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
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/6/2019 |
| Start Date: | March 29, 2013 |
| End Date: | March 31, 2020 |
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.
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.
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.
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.
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.
We found this trial at
105
sites
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Cleveland Clinic Taussig Cancer Center At Taussig Cancer Institute, more than 250 highly skilled doctors,...
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Univ of Texas, Southwestern Med Ctr of Dallas The story of UT Southwestern Medical Center...
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Mission Hospitals Mission Hospital, the flagship hospital of Mission Health, has been committed to improving...
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Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Poudre Valley Hospital A 270-bed regional medical center offering a wide array of treatments, surgeries,...
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Front Range Cancer Specialists At Front Range Cancer Specialists, we are dedicated to providing quality...
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Queen's Medical Center The Queen's Medical Center, located in downtown Honolulu, Hawaii, is a private,...
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Straub Clinic And Hospital Founded in 1921, Straub Clinic & Hospital is a fully integrated...
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Lutherville, Maryland 21093
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The West Clinic, PC Hello and welcome to our office. Although it is our pleasure...
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Sharp Memorial Hospital Sharp Memorial Hospital offers clinical excellence with the latest technology and patient-centered...
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Sibley Memorial Hospital Sibley Memorial Hospital, in Northwest Washington, D.C., has a distinguished history of...
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