A Randomized Phase II Study Comparing Single-Agent Docetaxel to Alternating Docetaxel-Gemcitabine as Primary Chemotherapy in Patients With Metastatic Breast Cancer
Inclusion Criteria:
- histologically verified diagnosis of breast carcinoma, at first diagnosis
- restricted previous adjuvant chemotherapy (completed >6 months prior the study)
- measurable and/or non-measurable disease
- previous radiotherapy is allowed if:terminated at least 10 days prior the sudy
therapy, at least one target lesion for evaluation of tumor response has not been
irradiated
- performance status 0-2 (WHO, Zubrod)
- adequate bone marrow reserve defined
- adequate liver / renal functions defined
Exclusion Criteria:
- any prior systematic chemotherapy for metastatic breast cancer
- expected survival time less than 12 weeks
- past or current history of malignant neoplasm other than breast carcinoma
- except for cured non-melanoma skin cancer or curatively treated in situ
carcinoma of the cervix uteri
- known brain metastases/leptomeningeal involvement
- active uncontrolled infection
- symptomatic peripheral neuropathy > grade 2 according to NCI
- patients whose lesions are assessable only by radionuclide scan or patients with
sclerotic bone lesions as the only site of disease
- concomitant illness that is contraindication to the use of corticosteroids
- other concomitant serious illness or medical condition, which may worsen due to the
treatment