Status:
COMPLETED
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
Lead Sponsor:
Puma Biotechnology, Inc.
Conditions:
HER2+ Metastatic Breast Cancer (MBC)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of neratinib plus capecitabine versus the combination of lapatinib plus capec...
Detailed Description
This is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of neratinib plus capecitabine versus the combination of lapatinib plus capec...
Eligibility Criteria
Inclusion
- Aged ≥18 years at signing of informed consent.
- Histologically confirmed MBC, current stage IV.
- Documented HER2 overexpression or gene-amplified tumor immunohistochemistry 3+ or 2+, with confirmatory fluorescence in situ hybridization (FISH) +.
- Prior treatment with at least two (2) HER2-directed regimens for metastatic breast cancer.
Exclusion
- Received previous therapy with capecitabine, neratinib, lapatinib, or any other HER2 directed tyrosine kinase inhibitor.
- Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.
Key Trial Info
Start Date :
March 29 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2019
Estimated Enrollment :
621 Patients enrolled
Trial Details
Trial ID
NCT01808573
Start Date
March 29 2013
End Date
December 9 2019
Last Update
June 11 2021
Active Locations (252)
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1
Ironwood Cancer and Research Centers
Chandler, Arizona, United States, 85224
2
Ironwood Cancer and Research Centers
Gilbert, Arizona, United States, 95297
3
Ironwood Cancer and Research Centers
Mesa, Arizona, United States, 85206
4
Ironwood Cancer and Research Centers
Scottsdale, Arizona, United States, 85202