Pyrotinib Plus Trastuzumab and Docetaxel with Different Antidiarrheal Strategies in Patients with HER2-Positive Recurrent or Metastatic Breast Cancer (PHAENNA): A Multicenter, Phase 1 Trial
PurposeThe outcomes of different antidiarrheal strategies in HER2-positive breast cancer patients treated with pyrotinib plus trastuzumab and docetaxel are unknown. Materials and Methods97 eligible patients received pyrotinib once daily from Cycle 1 Day 7 onwards, combined with intravenous trastuzumab and docetaxel on Day 1 of each 21-day cycle.In the 400PYR cohort, patients were treated with 400 mg pyrotinib, without mandatory antidiarrheal prophylaxis.In the 320PYR+Pro-L and 400PYR+Pro-L cohorts, patients were given 320 or 400 mg pyrotinib and loperamide prophylaxis.In the 320PYR cohort, patients were treated with 320 mg pyrotinib, without mandatory antidiarrheal prophylaxis.In the PYR-DE+Pro-L cohort, patients were treated with escalating pyrotinib doses and loperamide prophylaxis.
Authors
- Yehui Shi (ORCID: https://orcid.org/0000-0001-9649-7119)
- Yanqiong Liu (ORCID: https://orcid.org/0000-0001-9159-4278)
- Yandan Yao (ORCID: https://orcid.org/0000-0003-4277-4138)
- Guiying Bai
- Xiuping Lai
- Kaijing Zhao
- Herui Yao (ORCID: https://orcid.org/0000-0001-5520-6469)
- Jiaman Lin
- Hongtao Li (ORCID: https://orcid.org/0000-0001-6532-2092)
- Yimin Cui (ORCID: https://orcid.org/0000-0002-4186-1005)
- Qun Qin (ORCID: https://orcid.org/0000-0002-9732-7039)
- Xinshuai Wang
- Xiaoyu Zhu
- Shikai Wu
- Caiwen Du
- Pan Liu
- Wei Zhao
- Cuizhi Geng
- Zhuang Yu
- Huan Zhou
- Mingxia Wang
- Yu Cao
- Wei Ren
- Wei Li
- Shouman Wang
Institutions
- Qingdao University (CN)
- Hebei Medical University (CN)
- Central South University (CN)
- Sun Yat-sen University (CN)
- Chinese Academy of Medical Sciences & Peking Union Medical College (CN)
- Peking University (CN)
- Tianjin Medical University Cancer Institute and Hospital (CN)
- Sun Yat-sen Memorial Hospital (CN)
- Fourth Hospital of Hebei Medical University (CN)
- Affiliated Hospital of Qingdao University (CN)
- Peking University First Hospital (CN)
- First Affiliated Hospital of Henan University of Science and Technology (CN)
- First Bethune Hospital of Jilin University (CN)
- Jiangsu Hengrui Medicine (China) (CN)
- First Affiliated Hospital of Bengbu Medical College (CN)
- Affiliated Hospital of Shandong University of Traditional Chinese Medicine (CN)
- Xiangya Hospital Central South University (CN)
- Shandong First Medical University (CN)
Publication Details
- Journal
- Cancer Research and Treatment
- Published
- 2026-07-28
- DOI
- https://doi.org/10.4143/crt.2026.0400
- Primary Topic
- HER2/EGFR in Cancer Research
- Type
- article
- Field-Weighted Citation Impact
- 0.00