NSABP B-40

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

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