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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
Trial Status: complete
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 capecitabine in HER2+ MBC patients who have received two or
more prior HER2 directed regimens in the metastatic setting.
Inclusion Criteria
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 Criteria
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.
Additional locations may be listed on ClinicalTrials.gov for NCT01808573.
Locations matching your search criteria
United States
California
Los Angeles
Translational Research In Oncology - US Inc (TRIO-US)
Status: Active
Name Not Available
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Name Not Available
Hawaii
Honolulu
University of Hawaii Cancer Center
Status: Active
Name Not Available
New Jersey
New Brunswick
Rutgers Cancer Institute of New Jersey
Status: Active
Name Not Available
Pennsylvania
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not Available
Texas
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Status: Active
Name Not Available
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 capecitabine in HER2+ MBC patients who have received two or
more prior HER2 directed regimens in the metastatic setting. Patients will be randomized
in a 1:1 ratio to one of the following treatment arms:
- Arm A: neratinib (240 mg once daily) + capecitabine (1500 mg/m^2 daily, 750 mg/m^2
twice daily [BID])
- Arm B: lapatinib (1250 mg once daily) + capecitabine (2000 mg/m^2 daily, 1000 mg/m^2
BID)
Patients will receive either neratinib plus capecitabine combination or lapatinib plus
capecitabine combination until the occurrence of death, disease progression, unacceptable
toxicity, or other specified withdrawal criterion.
