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Sponsors and Collaborators: |
Spanish Breast Cancer Research Group Eli Lilly and Company |
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 |
Breast Cancer Neoplasm Metastasis |
Drug: gemcitabine |
Phase III |
Genetics Home Reference related topics: | breast cancer |
MedlinePlus related topics: | Breast Cancer Cancer |
ChemIDplus related topics: | Vinorelbine Vinorelbine tartrate Gemcitabine hydrochloride Gemcitabine |
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 |
Spanish Breast Cancer Research Group |
Eli Lilly and Company |
Study Chair: | Miguel Martín, MD. PhD. | Spanish Breast Cancer Research Group (GEICAM) |
"Click here for more information about this study GEICAM 2000-04 
  |
Study ID Numbers: | GEICAM 2000-04 |
First Received: | August 8, 2005 |
Last Updated: | February 6, 2007 |
ClinicalTrials.gov Identifier: | NCT00128310 |
Health Authority: | Spain: Spanish Agency of Medicines |
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