Phase I/II of Capecitabine and Vinorelbine in Elderly Patients (At Least 65 Years) With Metastatic Breast Cancer With or Without Bone Involvement

Date de début de l'étude : 1 mars 1999

DISEASE CHARACTERISTICS: Histologically or cytologically proven adenocarcinoma of the breast Phase I: Measurable or evaluable disease Phase II: Bidimensionally measurable disease No CNS metastases Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 65 and over Sex: Female Menopausal status: Postmenopausal Performance status: ECOG/SAKK 0-2 Life expectancy: At least 12 weeks Hematopoietic: Normal peripheral blood counts Hepatic: AST no greater than 2 times upper limit of normal (ULN) (no greater than 3 times ULN if liver metastases present) Renal: Creatinine no greater than 1.5 times ULN Other: No other prior or concurrent malignancy except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix No peripheral neuropathy grade 2 or higher No cognitive impairment or severe psychiatric disorder PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: More than 6 months since prior adjuvant chemotherapy No prior chemotherapy for metastatic or locally advanced disease No other concurrent chemotherapy Endocrine therapy: Prior hormonal therapy for metastatic disease allowed No continuous concurrent steroids No concurrent systemic endocrine therapy for breast cancer No other concurrent endocrine therapy Radiotherapy: No concurrent radiotherapy involving greater than 30% of bone marrow or mucosa Radiotherapy to nonindicator lesion allowed Surgery: Not specified Other: Bisphosphonates allowed if indicator lesion in nonbone site