Neo-/Adjuvant Phase Iii Trial To Compare Intense Dose-Dense (Idd) Treatment With Enpc To Tailored Dose-Dense (Dt) Therapy With Dtec-Dtd For Patients With High-Risk Early Breast Cancer: Results On Pathological Complete Response (Pcr) For Patients Treated Within The Neoadjuvant Setting.

568Background: GAIN-2 compares the effectiveness and safety of a predefined idd regimen (EnPC) vs. a dd regimen with modification of single doses depending on individual hematological and non-hematological toxicities (dtEC-dtD) as neo-/adjuvant treatment for patients with high risk breast cancer (BC) (NCT01690702). Methods: Patients with high risk BC (HER2+; triple negative BC (TNBC); luminal B-like: ER and/or PgR+, HER2-, Ki67 u003e 20%, N+; luminal A-like: ≥4 N+) were randomized to receive either iddEnPC (epirubicin 150mg/m2 q2w, nab-Paclitaxel 330mg/m2 q2w, cyclophosphamide 2000mg/m2 q2w for 3 cycles each) or dtEC-dtD (epirubicin 60-100mg/m2 and cyclophosphamide 450-1200mg/m2 q2w for 4 cycles followed by docetaxel 60-100mg/m2 q2w for 4 cycles). The primary objective of the trial is to compare the invasive disease-free survival (iDFS) between the two arms. pCR rates in the breast per arm (ypT0) in the neoadjuvant cohort will be reported. Results: In total the GAIN-2 trial accrued 2887 patients. From 08/2016...