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Prevention study for HER2-positive Breast Cancer
Official title Probiotics for Prevention of Neratinib-Induced Diarrhea in Breast Cancer Patients
ClinicalTrials.gov ID: NCT06892093
What this study is testing
What is Loperamide?
Loperamide is an investigational medicine, being studied as a potential treatment for her2-positive breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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%.
You likely can't join if
- 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...
- Severe cardiovascular diseases that may interfere with study treatment, including but not limited to: Life-threatening arrhythmias Advanced...
- 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...
See the full 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.
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.