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Gut bugs may hold key to cancer drug side effect

NCT ID NCT07264998

Knowledge-focused Sponsor: Hubei Cancer Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study explores whether the natural bacteria in your gut affect diarrhea caused by the breast cancer drug abemaciclib. Researchers will compare stool samples from 60 women who get diarrhea with those who don't. No new treatments are given—just observation to learn why some people have this side effect.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors predict or prevent diarrhea in breast cancer patients taking abemaciclib, improving treatment comfort.
What could go wrong
This is a small observational study with no intervention, so it cannot prove cause and effect. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This study will enroll a prospective cohort of female patients with hormone receptor-positive (HR⁺) breast cancer who are receiving treatment with Abemaciclib (as monotherapy or in combination) as part of their standard clinical care at Hubei Cancer Hospital. Participants will be prospectively assigned into two groups based on the presence or absence of drug-induced diarrhea, as defined by CTCAE v5.0 criteria: the Diarrhea Group and the Non-Diarrhea (Control) Group. The study involves the collection of clinical data, fecal samples, and optional blood samples for microbiome and biomarker analysis. No investigational intervention is administered in this phase of the study.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Abemaciclib Abemaciclib-related diarrhea Breast neoplasms Drug-induced diarrhea Gastrointestinal microbiome (focus) Hormone receptor-positive breast cancer Microbiome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hubei Cancer Hospital

    RECRUITING

    Wuhan, Hubei, 430079, China

More trials for these conditions

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