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

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 sever

Trial Details

NCT ID
NCT06892093
Phase
NA
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Probiotics
  • Placebo
  • Loperamide
Locations (sample)
  • Guangzhou, Guangdong, China|23.11667,113.25

Key Eligibility 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.

For full eligibility, visit ClinicalTrials.gov.

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