A clinical trial to test Vinorelbine + BIBW 2992 (type of anti cancer treatment) vs Vinorelbine + Herceptin (type of anti cancer treatment) in breast cancer Patients After Failing Herceptin Treatment
- Conditions
- Health Condition 1: null- Metastatic Breast Carcinoma
- Registration Number
- CTRI/2010/091/001360
- Lead Sponsor
- Boehringer Ingelheim India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 728
Histologically confirmed diagnosis of HER2-overexpression breast cancer
-Stage IV metastatic disease
-Must have progressed on one prior trastuzumab treatment
-no more than one prior trastuzumab based therapy regimen (either adjuvant or first-line)
-Must have received anthracycline and/or taxane based chemotherapy for adjuvant treatment of breast cancer or first-line treatment of metastatic breast cancer
-Must have (archived) tumour tissue sample available for central re-assessment of HER2-status
-At least one measurable lesion according to RECIST 1.1.
-ECOG score of 0 or 1 .
-Prior treatment with EGFR/HER2-targeted small molecules or antibodies other than trastuzumab
-Prior treatment with vinorelbine
-Known pre-existing interstitial lung disease
-Active brain metastases
-History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to randomisation.
-Cardiac left ventricular function with resting ejection fraction of less than 50%.
-Patients unable to comply with the protocol.
-Any contraindications for therapy with vinorelbine or trastuzumab.
-Known hypersensitivity to BIBW 2992 or the excipients of any of the trial drugs.
-Use of any investigational drug within 4 weeks of randomisation.
-Inadequate hepatic, renal and haematologic organ function
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint of this study is progression-free survival, defined as the time from the date of randomisation to the date of disease progression, or to the date of death if a patient died earlierTimepoint: date of randomisation to the date of disease progression
- Secondary Outcome Measures
Name Time Method -Overall survivalbest <br>-RECIST assessment and safety<br>-Tumour shrinkage<br>-Maintenance of body weight and ECOG<br>performance status<br>-Incidence of brain metastases<br>-Health-related quality of life<br>pharmacokinetics of BIBW 2992Timepoint: Till patient is alive