FAC Versus FAC Plus Weekly Paclitaxel as Adjuvant Treatment of Node Negative High Risk Breast Cancer Patients

Summary

This is a prospective, open-label, randomized, phase III trial. Patients will be stratified after breast surgery, as per investigational site; menopausal status; node negative diagnosis, as per sentinel-node technique versus lymphadenectomy; hormone receptor status (positive versus negative).

Timeline

Start

2003-09-19

Primary completion

2013-10-01

Completion

2013-10-01

Outcome

Met primary endpoint

paper 93% and 90.3% of patients receiving FAC-wP or FAC regimens, respectively, remained disease free PMID 23733779 ↗

paper hazard ratio [HR], 0.73; 95% CI, 0.54 to 0.99; log-rank P = .04 PMID 23733779 ↗

Publications

• Results Martin M, Ruiz A, Ruiz Borrego M, Barnadas A, Gonzalez S, Calvo L, Margeli Vila M, Anton A, Rodriguez-Lescure A, Segui-Palmer MA, Munoz-Mateu M, Dorca Ribugent J, Lopez-Vega JM, Jara C, Espinosa E, Mendiola Fernandez C, Andres R, Ribelles N, Plazaola A, Sanchez-Rovira P, Salvador Bofill J, Crespo C, Carabantes FJ, Servitja S, Chacon JI, Rodriguez CA, Hernando B, Alvarez I, Carrasco E, Lluch A. Fluorouracil, doxorubicin, and cyclophosphamide (FAC) versus FAC followed by weekly paclitaxel as adjuvant therapy for high-risk, node-negative breast cancer: results from the GEICAM/2003-02 study. J Clin Oncol. 2013 Jul 10;31(20):2593-9. doi: 10.1200/JCO.2012.46.9841. Epub 2013 Jun 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Paclitaxel	Small molecule	100 mg/m2	—
Background	Cyclophosphamide	Other / unclassified	500 mg/m2	—
Background	Doxorubicin	Other / unclassified	50 mg/m2	—
Background	fluorouracil	Small molecule	500 mg/m2	—

Indications