Observational Study of Gut Bacteria and Diarrhea in Women with HR-Positive Breast Cancer Taking Abemaciclib

What this Trial Is About

This research aims to understand why some patients with hormone receptor-positive breast cancer experience diarrhea when treated with Abemaciclib, a common medicine for this condition. The study focuses on the role of the natural bacteria in the gut, known as the gut microbiome, in causing this side effect. Researchers will compare the gut bacteria of patients who develop diarrhea with those who do not to learn more about this issue. The study is observational, meaning participants will continue their usual cancer treatment with Abemaciclib without receiving any new or experimental drugs. Participants will be grouped based on whether they experience diarrhea during treatment or not. The study involves collecting stool samples and optional blood samples at specific times to analyze gut bacteria types, functions, and biomarkers. Participants will provide samples and information during their treatment period, which lasts about six months on average. Researchers will assess differences in gut bacteria diversity, specific bacterial species, metabolic pathways, serum metabolites, and inflammatory markers. All personal data will be kept confidential and coded to protect privacy throughout the study.

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