Prediction of Response or Resistance to Dose Intensified Pre-Operative Epirubicin Therapy of Operable Breast Cancer
18 Years
N/A
Female
Breast Cancer
Trial Information
Prediction of Response or Resistance to Dose Intensified Pre-Operative Epirubicin Therapy of Operable Breast Cancer
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 epirubicin hydrochloride.
Secondary
- Determine the toxicity of this regimen in these patients.
- Determine the predictive value of HER2 gene amplification and topoisomerase II-alpha
gene amplification or deletion for disease progression and pathological and clinical
complete response in patients treated with this regimen.
- Correlate gene expression profiles with pathologic complete response, clinical complete
response, less than complete response, and disease progression in patients treated with
this regimen.
OUTLINE: Patients receive epirubicin hydrochloride IV on day 1 and pegfilgrastim
subcutaneously on day 2. Treatment repeats every 14 days for 4 courses in the absence of
disease progression or unacceptable toxicity. Four weeks later, patients undergo partial
mastectomy or simple mastectomy plus an axillary staging procedure.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Inclusion 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Complete pathological response rate by tumor analysis after surgery
Outcome Description:
No evidence of microscopic invasive tumor at the primary tumor site in the surgical specimen.
Outcome Time Frame:
4 weeks
Safety Issue:
No
Principal Investigator
George T. Budd, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
CASE3104
NCT ID:
NCT00253500
Start Date:
June 2002
Completion Date:
December 2010
Related Keywords:
- Breast Cancer
- stage II breast cancer
- stage I breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland, Ohio 44195 |
