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.
Inclusion Criteria
- 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 Criteria
- 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.
Arizona
Tucson
Banner University Medical Center - Tucson
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
California
San Francisco
UCSF Medical Center-Mount Zion
Status: CLOSED_TO_ACCRUAL
Massachusetts
Boston
Beth Israel Deaconess Medical Center
Status: CLOSED_TO_ACCRUAL
Brigham and Women's Faulkner Hospital
Status: CLOSED_TO_ACCRUAL
Dana-Farber Cancer Institute
Status: CLOSED_TO_ACCRUAL
Massachusetts General Hospital Cancer Center
Status: CLOSED_TO_ACCRUAL
Michigan
Detroit
Wayne State University / Karmanos Cancer Institute
Status: ADMINISTRATIVELY_COMPLETE
Minnesota
Rochester
Mayo Clinic in Rochester
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Missouri
Saint Louis
Siteman Cancer Center at Washington University
Status: COMPLETED
New York
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: COMPLETED
NYP / Columbia University Medical Center / Herbert Irving Comprehensive Cancer Center
Status: ADMINISTRATIVELY_COMPLETE
North Carolina
Durham
Duke University Medical Center
Status: COMPLETED
Ohio
Cleveland
Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Status: COMPLETED
Oregon
Portland
OHSU Knight Cancer Institute
Status: CLOSED_TO_ACCRUAL
Pennsylvania
Philadelphia
Thomas Jefferson University Hospital
Status: COMPLETED
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
South Carolina
Charleston
Medical University of South Carolina
Status: CLOSED_TO_ACCRUAL
Tennessee
Nashville
Vanderbilt University / Ingram Cancer Center
Status: COMPLETED
Texas
Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: CLOSED_TO_ACCRUAL
Vermont
Bennington
Southwestern Vermont Medical Center
Status: COMPLETED
Trial Phase Phase III
Trial Type Treatment
Lead Organization
Puma Biotechnology, Inc.
- Primary ID 3144A2-3004 / B1891004
- Secondary IDs NCI-2010-00365, 09-0530, 3144A2-3004, B1891004
- Clinicaltrials.gov ID NCT00878709