Trial Information

Summary: NSABP B-36 A clinical trial of adjuvant therapy comparing six cycles of 5-FU (5-Fluorouracil, Epirubicin and Cyclophosphamide (FEC) to four cycles of Adriamycin and Cyclophosphamide (AC) with or without Celecoxib, in patients with node-negative breast cancer.

This study is being done for patients who have been diagnosed with breast cancer that has not been found in any lymph nodes or anywhere else outside the breast tissue. The chance that the cancer will spread depends on how large it was, its appearance under a microscope and other tests that may have been preformed. Chemotherapy may decrease the chance of the cancer returning.

This study is being done to find out if 6 treatments of one combination of chemotherapy drugs 5-fluorouracil (5-FU), ellence (epirubicin) and cytoxan (cyclophosphamide) is better at treating the cancer than 4 treatments of a standard combination of chemotherapy drugs adriaymcin (doxorubicin) and cyclophosphamide. 5-FU, epirubicin and cyclophosphamide are one of the several combinations used for women with positive nodes but the combination has not been evaluated in women with negative nodes. This study is also being done to find out if adding the arthritis medicine Celebrex to your treatment will help prevent the cancer from coming back. Celecoxib acts by reducing the activity of an enzyme called COX-2. COX-2 has been associated with cancer cell growth in certain types of cancer, including breast cancer. Blocking the activity of this enzyme may reduce the chance of the breast cancer occurring again and may also reduce the chance of developing another type of cancer.

Eligibility Criteria:

• Primary breast tumor must be T1-3
• Lymph nodes must be negative
• Must have had either a lumpectomy or total mastectomy
• No clinical or radiologic evidence of metastatic disease

If you would like to learn more about participating in this study, please send an e-mail message using the form below.