Cancer Research and Treatment

Original Articles

Breast cancer

Trastuzumab Biosimilar (HLX02), Pertuzumab Plus Chemotherapy in Patients with HER2-Positive Metastatic Breast Cancer after Progression of Trastuzumab: A Prospective, Phase II Study: Ruyan Zhang, Xiaoran Liu, Guohong Song, Yan Zhang, Huiping Li; Cancer Res Treat. 2024;56(3):795-801. Published online December 20, 2023; DOI: https://doi.org/10.4143/crt.2023.1151

Purpose
This study aims to evaluate the efficacy and safety of trastuzumab biosimilar (HLX02) in combination with pertuzumab and chemotherapy in patients with human epidermal growth factor receptor 2 (HER2)–positive metastatic breast cancer (MBC) after progression of trastuzumab.
Materials and Methods
In this prospective, single-arm, phase II study, patients with HER2-positive MBC after progression of trastuzumab received pertuzuamb, HLX02, and chemotherapy in Beijing Cancer Hospital from March 2020 to December 2022. The primary endpoint was progression-free survival (PFS), and secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety. The study was registered with ClinicalTrials.gov (NCT05188495).
Results
A total of 45 patients were included in this study. Twelve patients (26.7%) were treated in second-line and 33 patients (73.3%) were in third-line and later setting. Eighty percent and 15.5% patients had previously received pyrotinib/lapatinib and T-DM1, respectively. With a median follow-up of 24.4 months (range, 1.2 to 43.9 months), the median PFS was 7.6 months (95% confidence interval, 4.3 to 10.9), OS was not reached, the ORR was 31.1%, and DCR was 91.1%. The treatment was well tolerated.
Conclusion
The combination of trastuzumab biosimilar HLX02, pertuzumab, and chemotherapy exhibited promising efficacy and a favorable safety profile as second- and beyond-line treatment in HER2-positive MBC.

Citations

Citations to this article as recorded by

Comprehensive Analysis of Comparison of Trastuzumab Reference with Biosimilars in the Treatment of HER2-Positive Breast Cancer: A Review
Aulia Khaerunisa, Ahsanal Kasasiah, Meisya Dwi Ananda, Naila Yusti Fadhilah, Shofiatulfuadah Retnaningrum Herlaesa
Jurnal Pijar MIPA.2026; 21(3): 463. CrossRef
Efficacy and safety of biosimilar trastuzumab (HLX02) in patients with HER2-positive advanced breast cancer: a retrospective real-world analysis
Xuan Ye, Linlin Wang, Wensheng Liu, Mengmeng Wang, Zihan Guo, Han Shan, Qing Zhai, Qiong Du
Frontiers in Oncology.2025;[Epub] CrossRef

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Real-World Evidence of Trastuzumab, Pertuzumab, and Docetaxel Combination as a First-Line Treatment for Korean Patients with HER2-Positive Metastatic Breast Cancer: Yong-Pyo Lee, Min-Sang Lee, HongSik Kim, Ji-Yeon Kim, Jin Seok Ahn, Young-Hyuck Im, Yeon Hee Park; Cancer Res Treat. 2022;54(4):1130-1137. Published online January 17, 2022; DOI: https://doi.org/10.4143/crt.2021.1103

Abstract PDF Supplementary Material PubReader ePub

Purpose
Trastuzumab has markedly improved the survival outcomes of patients with human epidermal growth factor receptor 2 (HER2)–positive breast cancer, and dual blockade of HER2 using trastuzumab and pertuzumab in combination with taxanes (THP) has become a standard of care for HER2-positive metastatic breast cancer (MBC) worldwide since the CLEOPATRA trial. We assessed the outcomes of THP as a first-line treatment for Korean HER2-positive MBC patients in the real-world setting.
Materials and Methods
Between August 2008 and October 2020, we identified 228 HER2-positive MBC patients who received THP as a first-line palliative chemotherapy. We analyzed survival outcomes, efficacy, and adverse events of THP retrospectively.
Results
After a median follow-up duration of 28.7 months, median overall survival and progression-free survival were 58.3 months (95% confidence interval [CI], 36.6 to 80.0) and 19.1 months (95% CI, 16.2 to 21.9), respectively. Better survival outcomes were observed in patient who received docetaxel for more than six cycles. Patients exposed to anti-HER2 directed therapies in a perioperative setting had poor survival outcomes. The overall response rate was 86.8% with a complete response (CR) rate of 17.7%. Among responders, 16.7% of patients sustained THP over 35 months and showed better survivals and higher CR rates. Adverse events were comparable to those reported in previous studies.
Conclusion
In a real-world context, clinical outcomes of Korean HER2-positive MBC patients treated with THP were similar to those of patients in the CLEOPATRA trial. Much longer follow-up results would be warranted.

Citations

Citations to this article as recorded by

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Pooya Jalali, Azhar Saeed, Sahar Taher, Anwaar Saeed
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From intravenous to subcutaneous pertuzumab/trastuzumab in breast cancer: Clinical and pharmacoeconomic drivers and barriers to switching
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Tumori Journal.2026; 112(1): 22. CrossRef
Pertuzumab–Docetaxel–Trastuzumab regimen in HER2-positive metastatic breast cancer: Real-world data from India
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Cancer Treatment and Research Communications.2026; 47: 101196. CrossRef
Translating CLEOPATRA into routine practice: National treatment patterns and survival for patients with HER2-positive metastatic breast cancer
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The Breast.2026; 89: 104852. CrossRef
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International Journal of Molecular Sciences.2025; 26(5): 1908. CrossRef
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Yi Guo, Gang Zheng, Yu Fan, Liangchang Li, Yang Sun
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Real-world impact of dual anti-HER2 antibodies on cardiac function in patients with human epidermal growth factor receptor 2–positive metastatic breast cancer
Kelvin KH. Bao, Jeffrey CH. Chan, Jocelyn G. Chan, Leone Sutanto, Ka Man Cheung, Harry HY. Yiu
The Breast.2024; 73: 103612. CrossRef
Bilateral inflammatory recurrence of HER-2 positive breast cancer: a unique case report and literature review
Rong Qin, Xiangyang Wang, Tingting Fan, Ting Wu, Chao Lu, Xun Shao, Liang Yin
Frontiers in Oncology.2024;[Epub] CrossRef
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Cancer Cell International.2022;[Epub] CrossRef

13,769 View
393 Download
10 Web of Science
9 Crossref

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