Adjuvant gemcitabine for high-risk breast cancer (BC) patients: Final survival results of the randomized phase III SUCCESS-A study.

1010 Background: Gemcitabine (G) has shown to have a relevant single agent efficacy and to improve chemotherapy response to taxanes in advanced BC patients. Aim of this study was to evaluate the effect of G on disease free survival (DFS) in high risk adjuvant BC patients. Methods: This is a phase III, randomized, open label trial of FEC-Doc vs. FEC-DocG (3 cycles of FEC (500/100/500 mg/m²) followed by 3 cycles of docetaxel (Doc; 100mg/mg²) every three weeks (q3w) vs. 3 cycles of FEC followed by 3 cycles of G (1,000 mg/m² d1,8) and Doc (75 mg/m²) q3w). Key inclusion criteria: stage N1 or T2–T4 or grade 3 or age ≤ 35 or hormone receptor (ER/PR) negative. Key exclusion criteria: locally recurrent/metastatic disease; prior systemic therapy or radiotherapy for current BC. Strata for randomization: nodal, ER/PR, menopausal and HER2 status and grading. Primary and secondary study aims were DFS and overall survival (OS). Survival rates were estimated by the Kaplan-Meier method. Cox regression models were fitted t...