Phase III Trial of Vinorelbine+BIBW 2992 vs Vinorelbine+Herceptin in BC Patients After Failing Herceptin Treatment

• Register: SLCTR
• Last refreshed on: 27 April 2013
• Main ID: SLCTR/2012/003
• Date of registration: 18/04/2012
• Primary sponsor: Boehringer Ingelheim India (Pvt) Ltd
• Public title: Phase III Trial of Vinorelbine+BIBW 2992 vs Vinorelbine+Herceptin in BC Patients After Failing Herceptin Treatment
• Scientific title: 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
• Date of first enrolment: 19/4/2012
• Target sample size: 790
• Recruitment status: other
• URL: http://www.slctr.lk/trial_details.asp?reg_id={A62C176A-3016-423D-ACD2-F0712F804B53}
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial

Countries of recruitment

Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, France, Germany, India, Israel, Italy, Korea, Mexico, Netherlands, Peru, Poland, Portugal, Spain, Slovakia, Sweden, South Africa, Taiwan, United States

Contacts

• Name: Sachin S. Sadekar
• Affiliation: Project Manager

• Name: Prof Asita De Selva
• Affiliation: Director

Key inclusion & exclusion criteria

Inclusion criteria: 1. Histologically confirmed diagnosis of HER2-overexpression breast cancer
2. Stage IV metastatic disease
3. Must have progressed on one prior trastuzumab treatment
4. no more than one prior trastuzumab based therapy regimen (either adjuvant or first-line)
5. Must have received anthracycline and/or taxane based chemotherapy for adjuvant treatment of breast cancer or first-line treatment of metastatic breast cancer
6. Must have (archived) tumour tissue sample available for central re-assessment of HER2-status
7. At least one measurable lesion according to RECIST 1.1.
8. ECOG score of 0 or 1.
Exclusion criteria: 1. Prior treatment with EGFR/HER2-targeted small molecules or antibodies other than trastuzumab
2. Prior treatment with vinorelbine
3. Known pre-existing interstitial lung disease
4. Active brain metastases
5. 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 randomization.
6. Cardiac left ventricular function with resting ejection fraction of less than 50%.
7. Patients unable to comply with the protocol.
8. Any contraindications for therapy with vinorelbine or trastuzumab.
9. Known hypersensitivity to BIBW 2992 or the excipients of any of the trial drugs.
10. Use of any investigational drug within 4 weeks of randomization.
11. Inadequate hepatic, renal and haematologic organ function

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Metastatic Breast Cancer

Intervention(s)

BIBW 2992 - once daily combined with weekly intravenous infusion of vinorelbine

Primary Outcome(s)

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

Secondary Outcome(s)

Overall survival- Best -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 2992

Secondary ID(s)

CTRI/2010/091/001360 (Clinical Trials Registry India), NCT01125566 (clinicaltrials.gov)

Source(s) of Monetary Support

Boehringer Ingelheim India (Pvt) Ltd