Cytoxan, Epirubicin and Capecitabine in Women With Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00146588
• Other study ID #: 02-036
• Status: Completed
• Phase: N/A
• First received: September 6, 2005
• Last updated: March 23, 2015
• Start date: April 2002
• Est. completion date: December 2004

Study information

• Verified date: October 2014
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Cyclophosphamide
Intravenously on day 1 of each 21-day treatment cycle for 12-18 weeks depending upon response.
• Epirubicin
Intravenously on day 1 of each 21-day treatment cycle for 12-18 weeks depending upon response.
• Capecitabine
Given orally on days 4-17 of each 21-day treatment cycle for 12-18 weeks depending upon response.

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (6)

Lead Sponsor	Collaborator
Craig A. Bunnell, MD, MPH	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Dana-Farber Cancer Institute, Massachusetts General Hospital, Pharmacia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the feasibility of administering cytoxan, epirubicin, and capecitabine to women with Stage I/II/IIIA breast cancer.		2 years	No