Status:
COMPLETED
Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
Lead Sponsor:
Puma Biotechnology, Inc.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab...
Eligibility Criteria
Inclusion
- Stage II through IIIC HER-2/erbB-2 positive breast cancer with node positive disease.
- Been treated for early breast cancer with standard of care duration of trastuzumab.
- Could have been treated neoadjuvantly but have not reached pathologic complete response.
Exclusion
- Positive clinical and radiologic assessments for local or regional recurrence of disease at the time of study entry.
- History of heart disease.
- Corrected QT (QTc) interval \>0.45 seconds
- History of gastrointestinal disease with diarrhea as the major symptom.
Key Trial Info
Start Date :
July 9 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 4 2019
Estimated Enrollment :
2840 Patients enrolled
Trial Details
Trial ID
NCT00878709
Start Date
July 9 2009
End Date
October 4 2019
Last Update
June 11 2021
Active Locations (494)
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1
Anniston Oncology
Anniston, Alabama, United States, 36207
2
Birmingham Hematology and Oncology Associates, LLC
Birmingham, Alabama, United States, 35205
3
Arizona Oncology Associates, PC - HAL
Phoenix, Arizona, United States, 85016
4
Arizona Oncology Associates, PC - NAHOA
Sedona, Arizona, United States, 86336