- 2026-06-10
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology 44(17)
- Hong-Fei Gao
- Guo-Lin Ye
- Ying Lin
- Qin Huang
- Jie Dong
- Yin Cao
- Yan-Xia Zhao
- Qian-Jun Chen
- Shi-Hui Ma
- Jie Ouyang
- Jin-Hui Ye
- Hua-Wei Yang
- Yuan-Qi Zhang
- Yong-Cheng Zhang
- Gang-Ling Zhang
- Wei Li
- Yunjian Zhang
- Zhi-Yong Wu
- Ying-Yi Lin
- Teng Zhu
- Liu-Lu Zhang
- Ci-Qiu Yang
- Mei Yang
- Hao Peng
- Bo Chen
- Yi-Tian Chen
- Fei Ji
- Min-Yi Cheng
- Jie-Qing Li
- Zefei Jiang
- Kun Wang
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Sample size
- n = 774
- Population
- women age 18 years or older with previously untreated, stage II and III, HER2-positive invasive breast cancer
- Methods
- Multicenter, randomized, phase III, noninferiority study comparing six 3-week cycles of TCbHP (taxane plus trastuzumab and pertuzumab with carboplatin) vs THP (taxane plus trastuzumab and pertuzumab without carboplatin)
- Blinding
- Open-label
- Duration
- six 3-week cycles
- Funding
- Unclear
Purpose
The neoCARHP aimed to investigate the efficacy and safety of investigator-selected taxane (docetaxel, paclitaxel, or nab-paclitaxel) plus trastuzumab and pertuzumab, with carboplatin (TCbHP) or without carboplatin (THP), in stage II and III human epidermal growth factor receptor 2 (HER2)-positive breast cancer.Methods
The neoCARHP was a multicenter, randomized, phase III, noninferiority study. Eligible patients were women age 18 years or older with previously untreated, stage II and III, HER2-positive invasive breast cancer. Patients were randomly assigned (1:1) to receive six 3-week cycles of TCbHP or THP. The primary end point was pathologic complete response (pCR) rate in the breast and axilla (ypT0/is ypN0) in the modified intention-to-treat (mITT) population (all randomly assigned patients receiving at least one dose of study treatment). Safety was evaluated in all patients who received any study treatment.Results
Between April 30, 2021, and August 27, 2024, 774 patients were randomly assigned and 766 were included in the mITT population (382 in THP and 384 in TCbHP). pCR was achieved in 245 (64.1% [95% CI, 59.1 to 69.0]) patients in the THP group and 253 (65.9% [60.9-70.6]) in the TCbHP group (absolute difference, -1.8% [95% CI, -8.5 to 5.0]; odds ratio, 0.93 [95% CI, 0.69 to 1.25]; Pnoninferiority = .0089). The THP group had fewer grade 3 and 4 adverse events (20.7% v 34.6%) and serious adverse events (1.3% v 4.7%) than the TCbHP group. The most common grade 3 and 4 adverse events with THP were neutropenia (6.8% v 16.4% with TCbHP), leukopenia (5.5% v 14.8%), and diarrhea (2.6% v 4.2%). No treatment-associated deaths occurred.Conclusion
THP provided noninferior pCR rates and improved tolerability compared with TCbHP. Omitting carboplatin may be applicable in HER2-positive breast cancer.