Gut microbiome differences in people on abemaciclib who do or don't get diarrhea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hubei Cancer Hospital
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Xinhong Wu Principal Investigator
• Email: wuxinhong_9@sina.com
• Phone: 18602726300

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.