Status:
RECRUITING
Probiotics for Prevention of Neratinib-Induced Diarrhea in Breast Cancer Patients
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborating Sponsors:
Jiangnan University
Conditions:
HER2-positive Breast Cancer
Diarrhea Caused by Drug
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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: ...
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 ev...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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.
- 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.
- Exclusion Criteria
- 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.
- 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.
Exclusion
Key Trial Info
Start Date :
August 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
308 Patients enrolled
Trial Details
Trial ID
NCT06892093
Start Date
August 7 2025
End Date
December 1 2027
Last Update
September 8 2025
Active Locations (1)
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1
Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China