Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, inflammatory breast cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed invasive adenocarcinoma of the breast, meeting any of the following criteria: T4, NX, M0 Any T, N2-N3, M0 Inflammatory breast cancer (redness over at least one-third of the breast), M0 No evidence of metastatic disease by chest x-ray, abdominal ultrasound or CT scan and bone scan Diagnosed within the past 8 weeks Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age 16 and over Sex Female Menopausal status Not specified Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Absolute granulocyte count at least 2,000/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 g/dL Hepatic Bilirubin less than upper limit of normal (ULN) Must meet criteria for 1 of the following: ALT and AST no greater than 1.5 times ULN AND alkaline phosphatase no greater than 2.5 times ULN ALT and AST normal AND alkaline phosphatase no greater than 5 times ULN Renal Creatinine no greater than 1.5 times ULN Cardiovascular Resting LVEF normal by MUGA or echocardiogram No congestive heart failure No angina pectoris No myocardial infarction within the past year No uncontrolled hypertension No uncontrolled arrhythmias Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective non-hormonal contraception No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix No symptomatic peripheral neuropathy grade 2 or greater No active infection No history of significant neurological or psychiatric disorders, including dementia or seizures No peptic ulcer No unstable diabetes mellitus No contraindication to dexamethasone No known sensitivity to E. coli-derived or polyethylene glycol products Willing to undergo core biopsies once prior to registration and core biopsies at 2 other timepoints while on study Geographically accessible for treatment and follow-up PRIOR CONCURRENT THERAPY: Biologic therapy No prior immunotherapy for breast cancer Chemotherapy No prior chemotherapy for breast cancer Endocrine therapy No prior hormonal therapy for breast cancer No concurrent corticosteroids except for premedication or hypersensitivity reaction No concurrent oral contraception Radiotherapy No prior radiotherapy for breast cancer Surgery No prior surgery for breast cancer other than biopsy Other No prior systemic therapy for breast cancer No other concurrent investigational drugs or anticancer treatment No concurrent preventative IV antibiotics
Sites / Locations
- CancerCare Manitoba
- Atlantic Health Sciences Corporation
- Odette Cancer Centre
- Univ. Health Network-Princess Margaret Hospital
- CHA-Hopital Du St-Sacrement
Arms of the Study
Arm 1
Experimental
Pegfilgrastim, docetaxel and epirubicin