Clinical Research Details
Title:
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
Purpose:
The purpose of this study is to determine whether the addition of bevacizumab to docetaxel with or without capecitabine or gemcitabine then AC, will increase the rate of pathologic complete response in the breast (pCR breast) relative to docetaxel then AC with or without bevacizumab and to determine whether the addition of bevacizumab to the docetaxel/anthracycline-based regimens (docetaxel then AC, docetaxel/capecitabine then AC and docetaxel/gemcitabine then AC) will increase the rate of pCR breast relative to the same docetaxel/anrthracycline-based regimens without bevacizumab.
Study Number:
202098081909
Number of Patients:
1200
Elgibility:
Participants must be women 18 years of age or older with a diagnosis of invasive adenocarcinoma of the breast that was made by core needle biopsy. The primary breast tumor must be palpable and measure at least 2.0 cm on physical exam.
Treatment:
Participants are assigned to one of six treatment groups:
Docetaxel Docetaxel with bevacizumab Docetaxel with capecitabine Docetaxel with capecitabine and bevacizumab Docetaxel with gemcitabine Docetaxel with gemcitabine and bevacizumab
This initial treatment will be followed by doxorubicin and cyclophosphamide prior to breast surgery.
Principal Investigator:
Enrollment Phone:
(708) 327-3222