Cytoxan, Epirubicin and Capecitabine in Women With Breast Cancer

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: Cyclophosphamide
* Drug: Epirubicin
* Drug: Capecitabine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cytoxan, Breast cancer, epirubicin, capecitabine