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.
The primary endpoint of study-5-year disease-free survival (DFS) will be assessed by Kaplan Meier analysis. Secondary endpoints included overall survival and analysis of the prognostic and predictive value of clinical and molecular markers. Associations and interactions will be assessed with a multivariable Cox proportional hazards model for DFS for the following covariates: age, menopausal status, tumor size, lymph node status, type of chemotherapy, tumor size, positive lymph nodes, HER2 status, and hormone receptor status. All statistical tests will be two-sided.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,289
Hospital Universitario Virgen de los Lirios
Alcoy, Alicante, Spain
Hospital General Universitario de Elche
Elche, Alicante, Spain
Hospital General Universitario de Elda
Elda, Alicante, Spain
Hospital Municipal de Badalona
Badalona, Barcelona, Spain
Hospital Unviersitario Germans Trias i Pujol
Badalona, Barcelona, Spain
disease-free survival
From the date of randomization of each patient included to the 1st documented evidence of recurrence
Time frame: 5 years
Overall survival
Overall survival will be measured from the day of randomization to the date of death from any cause
Time frame: From date of randomization until the date of death from any cause, assessed up to 100 months
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Althaia-Xarxa Assistencial de Manresa
Manresa, Barcelona, Spain
Corporació Sanitaria Parc Taulí
Sabadell, Barcelona, Spain
Hospital Espíritu Santo
Santa Coloma de Gramenet, Barcelona, Spain
Hospital Universitario Mutua de Terrassa
Terrassa, Barcelona, Spain
Consorci Sanitari de Terrassa
Terrassa, Barcelona, Spain
...and 54 more locations