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
Year: 2026
Type: article
Study design: Clinical Trial
Abstract: Purpose: The outcomes of different antidiarrheal strategies in HER2-positive breast cancer patients treated with pyrotinib plus trastuzumab and docetaxel are unknown. Materials and Methods: 97 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. Results: The incidence of grade 3 diarrhea in cohorts with loperamide prophylaxis was lower than in the 400PYR cohort. In the 3 cohorts with loperamide prophylaxis, the dose escalation cohort had the lowest incidence of grade 3 diarrhea. The incidence of grade 3 diarrhea in 320PYR cohort was similar to the 3 cohorts with prophylactic antidiarrheal loperamide. No event of grade 4 or 5 diarrhea was reported. Conclusion: Loperamide prophylaxis and pyrotinib dose escalation were associated with lower observed rates of grade 3 diarrhea in patients receiving pyrotinib plus trastuzumab and docetaxel. The lower rate observed in the 320PYR cohort should be interpreted cautiously and may reflect improved clinical management rather than a reproducible protocolized intervention.
Source: Cancer Research and Treatment
Institutions: Sun Yat-sen University, Sun Yat-sen Memorial Hospital, Tianjin Medical University, First Affiliated Hospital of Bengbu Medical College, Central South University, Xiangya Hospital Central South University, First Bethune Hospital of Jilin University, Hebei Medical University, Fourth Hospital of Hebei Medical University, Henan University of Science and Technology, First Affiliated Hospital of Henan University of Science and Technology, Affiliated Hospital of Qingdao University, Chinese Academy of Medical Sciences & Peking Union Medical College, Shandong First Medical University, Peking University First Hospital, Jiangsu Hengrui Medicine (China)
Language: English
Topic: HER2/EGFR in Cancer Research
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W7171502735
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