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Clinical Trials
Trial Name:

CALGB 40101
Intro: CALGB 40101: Cyclophosphamide and Doxorubicin (CA) versus Paclitaxel as Adjuvant Therapy for Women with Node-Negative Breast Cancer: A 2x2 Factorial Phase III Randomized Study
Condition:
Description: This study will determine the equivalence of paclitaxel given every two weeks with CA given every two weeks as adjuvant therapy for women with high-risk node-negative breast cancer for disease-free survival. Patients will be randomized to receive either CA or paclitaxel. Patients will then be randomized to duration of therapy and will receive either 4 or 6 cycles of therapy. Patients in the standard chemotherapy arm will receive cyclophosphamide and doxorubicin administered every 14 days for 4 or 6 cycles. Patients in the single agent arm will receive paclitaxel administered every 14 days for 4 or 6 cycles.
Criteria:
  1. Patients must have histologically confirmed invasive carcinoma of the female breast, with negative axillary lymph nodes
  2. Patients must have undergone either modified radical mastectomy or lumpectomy, within 84 days of registration
  3. Patients must not have received previous chemotherapy or hormonal therapy for this malignancy. Patients may have received up to 4 weeks of tamoxifen or another selective estrogen receptor modulator for prevention or for other indications
  4. Patients with locally advanced, metastatic or inflammatory breast cancer are not eligible
  5. Patients must have normal bone marrow, liver and kidney function.
Contact: For Cancer Information, Current Clinical Trials, and Referral to a Physician please call (216) 844-5432 or (800) 641-2422

Participant Confidentiality:

All information regarding participation in Clinical Trials is treated with the utmost confidentiality. University Hospitals Case Medical Center and the Division of Clinical Research recognize and respect the confidentiality of this information. Access to information related to clinical trials and their participants is restricted to authorized clinical trials personnel only.

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