tAnGo: A randomized phase III trial of gemcitabine (gem) in paclitaxel-containing, epirubicin/cyclophosphamide-based, adjuvant chemotherapy (CT) for women with early-stage breast cancer (EBC)

506 Background: After gem showed encouraging activity in advanced BC and pre-clinical evidence of a favorable interaction with paclitaxel, tAnGo was designed to evaluate, for the first time, its potential role in anthracycline and taxane containing adjuvant CT for EBC. Methods: tAnGo, an international phase III trial, compared EC-GT (4 cycles of epirubicin 90mg/m2 IV and cyclophosphamide 600mg/m2 IV day1 every (q) 3 weeks, followed by 4 cycles of paclitaxel 175mg/m2/3hour infusion day1 and gem 1,250mg/m2 IV days1 and 8 q3 weeks) with EC-T, in respect of disease-free survival (DFS) in women with invasive higher risk EBC, with definite indication for adjuvant CT. Stratification was by country, age, radiotherapy, and nodal, estrogen (ER) & HER2 status. Toxicity, dose delivery and QoL, presented at ASCO'04 and SABCS'06, showed both regimens to be safe, feasible and tolerable. We anticipated 550 DFS events at the preplanned primary endpoint efficacy analysis at 30 months (m) minimum follow-up (FU). Results: Be...