NCT00146588

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Craig A. Bunnell, MD, MPH · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

* 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.

Conditions

• Breast Cancer
• Stage I Breast Cancer
• Stage II Breast Cancer
• Stage IIIA Breast Cancer

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Intravenously on day 1 of each 21-day treatment cycle for 12-18 weeks depending upon response.
DRUG	Epirubicin	Intravenously on day 1 of each 21-day treatment cycle for 12-18 weeks depending upon response.
DRUG	Capecitabine	Given orally on days 4-17 of each 21-day treatment cycle for 12-18 weeks depending upon response.

Timeline

• Start date: 2002-04-01
• Primary completion: 2004-12-01
• Completion: 2004-12-01
• First posted: 2005-09-07
• Last updated: 2015-03-24

Locations

2 sites across 1 country: United States