Actively Recruiting
Probiotics for Prevention of Neratinib-Induced Diarrhea in Breast Cancer Patients
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2025-09-08
308
Participants Needed
1
Research Sites
120 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead Sponsor
J
Jiangnan University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Probiotics for Prevention of Neratinib-Induced Diarrhea in Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 years or older diagnosed with HER2-positive breast cancer
- Scheduled to receive Neratinib therapy, alone or in combination
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less with expected survival of at least 3 months
- Left ventricular ejection fraction (LVEF) of 50% or higher
- Prior treatment toxicities resolved to Grade 1 or less with AST and ALT at or below 2.5 times the upper limit of normal and total bilirubin at or below 1.5 times the upper limit of normal
- Adequate bone marrow function with white blood cell count at least 3.0 x 10^9/L, neutrophil count at least 1.5 x 10^9/L, platelet count at least 100 x 10^9/L, hemoglobin at least 90 g/L, and serum creatinine at or below 1.5 times the upper limit of normal
- No ongoing gastrointestinal symptoms such as blood in stool, chronic constipation, or abdominal pain
- No structural gastrointestinal abnormalities confirmed by gastroscopy or other relevant examinations
You will not qualify if you...
- Conditions severely impairing swallowing, digestion, or gastrointestinal drug absorption
- History of chronic gastrointestinal diseases including inflammatory bowel disease, gastrointestinal tumors, or malabsorption syndromes
- Severe cardiovascular diseases such as life-threatening arrhythmias, advanced atrioventricular block, unstable angina, significant pericardial disease, myocardial fibrosis, or uncontrolled hypertension
- Known allergy to Neratinib, probiotics, placebo, or loperamide
- Participation in any clinical trial involving investigational drugs within 4 weeks prior to enrollment or chronic use of medications causing constipation within 6 months
- Pregnancy, breastfeeding, or unwillingness to use effective contraception during the study
- Any medical, psychiatric, or social condition that may compromise safety, interfere with participation, or affect study results as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
J
Jianli Zhao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here