Epirubicin, Docetaxel, and Capecitabine in Treating Women With Stage IIIA or Stage IIIB Breast Cancer

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy, such as epirubicin, docetaxel, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects of giving epirubicin together with docetaxel and capecitabine and to see how well it works in treating women with stage IIIA or stage IIIB breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: Capecitabine; Docetaxel; Epirubicin

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed breast cancer

• Stage IIIA or IIIB disease (T3 N1 M0, T4 N1 M0, any T N2/N3 M0)

• Bidimensionally measurable or evaluable disease

• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Menopausal status not specified

• ECOG performance status 0-2

• Platelet count ≥ 100,000 cells/μL

• Total bilirubin normal

• Hemoglobin ≥ 8.0 g/dL

• ANC ≥ 1,000 cells/μL

• AST and ALT ≤ 2.5 times upper limit of normal

• Creatinine clearance ≥ 50 mL/min and serum creatinine normal

• Life expectancy ≥ 3 months

• No uncontrolled infection

• No chronic debilitating disease

• No lack of physical integrity of the upper gastrointestinal tract

• Able to swallow tablets

• No malabsorption syndrome

• No clinically significant cardiac disease not well controlled with medication (e.g., congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias [New York Heart Association class III-IV heart disease] or myocardial infarction within the last 12 months)

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer or adequately treated other noninvasive carcinomas

• No peripheral neuropathy ≥ grade 1

PRIOR CONCURRENT THERAPY:

• More than 4 weeks since prior major surgery and recovered

• No prior chemotherapy regimens including adjuvant therapy

• No organ allograft

• No concurrent sorivudine or bruvidine

• No other concurrent cytostatic, cytotoxic, immunomodulating agents, or radiotherapy