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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 ³.

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 ⁴, IBCSG-24-02 ⁵, or IBCSG-25-02 ⁶.

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 ⁷ 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 ⁸ 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.

Glossary Terms

A drug that is used to treat many types of cancer and is being studied in the treatment of other types of cancer. It is also used to treat some types of kidney disease in children. Cyclophosphamide attaches to DNA in cells and may kill cancer cells. It is a type of alkylating agent. Also called CTX and Cytoxan.

A drug that is used to treat many types of cancer and is being studied in the treatment of other types of cancer. Doxorubicin comes from the bacterium Streptomyces peucetius. It damages DNA and may kill cancer cells. It is a type of anthracycline antitumor antibiotic. Also called Adriamycin PFS, Adriamycin RDF, doxorubicin hydrochloride, hydroxydaunorubicin, and Rubex.

Describes cells that have a receptor protein that binds the hormone estrogen. Cancer cells that are estrogen receptor positive may need estrogen to grow, and may stop growing or die when treated with substances that block the binding and actions of estrogen. Also called ER+.

Treatment that adds, blocks, or removes hormones. For certain conditions (such as diabetes or menopause), hormones are given to adjust low hormone levels. To slow or stop the growth of certain cancers (such as prostate and breast cancer), synthetic hormones or other drugs may be given to block the body’s natural hormones. Sometimes surgery is needed to remove the gland that makes a certain hormone. Also called endocrine therapy, hormone therapy, and hormone treatment.

A drug used to treat breast cancer, ovarian cancer, and AIDS-related Kaposi sarcoma. It is also used together with another drug to treat non-small cell lung cancer. Paclitaxel is also being studied in the treatment of other types of cancer. It blocks cell growth by stopping cell division and may kill cancer cells. It is a type of antimitotic agent. Also called Taxol.

Research using animals to find out if a drug, procedure, or treatment is likely to be useful. Preclinical studies take place before any testing in humans is done.

Describes cells that have a protein to which the hormone progesterone will bind. Cancer cells that are progesterone receptor positive need progesterone to grow and will usually stop growing when treated with hormones that block progesterone from binding. Also called PR+.

A monoclonal antibody that binds to HER2 (human epidermal growth factor receptor 2), and can kill HER2-positive cancer cells. Monoclonal antibodies are made in the laboratory and can locate and bind to substances in the body, including cancer cells. Trastuzumab is used to treat breast cancer that is HER2-positive and has spread after treatment with other drugs. It is also used with other anticancer drugs to treat HER2-positive breast cancer after surgery. Trastuzumab is also being studied in the treatment of other types of cancer. Also called Herceptin.