Epirubicin in Treating Women Who Are Undergoing Surgery for Stage I, Stage II, or Stage III Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00253500
- Lead Sponsor
- Case Comprehensive Cancer Center
- 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 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.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 15
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Epirubicin pegfilgrastim - Epirubicin epirubicin hydrochloride - Epirubicin conventional surgery -
- Primary Outcome Measures
Name Time Method Complete pathological response rate by tumor analysis after surgery 4 weeks No evidence of microscopic invasive tumor at the primary tumor site in the surgical specimen.
- Secondary Outcome Measures
Name Time Method Complete clinical response rate by diagnostic mammogram at baseline and at 8 weeks 4 weeks Bilateral (if both breasts are present) Mammograms (within 4 weeks of study entry)
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 5 years 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.
Toxicity by physical exam and medical history every 14 days prior to surgery 2-4 weeks A physical exam Physical examination with recording of tumor size, if palpable.
Gene expression after surgery 5 years 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.
Trial Locations
- Locations (1)
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States