NCT07264998 Observational Study of Gut Microbiota in Abemaciclib-Treated Patients With and Without Diarrhea
| NCT ID | NCT07264998 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hubei Cancer Hospital |
| Condition | Breast Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-12-21 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2025-12-21 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07264998 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Breast Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07264998 currently recruiting?
Yes, NCT07264998 is actively recruiting participants. Contact the research team at wuxinhong_9@sina.com for enrollment information.
Where is the NCT07264998 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT07264998 clinical trial?
NCT07264998 is sponsored by Hubei Cancer Hospital. The trial plans to enroll 60 participants.