Fluorouracil, Epirubicin, and Cyclophosphamide (FEC) Versus FEC Plus Paclitaxel as Adjuvant Treatment for Node Positive Breast Cancer Patients
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|ClinicalTrials.gov Identifier: NCT00129922|
Recruitment Status : Completed
First Posted : August 12, 2005
Last Update Posted : September 27, 2005
The efficacy of adjuvant chemotherapy is limited in patients with a high risk of recurrence.
Also, for axillary positive node patients, optimum chemotherapy regimens are still under discussion. Some previous studies suggest that, in the subset of node-positive patients, treatments based on sequential administration of anthracyclines and taxanes are more efficient. Paclitaxel dose-dense (weekly) administration renders an improved therapeutic index (activity/toxicity).
The study is designed to compare 6 courses of FEC scheme (600/90/600), a combination of proven efficacy in node positive breast cancer patients, versus 4 FEC courses followed by 8 weekly paclitaxel administrations (100mg/m2).
The study hypothesis is that 5-year disease-free survival in the control arm will be 60%. The investigators expect to increase this by 8% with the experimental treatment. With an alpha error of 0.05, 80% power, and a post-randomization estimated drop-out rate of 10%, 1250 patients are needed, 625 per arm.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: paclitaxel||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter Randomized Phase III Clinical Trial to Compare 6 Courses of FEC (Fluorouracil, Epirubicin and Cyclophosphamide) Vs. 4 Courses of FEC Followed by 8 Weekly Paclitaxel Administrations, as Adjuvant Treatment for Node Positive Operable Breast Cancer Patients|
|Study Start Date :||November 1999|
|Estimated Study Completion Date :||July 2007|
- 5-year disease-free survival
- Overall survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00129922
|Spanish Breast Cancer Research Group (GEICAM)|
|San Sebastián de los Reyes, Madrid, Spain, 28700|
|Study Chair:||Álvaro Rodríguez-Lescure, MD||Spanish Breast Cancer Research Group (GEICAM)|
|Study Chair:||José Manuel López-Vega, MD||Spanish Breast Cancer Research Group (GEICAM)|
|Study Chair:||Enrique Aranda, MD||Spanish Breast Cancer Research Group (GEICAM)|