TITAN: Ixabepilone versus weekly paclitaxel following doxorubicin/cyclophosphamide (AC) adjuvant chemotherapy in triple-negative breast cancer (TNBC): Preliminary toxicity of a Sarah Cannon Research Institute phase III trial.

1103 Background: Ixabepilone (Ixa) is a potent tubulin polymerizer active in taxane refractory and locally advanced breast cancer as well as in TNBC. The clinical activity and toxicity profile of Ixa are similar to the taxanes with neuropathy and myelosuppression as dose-limiting toxicities. We present the preliminary toxicity of Ixa compared to weekly paclitaxel (Pac) following AC x 4, performed as part of the data safety monitoring in this trial. Methods: Eligibility criteria: TNBC (defined as ER and PR <10% by IHC and HER2 IHC 0-1+ or FISH negative), node positive or node negative with any tumor size, post surgery with no evidence metastatic disease. Patients (pts) were randomized to AC (60/600mg/m2) q3wks x4 followed by Ixa (40mg/m2 q 3wks x4) or weekly Pac (80mg/m2 x12 weeks). Growth factor support was permitted. Analysis is based on the first 226 women completing therapy (AC/Ixa, 120; AC/Pac, 106). Results: Median pt age was 54 years; 36% lymph node positive; 50% T2; 88% ductal histology. 10 pts (8%...