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NSABP-B-49

Docetaxel and Cyclophosphamide Compared to Anthracycline-Based Chemotherapy in Treating Women With HER2-Negative Breast Cancer

Summary

Drugs used in chemotherapy work in different ways to stop the growth of breast cancer cells, either by killing the cells or by stopping them from dividing. Giving the drugs in different combinations may kill more breast cancer cells. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating women with non-metastatic breast cancer.

OBJECTIVES:

Primary

  • To determine if the docetaxel and cyclophosphamide (TC) regimen is non-inferior to the anthracycline-based chemotherapy regimens in terms of invasive disease-free survival (DFS) by combining B-49 data with the docetaxel, doxorubicin, and cyclophophamide (TAC) and TC arms of NSABP B-46-I/USOR 07132 and the data from USOR 06-090.

This is a multicenter randomized study. Patients are stratified according to number of positive nodes (0 vs 1-3 vs 4-9 vs 10+) and hormone-receptor status (estrogen receptor [ER] and/or progesterone receptor [PgR] positive vs ER and PgR negative). Patients are randomized to 1 of 2 treatment arms.

After completion of study therapy, patients are followed up every 6 months through year 5 and then annually for years 6 to 10.

Trial Contact Information

Blanche Reiner RN, OCN 610-738-2515

Nona Blauvelt MSN, AOCN 610-738-2522

Last Updated: 1/6/2014