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An Observational Study of Patients With HER2-Positive Metastatic or Locally Advanced Breast Cancer Treated With Herceptin (Trastuzumab) in 1st Line and Without Progression For 3 Years

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ClinicalTrials.gov Identifier: NCT01480674
Recruitment Status : Completed
First Posted : November 29, 2011
Results First Posted : February 24, 2016
Last Update Posted : August 16, 2017
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Other
Condition Breast Cancer
Intervention Drug: Trastuzumab
Enrollment 160
Recruitment Details A total of 160 participants were recruited from 28 March 2011 to 16 November 2012.
Pre-assignment Details  
Arm/Group Title Trastuzumab
Hide Arm/Group Description Eligible participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab (Herceptin) as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
Period Title: Overall Study
Started 160
Safety Set 154
Analysed Set 128
Completed 125
Not Completed 35
Reason Not Completed
Death             23
Lost to Follow-up             2
visit not done             10
Arm/Group Title Trastuzumab
Hide Arm/Group Description Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
Overall Number of Baseline Participants 128
Hide Baseline Analysis Population Description
Analyzed set population included all enrolled participants without any protocol deviation used as a primary analysis population for all efficacy outcome measures.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 128 participants
61.3  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants
Female
128
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Tumor Hormone Receptor Status of Participants Without Progression
Hide Description The clinical and tumor characteristics including HER2 and Hormone Receptor (HR) status of metastatic breast cancer participants are analysed which are important factors which impact on Progression Free Survival.
Time Frame Up to 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures. Participants with available data at the time of evaluation were reported.
Arm/Group Title Trastuzumab
Hide Arm/Group Description:
Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
Overall Number of Participants Analyzed 125
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
HR Positive
57.6
(48.8 to 65.9)
HR Negative
42.4
(34.1 to 51.2)
2.Primary Outcome
Title Percentage of Participants With Prevalence of Bone Metastases Without Progression for at Least 3 Years After the Beginning of 1st Line Herceptin Treatment
Hide Description Bone metastasis occurs when cancer cells spread from their original site to a bone. Percentage of participants with prevalence of bone metastases without progression were reported
Time Frame Up to 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures. Participants with available data at the time of evaluation were reported.
Arm/Group Title Trastuzumab
Hide Arm/Group Description:
Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
Overall Number of Participants Analyzed 127
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
42.5
(34.3 to 51.2)
3.Secondary Outcome
Title Progression-free Survival
Hide Description The Progression-free survival (PFS) was defined as the time between the treatment start date (date of first trastuzumab infusion during the metastatic period) and the date of the first progressive disease or death from any cause. The method of assessment of disease progression was not outlined within the protocol, this was completed by each investigator in line with routine practice.
Time Frame Up to 12 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures.
Arm/Group Title Trastuzumab
Hide Arm/Group Description:
Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
Overall Number of Participants Analyzed 128
Median (95% Confidence Interval)
Unit of Measure: Years
6.44 [1] 
(5.68 to NA)
[1]
The value was not evaluated.
4.Secondary Outcome
Title Time to Progression
Hide Description The Time to progression (TTP) was defined as the time between the treatment start date (date of the first trastuzumab infusion during the metastatic period) and the date of the first progressive disease.
Time Frame Up to 12 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures.
Arm/Group Title Trastuzumab
Hide Arm/Group Description:
Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
Overall Number of Participants Analyzed 128
Median (95% Confidence Interval)
Unit of Measure: Years
6.44 [1] 
(5.77 to NA)
[1]
The value was not evaluated.
5.Secondary Outcome
Title Overall Survival
Hide Description The overall survival (OS) was defined as the time between the treatment start date (date of the first trastuzumab infusion during the metastatic period) and the death from any cause.
Time Frame Up to 12 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures.
Arm/Group Title Trastuzumab
Hide Arm/Group Description:
Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
Overall Number of Participants Analyzed 128
Median (95% Confidence Interval)
Unit of Measure: Years
NA [1] 
(NA to NA)
[1]
Median OS not achieved (only 12.5% of participants died).
6.Secondary Outcome
Title Dosage Schedule of Herceptin Treatment
Hide Description Participants who received trastuzumab are reported in the below table. The regimen of trastuzumab in first line treatment is presented as in frequency 1 infusion (inf) per week (W) and dose per infusion as mg/kg.
Time Frame Up to 12 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures. Participants with available data at specified time points are denoted as ‘n’.
Arm/Group Title Trastuzumab
Hide Arm/Group Description:
Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
Overall Number of Participants Analyzed 125
Measure Type: Number
Unit of Measure: Participants
Dose and frequency of inf:1 inf / W, n= 125 40
1 inf/2W, n= 125 2
1 inf / 3W, n= 125 82
3 inf/4W, n= 125 1
Dose per inf: 2 mg/kg, n= 124 10
3 mg/kg, n= 124 1
4 mg/kg, n= 124 39
6 mg/kg, n= 124 25
8 mg/kg, n= 124 49
7.Secondary Outcome
Title Number of Participants With Antineoplastic Treatment in Combination With Trastuzumab and After Discontinuation of Trastuzumab Treatment
Hide Description Antineoplastic treatment given in combination with and after discontinuation (Aft. Dis) of herceptin treatment included chemotherapy and hormonotherapy.
Time Frame Up to 12 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analyzed set population included all enrolled participants without any protocol deviation. This population set was used as a primary analysis population for all efficacy outcome measures. Participants with available data at specified time points are denoted as ‘n’.
Arm/Group Title Trastuzumab
Hide Arm/Group Description:
Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
Overall Number of Participants Analyzed 128
Measure Type: Number
Unit of Measure: Participants
With Trastuzumab, Chemotherapy, n= 119 117
With Trastuzumab, Hormonotherapy, n= 51 50
Aft. Dis, Chemotherapy n= 128 22
Aft. Dis, hormonotherapy n= 128 4
8.Secondary Outcome
Title Number of Participants With Any Adverse Events and Serious Adverse Events
Hide Description An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. The data was reported for prospective period.
Time Frame Up to 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The safety population set included of all participants who received at least one dose of study drug. Participants with available data in the prospective period were analysed.
Arm/Group Title Trastuzumab
Hide Arm/Group Description:
Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
Overall Number of Participants Analyzed 134
Measure Type: Number
Unit of Measure: Participants
Any AEs 30
Any SAEs 6
9.Secondary Outcome
Title The Duration of Treatment of Trastuzumab
Hide Description Total treatment duration and duration of the first line of treatment is reported.
Time Frame Up to 1 Year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analyzed Set population included all enrolled participants without any protocol deviation used as a primary analysis population for all efficacy outcome measures.
Arm/Group Title Trastuzumab
Hide Arm/Group Description:
Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
Overall Number of Participants Analyzed 128
Mean (Standard Deviation)
Unit of Measure: Years
First line of treatment 4.89  (2.13)
Total treatment duration 5.57  (2.36)
Time Frame Up to 1 year
Adverse Event Reporting Description An AE is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug .The data was reported for prospective period. Participants with available data in the prospective period were analysed.
 
Arm/Group Title Trastuzumab
Hide Arm/Group Description Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
All-Cause Mortality
Trastuzumab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Trastuzumab
Affected / at Risk (%)
Total   6/134 (4.48%) 
Cardiac disorders   
Cardiac failure congestive  1  1/134 (0.75%) 
Injury, poisoning and procedural complications   
Femoral neck fracture  1  2/134 (1.49%) 
Nervous system disorders   
Paraplegia  1  1/134 (0.75%) 
Coma  1  1/134 (0.75%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism  1  1/134 (0.75%) 
Vascular disorders   
Lymphoedema  1  1/134 (0.75%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Trastuzumab
Affected / at Risk (%)
Total   30/134 (22.39%) 
Blood and lymphatic system disorders   
Leukopenia  1  1/134 (0.75%) 
Lymphopenia  1  1/134 (0.75%) 
Cardiac disorders   
Atrioventricular extrasystoles  1  1/134 (0.75%) 
Left ventricular dysfunction  1  1/134 (0.75%) 
Ear and labyrinth disorders   
Deafness  1  1/134 (0.75%) 
Tinnitus  1  1/134 (0.75%) 
Vertigo  1  3/134 (2.24%) 
Endocrine disorders   
Cushing's syndrome  1  1/134 (0.75%) 
Gastrointestinal disorders   
Abdominal pain  1  1/134 (0.75%) 
Abdominal pain upper  1  1/134 (0.75%) 
Aphthous stomatitis  1  1/134 (0.75%) 
Diarrhoea  1  5/134 (3.73%) 
Gastrooesophageal reflux disease  1  2/134 (1.49%) 
Gingival bleeding  1  1/134 (0.75%) 
Gingivitis  1  2/134 (1.49%) 
Nausea  1  3/134 (2.24%) 
Rectal haemorrhage  1  1/134 (0.75%) 
Vomiting  1  1/134 (0.75%) 
General disorders   
Asthenia  1  6/134 (4.48%) 
Chest discomfort  1  1/134 (0.75%) 
Chest pain  1  1/134 (0.75%) 
Fatigue  1  1/134 (0.75%) 
Mucosal inflammation  1  1/134 (0.75%) 
Oedema  1  1/134 (0.75%) 
Oedema peripheral  1  2/134 (1.49%) 
Hepatobiliary disorders   
Cytolytic hepatitis  1  1/134 (0.75%) 
Infections and infestations   
Erysipelas  1  1/134 (0.75%) 
Herpes virus infection  1  1/134 (0.75%) 
Sinobronchitis  1  1/134 (0.75%) 
Urinary tract infection  1  3/134 (2.24%) 
Injury, poisoning and procedural complications   
Lumbar vertebral fracture  1  1/134 (0.75%) 
Radiation skin injury  1  1/134 (0.75%) 
Rib fracture  1  1/134 (0.75%) 
Investigations   
Alanine aminotransferase increased  1  1/134 (0.75%) 
Aspartate aminotransferase increased  1  1/134 (0.75%) 
Blood alkaline phosphatase increased  1  1/134 (0.75%) 
Blood glucose  1  1/134 (0.75%) 
Blood sodium  1  1/134 (0.75%) 
Ejection fraction decreased  1  1/134 (0.75%) 
Gamma-glutamyltransferase  1  1/134 (0.75%) 
Gamma-glutamyltransferase increased  1  2/134 (1.49%) 
Metabolism and nutrition disorders   
Hypercalcaemia  1  1/134 (0.75%) 
Hypercreatininaemia  1  2/134 (1.49%) 
Hyperglycaemia  1  1/134 (0.75%) 
Hypocalcaemia  1  1/134 (0.75%) 
Hypoglycaemia  1  1/134 (0.75%) 
Hypokalaemia  1  1/134 (0.75%) 
Hyponatraemia  1  2/134 (1.49%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  3/134 (2.24%) 
Back pain  1  1/134 (0.75%) 
Musculoskeletal chest pain  1  1/134 (0.75%) 
Musculoskeletal pain  1  2/134 (1.49%) 
Myalgia  1  1/134 (0.75%) 
Osteoarthritis  1  1/134 (0.75%) 
Pain in extremity  1  1/134 (0.75%) 
Periarthritis  1  1/134 (0.75%) 
Nervous system disorders   
Brain oedema  1  1/134 (0.75%) 
Headache  1  3/134 (2.24%) 
Neuropathy peripheral  1  1/134 (0.75%) 
Paraesthesia  1  1/134 (0.75%) 
Paresis  1  1/134 (0.75%) 
Sciatic nerve neuropathy  1  1/134 (0.75%) 
Sciatica  1  1/134 (0.75%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  1/134 (0.75%) 
Dyspnoea exertional  1  1/134 (0.75%) 
Lung disorder  1  1/134 (0.75%) 
Skin and subcutaneous tissue disorders   
Dermatitis acneiform  1  1/134 (0.75%) 
Erythema  1  1/134 (0.75%) 
Palmar-plantar erythrodysaesthesia syndrome  1  4/134 (2.99%) 
Rosacea  1  1/134 (0.75%) 
Skin exfoliation  1  1/134 (0.75%) 
Skin fissures  1  2/134 (1.49%) 
Surgical and medical procedures   
Cataract operation  1  1/134 (0.75%) 
Mastectomy  1  1/134 (0.75%) 
Vascular disorders   
Ischaemic limb pain  1  1/134 (0.75%) 
Lymphoedema  1  2/134 (1.49%) 
Subclavian vein thrombosis  1  1/134 (0.75%) 
Thrombophlebitis superficial  1  1/134 (0.75%) 
Vascular compression  1  1/134 (0.75%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.0
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.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Name/Title: Roche Trial Information Hotline
Organization: F. Hoffmann-La Roche AG
Phone: +41 616878333
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01480674     History of Changes
Other Study ID Numbers: ML23001
First Submitted: August 18, 2011
First Posted: November 29, 2011
Results First Submitted: January 27, 2016
Results First Posted: February 24, 2016
Last Update Posted: August 16, 2017