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Trial Name:

NSABP B-31
Intro: A Randomized Trial Comparing the Safety and Efficacy of Adriamycin and Cyclophosphamide Followed by Taxol (AC – T) to that of Adriamycin and Cyclophosphamide Followed by Taxol plus Herceptin (AC-T) in Node-Positive Breast Cancer Patients who have Tumors that Overexpress HER2.
Condition:
Description: This study will compare the cardiotoxicity of four cycles of Adriamycin and cyclophosphamide (AC) followed by four cycles of Taxol, with that of the same chemotherapy regimen plus Herceptin, in patients with operable, histologically node-positive breast cancer which overexpresses the HER2 protein. Patients will be randomized to 1 of 2 groups. Patients in group 1 will receive AC and Taxol for 4 cycles. Patients in group 2 will receive AC and Taxol for 4 cycles plus Herceptin weekly for 1 year.
Criteria:
  1. Patients must have a diagnosis of invasive adenocarcinoma that is HER2-positive
  2. Patients must have undergone either a total mastectomy and an axillary dissection or a lumpectomy and an axillary dissection
  3. Patients must not have metastatic disease
  4. Patients must have a life expectancy of at least 10 years, excluding a diagnosis of cancer
  5. Patients must have normal heart, 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

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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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