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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00146588

Enrollment

Registered

2005-09-07

Start date

2002-04-30

Completion date

2004-12-31

Last updated

2015-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer

Keywords

Breast cancer, cytoxan, epirubicin, capecitabine

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.

Interventions

DRUGCyclophosphamide

Intravenously on day 1 of each 21-day treatment cycle for 12-18 weeks depending upon response.

DRUGEpirubicin

Intravenously on day 1 of each 21-day treatment cycle for 12-18 weeks depending upon response.

DRUGCapecitabine

Given orally on days 4-17 of each 21-day treatment cycle for 12-18 weeks depending upon response.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026