A multicentre single arm phase 2 trial of neoadjuvant pyrotinib and letrozole plus dalpiciclib for triple-positive breast cancer

Nan Niu, Fang Qiu, Qianshi Xu, Guijin He, Xi Gu, Wenbin Guo, Dianlong Zhang, Zhigao Li, Yi Zhao, Yong Li, Ke Li, Hao Zhang, Peili Zhang, Yuanxi Huang, Gangling Zhang, Hongbin Han, Zhengang Cai, Pengfei Li, Hong Xu, Guanglei Chen, Jinqi Xue, Xiaofan Jiang, Alireza Hamidian Jahromi, Jinshi Li, Yu Zhao, Eduardo Faria Castro Fleury, Shiwen Huo, Huajun Li, Guy Jerusalem, Domenico Tripodi, Tong Liu (), Xinyu Zheng () and Caigang Liu ()
Additional contact information
Nan Niu: Shengjing Hospital of China Medical University
Fang Qiu: Shengjing Hospital of China Medical University
Qianshi Xu: Shengjing Hospital of China Medical University
Guijin He: Shengjing Hospital of China Medical University
Xi Gu: Shengjing Hospital of China Medical University
Wenbin Guo: Affiliated Hospital of Dalian Medical University
Dianlong Zhang: Affiliated Zhongshan Hospital of Dalian University
Zhigao Li: Cancer Hospital of Harbin Medical University
Yi Zhao: Shengjing Hospital of China Medical University
Yong Li: The Fifth Affiliated Hospital of China Medical University
Ke Li: Anshan Cancer Hospital
Hao Zhang: Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute
Peili Zhang: Baotou Cancer Hospital
Yuanxi Huang: Cancer Hospital of Harbin Medical University
Gangling Zhang: Baotou Cancer Hospital
Hongbin Han: Affiliated Hospital of China Medical University
Zhengang Cai: the First Affiliated Hospital of Dalian Medical University
Pengfei Li: Yan’an People’s Hospital
Hong Xu: Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute
Guanglei Chen: Shengjing Hospital of China Medical University
Jinqi Xue: Shengjing Hospital of China Medical University
Xiaofan Jiang: Shengjing Hospital of China Medical University
Alireza Hamidian Jahromi: Temple University Medical Center
Jinshi Li: the First Affiliated Hospital of China Medical University
Yu Zhao: Mayo Clinic College of Medicine
Eduardo Faria Castro Fleury: Instituto Brasileiro de Controle do Câncer Oncologia (IBCC Oncologia)
Shiwen Huo: Jiangsu Hengrui Pharmaceuticals
Huajun Li: Jiangsu Hengrui Pharmaceuticals
Guy Jerusalem: CHU Liège and Liège University
Domenico Tripodi: Sapienza University of Rome
Tong Liu: Cancer Hospital of Harbin Medical University
Xinyu Zheng: The First Affiliated Hospital of China Medical University
Caigang Liu: Shengjing Hospital of China Medical University

Nature Communications, 2022, vol. 13, issue 1, 1-9

Abstract: Abstract Current therapies for HER2-positive breast cancer have limited efficacy in patients with triple-positive breast cancer (TPBC). We conduct a multi-center single-arm phase 2 trial to test the efficacy and safety of an oral neoadjuvant therapy with pyrotinib, letrozole and dalpiciclib (a CDK4/6 inhibitor) in patients with treatment-naïve, stage II–III TPBC with a Karnofsky score of ≥70 (NCT04486911). The primary endpoint is the proportion of patients with pathological complete response (pCR) in the breast and axilla. The secondary endpoints include residual cancer burden (RCB)−0 or RCB-I, objective response rate (ORR), breast pCR (bpCR), safety and changes in molecular targets (Ki67) from baseline to surgery. Following 5 cycles of 4-week treatment, the results meet the primary endpoint with a pCR rate of 30.4% (24 of 79; 95% confidence interval (CI), 21.3–41.3). RCB-0/I is 55.7% (95% CI, 44.7–66.1). ORR is 87.4%, (95% CI, 78.1–93.2) and bpCR is 35.4% (95% CI, 25.8–46.5). The mean Ki67 expression reduces from 40.4% at baseline to 17.9% (P

Date: 2022
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DOI: 10.1038/s41467-022-34838-w

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