Breast NeoplasmsNCT07264998
Observational Study of Gut Microbiota in Abemaciclib-Treated Patients With and Without Diarrhea
An observational study of Breast Neoplasms and Hormone Receptor-Positive Breast Cancer, run by Hubei Cancer Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Neoplasms, Hormone Receptor-Positive Breast Cancer, Abemaciclib
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 21 Dec 2025to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Aged 18 to 75 years.
- Diagnosed with hormone receptor-positive (HR⁺) breast cancer.
- Currently receiving treatment with Abemaciclib (either as monotherapy or in combination with endocrine therapy) for a duration of at least 2 weeks.
- Willing and able to provide written informed consent for participation in the study.
Who cannot join
- History of major gastrointestinal diseases, such as inflammatory bowel disease, Crohn's disease, ulcerative colitis, or intestinal obstruction, or having undergone major gastrointestinal surgery.
- Recent use (within 1 month) of antibiotics, probiotics, or traditional Chinese medicine that may alter gut function.
- Pregnant or lactating women.
- Unwilling to provide informed consent or considered by the investigator to be unsuitable for the study for any other reason.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Xinhong Wu, 18602726300, wuxinhong_9@sina.com
Wu, wuxinhong_9@sina.com
About this study
Official title: Gut Microbiota Changes in Breast Cancer Patients Treated With Abemaciclib and Correlation With Drug-Induced Diarrhea: An Observational Cohort Study
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.
Read more
- 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.
- Conditions
- Breast Neoplasms, Hormone Receptor-Positive Breast Cancer, Abemaciclib, Abemaciclib-related Diarrhea, Drug-induced Diarrhea, Gastrointestinal Microbiome (Focus)
- Keywords
- Abemaciclib, Hormone receptor-positive breast cancer, Drug-induced diarrhea, Microbiome, Gastrointestinal microbiome, Microbiome biomarkers, Abemaciclib-related diarrhea
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Abema-Diarrhea | HR-positive breast cancer patients who develop diarrhea (Grade 1 or higher as per CTCAE v5.0 criteria) during treatment with Abemaciclib. This group will not receive any investigational intervention as part of the observational study. Fecal and blood samples will be collected for microbiome and biomarker analysis. | |
| Abema-NoDiarrhea | HR-positive breast cancer patients who do not develop diarrhea (Grade 0 as per CTCAE v5.0 criteria) during treatment with Abemaciclib. This group serves as the control cohort and will not receive any investigational intervention as part of the observational study. Fecal and blood samples will be collected for microbiome and biomarker analysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in gut microbiota beta diversity
Beta diversity of the gut microbiome (e.g., Weighted UniFrac distance) will be compared between the diarrhea group and the non-diarrhea group to assess overall microbial community structure differences.
Measured: Through study completion, an average of 6 months.
Identification of specific bacterial species enriched in non-diarrhea group
Metagenomic sequencing data will be analyzed (e.g., using LEfSe) to identify bacterial species that are significantly enriched in the non-diarrhea group compared to the diarrhea group (LDA Score > 2, p-value < 0.05).
Measured: Through study completion, an average of 6 months.
Secondary outcomes (4)
Difference in gut microbiota alpha diversity
Alpha diversity indices (Shannon, Chao1) of the gut microbiome will be compared between the diarrhea group and the non-diarrhea group.
Measured: Through study completion, an average of 6 months.
Difference in metagenomic functional pathways
Differential abundance analysis of functional pathways (e.g., KEGG Level 2/3) derived from metagenomic sequencing data between the two groups.
Measured: Through study completion, an average of 6 months.
Differential metabolites in serum
Differences in serum metabolomic profiles between the diarrhea and non-diarrhea groups.
Measured: Through study completion, an average of 6 months.
Difference in systemic inflammatory cytokine levels
Levels of inflammatory cytokines (e.g., IL-6, TNF-α, CRP) in serum will be compared between the two groups.
Measured: Through study completion, an average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start21 Dec 2025
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hubei Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinhong Wu, PhD, Hubei Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264998
- Sponsor's protocol ID
- LLHBCH2025YN-088
- Status last verified
- Oct 2025
- First submitted
- 24 Nov 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) that underlie the results reported in this study will not be shared publicly. The decision is based on the following considerations: to protect patient privacy and confidentiality, as the data contain sensitive clinical and genomic information; the informed consent obtained from participants does not include provisions for public data sharing; and the samples and data are collected under a specific ethical approval that limits their use to this research protocol. Summary results and aggregated data will be made available through publication.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiota Changes in Breast Cancer Patients Treated With Abemaciclib and Correlation With Drug-Induced Diarrhea: An Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07264998
- Acronym / sponsor ID
- LLHBCH2025YN-088
- Conditions
- Breast Neoplasms, Hormone Receptor-Positive Breast Cancer, Abemaciclib, Abemaciclib-related Diarrhea, Drug-induced Diarrhea, Gastrointestinal Microbiome (Focus)
- Keywords
- Abemaciclib, Hormone receptor-positive breast cancer, Drug-induced diarrhea, Microbiome, Gastrointestinal microbiome, Microbiome biomarkers, Abemaciclib-related diarrhea
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hubei Cancer HospitalUniversity, hospital or other
- Study start
- 21 Dec 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abema-Diarrhea | – | –HR-positive breast cancer patients who develop diarrhea (Grade 1 or higher as per CTCAE v5.0 criteria) during treatment with Abemaciclib. This group will not receive any investigational intervention as part of the observational study. Fecal and blood samples will be collected for microbiome and biomarker analysis. |
| Abema-NoDiarrhea | – | –HR-positive breast cancer patients who do not develop diarrhea (Grade 0 as per CTCAE v5.0 criteria) during treatment with Abemaciclib. This group serves as the control cohort and will not receive any investigational intervention as part of the observational study. Fecal and blood samples will be collected for microbiome and biomarker analysis. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Aged 18 to 75 years.
- Diagnosed with hormone receptor-positive (HR⁺) breast cancer.
- Currently receiving treatment with Abemaciclib (either as monotherapy or in combination with endocrine therapy) for a duration of at least 2 weeks.
- Willing and able to provide written informed consent for participation in the study.
Key exclusion criteria (4 listed)
- History of major gastrointestinal diseases, such as inflammatory bowel disease, Crohn's disease, ulcerative colitis, or intestinal obstruction, or having undergone major gastrointestinal surgery.
- Recent use (within 1 month) of antibiotics, probiotics, or traditional Chinese medicine that may alter gut function.
- Pregnant or lactating women.
- Unwilling to provide informed consent or considered by the investigator to be unsuitable for the study for any other reason.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in gut microbiota beta diversity
Time frame: Through study completion, an average of 6 months.
Beta diversity of the gut microbiome (e.g., Weighted UniFrac distance) will be compared between the diarrhea group and the non-diarrhea group to assess overall microbial community structure differences.
Identification of specific bacterial species enriched in non-diarrhea group
Time frame: Through study completion, an average of 6 months.
Metagenomic sequencing data will be analyzed (e.g., using LEfSe) to identify bacterial species that are significantly enriched in the non-diarrhea group compared to the diarrhea group (LDA Score > 2, p-value < 0.05).
4 secondary outcomes
Difference in gut microbiota alpha diversity
Time frame: Through study completion, an average of 6 months.
Difference in metagenomic functional pathways
Time frame: Through study completion, an average of 6 months.
Differential metabolites in serum
Time frame: Through study completion, an average of 6 months.
Difference in systemic inflammatory cytokine levels
Time frame: Through study completion, an average of 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) that underlie the results reported in this study will not be shared publicly. The decision is based on the following considerations: to protect patient privacy and confidentiality, as the data contain sensitive clinical and genomic information; the informed consent obtained from participants does not include provisions for public data sharing; and the samples and data are collected under a specific ethical approval that limits their use to this research protocol. Summary results and aggregated data will be made available through publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms and Hormone Receptor-Positive Breast Cancer, run by Hubei Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinhong Wu Principal Investigator (18602726300, wuxinhong_9@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in gut microbiota beta diversity (time frame: Through study completion, an average of 6 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.