Status:
COMPLETED
Study Evaluating Neratinib Plus Paclitaxel VS Trastuzumab Plus Paclitaxel In ErbB-2 Positive Advanced Breast Cancer
Lead Sponsor:
Puma Biotechnology, Inc.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This study is investigating the effects of an experimental drug (neratinib) in combination with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of women who have not rec...
Eligibility Criteria
Inclusion
- ErbB-2 positive locally recurrent or metastatic breast cancer
- Eastern Cooperative Oncology Group (ECOG) 0-2
- Measurable disease
- Availability of tumor tissue for HER2 status confirmation
Exclusion
- Prior systemic anti-cancer therapy other than endocrine therapy for locally recurrent or metastatic disease
- Prior erbB-2 inhibitor other than trastuzumab or lapatinib in the neoadjuvant or adjuvant setting
- Progression/recurrence within 12 months after completion of adjuvant or neoadjuvant therapy
- History of heart disease
- History of gastrointestinal disease
Key Trial Info
Start Date :
August 21 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2018
Estimated Enrollment :
479 Patients enrolled
Trial Details
Trial ID
NCT00915018
Start Date
August 21 2009
End Date
June 28 2018
Last Update
August 22 2018
Active Locations (195)
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1
Ventura County Hematology-Oncology Specialists
Oxnard, California, United States, 93030
2
Redwood Regional Medical Group
Santa Rosa, California, United States, 95403
3
Cancer Center of Central Connecticut
Plainville, Connecticut, United States, 06062
4
Palm Beach Institute of Hematology and Oncology
Boynton Beach, Florida, United States, 33435