Observational Study of Gut Microbiota in Abemaciclib-Treated Patients With and Without Diarrhea
NCT ID: NCT07264998
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
60 participants
OBSERVATIONAL
2025-12-31
2026-07-31
Brief Summary
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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.
* They will be placed into one of two groups: those who experience diarrhea and those who do not.
* Participants will be asked to provide stool (feces) samples and may also provide optional blood samples at specific times during their treatment.
* Researchers will analyze these samples in the lab to study the types and functions of the gut bacteria.
Who can participate?
* Adult women (aged 18-75) diagnosed with HR-positive breast cancer.
* Currently receiving treatment with Abemaciclib for at least 2 weeks.
* Must be willing to provide informed consent and follow the study procedures.
What are the potential benefits? Participants will not receive any direct medical benefit from taking part in this study. However, the information learned may help researchers better understand why diarrhea occurs and, in the future, could lead to new ways to prevent or treat this side effect for other cancer patients.
How is privacy protected? All personal information and samples collected will be de-identified using a unique code. This means that the data used for analysis cannot be directly linked back to the participant's identity. All data is stored securely according to strict ethical guidelines.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Abema-Diarrhea
HR-positive breast cancer patients who develop diarrhea (Grade 1 or higher as per CTCAE v5.0 criteria) during treatment with Abemaciclib. This group will not receive any investigational intervention as part of the observational study. Fecal and blood samples will be collected for microbiome and biomarker analysis.
No interventions assigned to this group
Abema-NoDiarrhea
HR-positive breast cancer patients who do not develop diarrhea (Grade 0 as per CTCAE v5.0 criteria) during treatment with Abemaciclib. This group serves as the control cohort and will not receive any investigational intervention as part of the observational study. Fecal and blood samples will be collected for microbiome and biomarker analysis.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Hubei Cancer Hospital
OTHER
Responsible Party
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Xinhong Wu, PhD
vice-president
Locations
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Hubei Cancer Hospital
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LLHBCH2025YN-088
Identifier Type: -
Identifier Source: org_study_id
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