Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07264998 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 3, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 2025 to Dec 21, 2025
    • Site details revised
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07264998
Lead Sponsor Hubei Cancer Hospital
Conditions
(from sponsor)		 Breast Neoplasms, Hormone Receptor-Positive Breast Cancer, Abemaciclib, Abemaciclib-related Diarrhea, Drug-induced Diarrhea, Gastrointestinal Microbiome (Focus), Microbiome
Related terms Breast Neoplasms
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov