Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2023 Jan;197(1):93-101.
doi: 10.1007/s10549-022-06770-6. Epub 2022 Oct 30.

Pyrotinib combined with trastuzumab and chemotherapy for the treatment of human epidermal growth factor receptor 2-positive metastatic breast cancer: a single-arm exploratory phase II trial

Xiao-Feng Xie  1 , Qiu-Yi Zhang  1 , Jia-Yi Huang  1 , Li-Ping Chen  1 , Xiao-Feng Lan  1 , Xue Bai  1 , Lin Song  1 , Shui-Ling Xiong  1 , Si-Jia Guo  1 , Cai-Wen Du  2   3
Affiliations
Clinical Trial

Pyrotinib combined with trastuzumab and chemotherapy for the treatment of human epidermal growth factor receptor 2-positive metastatic breast cancer: a single-arm exploratory phase II trial

Xiao-Feng Xie et al. Breast Cancer Res Treat. 2023 Jan.

Abstract

Purpose: A substantial need for effective and safe treatment options is still unmet for patients with heavily pre-treated human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). Herein, we assessed the efficacy and safety of pyrotinib plus trastuzumab and chemotherapy in patients with heavily treated HER2-positive MBC.

Methods: In this single-arm exploratory phase II trial, patients with HER2-positive MBC previously treated with trastuzumab plus lapatinib or pertuzumab, received pyrotinib plus trastuzumab and chemotherapy. The primary end point was progression-free survival (PFS) in the total population (TP). Secondary end points included PFS in the subgroup with brain metastases (Sub-BrM), confirmed objective response rate (ORR), clinical benefit rate (CBR), disease control rate (DCR), exploration of predictive factors of PFS, and safety.

Results: Between November 1, 2018, and March 31, 2021, 40 patients were eligible for this study. The median PFS reached 7.5 months (95% confidence interval [CI] 4.7 to 9.9 months) and 9.4 months (95% CI 6.6 to 12.1 months) in the TP and Sub-BrM, respectively. ORR was 50.5% (20/40). CBR was 75.5% (30/40) and DCR reached 97.5% (39/40). Cox univariate and multivariate analyses demonstrated that liver or/and lung metastases was the significant adverse prognostic factor for PFS (p = 0.018; p = 0.026; respectively). The most frequent grade 3 or 4 treatment-related adverse events were diarrhea, neutropenia and leukopenia. No new safety signals were observed.

Conclusion: Pyrotinib plus trastuzumab and chemotherapy offered a promising option with manageable safety profile for heavily pre-treated HER2-positive MBC, especially for those without liver or/and lung metastases.

Keywords: Chemotherapy; Human epidermal growth factor receptor 2 (HER2); Metastatic breast cancer (MBC); Pyrotinib; Trastuzumab.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Fig. 1
Fig. 1
Kaplan–Meier estimates of progression-free survival in the total population. mPFS median progression-free survival, CI confidence interval
Fig. 2
Fig. 2
Kaplan–Meier estimates of progression-free survival in the subgroup with brain metastases. mPFS median progression-free survival, CI confidence interval
Fig. 3
Fig. 3
Kaplan–Meier estimates of progression-free survival in subgroups with or without liver and/or lung metastases. mPFS median progression-free survival, CI confidence interval
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71:209–249. doi: 10.3322/caac.21660. - DOI - PubMed
    1. Cameron D, Piccart-Gebhart MJ, Gelber RD, Procter M, Goldhirsch A, de Azambuja E, Castro G, Untch M, Smith I, Gianni L, Baselga J, Al-Sakaff N, Lauer S, McFadden E, Leyland-Jones B, Bell R, Dowsett M, Jackisch C. 11 years' follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive early breast cancer: final analysis of the HERceptin adjuvant (HERA) trial. The Lancet. 2017;389:1195–1205. doi: 10.1016/s0140-6736(16)32616-2. - DOI - PMC - PubMed
    1. Slamon DJ, Clark GM, Wong SG, Levin WJ, Ullrich A, McGuire WL. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science. 1987;235:177–182. doi: 10.1126/science.3798106. - DOI - PubMed
    1. National Comprehensive Cancer Network (NCCN) (2021) Clinical practice guidelines in oncology: breast cancer. Version 1.2022. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf - PubMed
    1. Pernas S, Tolaney SM. HER2-positive breast cancer: new therapeutic frontiers and overcoming resistance. Therap Adv Med Oncol. 2019;11:175883591983351. doi: 10.1177/1758835919833519. - DOI - PMC - PubMed

Publication types