Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
Trial Status: Complete
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.
- 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.
- 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.
Banner University Medical Center - Tucson
UCSF Medical Center-Mount Zion
Beth Israel Deaconess Medical Center
Brigham and Women's Faulkner Hospital
Dana-Farber Cancer Institute
Massachusetts General Hospital Cancer Center
Wayne State University / Karmanos Cancer Institute
Mayo Clinic in Rochester
Siteman Cancer Center at Washington University
Laura and Isaac Perlmutter Cancer Center at NYU Langone
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Duke University Medical Center
Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
OHSU Knight Cancer Institute
Thomas Jefferson University Hospital
University of Pittsburgh Cancer Institute (UPCI)
Medical University of South Carolina
Vanderbilt University / Ingram Cancer Center
UT Southwestern / Simmons Cancer Center-Dallas
Southwestern Vermont Medical Center
Trial Phase Phase III
Trial Type Treatment
Puma Biotechnology, Inc.
- Primary ID 3144A2-3004 / B1891004
- Secondary IDs NCI-2010-00365, B1891004, 09-0530, 3144A2-3004
- Clinicaltrials.gov ID NCT00878709