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S0221 Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer


Phase III Trial of Continuous Schedule AC + G vs. Q 2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High-Risk Node-Negative Breast Cancer


Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating resected breast cancer.


This randomized phase III trial is comparing 2 different regimens of combination chemotherapy to see how well they work in treating patients who have undergone surgery for stage I, stage II, or stage III breast cancer.

Study Status: Active, not recruiting


Condition Intervention Phase
Breast Cancer Biological: pegfilgrastim
Drug: AC regimen
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: paclitaxel
Phase 3

Verified by Southwest Oncology Group May, 2013

Sponsored by: Southwest Oncology Group
Information provided by: Southwest Oncology Group identifier: NCT00070564

Study Type: Interventional

Study Design: Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Cleveland Clinic Beachwood Family Health and Surgery Center
Beachwood, Ohio 44122
United States

Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio 44195
United States

Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio 44111
United States

Cleveland Clinic Cancer Center
Independence, Ohio 44131
United States

Cleveland Clinic Foundation - Strongsville
Strongsville, Ohio 44136
United States

Cleveland Clinic - Wooster
Wooster, Ohio 44691
United States

George Thomas Budd, MD., Study Chair
Halle C Moore, MD., Study Director

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