Docetaxel in Treating Older Women With Metastatic Breast Cancer
Breast Cancer

About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring stage IV breast cancer, recurrent breast cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the breast Metastatic disease Measurable disease by CT scan or MRI Requires first-line chemotherapy for metastatic disease Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age 70 and over Sex Female Menopausal status Not specified Performance status Meets both of the following criteria: Lawton's Instrumental Activities of Daily Living score ≥ 4 Katz's Activities of Daily Living score ≥ 4 Life expectancy More than 3 months Hematopoietic Hemoglobin > 10 g/dL Neutrophil count > 1,500/mm^3 Platelet count > 100,000/mm^3 Hepatic ALT and AST < 1.5 times normal Bilirubin normal Alkaline phosphatase < 2.5 times normal Renal Creatinine clearance > 30 mL/min Cardiovascular No congestive heart failure No unstable angina pectoris No myocardial infarction within the past year No uncontrolled hypertension No high-risk uncontrolled arrhythmias Other Geriatric Depression Score < 12 No active uncontrolled infection No active peptic ulcer No uncontrolled diabetes mellitus No inflammatory bowel disease No history of hypersensitivity to docetaxel or drugs formulated with polysorbate 80 No history of significant neurologic or psychiatric disorders, including psychotic disorders, dementia, or seizures, that would preclude giving informed consent No familial, social, geographical, or psychological condition that would preclude study follow-up No definite contraindication to corticosteroids No other serious illness or medical condition No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy No prior or concurrent trastuzumab (Herceptin^®) Chemotherapy Prior neoadjuvant or adjuvant chemotherapy for breast cancer allowed More than 2 years since prior docetaxel or paclitaxel No other concurrent chemotherapy Endocrine therapy No more than 1 prior hormonal therapy regimen for metastatic disease At least 10 days since prior hormonal therapy No concurrent hormonal therapy No concurrent chronic corticosteroids Concurrent low-dose corticosteroids (≤ 20 mg/day of methylprednisolone or equivalent) allowed provided treatment was initiated > 6 months before study entry Radiotherapy Not specified Surgery Not specified Other More than 30 days since prior active treatment on another clinical trial Concurrent bisphosphonates allowed for bone metastases, osteoporosis, or osteopenia No other concurrent anticancer therapy No other concurrent investigational drugs
Sites / Locations
- Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
- Institut Curie Hopital
- Centre Henri Becquerel
- C.H. Senlis
- Institut Gustave Roussy
- Istituto Nazionale Di Riposo e Cura per Anziani
- Clinique De Genolier