Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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.
Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 .
You may not be if
Prior treatment with Epidermal Growth Factor Receptor/Human Epidermal Growth Factor Receptor(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
