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Gut Microbiota and Diarrhea in Breast Cancer Patients Receiving Pyrotinib

Recruitingn/aAges 18 Years - 75 YearsAllHubei Cancer Hospital
NCT07264985 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 ef

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patients aged 18-75 years, regardless of gender. 2. Diagnosed with HER2-positive breast cancer and currently receiving pyrotinib treatment (either as monotherapy or in combination with endocrine therapy), with a treatment duration of ≥ 2 weeks. 3. Voluntarily agree to participate in this study and provide written informed consent. Exclusion Criteria: 1. History of significant gastrointestinal diseases (e.g., inflammatory bowel disease, Crohn's disease, ulcerative colitis, intestinal obstruction) or previous major gastrointestinal surgery. 2. Recent use (within 1 month) of antibiotics, probiotics, or traditional Chinese medicine intended to alter intestinal function. 3. Pregnant or lactating women. 4. Patients who refuse to provide informed consent or explicitly express unwillingness to participate. Patients found not meeting the inclusion criteria after enrollment will be discontinued from the study.
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What it tests

  • Not listed
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Where

1 site
Hubei Cancer Hospital
Wuhan, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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