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Gut Microbiota Changes in Breast Cancer Patients Treated With Abemaciclib and Correlation With Drug-Induced Diarrhea: An Observational Cohort Study

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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. * 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Aged 18 to 75 years.

• Diagnosed with hormone receptor-positive (HR⁺) breast cancer.

• Currently receiving treatment with Abemaciclib (either as monotherapy or in combination with endocrine therapy) for a duration of at least 2 weeks.

• Willing and able to provide written informed consent for participation in the study.

Locations
Other Locations
China
Hubei Cancer Hospital
RECRUITING
Wuhan
Contact Information
Primary
Xinhong Wu Principal Investigator
wuxinhong_9@sina.com
18602726300
Time Frame
Start Date: 2025-12-21
Estimated Completion Date: 2026-07
Participants
Target number of participants: 60
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Hubei Cancer Hospital

This content was sourced from clinicaltrials.gov

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