tumor Response to Neoadjuvant Therapy as Measured by Ultrasound Immediately Before Surgery
Hide Description Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions
Time Frame After treatment, week 12-15
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients reported by best overall response data. Patients are excluded if best overall response data is not accessible or not evaluable.
Arm/Group Title Cisplatin and Paclitaxel + RAD001 Cisplatin and Paclitaxel + Placebo
Hide Arm/Group Description:

Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks

cisplatin: Given IV

everolimus: Given orally

paclitaxel: Given IV

Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment

Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks

cisplatin: Given IV

paclitaxel: Given IV

placebo: Given orally

Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment

Overall Number of Participants Analyzed 96 48
Measure Type: Number
Unit of Measure: participants
Complete Response 48 23
Partial Response 27 19
Stable Disease 18 5
Progressive Disease 2 0
Not Evaluable 1 1
4.Secondary Outcome
Title Number of Patients With Each Worst-grade Toxicity Response
Hide Description Tables represent the number of patients with their worst-grade toxicity at each of five grades (grade 1, least severe to grade 5, most severe) following NCI Common Toxicity Criteria. Not all participants necessarily have an adverse event, thus not everyone will be accounted for in worst-grade toxicities. Likewise, one participant can potentially have more than one event in various grades 1-5 which accounts for the difference in number of patients analyzed and total number in the worst-grade toxicity tables.
Time Frame week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Total number of patients reported with any toxicity related to study treatment.
Arm/Group Title Cisplatin and Paclitaxel + RAD001 Cisplatin and Paclitaxel + Placebo
Hide Arm/Group Description:

Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks

cisplatin: Given IV

everolimus: Given orally

paclitaxel: Given IV

Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment

Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks

cisplatin: Given IV

paclitaxel: Given IV

placebo: Given orally

Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment

Overall Number of Participants Analyzed 96 49
Measure Type: Number
Unit of Measure: participants
Number of patients with worst-grade toxicity 1 9 5
Number of patients with worst-grade toxicity 2 40 28
Number of patients with worst-grade toxicity 3 39 9
Number of patients with worst-grade toxicity 4 3 1
Number of patients with worst-grade toxicity 5 0 0
5.Other Pre-specified Outcome
Title Therapy-mediated Changes in Cell Cycle Position, Proliferation, and Apoptosis as Well as Status, Levels, and Phosphorylation State of p53, p73, and p63 and Select p53 Family Target Genes
Hide Description To determine the relevance of pathway modulation in triple negative breast cancer cell networking
Time Frame Before treatment, on day 3-5 of week 1, and at week 12
Outcome Measure Data Not Reported
6.Other Pre-specified Outcome
Title Ability of p63 and p73 Gene Signatures to Predict Patient Response
Hide Description To determine the levels of P63 and p73 in order to correlate these levels with patient response to treatment to help define a biomarker signature associated with p63/p73 dependence in triple negative breast cancers
Time Frame Before treatment, on day 3-5 of week 1, and at week 12
Outcome Measure Data Not Reported
Time Frame 1 year, 2 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I Arm II
Hide Arm/Group Description

Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks

cisplatin: Given IV

everolimus: Given orally

paclitaxel: Given IV

Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment

Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks

cisplatin: Given IV

paclitaxel: Given IV

placebo: Given orally

Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment

All-Cause Mortality
Arm I Arm II
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I Arm II
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/96 (22.92%)      6/49 (12.24%)    
Blood and lymphatic system disorders     
Anemia  1/96 (1.04%)  1 0/49 (0.00%)  0
lymphopenia  1/96 (1.04%)  1 0/49 (0.00%)  0
Cardiac disorders     
cardiac ischemia/infarction  1/96 (1.04%)  1 0/49 (0.00%)  0
sinus tachycardia  2/96 (2.08%)  2 0/49 (0.00%)  0
Gastrointestinal disorders     
Dehydration  5/96 (5.21%)  5 1/49 (2.04%)  1
colitis  1/96 (1.04%)  1 0/49 (0.00%)  0
diarrhea  5/96 (5.21%)  5 0/49 (0.00%)  0
ileus  1/96 (1.04%)  1 0/49 (0.00%)  0
nausea  2/96 (2.08%)  2 1/49 (2.04%)  1
vomiting  1/96 (1.04%)  1 1/49 (2.04%)  1
distal small bowel obstruction  1/96 (1.04%)  1 0/49 (0.00%)  0
General disorders     
edema  1/96 (1.04%)  1 0/49 (0.00%)  0
fatigue  2/96 (2.08%)  2 0/49 (0.00%)  0
Fever with absence of neutropenia  5/96 (5.21%)  5 0/49 (0.00%)  0
pain - chest  1/96 (1.04%)  1 0/49 (0.00%)  0
Immune system disorders     
Allergic reaction to study drug  1/96 (1.04%)  1 0/49 (0.00%)  0
Infections and infestations     
infection- respiratory  5/96 (5.21%)  5 1/49 (2.04%)  1
infection with unknown ANC  1/96 (1.04%)  1 1/49 (2.04%)  1
Sepsis  0/96 (0.00%)  0 1/49 (2.04%)  1
Seroma  0/96 (0.00%)  0 1/49 (2.04%)  1
infection - other  0/96 (0.00%)  0 1/49 (2.04%)  1
Investigations     
creatinine increased  3/96 (3.13%)  3 0/49 (0.00%)  0
hemaglobin increased  2/96 (2.08%)  2 0/49 (0.00%)  0
Metabolism and nutrition disorders     
hypokalemia  1/96 (1.04%)  1 0/49 (0.00%)  0
Musculoskeletal and connective tissue disorders     
pain - extremity  1/96 (1.04%)  1 0/49 (0.00%)  0
Nervous system disorders     
dizziness  1/96 (1.04%)  1 0/49 (0.00%)  0
Psychiatric disorders     
mental status altered  1/96 (1.04%)  1 0/49 (0.00%)  0
Renal and urinary disorders     
Renal failure  1/96 (1.04%)  1 0/49 (0.00%)  0
urinary retention  1/96 (1.04%)  1 0/49 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
dyspnea  2/96 (2.08%)  2 0/49 (0.00%)  0
flu-like symptoms  1/96 (1.04%)  1 0/49 (0.00%)  0
pneumonitis  1/96 (1.04%)  1 0/49 (0.00%)  0
Vascular disorders     
cerebrovascular ischemia  0/96 (0.00%)  0 1/49 (2.04%)  1
syncope  2/96 (2.08%)  2 2/49 (4.08%)  2
Thrombosis  3/96 (3.13%)  3 1/49 (2.04%)  1
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I Arm II
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   96/96 (100.00%)      49/49 (100.00%)    
Blood and lymphatic system disorders     
Leukocytes (total WBC)  66/96 (68.75%)  104 32/49 (65.31%)  33
Lymphopenia  7/96 (7.29%)  8 2/49 (4.08%)  2
Thrombocytopenia  40/96 (41.67%)  44 3/49 (6.12%)  3
Cardiac disorders     
Cardiac General  10/96 (10.42%)  11 1/49 (2.04%)  1
Ear and labyrinth disorders     
Auditory - other  5/96 (5.21%)  5 2/49 (4.08%)  2
Endocrine disorders     
hypothyroidism  6/96 (6.25%)  6 3/49 (6.12%)  3
Eye disorders     
visual disorders - other  10/96 (10.42%)  10 4/49 (8.16%)  4
Gastrointestinal disorders     
Constipation  35/96 (36.46%)  38 19/49 (38.78%)  20
Diarrhea  44/96 (45.83%)  49 13/49 (26.53%)  14
Abdominal cramping  5/96 (5.21%)  5 6/49 (12.24%)  7
Heartburn, dyspepsia, reflux, GERD  47/96 (48.96%)  48 20/49 (40.82%)  20
Mucositis/stomatitis  37/96 (38.54%)  37 9/49 (18.37%)  9
Nausea  64/96 (66.67%)  67 20/49 (40.82%)  20
Vomiting  13/96 (13.54%)  13 7/49 (14.29%)  9
Gastrointestinal - Other  8/96 (8.33%)  8 2/49 (4.08%)  2
General disorders     
General Disorders, other  9/96 (9.38%)  10 5/49 (10.20%)  6
fatigue  69/96 (71.88%)  83 36/49 (73.47%)  44
Pain - abdomen  3/96 (3.13%)  3 4/49 (8.16%)  5
pain - breast  9/96 (9.38%)  9 4/49 (8.16%)  4
Pain - headache  17/96 (17.71%)  19 17/49 (34.69%)  18
Pain chest  5/96 (5.21%)  5 3/49 (6.12%)  3
Pain - other  17/96 (17.71%)  17 6/49 (12.24%)  6
Fever  6/96 (6.25%)  6 2/49 (4.08%)  2
Immune system disorders     
Allergic reaction - including drug fever  14/96 (14.58%)  14 3/49 (6.12%)  3
Infections and infestations     
infection - lung  5/96 (5.21%)  5 0/49 (0.00%)  0
Infection - sinus  6/96 (6.25%)  6 2/49 (4.08%)  2
Infection - Other  6/96 (6.25%)  6 5/49 (10.20%)  5
Infection - upper respiratory  3/96 (3.13%)  3 5/49 (10.20%)  6
Investigations     
Neutropenia  51/96 (53.13%)  63 17/49 (34.69%)  19
weight changes (gain or loss)  6/96 (6.25%)  6 3/49 (6.12%)  3
Metabolism and nutrition disorders     
Alkaline Phosphatase  14/96 (14.58%)  21 4/49 (8.16%)  5
Serum glutamic pyruvic transaminase  23/96 (23.96%)  33 5/49 (10.20%)  7
Anorexia  7/96 (7.29%)  8 7/49 (14.29%)  7
Serum glutamic oxaloacetic transaminase  30/96 (31.25%)  36 4/49 (8.16%)  5
hypocalcemia  19/96 (19.79%)  27 7/49 (14.29%)  7
hypercholesteremia  6/96 (6.25%)  6 3/49 (6.12%)  3
hyperglycemia  45/96 (46.88%)  56 18/49 (36.73%)  27
hypoglycemia  4/96 (4.17%)  4 3/49 (6.12%)  5
hypermagnesemia  11/96 (11.46%)  11 7/49 (14.29%)  7
Metabolic/laboratory - other  23/96 (23.96%)  25 13/49 (26.53%)  13
Potassium serum high  5/96 (5.21%)  5 2/49 (4.08%)  2
Potassium serum low  21/96 (21.88%)  21 5/49 (10.20%)  5
Hyponatremia  15/96 (15.63%)  15 11/49 (22.45%)  12
Musculoskeletal and connective tissue disorders     
Arthritis  6/96 (6.25%)  6 3/49 (6.12%)  3
Myalgias  5/96 (5.21%)  5 2/49 (4.08%)  2
Musculoskeletal/Soft Tissue - other  13/96 (13.54%)  13 3/49 (6.12%)  4
pain - back  13/96 (13.54%)  14 3/49 (6.12%)  3
Pain - extremity  10/96 (10.42%)  10 11/49 (22.45%)  11
Pain - joint  7/96 (7.29%)  8 6/49 (12.24%)  6
Nervous system disorders     
Dizziness  7/96 (7.29%)  7 7/49 (14.29%)  7
neuropathy  47/96 (48.96%)  47 29/49 (59.18%)  29
Neurology - other  13/96 (13.54%)  13 9/49 (18.37%)  9
dysgeusia (taste alteration)  9/96 (9.38%)  10 14/49 (28.57%)  15
Psychiatric disorders     
Insomnia  20/96 (20.83%)  20 10/49 (20.41%)  10
anxiety  28/96 (29.17%)  28 10/49 (20.41%)  10
depression  17/96 (17.71%)  17 9/49 (18.37%)  10
Renal and urinary disorders     
Edema  14/96 (14.58%)  23 4/49 (8.16%)  4
infection - urinary  7/96 (7.29%)  7 1/49 (2.04%)  1
Renal/Genitourinary - Other  6/96 (6.25%)  6 5/49 (10.20%)  5
Reproductive system and breast disorders     
Sexual/Reproduction -dryness, soreness, itching  7/96 (7.29%)  7 2/49 (4.08%)  2
Respiratory, thoracic and mediastinal disorders     
allergic rhinitis  9/96 (9.38%)  9 6/49 (12.24%)  6
Allergy - other  6/96 (6.25%)  6 1/49 (2.04%)  1
Epistaxis  20/96 (20.83%)  20 8/49 (16.33%)  8
Cough  14/96 (14.58%)  15 5/49 (10.20%)  5
Dyspnea  14/96 (14.58%)  14 7/49 (14.29%)  8
Mucositis oral  9/96 (9.38%)  12 0/49 (0.00%)  0
Upper Respiratory - other  11/96 (11.46%)  11 6/49 (12.24%)  6
Skin and subcutaneous tissue disorders     
Rashes  38/96 (39.58%)  41 16/49 (32.65%)  17
alopecia  32/96 (33.33%)  33 11/49 (22.45%)  11
Pruritus (itching)  7/96 (7.29%)  7 3/49 (6.12%)  3
Desquamation (skin scaling)  8/96 (8.33%)  8 2/49 (4.08%)  2
Acne/acneiform  19/96 (19.79%)  19 4/49 (8.16%)  4
Vascular disorders     
Flushing  6/96 (6.25%)  6 15/49 (30.61%)  15
Hypertension  24/96 (25.00%)  24 15/49 (30.61%)  15
1
Term from vocabulary, CTCAE (4.0)
The number of participants in each arm will not necessarily coincide with the number of participants affected in the respective arm. Some participants my have more than one event and/or some participants may not have an event at all.
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.
Results Point of Contact
Name/Title: Dr. Ingrid Mayer
Organization: Vanderbilt-Ingram Cancer Center
Phone: 615-936-2033
Responsible Party: Ingrid Mayer, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00930930     History of Changes
Other Study ID Numbers: VICC BRE 0904
P30CA068485 ( U.S. NIH Grant/Contract )
VU-VICC-BRE-0904
IRB# 090291
First Submitted: July 1, 2009
First Posted: July 2, 2009
Results First Submitted: October 30, 2014
Results First Posted: May 7, 2015
Last Update Posted: May 7, 2015