Title:
NSABP B49 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
Protocol Number:
ENSABPB49
Phase:
Phase III
Physician:
Antonio Wolff
Purpose:
The purpose of this study to find out if the chemotherapy drugs docetaxel and cyclophosphamide are as effective as the chemotherapy drugs doxorubicin, cyclophosphamide, and paclitaxel in treating your type of breast cancer. All of these drugs are approved by the FDA for the treatment of breast cancer and are currently used as standard treatments. This study is being done to compare the side effects and benefits of each chemotherapy combination.
Eligibility:
Women who have been recommended and have agreed to receive chemotherapy are eligible to participate in this study.
Treatment:
If you agree to participate, you will sign a consent form and then have screening tests to make sure it is safe for you to join the study. If you are eligible to participate, you will be randomized to one of two study groups, called "arms."If you are randomized to Arm 1, you will receive treatment with one of the following chemotherapy regimens. Chemotherapy treatments are usually described as cycles (for example: if you will receive a chemotherapy regimen for 4 cycles, this means you will receive it 4 times). The regimen you receive will be selected by you and your doctor:â?¢ Regimen A: Docetaxel (T) + Doxorubicin (A) + Cyclophosphamide (C) once every 3 weeks for 6 cyclesâ?¢ Regimen B: Doxorubicin (A) + Cyclophosphamide (C) once every 3 weeks for 4 cycles followed by paclitaxel once per week for 12 weeksâ?¢ Regimen C: Doxorubicin (A) + Cyclophosphamide (C) once every 2 weeks for 4 cycles followed by paclitaxel once per week for 12 weeksâ?¢ Regimen D: Doxorubicin (A) + Cyclophosphamide (C) once every 2 weeks for 4 cycles followed by paclitaxel once every 2 weeks for 4 cyclesIf you are randomized to Arm 2, you will receive:â?¢ Docetaxel (T) + Cyclophosphamide (C) once every 3 weeks for 6 cycles.
Population:
Adult
Last Update
06/17/2013 04:02 AM


