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Principal Name   Harvey Zimbler, MD
Contact Name   Gloria Gero
Phone   (413) 496-8205
Alternate Phone   (423) 443-6000
Fax   (413) 443-2203
Title   B-49 - "A Phase III Clinical Trial Comparing the Combination of Docetaxel Plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women with Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer"
Description   THe B-49 study, a multicenter, open-label, randomized Phase III, adjuvant therapy trial, will compare the value of a non-anthracycline-based chemotherapy regimen relative to anthracycline-based chemotherapy regimens in women with resected noe-positive or high-risk node-negative, HER@-negative breast cancer. This trial will compare invasive disease-free survival of a regimen of docetaxel and cyclophosphamide (TC) to anthracycline-based chemotherapy regiemsn. Secondary aims will evaluate the regimens in terms of disease-free survival, overall survival, and recurrence-free interval. The toxicities of the regimens will also be compared.

The study will enroll 1843 patients overa period of approximately 2 years and 4 months.
Treatment   Oncology
Inclusion/Notes   Patient eligibility:
-must be female
-patient over 18 years old
-ECOG performance status of 0-1
-Tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination
-breast cancer must be HER2-negative
-staging criterialmust be met accordinag to AJCC criteria
-patient must have undergone either a total mastectomy or breast-conserving surgery (lumpectomy)
-Margins must be histologically free of invasive tumor and DCIS
-Patient must have ER analysis performed on Primary tumor prior to randomizatoin

-T4 tumors including inflammatory breast cancer
-definitive clinical or radiologic evidence of metastatic disease
-history of ipsilateral invasive breast cancer or ipsilateral DCIS
-any sex hormonal therapy, e.g.,birth control pills, ovarian hormone replacement therapy.
-known active hepatitis B or hepatitis C with abnormal liver funciton tested
-cardiac disease wthat would preclude the use of the durgs included in the treatment regiemsn.
-unstable diabetes mellitus
Status   accruing
Start Date   03/09/2012
Current Trial Type   treatment

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