NCT00191243
Completed
Phase 2
A Randomized Phase II Study Comparing Single-Agent Docetaxel to Alternating Docetaxel-Gemcitabine as Primary Chemotherapy in Patients With Metastatic Breast Cancer
Overview
- Phase
- Phase 2
- Intervention
- Gemcitabine
- Conditions
- Breast Cancer
- Sponsor
- Eli Lilly and Company
- Enrollment
- 237
- Locations
- 1
- Primary Endpoint
- Time to treatment failure (TTTF)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
B
Intervention: Gemcitabine
A
Intervention: Gemcitabine
A
Intervention: docetaxel
B
Intervention: docetaxel
Outcomes
Primary Outcomes
Time to treatment failure (TTTF)
Time Frame: baseline to stopping treatment
Secondary Outcomes
- Duration of response(time of response to progressive disease)
- Overall survival(baseline to date of death from any cause)
- Time to progressive disease(baseline to measured progressive disease)
- Response rate(baseline to measured progressive disease)
Study Sites (1)
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