NSABP B-31

A Randomized Trial Comparing The Safety And Efficacy Of Adriamycin And Cyclophosphamide Followed By Taxol (AC?T) To That Of Adriamycin And Cyclophosphamide Followed By Taxol Plus Herceptin (AC?T + H) In Node-Positive Breast Cancer Patients Who Have Tumors That Overexpress HER2

Principal Investigator

Edward Romond

Status

Disease Site

Breast [BR] Breast

Phase

III

Developmental Therapeutics

No

Primary Objective

To assess the safety and efficacy of the combination of Herceptin and chemotherapy in the treatment of 2700 node-positive breast cancer patients whose tumors overexpress the HER2 protein or demonstrate evidence of HER2 gene-amplification.

Patient Population

Node-positive breast cancer patients who have tumors that overexpress HER2

Protocol Record Retention Dates
Date Records No Longer to be Kept by US Sites: 03/31/2023
Date Records No Longer to be kept by Canadian Sites: 03/31/2045
Date Records for B-31.1 No Longer to be kept by Canadian Sites: 03/31/2023

Target Accrual

2130