Neoadjuvant camrelizumab plus nab-paclitaxel and epirubicin in early triple-negative breast cancer: a single-arm phase II trial

Chengzheng Wang, Zhenzhen Liu (), Xiuchun Chen, Jianghua Qiao, Zhenduo Lu, Lianfang Li, Xianfu Sun, Chongjian Zhang, Xiayu Yue, Qingxin Xia, He Zhang and Min Yan
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Chengzheng Wang: The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Zhenzhen Liu: The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Xiuchun Chen: The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Jianghua Qiao: The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Zhenduo Lu: The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Lianfang Li: The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Xianfu Sun: The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Chongjian Zhang: The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Xiayu Yue: The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Qingxin Xia: The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
He Zhang: The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Min Yan: The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital

Nature Communications, 2023, vol. 14, issue 1, 1-8

Abstract: Abstract Immunotherapy combined with chemotherapy has been demonstrated to be effective in early triple-negative breast cancer (TNBC). In this single-arm, phase II study with Simon’s two-stage design, we investigated the efficacy and safety of neoadjuvant camrelizumab plus chemotherapy in patients with early TNBC (NCT04213898). Eligible female patients aged 18 years or older with histologically confirmed treatment-naïve early TNBC were treated with camrelizumab (200 mg, on day 1), nab-paclitaxel (125 mg/m2, on days 1, 8, and 15), and epirubicin (75 mg/m2, on day 1) every three weeks for six cycles. The primary end point was the pathological complete response; secondary endpoints included safety, objective response rate, and long-term survival outcomes of event-free survival, disease-free survival, and distant disease-free survival. A total of 39 patients were enrolled between January 2020 and October 2021. Twenty-five patients achieved a pathological complete response (64.1%, 95%CI: 47.2, 78.8). The objective response rate was 89.7% (95%CI: 74.8, 96.7), including 35 patients with partial responses. Treatment-related adverse events of grade 3 or 4 occurred in 30 (76.9%) patients. In conclusion, the trial meets the prespecified endpoints showing promising efficacy and manageable safety of neoadjuvant camrelizumab plus nab-paclitaxel and epirubicin chemotherapy in female patients with early TNBC. Long-term survival outcomes are still pending.

Date: 2023
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DOI: 10.1038/s41467-023-42479-w

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