Combined pyrotinib and fulvestrant for hormone receptor‐positive and HER2‐positive metastatic breast cancer: A multicenter, single‐arm, phase II trial
Abstract 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 enr...
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2025-01-01
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| Series: | MedComm |
| Online Access: | https://doi.org/10.1002/mco2.70031 |
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| author | Jianli Zhao Yunfang Yu Wei Ren Linxiaoxiao Ding Yongjian Chen Peng Yuan Jian Yue Yaping Yang Guorong Zou Tao Chen Jie Chai Li Zhang Wenjing Wu Yinduo Zeng Xiujuan Gui Yangyang Cai Simin Luo Zhongyu Yuan Kang Zhang Herui Yao Ying Wang |
| author_facet | Jianli Zhao Yunfang Yu Wei Ren Linxiaoxiao Ding Yongjian Chen Peng Yuan Jian Yue Yaping Yang Guorong Zou Tao Chen Jie Chai Li Zhang Wenjing Wu Yinduo Zeng Xiujuan Gui Yangyang Cai Simin Luo Zhongyu Yuan Kang Zhang Herui Yao Ying Wang |
| author_sort | Jianli Zhao |
| collection | DOAJ |
| description | Abstract 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 ZNF217 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. |
| format | Article |
| id | doaj-art-f1f23b22c1a3498ead9f5cd394ec5b04 |
| institution | Kabale University |
| issn | 2688-2663 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | MedComm |
| spelling | doaj-art-f1f23b22c1a3498ead9f5cd394ec5b042025-01-20T01:45:44ZengWileyMedComm2688-26632025-01-0161n/an/a10.1002/mco2.70031Combined pyrotinib and fulvestrant for hormone receptor‐positive and HER2‐positive metastatic breast cancer: A multicenter, single‐arm, phase II trialJianli Zhao0Yunfang Yu1Wei Ren2Linxiaoxiao Ding3Yongjian Chen4Peng Yuan5Jian Yue6Yaping Yang7Guorong Zou8Tao Chen9Jie Chai10Li Zhang11Wenjing Wu12Yinduo Zeng13Xiujuan Gui14Yangyang Cai15Simin Luo16Zhongyu Yuan17Kang Zhang18Herui Yao19Ying Wang20Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation Department of Medical Oncology Breast Tumor Centre Phase I Clinical Trial Centre, Clinical Research Design Division, Clinical Research Center Sun Yat‐sen Memorial Hospital Sun Yat‐sen University Guangzhou Guangdong ChinaGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation Department of Medical Oncology Breast Tumor Centre Phase I Clinical Trial Centre, Clinical Research Design Division, Clinical Research Center Sun Yat‐sen Memorial Hospital Sun Yat‐sen University Guangzhou Guangdong ChinaGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation Department of Medical Oncology Breast Tumor Centre Phase I Clinical Trial Centre, Clinical Research Design Division, Clinical Research Center Sun Yat‐sen Memorial Hospital Sun Yat‐sen University Guangzhou Guangdong ChinaGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation Department of Medical Oncology Breast Tumor Centre Phase I Clinical Trial Centre, Clinical Research Design Division, Clinical Research Center Sun Yat‐sen Memorial Hospital Sun Yat‐sen University Guangzhou Guangdong ChinaDermatology and Venereology Division Department of Medicine Solna Center for Molecular Medicine Karolinska Institute Stockholm Stockholm SwedenDepartment of VIP Medical Services National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College Beijing ChinaDepartment of VIP Medical Services National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College Beijing ChinaGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation Department of Medical Oncology Breast Tumor Centre Phase I Clinical Trial Centre, Clinical Research Design Division, Clinical Research Center Sun Yat‐sen Memorial Hospital Sun Yat‐sen University Guangzhou Guangdong ChinaDepartment of Medical Oncology the Affiliated Panyu Central Hospital of Guangzhou Medical University Guangzhou Guangdong ChinaGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation Department of Medical Oncology Breast Tumor Centre Phase I Clinical Trial Centre, Clinical Research Design Division, Clinical Research Center Sun Yat‐sen Memorial Hospital Sun Yat‐sen University Guangzhou Guangdong ChinaGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation Department of Medical Oncology Breast Tumor Centre Phase I Clinical Trial Centre, Clinical Research Design Division, Clinical Research Center Sun Yat‐sen Memorial Hospital Sun Yat‐sen University Guangzhou Guangdong ChinaGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation Department of Medical Oncology Breast Tumor Centre Phase I Clinical Trial Centre, Clinical Research Design Division, Clinical Research Center Sun Yat‐sen Memorial Hospital Sun Yat‐sen University Guangzhou Guangdong ChinaGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation Department of Medical Oncology Breast Tumor Centre Phase I Clinical Trial Centre, Clinical Research Design Division, Clinical Research Center Sun Yat‐sen Memorial Hospital Sun Yat‐sen University Guangzhou Guangdong ChinaGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation Department of Medical Oncology Breast Tumor Centre Phase I Clinical Trial Centre, Clinical Research Design Division, Clinical Research Center Sun Yat‐sen Memorial Hospital Sun Yat‐sen University Guangzhou Guangdong ChinaGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation Department of Medical Oncology Breast Tumor Centre Phase I Clinical Trial Centre, Clinical Research Design Division, Clinical Research Center Sun Yat‐sen Memorial Hospital Sun Yat‐sen University Guangzhou Guangdong ChinaGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation Department of Medical Oncology Breast Tumor Centre Phase I Clinical Trial Centre, Clinical Research Design Division, Clinical Research Center Sun Yat‐sen Memorial Hospital Sun Yat‐sen University Guangzhou Guangdong ChinaGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation Department of Medical Oncology Breast Tumor Centre Phase I Clinical Trial Centre, Clinical Research Design Division, Clinical Research Center Sun Yat‐sen Memorial Hospital Sun Yat‐sen University Guangzhou Guangdong ChinaDepartment of Medical Oncology Sun Yat‐Sen University Cancer Center the State Key Laboratory of Oncology in South China Collaborative Innovation Center for Cancer Medicine Guangzhou Guangdong ChinaFaculty of Medicine Macau University of Science and Technology Taipa Macao PR ChinaGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation Department of Medical Oncology Breast Tumor Centre Phase I Clinical Trial Centre, Clinical Research Design Division, Clinical Research Center Sun Yat‐sen Memorial Hospital Sun Yat‐sen University Guangzhou Guangdong ChinaGuangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation Department of Medical Oncology Breast Tumor Centre Phase I Clinical Trial Centre, Clinical Research Design Division, Clinical Research Center Sun Yat‐sen Memorial Hospital Sun Yat‐sen University Guangzhou Guangdong ChinaAbstract 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 ZNF217 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.https://doi.org/10.1002/mco2.70031 |
| spellingShingle | Jianli Zhao Yunfang Yu Wei Ren Linxiaoxiao Ding Yongjian Chen Peng Yuan Jian Yue Yaping Yang Guorong Zou Tao Chen Jie Chai Li Zhang Wenjing Wu Yinduo Zeng Xiujuan Gui Yangyang Cai Simin Luo Zhongyu Yuan Kang Zhang Herui Yao Ying Wang Combined pyrotinib and fulvestrant for hormone receptor‐positive and HER2‐positive metastatic breast cancer: A multicenter, single‐arm, phase II trial MedComm |
| title | Combined pyrotinib and fulvestrant for hormone receptor‐positive and HER2‐positive metastatic breast cancer: A multicenter, single‐arm, phase II trial |
| title_full | Combined pyrotinib and fulvestrant for hormone receptor‐positive and HER2‐positive metastatic breast cancer: A multicenter, single‐arm, phase II trial |
| title_fullStr | Combined pyrotinib and fulvestrant for hormone receptor‐positive and HER2‐positive metastatic breast cancer: A multicenter, single‐arm, phase II trial |
| title_full_unstemmed | Combined pyrotinib and fulvestrant for hormone receptor‐positive and HER2‐positive metastatic breast cancer: A multicenter, single‐arm, phase II trial |
| title_short | Combined pyrotinib and fulvestrant for hormone receptor‐positive and HER2‐positive metastatic breast cancer: A multicenter, single‐arm, phase II trial |
| title_sort | combined pyrotinib and fulvestrant for hormone receptor positive and her2 positive metastatic breast cancer a multicenter single arm phase ii trial |
| url | https://doi.org/10.1002/mco2.70031 |
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