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Clinical Cancer Details

Protocol No.: NSABP B-40
Title: 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.
Staging: Stage 1, Stage 2,
Objective: The National Surgical Adjuvant Breast and Bowel Project (NSABP) has a long history of conducting clinical trials evaluating pre-operative or primary chemotherapy in the treatment of patients with operable breast cancer.  The proposed trial represents the next logical step in the evolution of this treatment approach and builds on the results of clinical trials and correlative science studies performed by the NSABP as well as by other investigators.
Overview:
  • HER-2 Negative Invasive Breast Cancer
  • Diagnosed by Core Biopsy with Palpable >2.0 cm breast mass
  • Required tissue collection for submission prior to randomization - four core needle biospy tissue samples
  • Randomized to 1 of 6 Pre Operative Therapy Regimens
  • Re-Evaluation post chemo followed by surgery (lumpectomy/mastectomy)
Eligibility Requirements:
No requirement
This protocol has complex eligibility criteria. Please contact us for further information:
Contact Name: Debbie Reynolds, RN, OCN  
Contact Phone: 386.254.4213 or
Contact Email: debbie.reynolds@halifax.org
Contact: Center for Oncology
303 N. Clyde Morris Blvd.
Daytona Beach, Florida 32114
386.254.4213
Debbie Reynolds, RN, OCN

Center for Oncology
303 N. Clyde Morris Blvd.
Daytona Beach, Florida 32114
386.254.4213
Kathleen Brady, RN, BA

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