CTRI/2010/091/001360
Active, not recruiting
Phase 3
An open label, randomised phase III trial of BIBW 2992 and vinorelbine versus trastuzumab and vinorelbine in patients with metastatic HER2-overexpressing breast cancer failing one prior trastuzumab treatment
Boehringer Ingelheim India Pvt Ltd0 sites728 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Metastatic Breast Carcinoma
- Sponsor
- Boehringer Ingelheim India Pvt Ltd
- Enrollment
- 728
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 .
Exclusion Criteria
- •\-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.
Outcomes
Primary Outcomes
Not specified
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