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Name of the Trial

Phase III Randomized Study of Four Schedules of Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Patients with Node-Positive or High-Risk Node-Negative Breast Cancer (SWOG-S0221). See the protocol summary.

Principal Investigators

Dr. G. Thomas Budd and Dr. Halle C. F. Moore from the Southwest Oncology Group.

Dr. G. Thomas Budd Principal Investigator

Why This Trial Is Important

Different chemotherapy drugs may affect tumors in different ways. Combining more than one drug and giving them after surgery may be effective in killing any tumor cells not removed surgically. It is important, however, to determine which combination of drugs - and the schedule for administering them - produces the best results while causing the fewest side effects. For example, some drugs may provide additional benefits, such as helping to block blood flow to tumors (a process called antiangiogenesis), and be more tolerable if administered more frequently but in lower doses.

This trial compares the effectiveness of four different treatment schedules using the drugs doxorubicin, cyclophosphamide, and paclitaxel in treating patients who have undergone surgery for stage I, II, or III breast cancer.

"Preclinical studies have suggested that a 'metronomic' chemotherapy regimen, the administration of moderate doses more frequently, may optimize the antiangiogenic effects of chemotherapies," said Dr. Budd. "Furthermore, this type of regimen may serve as a ready platform upon which to add future antiangiogenic agents as they become available."

Note: Patients in this trial whose tumors test positive for the HER2/neu protein will receive trastuzumab (Herceptin) concurrently with or following chemotherapy. Women whose tumors are estrogen-receptor and/or progesterone-receptor positive will receive hormonal therapy following chemotherapy. Premenopausal patients in this trial may enroll concurrently in one of the following clinical trials: SWOG-S0230, IBCSG-24-02, or IBCSG-25-02.

Who Can Join This Trial

This trial seeks to enroll 4,500 women and men age 18 and older who have high-risk stage I-III invasive breast cancer and have had their tumors surgically removed. See the full list of eligibility criteria for this trial.

Study Sites and Contact Information

Multiple study sites in the United States are enrolling patients in the trial. See the list of study contacts or call the NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll free and completely confidential.

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