Docetaxel vs. Docetaxel-Gemcitabine in Breast Cancer
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
Randomized,non-blinded,multi-center study in patients with metastatic breast cancer.Patients will be treated with docetaxel or docetaxel-gemcitabine.
Aim of the study is to assess the optimal dosage and safety in this setting.
Enrollment
Sex
Ages
Volunteers
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
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any prior systematic chemotherapy for metastatic breast cancer
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expected survival time less than 12 weeks
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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
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known brain metastases/leptomeningeal involvement
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active uncontrolled infection
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symptomatic peripheral neuropathy > grade 2 according to NCI
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patients whose lesions are assessable only by radionuclide scan or patients with sclerotic bone lesions as the only site of disease
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concomitant illness that is contraindication to the use of corticosteroids
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other concomitant serious illness or medical condition, which may worsen due to the treatment
Trial design
Primary purpose
Allocation
Interventional model
Masking
237 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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