Cytoxan, Epirubicin and Capecitabine in Women With Breast Cancer

Completed · Not applicable

Conditions studied: Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer

In brief

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.

Key facts

Study ID

NCT00146588

Run by

Craig A. Bunnell, MD, MPH

People needed

55

Starts

2002-04-01

Expected to finish

2004-12-01

Last updated by the study team

2015-03-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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