Roche BO27938 / NSABP B-50-I / GBG 77 - 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

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Roche BO27938 / NSABP B-50-I / GBG 77 - 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

The primary efficacy objective for this study is as follows:
- To compare invasive disease-free survival (IDFS) 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
The secondary efficacy objective for this study is as follows:
- To compare IDFS including second non-breast cancers, disease-free survival (DFS), overall survival (OS), and distant recurrence-free interval (DRFI) between the 2 treatment arms
Safety Objectives
The safety objective for this study is as follows:
- To compare cardiac safety and overall safety between the 2 treatment arms

Protocol Number041303
Principal InvestigatorAntoinette Tan
PhasePhase III
ScopeNational
Applicable Disease SitesBreast - Female
Therapies InvolvedChemotherapy (NOS)
Drugs InvolvedTrastuzumab emtansine
TRASTUZUMAB
Participating InstitutionsRutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.