Gut microbiome differences in people on abemaciclib who do or don't get diarrhea
Gut Microbiota Changes in Breast Cancer Patients Treated With Abemaciclib and Correlation With Drug-Induced Diarrhea: An Observational Cohort Study
This project will compare gut bacteria in people with HR-positive breast cancer who are taking abemaciclib to see if differences are linked to developing diarrhea.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Hubei Cancer Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT07264998 on ClinicalTrials.gov |
What this trial studies
This observational study enrolls patients with HR-positive breast cancer who are already receiving abemaciclib and groups them by whether they develop treatment-related diarrhea. Researchers will collect clinical information and characterize participants' gut microbiota to look for differences between the diarrhea and no-diarrhea groups. No experimental drugs are given and patients continue their usual cancer care while samples and data are collected. Findings may identify microbial patterns associated with abemaciclib-related diarrhea that could guide future prevention or management strategies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–75 with hormone receptor–positive breast cancer who have been taking abemaciclib for at least two weeks and can give written informed consent.
Not a fit: Patients with major prior gastrointestinal disease, recent antibiotics/probiotics or similar treatments, pregnant or breastfeeding women, or those not on abemaciclib are unlikely to benefit from this study.
Why it matters
Potential benefit: If a clear microbiome link is found, it could help predict who is at higher risk for diarrhea and point to ways to prevent or lessen this side effect.
How similar studies have performed: Some prior research has linked the gut microbiome to chemotherapy-related gastrointestinal effects, but using microbiome profiles to explain abemaciclib-specific diarrhea is relatively novel and not yet well established.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Wuhan, Hubei
- Hubei Cancer Hospital — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Xinhong Wu Principal Investigator
- Email: wuxinhong_9@sina.com
- Phone: 18602726300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.