A Randomized Phase III Trial of Neoadjuvant Therapy in Patients with Palpable and Operable Breast Cancer Evaluating the Effect on Pathologic Complete Response (pCR) of Adding Capecitabine or Gemcitabine to Docetaxel when Administered Before AC with or without Bevacizumab and Correlative Science Studies Attempting to Identify Predictors of High Likelihood for pCR with Each of the Regimens
Principal Investigator
Harry Bear, MD, PhD
Status
Complete
Date Opened To Accrual
November 20 2006
Date Closed to Accrual
June 30 2010
Date of Study Termination
January 31 2019
Disease Site
Breast [BR]
Breast
Phase
III
Developmental Therapeutics
No
Primary Objective
To determine whether the combination of docetaxel/capecitabine→AC or docetaxel/gemcitabine→AC, with or without bevacizumab, will increase the rate of pathologic complete response in the breast (pCR breast) relative to docetaxel®AC with or without bevacizumab.
To determine whether the addition of bevacizumab to the docetaxel/anthracycline-based regimens (docetaxel→AC, docetaxel/capecitabine→AC, and docetaxel/gemcitabine→AC) will increase the rate of pCR breast relative to the same docetaxel/anthracycline-based regimens without bevacizumab.
Patient Population
Patients with palpable and operable HER2-negative breast cancer
Target Accrual
1200
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.