Neoadjuvant Taxane Plus Trastuzumab and Pertuzumab With or Without Carboplatin in Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: The Randomized Noninferiority Phase III neoCARHP Trial
Abstract
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]; P noninferiority = .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.
Article Details
Journal Info
Journal of Clinical Oncology
Lippincott Williams & Wilkins
Authors (31)
Hong-Fei Gao
Department of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, China
Guo-Lin Ye
Department of Breast Surgery, The First People's Hospital of Foshan, Foshan, China
Ying Lin
Induced Proximity Platform, Amgen Research
Qin Huang
Department of Cardiology, Children’s Hospital of Fudan University (Xiamen Branch), Xiamen, China
Jie Dong
Yin Cao
Yan-Xia Zhao
State Key Laboratory for Structural Chemistry of Unstable and Stable Species
Qian-Jun Chen
State Key Laboratory of Traditional Chinese Medicine Syndrome, Guangdong Provincial Key Laboratory of Clinical Research on Traditional Chinese Medicine Syndrome, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China
Shi-Hui Ma
Breast Central Region 1, Zhongshan City People's Hospital, Zhongshan, China
Jie Ouyang
1School of Biomedical Sciences, Hunan University, Changsha, China
Jin-Hui Ye
Breast Oncology Department, The First People's Hospital of Zhaoqing, Zhaoqing, Guangdong, China
Hua-Wei Yang
Yuan-Qi Zhang
Breast Surgery, Affiliated Hospital of Guangdong Medical University, Zhanjiang, China
Yong-Cheng Zhang
The First Affiliated Hospital/The First Clinical Medicine School of Guangdong Pharmaceutical University, Guangzhou, China
Gang-Ling Zhang
Breast Center, Baotou Cancer Hospital, Baotou, China
Wei Li
Yunjian Zhang
Zhi-Yong Wu
Diagnosis and Treatment Center of Breast Diseases, Shantou Central Hospital, Shantou, China
Ying-Yi Lin
School of Medicine, South China University of Technology, Guangzhou, China
Teng Zhu
Department of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, China
Liu-Lu Zhang
Department of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, China
Ci-Qiu Yang
Department of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, China
Mei Yang
College of Chemistry
Hao Peng
State Key Laboratory of Physical Chemistry of Solid Surfaces, Department of Chemistry
Bo Chen
Yi-Tian Chen
Department of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, China
Fei Ji
Min-Yi Cheng
Department of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, China
Jie-Qing Li
Department of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, China
Zefei Jiang
Department of Breast Cancer, Fifth Medical Center of People’s Liberation Army General Hospital, Beijing
Kun Wang
Beijing National Laboratory for Molecular Science, State Key Laboratory of Rare Earth Materials Chemistry and Applications, College of Chemistry and Molecular Engineering