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A Phase III Trial of Cyclophosphamide and Doxorubicin Versus Paclitaxel as Adjuvant Therapy for Women with Node-Negative Breast Cancer
[Protocol 04-042]
- Full Title :
- CYCLOPHOSPHAMIDE AND DOXORUBICIN (CA X 4 CYCLES)VERSUS PACLITAXEL (4 CYCLES) AS ADJUVANT THERAPY FOR BREAST CANCER IN WOMEN WITH 0-3 POSITIVE AXILLARY LYMPH NODES: A PHASE III RANDOMIZED STUDY (CALGB 40101)
- Purpose :
Chemotherapy given after surgery to remove breast cancer reduces the chance of the cancer returning in other parts of the body. A combination of the anticancer drugs cyclophosphamide and doxorubicin (CA), given through a vein every 3 weeks for four treatments, has been a standard therapy for many patients with breast cancer that has not spread to the lymph nodes ("node-negative" cancer).
Paclitaxel (Taxol) is an anticancer drug that is approved for treating patients whose breast cancer has spread to the lymph nodes or other parts of the body. The use of paclitaxel to treat node-negative breast cancer is investigational. Based on previous studies, there is a strong chance that treatment with paclitaxel alone will be as good, if not better, than adjuvant therapy with CA therapy in patients with node-negative breast cancer.
The purpose of this study is to compare the effectiveness and side effects of the standard adjuvant CA chemotherapy with paclitaxel treatment. The standard treatment with CA or paclitaxel in the adjuvant setting is four cycles (8 weeks) of either. In this trial, investigators are also studying whether six cycles (12 weeks) of treatment would be better than the standard approach.
- Eligibility :
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of adenocarcinoma of the breast that has not spread to the lymph nodes. Patients must be candidates for chemotherapy and may not have had any prior chemotherapy or hormonal therapy (though up to 4 weeks of prior tamoxifen therapy is permitted).
- Patients must have breast surgery prior to entering the study.
- Patients must be age 18 or older.
For more information and to see if you are eligible for this study, please contact Dr. Diana Lake at 646-888-5444.
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