Combined pyrotinib and fulvestrant for hormone receptor‐positive and HER2‐positive metastatic breast cancer: A multicenter, single‐arm, phase II trial
This multicenter, single-arm, phase II clinical trial (NCT04034589) evaluated the efficacy and safety of pyrotinib combined with fulvestrant in patients with HR-positive/HER2-positive metastatic breast cancer who had experienced trastuzumab treatment failure. A total of 46 patients were enrolled, receiving pyrotinib orally once daily and fulvestrant intramuscularly on days 1 and 15 of cycle 1, followed by monthly doses on day 1. The primary endpoint was progression-free survival (PFS), while secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety. The median PFS was 18.2 months (95% CI, 11.9-31.1) overall, 19.5 months (95% CI, 10.6-NA) for those receiving the combination as first-line therapy, and 18.4 months (95% CI, 16.7-NA) for patients with brain metastases. Median OS was not reached, with a 3-year OS rate of 75.2% (95% CI, 62.8-90.2%). The ORR was 32.5%, and the DCR was 97.5%. Responses were observed in patients with low tumor mutation burden and <i>ZNF217</i> mutation. Importantly, no grade 4 or higher treatment-related adverse events or deaths were reported, indicating a favorable safety profile. In conclusion, the combination of pyrotinib and fulvestrant demonstrated promising antitumor activity and acceptable safety in HR-positive/HER2-positive metastatic breast cancer patients.
Authors
- Yangyang Cai (ORCID: https://orcid.org/0000-0002-5961-8847)
- Zhongyu Yuan (ORCID: https://orcid.org/0000-0002-2920-9671)
- Peng Yuan (ORCID: https://orcid.org/0000-0003-4627-8203)
- Jie Chai
- Yunfang Yu (ORCID: https://orcid.org/0000-0003-2579-6220)
- Linxiaoxiao Ding
- Jian Yue (ORCID: https://orcid.org/0009-0009-9868-0959)
- Xiujuan Gui
- Herui Yao (ORCID: https://orcid.org/0000-0001-5520-6469)
- Yongjian Chen (ORCID: https://orcid.org/0000-0002-6784-4828)
- Li Zhang (ORCID: https://orcid.org/0000-0003-0595-0761)
- Kang Zhang (ORCID: https://orcid.org/0000-0002-4549-1697)
- Wenjing Wu
- Tao Chen (ORCID: https://orcid.org/0000-0003-3708-1409)
- Simin Luo
- Jianli Zhao (ORCID: https://orcid.org/0000-0003-1980-3236)
- Guorong Zou (ORCID: https://orcid.org/0000-0002-6335-2420)
- Yaping Yang (ORCID: https://orcid.org/0000-0002-5046-1919)
- Wei Ren
- Yinduo Zeng
- Ying Wang (ORCID: https://orcid.org/0000-0002-2571-9367)
Institutions
- Macau University of Science and Technology (MO)
- Sun Yat-sen University (CN)
- Chinese Academy of Medical Sciences & Peking Union Medical College (CN)
- Wenzhou Medical University (CN)
- Karolinska Institutet (SE)
- Affiliated Eye Hospital of Wenzhou Medical College (CN)
- Sun Yat-sen Memorial Hospital (CN)
- Panyu District Central Hospital (CN)
- Sun Yat-sen University Cancer Center (CN)
- State Key Laboratory of Oncology in South China
- Xiaomi (China) (CN)
- Guangzhou Medical University (CN)
Publication Details
- Journal
- MedComm
- Published
- 2024-12-20
- DOI
- https://doi.org/10.1002/mco2.70031
- Citations
- 4
- Primary Topic
- HER2/EGFR in Cancer Research
- Type
- article
- Field-Weighted Citation Impact
- 1.13
Funders
- National Natural Science Foundation of China
- National Key Research and Development Program of China
- Science and Technology Planning Project of Guangdong Province
- Basic and Applied Basic Research Foundation of Guangdong Province