Breast CancerNCT07264985
Gut Microbiota and Diarrhea in Breast Cancer Patients Receiving Pyrotinib
An observational study of Breast Cancer and Drug-Related Side Effects, run by Hubei Cancer Hospital at 1 site in China.
Trial summary
Background: Pyrotinib is an effective targeted drug for HER2-positive breast cancer, but it very frequently causes diarrhea, which can be severe enough to disrupt treatment and reduce patients' quality of life. The reason why some patients develop diarrhea while others do not is not well understood. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Breast Cancer, Drug-Related Side Effects, Diarrhea
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2025to Jul 2027
- 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: The study population consists of adult patients (aged 18-75) diagnosed with HER2-positive breast cancer who are currently undergoing treatment with pyrotinib (either as monotherapy or in combination). This is a prospective observational cohort study where participants are not assigned to an intervention but are instead grouped based on the natural outcome of whether they develop drug-induced diarrhea during the observation period. This creates two primary cohorts for comparison: the 'Diarrhea Group' and the 'Non-Diarrhea Group'. All participants will continue their standard pyrotinib treatment and clinical care throughout the study.
Who may be able to join
- Patients aged 18-75 years, regardless of gender.
- Diagnosed with HER2-positive breast cancer and currently receiving pyrotinib treatment (either as monotherapy or in combination with endocrine therapy), with a treatment duration of ≥ 2 weeks.
- Voluntarily agree to participate in this study and provide written informed consent.
Who cannot join
- History of significant gastrointestinal diseases (e.g., inflammatory bowel disease, Crohn's disease, ulcerative colitis, intestinal obstruction) or previous major gastrointestinal surgery.
- Recent use (within 1 month) of antibiotics, probiotics, or traditional Chinese medicine intended to alter intestinal function.
- Pregnant or lactating women.
- Patients who refuse to provide informed consent or explicitly express unwillingness to participate. Patients found not meeting the inclusion criteria after enrollment will be discontinued from the study.
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
Xinhong Wu, wuxinhong_9@sina.com
About this study
Official title: Gut Microbiota Changes in Breast Cancer Patients Treated With Pyrotinib and Correlation With Drug-Induced Diarrhea: An Observational Cohort Study
Background:
Pyrotinib is an effective targeted drug for HER2-positive breast cancer, but it very frequently causes diarrhea, which can be severe enough to disrupt treatment and reduce patients' quality of life. The reason why some patients develop diarrhea while others do not is not well understood. Recent research suggests that the community of bacteria in the gut (gut microbiota) may play a key role in this side effect.
Read more
What is the purpose of this study? This is an observational study (Phase 1) that aims to understand the relationship between pyrotinib treatment, changes in gut bacteria, and the occurrence of diarrhea. The main goal is to compare the gut bacteria of patients who develop diarrhea while taking pyrotinib with those who do not. Researchers hope to identify specific bacteria that might protect against diarrhea, which could lead to new ways to prevent or treat this side effect in the future.
What will happen in the study? Patients with HER2-positive breast cancer who are being treated with pyrotinib will be invited to participate. They will be divided into two groups: those who experience diarrhea and those who do not. Participants will provide stool samples at specific time points (e.g., 2 and 4 weeks after starting pyrotinib). They will also allow researchers to collect information from their medical records about their clinical condition and diarrhea symptoms. No experimental intervention will be administered in this phase of the study; all patients will receive standard medical care.
Potential Benefits:
Participants will not receive any direct benefit from this observational phase of the study. However, the information gathered may help scientists better understand pyrotinib-induced diarrhea and develop future strategies to help other breast cancer patients manage this side effect more effectively.
- Conditions
- Breast Cancer, Drug-Related Side Effects, Diarrhea
- Keywords
- Pyrotinib, Diarrhea, Gut Microbiota, HER2-Positive Breast Cancer, Microbiome, Drug Side Effect, Metagenomics, Observational Study
- Medical subject headings
- Breast Neoplasms, Diarrhea, Drug-Related Side Effects and Adverse Reactions
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 |
|---|---|---|
| Diarrhea Group | This cohort consists of HER2-positive breast cancer patients receiving pyrotinib treatment who develop diarrhea (graded as ≥ Grade 1 according to CTCAE v5.0) during the observation period. Participants in this group will provide stool samples and clinical data for comparison with the non-diarrhea group. No study intervention is administered; all patients receive standard medical care. | |
| Non-Diarrhea Group | This cohort consists of HER2-positive breast cancer patients receiving pyrotinib treatment who do not develop diarrhea (Grade 0 according to CTCAE v5.0) during the observation period. Participants in this group will provide stool samples and clinical data, serving as a control for comparison with the diarrhea group. No study intervention is administered; all patients receive standard medical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in gut microbiota β-diversity between the Diarrhea group and the Non-diarrhea group.
Beta diversity (e.g., using UniFrac distance) of the gut microbiota will be compared between the two groups based on metagenomic sequencing data. A statistically significant difference (P < 0.05) is expected.
Measured: Through study completion, an average of 6 months.
Identification of specific bacterial species enriched in the Non-diarrhea group.
Metagenomic sequencing data will be analyzed to identify bacterial species that are significantly more abundant in the Non-diarrhea group compared to the Diarrhea group, using statistical methods such as LEfSe (Linear Discriminant Analysis Effect Size) with a threshold of LDA Score > 2 and P < 0.05.
Measured: Through study completion, an average of 6 months.
Secondary outcomes (4)
Difference in gut microbiota α-diversity between groups.
Alpha diversity indices (e.g., Shannon index, Chao1 index) of the gut microbiota will be compared between the Diarrhea and Non-diarrhea groups.
Measured: Through study completion, an average of 6 months.
Differences in metagenomic functional pathways between groups.
Metagenomic sequencing data will be annotated using databases like KEGG. The abundance of functional pathways (e.g., KEGG Level 2 or 3) will be compared between the two groups to identify differentially abundant metabolic or functional modules.
Measured: Through study completion, an average of 6 months.
Differences in serum inflammatory cytokine levels between groups.
Levels of systemic inflammatory cytokines (e.g., IL-6, TNF-α, CRP) measured in serum samples by ELISA or other assays will be compared between the Diarrhea and Non-diarrhea groups.
Measured: Through study completion, an average of 6 months.
Differences in serum metabolomic profiles between groups.
Metabolomic profiling of serum samples will be performed (e.g., by mass spectrometry). The metabolic profiles will be compared between the two groups to identify differentially abundant metabolites.
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 start25 Dec 2025
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- NCT07264985
- Sponsor's protocol ID
- LLHBCH2025YN-087
- Status last verified
- Oct 2025
- First submitted
- 24 Nov 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Individual Participant Data (IPD) collected in this study will not be made publicly available. The primary reasons are to protect patient privacy and confidentiality, as the dataset contains detailed genetic (metagenomic) and clinical information that could potentially be used to identify individuals. Furthermore, the data is integral to ongoing and future research by the investigative team, including the development of synthetic probiotics, which may involve intellectual property considerations.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 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 Pyrotinib and Correlation With Drug-Induced Diarrhea: An Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07264985
- Acronym / sponsor ID
- LLHBCH2025YN-087
- Conditions
- Breast Cancer, Drug-Related Side Effects, Diarrhea
- Keywords
- Pyrotinib, Diarrhea, Gut Microbiota, HER2-Positive Breast Cancer, Microbiome, Drug Side Effect, Metagenomics, Observational Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hubei Cancer HospitalUniversity, hospital or other
- Study start
- 25 Dec 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (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.
Background:
Pyrotinib is an effective targeted drug for HER2-positive breast cancer, but it very frequently causes diarrhea, which can be severe enough to disrupt treatment and reduce patients' quality of life. The reason why some patients develop diarrhea while others do not is not well understood. Recent research suggests that the community of bacteria in the gut (gut microbiota) may play a key role in this side effect.
What is the purpose of this study? This is an observational study (Phase 1) that aims to understand the relationship between pyrotinib treatment, changes in gut bacteria, and the occurrence of diarrhea. The main goal is to compare the gut bacteria of patients who develop diarrhea while taking pyrotinib with those who do not. Researchers hope to identify specific bacteria that might protect against diarrhea, which could lead to new ways to prevent or treat this side effect in the future.
What will happen in the study? Patients with HER2-positive breast cancer who are being treated with pyrotinib will be invited to participate. They will be divided into two groups: those who experience diarrhea and those who do not. Participants will provide stool samples at specific time points (e.g., 2 and 4 weeks after starting pyrotinib). They will also allow researchers to collect information from their medical records about their clinical condition and diarrhea symptoms. No experimental intervention will be administered in this phase of the study; all patients will receive standard medical care.
Potential Benefits:
Participants will not receive any direct benefit from this observational phase of the study. However, the information gathered may help scientists better understand pyrotinib-induced diarrhea and develop future strategies to help other breast cancer patients manage this side effect more effectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diarrhea Group | – | –This cohort consists of HER2-positive breast cancer patients receiving pyrotinib treatment who develop diarrhea (graded as ≥ Grade 1 according to CTCAE v5.0) during the observation period. Participants in this group will provide stool samples and clinical data for comparison with the non-diarrhea group. No study intervention is administered; all patients receive standard medical care. |
| Non-Diarrhea Group | – | –This cohort consists of HER2-positive breast cancer patients receiving pyrotinib treatment who do not develop diarrhea (Grade 0 according to CTCAE v5.0) during the observation period. Participants in this group will provide stool samples and clinical data, serving as a control for comparison with the diarrhea group. No study intervention is administered; all patients receive standard medical care. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients (aged 18-75) diagnosed with HER2-positive breast cancer who are currently undergoing treatment with pyrotinib (either as monotherapy or in combination). This is a prospective observational cohort study where participants are not assigned to an intervention but are instead grouped based on the natural outcome of whether they develop drug-induced diarrhea during the observation period. This creates two primary cohorts for comparison: the 'Diarrhea Group' and the 'Non-Diarrhea Group'. All participants will continue their standard pyrotinib treatment and clinical care throughout the study.
Key inclusion criteria (3 listed)
- Patients aged 18-75 years, regardless of gender.
- Diagnosed with HER2-positive breast cancer and currently receiving pyrotinib treatment (either as monotherapy or in combination with endocrine therapy), with a treatment duration of ≥ 2 weeks.
- Voluntarily agree to participate in this study and provide written informed consent.
Key exclusion criteria (4 listed)
- History of significant gastrointestinal diseases (e.g., inflammatory bowel disease, Crohn's disease, ulcerative colitis, intestinal obstruction) or previous major gastrointestinal surgery.
- Recent use (within 1 month) of antibiotics, probiotics, or traditional Chinese medicine intended to alter intestinal function.
- Pregnant or lactating women.
- Patients who refuse to provide informed consent or explicitly express unwillingness to participate. Patients found not meeting the inclusion criteria after enrollment will be discontinued from the study.
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 β-diversity between the Diarrhea group and the Non-diarrhea group.
Time frame: Through study completion, an average of 6 months.
Beta diversity (e.g., using UniFrac distance) of the gut microbiota will be compared between the two groups based on metagenomic sequencing data. A statistically significant difference (P < 0.05) is expected.
Identification of specific bacterial species enriched in the Non-diarrhea group.
Time frame: Through study completion, an average of 6 months.
Metagenomic sequencing data will be analyzed to identify bacterial species that are significantly more abundant in the Non-diarrhea group compared to the Diarrhea group, using statistical methods such as LEfSe (Linear Discriminant Analysis Effect Size) with a threshold of LDA Score > 2 and P < 0.05.
4 secondary outcomes
Difference in gut microbiota α-diversity between groups.
Time frame: Through study completion, an average of 6 months.
Differences in metagenomic functional pathways between groups.
Time frame: Through study completion, an average of 6 months.
Differences in serum inflammatory cytokine levels between groups.
Time frame: Through study completion, an average of 6 months.
Differences in serum metabolomic profiles between groups.
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 16 Jul 2026.
- Individual participant dataSharing planned: No. The Individual Participant Data (IPD) collected in this study will not be made publicly available. The primary reasons are to protect patient privacy and confidentiality, as the dataset contains detailed genetic (metagenomic) and clinical information that could potentially be used to identify individuals. Furthermore, the data is integral to ongoing and future research by the investigative team, including the development of synthetic probiotics, which may involve intellectual property considerations.
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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 Cancer and Drug-Related Side Effects, 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 3 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 16 Jul 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 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 β-diversity between the Diarrhea group and the Non-diarrhea group. (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 16 Jul 2026.