Health Condition 1: null- Metastatic Breast Carcinoma
Conditions
Interventions
Intervention1: BIBW 2992: once daily combined with weekly intravenous infusion of vinorelbine
Control Intervention1: Trastuzumab: 2mg/kg intravenously every week combined with weekly intravenous infus
Sponsors
Boehringer Ingelheim India Pvt Ltd
Eligibility
Inclusion 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
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. -Inadequate hepatic, renal and haematologic organ function
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| -Overall survivalbest -RECIST assessment and safety -Tumour shrinkage -Maintenance of body weight and ECOG performance status -Incidence of brain metastases -Health-related quality of life pharmacokinetics of BIBW 2992Timepoint: Till patient is alive | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Finland, France, Germany, India, Iraq, Italy, Mexico, Netherlands, Peru, Poland, Portugal, Republic of Korea, Slovenia, South Africa, Spain, Sweden, Taiwan, United States of America
Contacts
Public ContactDr Partha Gokhale
Boehringer Ingelheim India Pvt Ltd
Outcome results
None listed