This trial is active, not recruiting.

Condition breast neoplasms
Treatments bibw 2992, trastuzumab, vinorelbine
Phase phase 3
Targets EGFR, HER2, HER4
Sponsor Boehringer Ingelheim
Start date June 2010
End date June 2013
Trial size 508 participants
Trial identifier NCT01125566, 1200.75, 2009-015476-98


To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v. chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed one prior trastuzumab (Herceptin®) treatment

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
patients receive weekly intravenous infusion of trastuzumab and vinorelbine
patients receive trastuzumab 2mg/kg intravenously every week
patients receive vinorelbine 25mg/m² intravenously every week
patients receive BIBW 2992 tablets once daily combined with weekly intravenous infusion of vinorelbine
bibw 2992
patients receive BIBW 2992 tablets once daily and can reduce dose for adverse event management
patients receive vinorelbine 25mg/m² intravenously every week

Primary Outcomes

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 earlier
time frame: 34 months

Secondary Outcomes

Best RECIST assessment
time frame: 34 months
Overall survival
time frame: 34 months
Objective response
time frame: 34 months

Eligibility Criteria

Female participants at least 18 years old.

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. - Inadequate hepatic, renal and haematologic organ function

Additional Information

Official title LUX-Breast 1; 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
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.