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Observational Study of Gut Microbiota in Abemaciclib-Treated Patients With and Without Diarrhea

Recruitingn/aAges 18 Years - 75 YearsAllHubei Cancer Hospital
NCT07264998 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Why is this study being done? Many patients with a type of breast cancer (called HR-positive) take a medicine called Abemaciclib. While this medicine is effective, a very common side effect is diarrhea, which can be severe enough to disrupt treatment and reduce quality of life. The reason why some patients get diarrhea and others do not is not well understood. This study aims to investigate whether the natural bacteria living in the gut (known as the gut microbiome) play a role in this side effect. Researchers will compare the gut bacteria of patients who develop diarrhea with those who do not. What will happen in the study? This is an observational study, which means that patients will receive their normal cancer treatment and will not be given any new or experimental drugs as part of this initial phase. * Patients who are already being treated with Abemaciclib will be invited to join

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Aged 18 to 75 years. 2. Diagnosed with hormone receptor-positive (HR⁺) breast cancer. 3. Currently receiving treatment with Abemaciclib (either as monotherapy or in combination with endocrine therapy) for a duration of at least 2 weeks. 4. Willing and able to provide written informed consent for participation in the study. Exclusion Criteria: 1. History of major gastrointestinal diseases, such as inflammatory bowel disease, Crohn's disease, ulcerative colitis, or intestinal obstruction, or having undergone major gastrointestinal surgery. 2. Recent use (within 1 month) of antibiotics, probiotics, or traditional Chinese medicine that may alter gut function. 3. Pregnant or lactating women. 4. Unwilling to provide informed consent or considered by the investigator to be unsuitable for the study for any other reason.
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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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