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
. 2025 Jul 3:16:1594799.
doi: 10.3389/fphar.2025.1594799. eCollection 2025.

Efficacy and safety of leuprorelin (Boennuokang®) plus endocrine therapy in premenopausal women with HR+/HER2- breast cancer

Xiuping Wu #  1 , Yinfeng Lin #  1 , Wangmei Xie  1 , Yan Jiang  1 , Zhenchao Xu  1 , Kai He  1 , Shuyu Li  1
Affiliations

Efficacy and safety of leuprorelin (Boennuokang®) plus endocrine therapy in premenopausal women with HR+/HER2- breast cancer

Xiuping Wu et al. Front Pharmacol. .

Abstract

Background: Leuprorelin shows good efficacy in premenopausal women with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer. However, more real-world evidence is required. This real-world study aimed to explore the efficacy and safety of leuprorelin (Boennuokang®) plus endocrine therapy in premenopausal women with HR+/HER2- breast cancer.

Methods: A total of 229 premenopausal women with HR+/HER2- breast cancer receiving adjuvant leuprorelin plus endocrine therapy were included in this retrospective study. Leuprorelin (Boennuokang®) was administered 3.75 mg subcutaneously every 28 days following surgery. Endocrine therapy contained aromatase inhibitors, selective estrogen receptor modulators, and selective estrogen receptor degraders. The median follow-up duration of this study was 38.1 months.

Results: The estradiol (E2) level was declined from 46.0 to 19.0 pg/mL over 24 months (P < 0.001). E2 from month 3 to month 24 was maintained below 30 pg/mL (menopausal level). During 24 months, the follicle-stimulating hormone level was decreased from 7.7 to 4.8 mIU/mL, and the luteinizing hormone level was decreased from 7.9 to 0.2 mIU/mL (both P < 0.001). During the follow-up period, 9 patients experienced disease recurrence. The 10-year accumulating progression-free survival (PFS) rate was 91.7%. Comorbidity (yes vs no) was independently related to shorter progression-free survival (hazard ratio: 10.957, P = 0.003). Bone soreness (6.1%) was the most common adverse event, followed by hot flushes (3.5%), morning stiffness (1.3%), and muscle soreness (1.3%).

Conclusion: Leuprorelin (Boennuokang®) plus endocrine therapy reduces gonadotropins and sex hormones and results in satisfactory survival rates with good safety profiles in premenopausal women with HR+/HER2- breast cancer.

Keywords: efficacy; hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer; leuprorelin (Boennuokang ®); premenopausal women; safety.

PubMed Disclaimer

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as potential conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Changes in E2, FSH, and LH after leuprorelin (Boennuokang®) plus endocrine therapy in premenopausal women with HR+/HER2− breast cancer. E2 (A), FSH (B), and LH (C) all exhibited a decreasing trend following leuprorelin (Boennuokang®) plus endocrine therapy in premenopausal women with HR+/HER2− breast cancer.
FIGURE 2
FIGURE 2
The 10-year accumulating PFS rate was 91.7% in premenopausal women with HR+/HER2− breast cancer receiving leuprorelin (Boennuokang®) plus endocrine therapy.
See this image and copyright information in PMC

References

    1. Arboleda B., Bartsch R., de Azambuja E., Hamilton E., Harbeck N., Klemp J., et al. (2022). Ovarian function suppression: a deeper consideration of the role in early breast cancer and its potential impact on patient outcomes: a consensus statement from an International Expert Panel. Oncologist 27, 722–731. 10.1093/oncolo/oyac101 - DOI - PMC - PubMed
    1. Bray F., Laversanne M., Sung H., Ferlay J., Siegel R. L., Soerjomataram I., et al. (2024). Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J. Clin. 74, 229–263. 10.3322/caac.21834 - DOI - PubMed
    1. Brett J. O., Mayer E. L. (2023). New developments in systemic management for high-risk early-stage hormone-receptor-positive, HER2-negative breast cancer. Curr. Treat. Options Oncol. 24, 594–610. 10.1007/s11864-023-01082-3 - DOI - PubMed
    1. Burstein H. J., Lacchetti C., Anderson H., Buchholz T. A., Davidson N. E., Gelmon K. A., et al. (2019). Adjuvant endocrine therapy for women with hormone receptor-positive breast cancer: ASCO Clinical Practice Guideline Focused update. J. Clin. Oncol. 37, 423–438. 10.1200/jco.18.01160 - DOI - PubMed
    1. Cao L. Q., Sun H., Xie Y., Patel H., Bo L., Lin H., et al. (2024). Therapeutic evolution in HR+/HER2-breast cancer: from targeted therapy to endocrine therapy. Front. Pharmacol. 15, 1340764. 10.3389/fphar.2024.1340764 - DOI - PMC - PubMed

LinkOut - more resources