NSABP B-50-I
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NSABP B-50-I / GBG 77/ BO27938 (Katherine)

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