Cytoxan, Epirubicin and Capecitabine in Women With Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer; Stage I Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer

• Registration Number: NCT00146588
• Lead Sponsor: Craig A. Bunnell, MD, MPH

Brief 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.

Study Timeline

• Study Start: 2002-04
• Primary Completion: 2004-12
• Study Completion: 2004-12
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-07
• Status Verified: 2014-10
• Last Update Submitted: 2015-03-23
• Last Update Posted: 2015-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To determine the feasibility of administering cytoxan, epirubicin, and capecitabine to women with Stage I/II/IIIA breast cancer.	2 years

Trial Locations

Locations (2)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Center; 🇺🇸 Boston, Massachusetts, United States