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A multicentre single arm phase 2 trial of neoadjuvant pyrotinib and letrozole plus dalpiciclib for triple-positive breast cancer
Niu, Nan Qiu, Fang Xu, Qianshi He, Guijin Gu, Xi Guo, Wenbin Zhang, Dianlong Li, Zhigao Zhao, Yi Li, Yong
Niu, Nan
Qiu, Fang
Xu, Qianshi
He, Guijin
Gu, Xi
Guo, Wenbin
Zhang, Dianlong
Li, Zhigao
Zhao, Yi
Li, Yong
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Journal article
Date
2022-11-17
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Committee member
Department
Surgery
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http://dx.doi.org/10.1038/s41467-022-34838-w
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 < 0.001) at time of surgery. The most frequent grade 3 or 4 adverse events are neutropenia, leukopenia, and diarrhoea. There is no serious adverse event- or treatment-related death. This fully oral, chemotherapy-free, triplet combined therapy has the potential to be an alternative neoadjuvant regimen for patients with TPBC.
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Niu, N., Qiu, F., Xu, Q. et al. A multicentre single arm phase 2 trial of neoadjuvant pyrotinib and letrozole plus dalpiciclib for triple-positive breast cancer. Nat Commun 13, 7043 (2022). https://doi.org/10.1038/s41467-022-34838-w
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Nature Research
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Nature Communications, Vol. 13
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