HER2-positive Breast CancerNCT06892093
Probiotics for Prevention of Neratinib-Induced Diarrhea in Breast Cancer Patients
A study testing Probiotics and Loperamide in people with HER2-positive Breast Cancer and Diarrhea Caused by Drug, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
This study aims to evaluate the efficacy and safety of probiotics for the prevention of diarrhea in patients with breast cancer receiving the tyrosine kinase inhibitor (TKI) Neratinib. Study Design: This is a prospective, randomized controlled clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER2-positive Breast Cancer, Diarrhea Caused by Drug, Neratinib
- What is being tested?
- Probiotics and Loperamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 308 participants
- Where
- 1 siteChina
- Study dates
- 7 Aug 2025to Dec 2027
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following criteria:
- Female patients aged ≥18 years, diagnosed with HER2-positive breast cancer.
- Scheduled to receive Neratinib therapy (monotherapy or in combination), based on clinical guidelines.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, with an expected survival of at least 3 months.
- Left ventricular ejection fraction (LVEF) ≥ 50%.
- Resolution of any prior treatment-related toxicity to Grade ≤1 (per CTCAE v5.0), with AST and ALT ≤ 2.5 × the upper limit of normal (ULN), and total bilirubin ≤ 1.5 × ULN.
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- Adequate bone marrow function, defined as:
- White blood cell count ≥ 3.0 × 10⁹/L Neutrophil count ≥ 1.5 × 10⁹/L Platelet count ≥ 100 × 10⁹/L Hemoglobin ≥ 90 g/L Serum creatinine ≤ 1.5 × ULN
- No persistent gastrointestinal symptoms, such as hematochezia, chronic constipation, or abdominal pain.
- No evidence of structural gastrointestinal abnormalities confirmed by gastroscopy or other relevant examinations.
Who cannot join
- Participants will be excluded if they meet any of the following criteria:
- Conditions that significantly impair swallowing, digestion, or gastrointestinal drug absorption.
- History of chronic gastrointestinal diseases, including but not limited to inflammatory bowel disease (IBD), gastrointestinal tumors, or malabsorption syndromes.
- Severe cardiovascular diseases that may interfere with study treatment, including but not limited to:
- Life-threatening arrhythmias Advanced atrioventricular block Unstable angina Clinically significant pericardial disease Myocardial fibrosis Uncontrolled hypertension
- Known hypersensitivity to any component of Neratinib, probiotics, placebo, or loperamide.
Show all 9Show fewer
- Prior participation in any clinical trial involving investigational drugs within 4 weeks prior to enrollment, or chronic use of medications that may induce constipation within 6 months.
- Pregnant or lactating women, or those unwilling to use effective contraception during the study period.
- Any medical, psychiatric, or social condition that, in the investigator's judgment, could compromise the safety of the participant, interfere with study participation, or confound the study results.
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
Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Jianli Zhao, +86 15920589334, zhaojianli1988@126.com
About this study
Official title: Efficacy and Safety of Probiotics Versus Standard Care in Preventing Diarrhea Induced by Neratinib in Breast Cancer Patients: A Prospective Randomized Controlled Clinical Trial
This study aims to evaluate the efficacy and safety of probiotics for the prevention of diarrhea in patients with breast cancer receiving the tyrosine kinase inhibitor (TKI) Neratinib.
Study Design: This is a prospective, randomized controlled clinical trial. Participants will be randomly assigned to either a probiotics intervention group or a placebo-controlled group. Both groups will receive prophylactic loperamide according to the FDA-recommended dosing schedule for neratinib-associated diarrhea.
Read more
Primary Objective: To evaluate the efficacy of probiotics in reducing the incidence and severity of diarrhea in patients receiving Neratinib.
Secondary Objectives: This study will also investigate the effects of probiotics on gut microbiota composition and their potential impact on drug efficacy.
Study Duration: Enrollment is planned from August 2025 to June 2027 at Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University. Both the intervention and control groups will receive treatment for a total of six weeks (two cycles of three weeks each). No post-treatment observation period is included.
Eligibility Criteria: Participants must be diagnosed with HER2-positive breast cancer and scheduled to receive Neratinib. Exclusion criteria include patients with severe gastrointestinal disorders or recent probiotic consumption.
Read the detailed description
Breast cancer patients treated with the tyrosine kinase inhibitor (TKI) Neratinib often experience severe diarrhea, leading to treatment interruptions, dose reductions, or discontinuation. Emerging evidence highlights the role of gut microbiota in drug metabolism and gastrointestinal toxicity. Probiotics have been proposed as a potential intervention to modulate gut microbiota and mitigate diarrhea; however, their efficacy in preventing Neratinib-induced diarrhea remains inconclusive.
This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy and safety of probiotics in preventing diarrhea in HER2-positive breast cancer patients receiving Neratinib. The study will also explore the impact of probiotics on gut microbiota composition and potential microbiome-mediated mechanisms that may enhance treatment adherence and therapeutic outcomes.
Participants will be randomly assigned in a 1:1 ratio to either a probiotics group or a placebo group. Both groups will receive prophylactic loperamide in accordance with the dosing schedule recommended by the U.S. Food and Drug Administration (FDA) for the prevention of Neratinib-associated diarrhea, ensuring consistency with the approved prescribing information.
Participants will receive treatment for a total of six weeks, corresponding to two treatment cycles.
Metagenomic sequencing and targeted metabolomics will be performed on stool samples to investigate gut microbial composition and metabolic changes. Additional analyses will assess the association between gut-derived metabolites and immune cell activation, aiming to elucidate potential interactions among gut microbiota, metabolites, and immune responses.
Sun Yat-sen Memorial Hospital will serve as the coordinating center for this planned multicenter trial. Currently, it is the only active site, and additional participating centers will be added progressively as they are initiated.
- Being tested
- Probiotics, Placebo, Loperamide
- Keywords
- Neratinib, Probiotics, Diarrhea, Breast Cancer
- Medical subject headings
- Diarrhea, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
Participants in this group will receive a daily dose of probiotics as an adjunct to standard Neratinib therapy. The probiotics will be administered orally as a granule formulation dissolved in water, for a total duration of 6 weeks (two treatment cycles). Loperamide will be administered prophylactically according to the FDA-recommended schedule to prevent Neratinib-associated diarrhea. The aim is to assess the efficacy of probiotics in reducing Neratinib-induced diarrhea and improving quality of life.
PlaceboDietary supplement
Participants in this group will receive a daily dose of a placebo that is identical in appearance, taste, and administration method to the probiotic granules, in addition to standard Neratinib therapy. The placebo will be administered orally as a granule formulation dissolved in water, for a total duration of 6 weeks. Loperamide will also be administered prophylactically to all participants in accordance with FDA recommendations. This group will serve as a control to evaluate the true effect of probiotics on Neratinib-induced diarrhea.
LoperamideDrug
All participants will receive prophylactic loperamide to reduce the risk of Neratinib-induced diarrhea. Loperamide will be administered according to the FDA-recommended schedule: 4 mg TID for the first 14 days of treatment, then 4 mg BID from Day 15 to Day 42. This intervention is implemented as a standard supportive therapy and not as a randomized variable.
| Study group | Role | What they receive |
|---|---|---|
| Probiotics + Neratinib + Loperamide | Experimental | Not described Receives: Dietary Supplement: Probiotics; Drug: Loperamide |
| Placebo + Neratinib + Loperamide | Placebo comparator | Not described Receives: Dietary Supplement: Placebo; Drug: Loperamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Grade ≥3 Diarrhea
The incidence of grade 3 or higher diarrhea during the 6-week treatment period, assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Up to 6 weeks
Secondary outcomes (9)
Incidence of Any Grade Diarrhea
The incidence of diarrhea of any grade during the 6-week treatment period, assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Measured: Up to 6 weeks
Duration of First Episode of Grade 3 Diarrhea
The duration (in days) of the first episode of grade 3 diarrhea experienced by participants during the 6-week treatment period, assessed using the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Duration is defined from onset to recovery (downgrade to grade ≤2).
Measured: Up to 6 weeks
Proportion of Participants Hospitalized Due to Diarrhea
The proportion of participants who require hospitalization due to diarrhea-related complications during the treatment period.
Measured: Up to 6 weeks
Loperamide Usage Patterns
Frequency, total dosage, and compliance of loperamide use during the treatment period, including any dose modifications or discontinuation. Data will be collected through medication records and patient diaries.
Measured: Up to 6 weeks
Change from Baseline in Overall Quality of Life Assessed by EORTC QLQ-C30
Changes in quality of life assessed using the EORTC QLQ-C30 questionnaire. The tool evaluates overall health status and functioning, including physical, role, emotional, cognitive, and social domains. Higher scores in functional and global health scales indicate better quality of life, while higher scores in symptom scales indicate greater symptom burden.
Measured: Baseline, Weeks 2, 4, and 6 (End of Study)
Change from Baseline in Diarrhea-Related Quality of Life Assessed by FACT-D
Changes in diarrhea-related quality of life assessed using the FACT-D subscale of the Functional Assessment of Cancer Therapy system. This tool specifically evaluates the severity and impact of diarrhea symptoms on patients' daily life and well-being. Higher scores indicate fewer symptoms and better diarrhea-related quality of life.
Measured: Baseline, Weeks 2, 4, and 6 (End of Study)
Incidence of Treatment-Related Adverse Events (AEs)
The incidence of treatment-related adverse events (AEs) in participants receiving probiotics plus Neratinib versus the control group. AEs, including nausea, allergic reactions, and other related symptoms, will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Measured: Up to 6 weeks
Incidence of Serious Adverse Events (SAEs)
The incidence of serious adverse events (SAEs) associated with probiotics or Neratinib treatment. SAEs, including severe allergic reactions, life-threatening complications, or hospitalizations, will be recorded and summarized to assess potential safety concerns.
Measured: Up to 6 weeks
Rate of Treatment Discontinuation Due to Adverse Events
The proportion of participants who discontinue Neratinib treatment due to adverse events. The outcome will compare discontinuation rates between the probiotic and placebo groups to evaluate tolerability.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start7 Aug 2025
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 308 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangnan University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892093
- Sponsor's protocol ID
- SYSKY-2025-105-02
- Status last verified
- Jun 2026
- First submitted
- 11 Mar 2025
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Probiotics Versus Standard Care in Preventing Diarrhea Induced by Neratinib in Breast Cancer Patients: A Prospective Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06892093
- Acronym / sponsor ID
- SYSKY-2025-105-02
- Keywords
- Neratinib, Probiotics, Diarrhea, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 308 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Jiangnan University
- Study start
- 7 Aug 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 Mar 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.
This study aims to evaluate the efficacy and safety of probiotics for the prevention of diarrhea in patients with breast cancer receiving the tyrosine kinase inhibitor (TKI) Neratinib.
Study Design: This is a prospective, randomized controlled clinical trial. Participants will be randomly assigned to either a probiotics intervention group or a placebo-controlled group. Both groups will receive prophylactic loperamide according to the FDA-recommended dosing schedule for neratinib-associated diarrhea.
Primary Objective: To evaluate the efficacy of probiotics in reducing the incidence and severity of diarrhea in patients receiving Neratinib.
Secondary Objectives: This study will also investigate the effects of probiotics on gut microbiota composition and their potential impact on drug efficacy.
Study Duration: Enrollment is planned from August 2025 to June 2027 at Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University. Both the intervention and control groups will receive treatment for a total of six weeks (two cycles of three weeks each). No post-treatment observation period is included.
Eligibility Criteria: Participants must be diagnosed with HER2-positive breast cancer and scheduled to receive Neratinib. Exclusion criteria include patients with severe gastrointestinal disorders or recent probiotic consumption.
Detailed description
Breast cancer patients treated with the tyrosine kinase inhibitor (TKI) Neratinib often experience severe diarrhea, leading to treatment interruptions, dose reductions, or discontinuation. Emerging evidence highlights the role of gut microbiota in drug metabolism and gastrointestinal toxicity. Probiotics have been proposed as a potential intervention to modulate gut microbiota and mitigate diarrhea; however, their efficacy in preventing Neratinib-induced diarrhea remains inconclusive.
This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy and safety of probiotics in preventing diarrhea in HER2-positive breast cancer patients receiving Neratinib. The study will also explore the impact of probiotics on gut microbiota composition and potential microbiome-mediated mechanisms that may enhance treatment adherence and therapeutic outcomes.
Participants will be randomly assigned in a 1:1 ratio to either a probiotics group or a placebo group. Both groups will receive prophylactic loperamide in accordance with the dosing schedule recommended by the U.S. Food and Drug Administration (FDA) for the prevention of Neratinib-associated diarrhea, ensuring consistency with the approved prescribing information.
Participants will receive treatment for a total of six weeks, corresponding to two treatment cycles.
Metagenomic sequencing and targeted metabolomics will be performed on stool samples to investigate gut microbial composition and metabolic changes. Additional analyses will assess the association between gut-derived metabolites and immune cell activation, aiming to elucidate potential interactions among gut microbiota, metabolites, and immune responses.
Sun Yat-sen Memorial Hospital will serve as the coordinating center for this planned multicenter trial. Currently, it is the only active site, and additional participating centers will be added progressively as they are initiated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics + Neratinib + Loperamide | Experimental | Dietary Supplement: Probiotics, Drug: Loperamide |
| Placebo + Neratinib + Loperamide | Placebo comparator | Dietary Supplement: Placebo, Drug: Loperamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Female patients aged ≥18 years, diagnosed with HER2-positive breast cancer.
- Scheduled to receive Neratinib therapy (monotherapy or in combination), based on clinical guidelines.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2, with an expected survival of at least 3 months.
- Left ventricular ejection fraction (LVEF) ≥ 50%.
- Resolution of any prior treatment-related toxicity to Grade ≤1 (per CTCAE v5.0), with AST and ALT ≤ 2.5 × the upper limit of normal (ULN), and total bilirubin ≤ 1.5 × ULN.
Key exclusion criteria (9 listed)
- Conditions that significantly impair swallowing, digestion, or gastrointestinal drug absorption.
- History of chronic gastrointestinal diseases, including but not limited to inflammatory bowel disease (IBD), gastrointestinal tumors, or malabsorption syndromes.
- Severe cardiovascular diseases that may interfere with study treatment, including but not limited to:
- Life-threatening arrhythmias Advanced atrioventricular block Unstable angina Clinically significant pericardial disease Myocardial fibrosis Uncontrolled hypertension
- Known hypersensitivity to any component of Neratinib, probiotics, placebo, or loperamide.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticsParticipants in this group will receive a daily dose of probiotics as an adjunct to standard Neratinib therapy. The probiotics will be administered orally as a granule formulation dissolved in water, for a total duration of 6 weeks (two treatment cycles). Loperamide will be administered prophylactically according to the FDA-recommended schedule to prevent Neratinib-associated diarrhea. The aim is to assess the efficacy of probiotics in reducing Neratinib-induced diarrhea and improving quality of life. | Dietary supplement | Probiotics + Neratinib + Loperamide |
| PlaceboParticipants in this group will receive a daily dose of a placebo that is identical in appearance, taste, and administration method to the probiotic granules, in addition to standard Neratinib therapy. The placebo will be administered orally as a granule formulation dissolved in water, for a total duration of 6 weeks. Loperamide will also be administered prophylactically to all participants in accordance with FDA recommendations. This group will serve as a control to evaluate the true effect of probiotics on Neratinib-induced diarrhea. | Dietary supplement | Placebo + Neratinib + Loperamide |
| LoperamideAll participants will receive prophylactic loperamide to reduce the risk of Neratinib-induced diarrhea. Loperamide will be administered according to the FDA-recommended schedule: 4 mg TID for the first 14 days of treatment, then 4 mg BID from Day 15 to Day 42. This intervention is implemented as a standard supportive therapy and not as a randomized variable. | Drug | Placebo + Neratinib + Loperamide, Probiotics + Neratinib + Loperamide |
Primary outcome
Incidence of Grade ≥3 Diarrhea
Time frame: Up to 6 weeks
The incidence of grade 3 or higher diarrhea during the 6-week treatment period, assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
9 secondary outcomes
Incidence of Any Grade Diarrhea
Time frame: Up to 6 weeks
Duration of First Episode of Grade 3 Diarrhea
Time frame: Up to 6 weeks
Proportion of Participants Hospitalized Due to Diarrhea
Time frame: Up to 6 weeks
Loperamide Usage Patterns
Time frame: Up to 6 weeks
Change from Baseline in Overall Quality of Life Assessed by EORTC QLQ-C30
Time frame: Baseline, Weeks 2, 4, and 6 (End of Study)
Change from Baseline in Diarrhea-Related Quality of Life Assessed by FACT-D
Time frame: Baseline, Weeks 2, 4, and 6 (End of Study)
Incidence of Treatment-Related Adverse Events (AEs)
Time frame: Up to 6 weeks
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 6 weeks
Rate of Treatment Discontinuation Due to Adverse Events
Time frame: Up to 6 weeks
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 17 Jun 2026.
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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?
A study testing Probiotics and Loperamide in people with HER2-positive Breast Cancer and Diarrhea Caused by Drug, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 10 inclusion and 9 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 17 Jun 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. Some participants in this study may receive a placebo. 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 Jianli Zhao (+86 15920589334, zhaojianli1988@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Grade ≥3 Diarrhea (time frame: Up to 6 weeks). 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 17 Jun 2026.