Epirubicin in Treating Women Who Are Undergoing Surgery for Stage I, Stage II, or Stage III 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.
Drug: epirubicin hydrochloride
Procedure: conventional surgery
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prediction of Response or Resistance to Dose Intensified Pre-Operative Epirubicin Therapy of Operable Breast Cancer|
- Complete pathological response rate by tumor analysis after surgery [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]No evidence of microscopic invasive tumor at the primary tumor site in the surgical specimen.
- Complete clinical response rate by diagnostic mammogram at baseline and at 8 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]Bilateral (if both breasts are present) Mammograms (within 4 weeks of study entry)
- Toxicity by physical exam and medical history every 14 days prior to surgery [ Time Frame: 2-4 weeks ] [ Designated as safety issue: Yes ]A physical exam Physical examination with recording of tumor size, if palpable.
- Predictive value of HER2 gene amplification and topoisomerase II-alpha gene amplification or deletions for pathologic complete response, clinical complete response or disease progression after surgery [ Time Frame: 5 years ] [ Designated as safety issue: No ]Patients whose tumors are positive for estrogen receptor (>1% staining by immunohistochemistry) or progesterone receptor (institutional definition) should receive post-operative hormonal therapy for 5 years.
- Gene expression after surgery [ Time Frame: 5 years ] [ Designated as safety issue: No ]Patients whose tumors are positive for estrogen receptor (>1% staining by immunohistochemistry) or progesterone receptor (institutional definition) should receive post-operative hormonal therapy for 5 years.
|Study Start Date:||June 2002|
|Study Completion Date:||December 2010|
|Primary Completion Date:||September 2005 (Final data collection date for primary outcome measure)|
6 mg in a syringe
Other Name: NeulastaDrug: epirubicin hydrochloride
120 MG q 2 weeks for 4 cyclesProcedure: conventional surgery
to remove small piece of cancer
Other Name: Biopsy will involve a small surgical incision to remove a piece of the 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00253500
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44195-9001|
|Study Chair:||George T. Budd, MD||Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|