• Li Chen, Hui Li, Hao Zhang, Huawei Yang, Jun Qian, Zhihua Li, Yu Ren, Shu Wang, Peifen Fu, Hongjian Yang, Yunjiang Liu, Jing Sun, Jianyun Nie, Ruiwen Lei, Yongzhong Yao, Anqin Zhang, Shouman Wang, Xiaopeng Ma, Zhong Ouyang, Hongwei Yang, Song-Yang Wu, Shuo-Wen Cao, Kun Wang, Aimei Jiang, Quchang Ouyang, Da Pang, Limin Wei, Xiaoming Zha, Yu Shen, Xiangwen Qu, Fei Wu, Xiaoyu Zhu, Zhonghua Wang, Lei Fan, and Zhi-Ming Shao.
• Department of Breast Surgery, Fudan University Shanghai Cancer Center and Key Laboratory of Breast Cancer in Shanghai.
• JAMA. 2024 Dec 13.

ImportancePreferred neoadjuvant strategies for early or locally advanced triple-negative breast cancer include a 4-drug chemotherapy regimen containing anthracyclines, cyclophosphamide, taxanes, and platinum. Blockade of the programmed death receptor 1/ligand-1 (PD-1/PD-L1) pathway may improve efficacy of classic neoadjuvant chemotherapy. Camrelizumab, an anti-PD-1 antibody, has showed antitumor activity in advanced triple-negative breast cancer.ObjectiveTo evaluate the efficacy and adverse events of camrelizumab plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy for patients with early or locally advanced triple-negative breast cancer.Design, Setting, And ParticipantsThis randomized, double-blind, phase 3 trial enrolled patients from 40 hospitals in China between November 25, 2020, and May 12, 2023 (data cutoff: September 30, 2023). A total of 441 eligible patients were enrolled.InterventionsPatients were randomized in a 1:1 ratio to receive either camrelizumab 200 mg (n = 222) or placebo (n = 219) combined with chemotherapy every 2 weeks. The chemotherapy included nab-paclitaxel (100 mg/m2) and carboplatin (area under the curve, 1.5) on days 1, 8, and 15 in 28-day cycles for the first 16 weeks followed by epirubicin (90 mg/m2) and cyclophosphamide (500 mg/m2) every 2 weeks for 8 weeks.Main Outcomes And MeasuresThe primary end point was pathological complete response (defined as no invasive tumor in breast and lymph nodes [ypT0/Tis ypN0]).ResultsAmong 441 females randomized (median age, 48 years), the median (range) follow-up duration from randomization was 14.4 (0.0-31.8) months. Pathological complete response was achieved in 126 patients (56.8% [95% CI, 50.0%-63.4%]) in the camrelizumab-chemotherapy group and 98 patients (44.7% [95% CI, 38.0%-51.6%]) in the placebo-chemotherapy group (rate difference, 12.2% [95% CI, 3.3%-21.2%]; 1-sided P = .004). In the neoadjuvant phase, adverse events of grade 3 or higher occurred in 198 patients (89.2%) in the camrelizumab-chemotherapy group and 182 (83.1%) in the placebo-chemotherapy group; serious adverse events occurred in 77 patients (34.7%) in the camrelizumab-chemotherapy group and 50 (22.8%) in the placebo-chemotherapy group, with fatal adverse events occurring in 2 patients (0.9%) in the camrelizumab-chemotherapy group.Conclusions And RelevanceAmong patients with early or locally advanced triple-negative breast cancer, the addition of camrelizumab to neoadjuvant chemotherapy significantly improved pathological complete response.Trial RegistrationClinicalTrials.gov Identifier: NCT04613674.

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