A Randomized, Multicenter, Open-Label Phase Iii Study To Evaluate The Efficacy And Safety Of Trastuzumab Emtansine Versus Trastuzumab As Adjuvant Therapy For Patients With Her2-Positive Primary Breast Cancer Who Have Residual Tumor Present Pathologically In The Breast Or Axillary Lymph Nodes Following Preoperative Therapy
Primary Objective: To compare invasive disease-free survival in patients with residual invasive breast cancer after treatment with preoperative chemotherapy and HER2-directed therapy including trastuzumab followed by surgery between the 2 treatment arms
Patient Population:HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy including trastuzumab followed by surgery, with a finding of residual invasive disease in the breast or axillary lymph nodes.
Target Accrual: 1,484 patients
Status: Active. Not recruiting participants
ClinicalTrials.gov Identifier:: NCT01772472
The Mission of NSABP Foundation, Inc. is to design and conduct practice changing cancer research, including clinical trials and laboratory studies in the medical, surgical and prevention settings in order to improve the survival outcome and quality of life of patients with breast and colorectal cancer, and to disseminate the results of NSABP collaborative research to benefit the world-wide community.
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