Breast Cancer
Conditions
Keywords
stage II breast cancer, stage I breast cancer, stage IIIA breast cancer, stage IIIB breast cancer
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.
Interventions
BIOLOGICALpegfilgrastim
6 mg in a syringe
DRUGepirubicin hydrochloride
120 MG q 2 weeks for 4 cycles
PROCEDUREconventional surgery
to remove small piece of cancer
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 120 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed