Probiotics for Prevention of Pyrotinib/Neratinib-Induced Diarrhea in Breast Cancer Patients

Launched by SUN YAT-SEN MEMORIAL HOSPITAL OF SUN YAT-SEN UNIVERSITY · Mar 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether probiotics can help prevent diarrhea in women with HER2-positive breast cancer who are taking specific cancer medications called Pyrotinib or Neratinib. Diarrhea is a common side effect of these medications, and the researchers want to see if taking probiotics—beneficial bacteria that can improve gut health—can reduce the severity and frequency of this issue. During the study, participants will be randomly assigned to either receive probiotics or a placebo (a non-active treatment) for 12 weeks, followed by a 4-week observation period.

To be eligible for this trial, participants need to be female, at least 18 years old, and diagnosed with HER2-positive breast cancer. They must also be scheduled to receive either Pyrotinib or Neratinib and generally be in good health, with no serious gastrointestinal issues. Throughout the study, participants will be allowed to take medication to manage any diarrhea that occurs. The trial is set to start enrolling patients in January 2025 and will take place at Sun Yat-Sen Memorial Hospital. This research could provide important information on how to better manage side effects of cancer treatments and improve the quality of life for patients.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• Participants must meet all of the following criteria:
• • 1. Female patients aged ≥18 years, diagnosed with HER2-positive breast cancer.
• • 2. Eligible for pan-HER TKI therapy, including Pyrotinib or Neratinib, based on clinical guidelines.
• • 3. ECOG performance status ≤ 2, with an expected survival of at least 3 months.
• • 4. Left ventricular ejection fraction (LVEF) ≥ 50%.
• • 5. Resolution of prior treatment-related toxicity to Grade ≤1 (CTCAE v5.0), with AST and ALT ≤ 2.5 times the upper normal limit, and total bilirubin ≤ 1.5 times the upper normal limit.
• • 6. 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, and serum creatinine ≤ 1.5 times the upper normal limit.
• • 7. No persistent gastrointestinal symptoms (e.g., hematochezia, chronic constipation, or abdominal pain).
• • 8. No evidence of structural gastrointestinal abnormalities based on gastroscopy or other relevant examinations.
• Exclusion Criteria:
• Patients will be excluded if they meet any of the following criteria:
• • 1. Conditions that impair swallowing or drug absorption.
• • 2. Presence of other gastrointestinal diseases, including but not limited to inflammatory bowel disease or gastrointestinal tumors.
• • 3. Severe cardiovascular disease or conditions incompatible with chemotherapy, including but not limited to life-threatening arrhythmias, advanced atrioventricular block, unstable angina, clinically significant pericardial disease, myocardial fibrosis, or uncontrolled hypertension.
• • 4. Known hypersensitivity to any active ingredient or component of the investigational drug.
• • 5. Prior radiotherapy, chemotherapy, endocrine therapy, or investigational drug trials within 4 weeks before enrollment, or history of chronic use of constipation-inducing medications within 6 months before enrollment.
• • 6. Pregnant or lactating women or those unwilling to adopt effective contraception during the study period.
• • 7. Any condition, at the investigator's discretion, that may compromise patient safety, interfere with study participation, or affect the interpretation of study results.