patients with metastatic HER2 over-expressing breast cancer MedDRA version: 14.1 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: LLT Classification code 10065430 Term: HER-2 positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: LLT Classification code 1002
Conditions
Interventions
Product Name: BIBW 2992 20 mg FCT
Product Code: BIBW 2992
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: BIBW 2992
Concentration unit: mg milligram(s)
Concentration type: equal
Concentr
Sponsors
Boehringer Ingelheim
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •patients with metastatic HER2-positive breast cancer •no prior HER2-targeted treatment other than trastuzumab allowed •no prior vinorelbine treatment allowed •patients should have received prior taxane and/or anthracycline containing chemotherapy •patients must have progressed on one prior trastuzumab treatment, i.e. patients with: - First-line metastatic breast cancer failing on adjuvant trastuzumab or within 12 months of completion of adjuvant trastuzumab treatment; prior trastuzumab treatment must have been at least 9 weeks - Second-line metastatic breast cancer failing on first-line trastuzumab or within 6 months of completion of first-line trastuzumab treatment; prior trastuzumab treatment must have been at least 6 weeks •Must have (archived) tumour tissue sample available for central re-assessment of HER2-status and prove HER2-positive. HER2 status must be confirmed by sponsor contracted laboratory prior to randomisation. •At least one measurable lesion according to RECIST 1.1 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 680 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
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.Radiotherapy, chemotherapy, hormone therapy, immunotherapy or surgery (other than biopsy) within 4 weeks (2 weeks for hormone therapy, 3 weeks for trastuzumab) prior to randomisation. 5.Active brain metastases (defined as stable for 1.5 times upper limit of normal. 14.Bilirubin > 1.5 times upper limit of normal. 15.Aspartate amino transferase (AST) or alanine amino transferase (ALT) > 2.5 times the upper limit of normal (ULN) (if related to liver metastases > 5 times ULN). 16.Women of childbearing potential, unwilling to use a medically acceptable method of contraception during the trial, see Section 5.2.2.4. 17.Pregnancy or breast-feeding. 18.Patients unable to comply with the protocol. 19.Known hepatitis B infection, known hepatitis C infection or known HIV carrier. 20.Known or suspected active drug or alcohol abuse. 21.Requirement for treatment with any of the prohibited concomitant medications listed in section 4.2.2.1. 22.Any contraindications for therapy with vinorelbine or trastuzumab. 23.Known hypersensitivity to BIBW 2992 or the excipients of any of the trial drugs. 24.Use of any investigational drug within 4 weeks of randomisation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to determine whether BIBW 2992 and vinorelbine i.v. prolongs progression-free survival (PFS) in comparison to trastuzumab and vinorelbine i.v.;Secondary Objective: Secondary objectives are: - further evaluation of efficacy (best RECIST assessment, overall survival, tumour shrinkage), - health status (ECOG, weight) - quality of life - safety (adverse events, laboratory) - pharmacokinetics;Primary end point(s): 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. The analysis will be based upon the evaluation of tumour imaging as reviewed by an independent central unit, blinded to treatment assignments. ;Timepoint(s) of evaluation of this end point: The primary analysis of PFS will be conducted when at least 484 patients have progressed (based on central review) or died. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Best RECIST assessment - Overall survival;Timepoint(s) of evaluation of this end point: The first analysis will be performed at same timepoint than primary analysis A second overall survival analysis should be performed approximately 42 months after the start of recruitment. | — |
Countries
Argentina, Australia, Austria, Belarus, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Egypt, Finland, France, Germany, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Latvia, Lebanon, Lithuania, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Taiwan, Turkey, United Arab Emirates, United Kingdom, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed