Efficacy and safety analysis of trastuzumab and paclitaxel based regimen plus carboplatin or epirubicin as neoadjuvant therapy for clinical stage II-III, HER2-positive breast cancer patients: a phase 2, open-label, multicenter, randomized trial

摘要: This trial was designed to compare the efficacy and safety between epirubicin (E) carboplatin (C) in combination with paclitaxel (P) trastuzumab (H) neoadjuvant setting. In 13 Chinese cancer centers, 100 patients HER2-positive, locally advanced breast were 1:1 randomized receive medication as follows: weekly combined for PCH group, or every 3 weeks PEH group. Patients given 4 6 cycles of chemotherapy. The primary endpoint pathologic complete response (pCR) rate, which no significant difference regimen (39.1% vs. 48.8%; p=0.365). However, achieved higher pCR luminal-B (HER2-poitive) subgroup (55.0% 24.0%; p = 0.033), but not ERBB2+ (42.9% 57.1%; 0.355). showed a favorable PIK3CA mutated (69.2% vs.23.5%, p=0.012). No observed analysis TP53 mutation status, PTEN expression, FCGR2A SNP FCGR3A SNP. Both regimens chemotherapy achieve similar safety. might improve especially subtype subtype. is feasible less likely increase incidence acute cardiac events compared PCH.