Status:
COMPLETED
Epirubicin in Treating Women Who Are Undergoing Surgery for Stage I, Stage II, or Stage III Breast Cancer
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-120 years
Phase:
PHASE2
Brief 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 be...
Detailed Description
OBJECTIVES: Primary * Determine the complete pathological and clinical response rate in women undergoing surgery for resectable stage I-III breast cancer treated with neoadjuvant dose-intensified ep...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00253500
Start Date
June 1 2002
End Date
December 1 2010
Last Update
July 24 2020
Active Locations (1)
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1
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195-9001