Cytoxan, Epirubicin and Capecitabine in Women With Breast Cancer

A Pilot Study of Cytoxan, Epirubicin, and Capecitabine in Women With Stage I/II/IIIA Breast Cancer

The purpose of this study is to find out what effects (good and bad) a combination of cytoxan, epirubicin, and capecitabine have on women with Stage II/II/IIIA breast cancer.

• Each treatment cycle lasts 21 days and patients will participate in a least 4 cycles, but no more than 6 cycles of treatment.
• Patients will receive cytoxan (cyclophosphamide) and epirubicin intravenously on day 1 of each treatment cycle. On days 4-17 of each cycle, patients will take capecitabine orally twice a day.
• While on the study patients will be required to complete a diary of they capecitabine treatment.
• Blood tests will be performed each week along with surveys at the beginning of the trial and certain follow-up visits to evaluate the patient's experience with the oral chemotherapy.
• Patients will be on the treatment for 12-18 weeks depending upon whether or not the disease progresses or the patient develops inacceptable side effects.

Inclusion Criteria:

• Histologically confirmed Stage I-III breast cancer. If Stage I, should be deemed of sufficiently high risk of developing recurrent disease to warrant participation.
• 18 years of age or older
• ANC > 1,000/mm3
• Platelet count > 100,000/mm3
• Hemoglobin > 10
• Creatinine < 2.0
• SGOT < 2 x ULN
• Bilirubin < 1.5mg/dl
• Able to swallow and retain oral medication
• LVEF greater than or equal to 50%
• ECOG performance status of 0 or 1

Exclusion Criteria:

• Pregnant or lactating
• Prior malignancy within 5 years (excluding squamous or basal cell skin cancers)
• Prior chemotherapy within 5 years
• Prior anthracycline therapy
• Serious comorbid physical or psychological condition