Prediction of Response or Resistance to Dose Intensified Pre-Operative Epirubicin Therapy of Operable Breast Cancer
- 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.
- 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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete pathological response rate by tumor analysis after surgery
No evidence of microscopic invasive tumor at the primary tumor site in the surgical specimen.
George T. Budd, MD
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
United States: Food and Drug Administration
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Cleveland, Ohio 44195|