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Study identifier: NCT07264985 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Gut Microbiota and Diarrhea in Breast Cancer Patients Receiving Pyrotinib

Condition: Breast Cancer · Drug-Related Side Effects · Diarrhea  ·  Sponsor: Hubei Cancer Hospital

PhaseN/A
Planned participants60
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

About this study

Background: Pyrotinib is an effective targeted drug for HER2-positive breast cancer, but it very frequently causes diarrhea, which can be severe enough to disrupt treatment and reduce patients' quality of life. The reason why some patients develop diarrhea while others do not is not well understood. Recent research suggests that the community of bacteria in the gut (gut microbiota) may play a key role in this side effect. What is the purpose of this study? This is an observational study (Phase 1) that aims to understand the relationship between pyrotinib treatment, changes in gut bacteria, and the occurrence of diarrhea. The main goal is to compare the gut bacteria of patients who develop diarrhea while taking pyrotinib with those who do not. Researchers hope to identify specific bacteria that might protect against diarrhea, which could lead to new ways to prevent or treat this side effect in the future. What will happen in the study? Patients with HER2-positive breast cancer who are being treated with pyrotinib will be invited to participate. They will be divided into two groups: those who experience diarrhea and those who do not. Participants will provide stool samples at specific time points (e.g., 2 and 4 weeks after starting pyrotinib). They will also allow researchers to collect information from their medical records about their clinical condition and diarrhea symptoms. No experimental intervention will be administered in this phase of the study; all patients will re…

This description comes directly from the study's public registry record.

Talk to the study team

Xinhong Wu Wu, Principal Investigator  ·  18602726300  ·  wuxinhong_9@sina.com

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Locations (1)

Hubei Cancer HospitalWuhan, Hubei, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT07264985