Breast Cancer Clinical Trial
Official title:
Prediction of Response or Resistance to Dose Intensified Pre-Operative Epirubicin Therapy of Operable Breast Cancer
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.
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.
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