Epirubicin in Treating Women Who Are Undergoing Surgery for Stage I, Stage II, or Stage III Breast Cancer

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy, such as epirubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving epirubicin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well epirubicin works in treating women who are undergoing surgery for stage I, stage II, or stage III breast cancer.

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

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Epirubicin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed invasive breast cancer

• Stage I, II, or III disease (T1, T2, or T4; N0-2; M0)

• Resectable disease

• Unidimensionally measurable disease

• Primary tumor ≥ 2 cm

• No known distant metastases

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Sex

• Female

Menopausal status

• Not specified

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• WBC ≥ 3,500/mm^3

• Hemoglobin ≥ 8 g/dL

• Platelet count ≥ 100,000/mm^3

• No known untreated bleeding diathesis

Hepatic

• AST ≤ 2 times upper limits of normal

• Bilirubin ≤ 1.5 mg/dL

Renal

• Creatinine ≤ 1.5 mg/dL OR

• Creatinine clearance ≥ 60 mL/min

Cardiovascular

• LVEF ≥ 50% on echocardiogram, MUGA, or cardiac catheterization

Other

• Not pregnant or breastfeeding

• Fertile patients must use effective contraception

• Negative pregnancy test

• No concurrent illness that would preclude study treatment

• No known hypersensitivity to Escherichia coli-derived proteins, pegfilgrastim, filgrastim (G-CSF), or any other component of these products

PRIOR CONCURRENT THERAPY: Not specified