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, MD
Status
Terminated
Date Opened To Accrual
February 21 2000
Date Closed to Accrual
April 25 2005
Date of Study Termination
March 31 2020
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
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.