Status:
COMPLETED
Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer
Lead Sponsor:
Puma Biotechnology, Inc.
Conditions:
Advanced Breast Cancer
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This is a study of an experimental drug (neratinib) versus a combination of drugs (lapatinib and capecitabine) in women who have erbB-2 (HER-2) positive metastatic or locally advanced breast cancer. T...
Eligibility Criteria
Inclusion
- Stage IIIB, IIIC, or IV erbB2 (HER2) positive breast cancer
- Prior use of Herceptin (trastuzumab), and a taxane
- Adequate cardiac and renal function
Exclusion
- More than 2 prior Herceptin (trastuzumab) regimens or prior use of Xeloda (capecitabine) and / or Tykerb (lapatinib) \[Tyverb\]
- Bone as the only site of disease
- Active central nervous system metastases (subjects should be stable and off anticonvulsants and steroids)
- Significant gastrointestinal disorder with diarrhea as major symptom
Key Trial Info
Start Date :
February 4 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 3 2018
Estimated Enrollment :
233 Patients enrolled
Trial Details
Trial ID
NCT00777101
Start Date
February 4 2009
End Date
June 3 2018
Last Update
August 9 2018
Active Locations (152)
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1
Arizona Oncology Associates HOPE
Tucson, Arizona, United States, 85704-7891
2
Southwest Cancer Care
Murrieta, California, United States, 92562
3
UC Irvine Medical Center
Orange, California, United States, 92868-3298
4
Aptium Oncology/Comprehensive Cancer Center at Desert Regional Medical Center
Palm Springs, California, United States, 92262