Gut Microbiota and Diarrhea in Breast Cancer Patients Receiving Pyrotinib
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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 receive standard medical care. Potential Benefits: Participants will not receive any direct benefit from this observational phase of the study. However, the information gathered may help scientists better understand pyrotinib-induced diarrhea and develop future strategies to help other breast cancer patients manage this side effect more effectively.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18-75 lat, niezależnie od płci
- •Rozpoznany rak piersi HER2-dodatni i aktualnie leczony pirotinikbem (samodzielnie lub w kombinacji z innymi lekami), przez co najmniej 2 tygodnie
- •Dobrowolna zgoda na udział w badaniu i podpisanie oświadczenia zgody
✗ Disqualifies
- •Historia poważnych chorób jelit (zapalenie jelit, choroba Leśniowskiego-Crohna, wrzodziejące zapalenie jelita grubego) lub przebyta duża operacja jelit
- •Używanie antybiotyków, probiotyków lub tradycyjnych leków na funkcje jelit w ostatnim miesiącu
- •Ciąża lub karmienie piersią
- •Brak zgody na udział w badaniu
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- July 16, 2026
- Sex
- No restrictions
Locations (1)
Hubei Cancer Hospital
Wuhan, China
Trial contact
Xinhong Wu Wu, Principal Investigator
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/17/2026.
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