Phase 3 trial of addition of carboplatin to neoadjuvant taxane-trastuzumab-pertuzumab for HER2-positive breast cancer

The multicenter phase 3 noninferiority neoCARHP trial in China investigated the efficacy and safety of neoadjuvant investigator-selected taxane (docetaxel, paclitaxel, or nab-paclitaxel) plus trastuzumab and carboplatin (TCbHP) or without carboplatin (THP) for previously untreated stage II and III HER2-positive breast cancer. A total of 774 patients were randomized and 766 were included in the modified intention-to-treat population (382 in THP and 384 in TCbHP). The primary endpoint was pathologic complete response (pCR) rate in breast and axilla. pCR was achieved in 64.1% of patients with the THP group and 65.9% of patients in the TCbHP group (p for noninferiority = 0.0089). The THP group had fewer grade 3 and 4 adverse events (20.7% versus 34.6%) and serious adverse events (1.3% versus 4.7%) than the TCbHP group. The authors conclude that THP provided noninferior pCR rates and improved tolerability compared with TCbHP. Omitting carboplatin may be applicable in HER2-positive breast cancer.