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Sponsors and Collaborators: |
Spanish Breast Cancer Research Group Eli Lilly and Company |
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Information provided by: | Spanish Breast Cancer Research Group |
ClinicalTrials.gov Identifier: | NCT00128310 |
The investigators assume that progression-free survival mean time for patients treated with vinorelbine will be 3 months, and for patients treated with gemcitabine plus vinorelbine will be 5 months. That implies a reduction in risk ratio of 40% (Hazard ratio = 1,67). Assuming a bilateral alpha error of 0.05 and beta error of 10%, and the number of events needed if 60% of patients have progressed after 1 year, the number of patients needed per treatment arm is 114. Considering a 10% post-randomization drop-out, the final number of patients is 252 (126 per arm).
Condition | Intervention | Phase |
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Breast Cancer Neoplasm Metastasis |
Drug: gemcitabine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized Phase III Trial Comparing Vinorelbine vs. Gemcitabine Plus Vinorelbine in Patients With Advanced Breast Cancer, Previously Treated With Anthracyclines and Taxanes |
Estimated Enrollment: | 252 |
Study Start Date: | January 2001 |
Estimated Study Completion Date: | October 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Spain, Madrid | |
Spanish Breast Cancer Research Group (GEICAM) | |
San Sebastián de los Reyes, Madrid, Spain, 28700 | |
Venezuela | |
Grupo Andino de Investigación en Oncología (GAICO) | |
Valencia, Venezuela |
Study Chair: | Miguel Martín, MD. PhD. | Spanish Breast Cancer Research Group (GEICAM) |
Study ID Numbers: | GEICAM 2000-04 |
Study First Received: | August 8, 2005 |
Last Updated: | February 6, 2007 |
ClinicalTrials.gov Identifier: | NCT00128310 |
Health Authority: | Spain: Spanish Agency of Medicines |
Drug-resistant metastatic breast cancer |
Vinorelbine Skin Diseases Neoplasm Metastasis Breast Neoplasms |
Gemcitabine Taxane Breast Diseases |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Immunosuppressive Agents |
Antiviral Agents Pharmacologic Actions Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes Radiation-Sensitizing Agents Therapeutic Uses Antineoplastic Agents, Phytogenic |