A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting
Not Applicable
Recruiting
- Conditions
- Neoplasms
- Registration Number
- KCT0001143
- Lead Sponsor
- Puma Biotechnology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 9
Inclusion Criteria
Aged =18 years at signing of informed consent.
- Histologically confirmed metastatic breast cancer(MBC), current stage IV.
- Documented HER2 overexpression or gene-amplified tumor (immunohistochemistry [IHC] 3+ or IHC 2+ with confirmatory fluorescence in situ hybridization [FISH]+).
- Prior treatment with at least two (2) HER2-directed regimens for metastatic breast cancer.
Note: There are additional inclusion criteria. The study center will determine if you meet all of the criteria.
Exclusion Criteria
Received previous therapy with capecitabine, neratinib, lapatinib, or any other HER2 directed tyrosine kinase inhibitor.
Note: There are additional exclusion criteria. The study center will determine if you meet all of the criteria.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Independently assessed Progression Free Survival
- Secondary Outcome Measures
Name Time Method Investigator Assessed Progression Free Survival;Objective Response Rate (ORR);Clinical Benefit Rate (CBR) defined as Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) for = 24 weeks;Duration of Response (DOR);Time to intervention for symptomatic metastatic central nervous system disease;Safety (Adverse Events [AEs] and Serious Adverse Events [SAEs]);Health Outcomes Assessments [Quality of Life Questionnaires; EORTC QLQ-C30, EORTC QLQ-BR23, and EQ-5D-5L]