Cytoxan, Epirubicin and Capecitabine in Women With Breast Cancer

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Craig A. Bunnell, MD, MPH
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Dana-Farber Cancer Institute; Massachusetts General Hospital; Pharmacia
• Treatments: Capecitabine; Cyclophosphamide; Epirubicin

Criteria

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