Randomized Trial Comparing Standard Neoadjuvant Chemotherapy to Genomic Driven Chemotherapy Regimen in Patients With Breast Cancer
After a core biopsy, each tumor is profiled using Affymetrix U133plus2 gene expression
array. DLD30 score (Hess, JCO, 2006) and TOP2A expression are quantified. Patients are then
either treated with 4FEC followed by 4 docetaxel (standard arm) or by a genomic-driven
regimen (experiemental arm). In the experimental arm, patients with high DLD30 receive 3
months weekly paclitaxel followed by 4 FEC, patients with high TOP2A receive 4FEC then 4
docetaxel, patients with low DLD30 and low TOP2A are treated with 6 cycles of
docetaxel-capecitabine.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete response rate based on the histology
Tumoral assessment at 4 and 8 cycles
No
Florence LEREBOURS, MD
Principal Investigator
Centre René Huguenin
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
CSET1376
NCT01180335
January 2009
December 2011
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