Gut Microbiota and Diarrhea in Breast Cancer Patients Receiving Pyrotinib

Hubei Cancer Hospital

Status: Not yet enrolling

Conditions: Breast Cancer; Diarrhea; Drug-Related Side Effects

Study type: Observational

Funder types: Other

Identifiers

NCT07264985

LLHBCH2025YN-087

Details and patient eligibility

About

Background:

Pyrotinib is an effective targeted drug for HER2-positive breast cancer, but it very frequently causes diarrhea, which can be severe enough to disrupt treatment and reduce patients' quality of life. The reason why some patients develop diarrhea while others do not is not well understood. Recent research suggests that the community of bacteria in the gut (gut microbiota) may play a key role in this side effect.

What is the purpose of this study? This is an observational study (Phase 1) that aims to understand the relationship between pyrotinib treatment, changes in gut bacteria, and the occurrence of diarrhea. The main goal is to compare the gut bacteria of patients who develop diarrhea while taking pyrotinib with those who do not. Researchers hope to identify specific bacteria that might protect against diarrhea, which could lead to new ways to prevent or treat this side effect in the future.

What will happen in the study? Patients with HER2-positive breast cancer who are being treated with pyrotinib will be invited to participate. They will be divided into two groups: those who experience diarrhea and those who do not. Participants will provide stool samples at specific time points (e.g., 2 and 4 weeks after starting pyrotinib). They will also allow researchers to collect information from their medical records about their clinical condition and diarrhea symptoms. No experimental intervention will be administered in this phase of the study; all patients will receive standard medical care.

Potential Benefits:

Participants will not receive any direct benefit from this observational phase of the study. However, the information gathered may help scientists better understand pyrotinib-induced diarrhea and develop future strategies to help other breast cancer patients manage this side effect more effectively.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients aged 18-75 years, regardless of gender.
2. Diagnosed with HER2-positive breast cancer and currently receiving pyrotinib treatment (either as monotherapy or in combination with endocrine therapy), with a treatment duration of ≥ 2 weeks.
3. Voluntarily agree to participate in this study and provide written informed consent.

Exclusion criteria

1. History of significant gastrointestinal diseases (e.g., inflammatory bowel disease, Crohn's disease, ulcerative colitis, intestinal obstruction) or previous major gastrointestinal surgery.
2. Recent use (within 1 month) of antibiotics, probiotics, or traditional Chinese medicine intended to alter intestinal function.
3. Pregnant or lactating women.
4. Patients who refuse to provide informed consent or explicitly express unwillingness to participate. Patients found not meeting the inclusion criteria after enrollment will be discontinued from the study.

Trial design

60 participants in 2 patient groups

Diarrhea Group

Description:

This cohort consists of HER2-positive breast cancer patients receiving pyrotinib treatment who develop diarrhea (graded as ≥ Grade 1 according to CTCAE v5.0) during the observation period. Participants in this group will provide stool samples and clinical data for comparison with the non-diarrhea group. No study intervention is administered; all patients receive standard medical care.

Non-Diarrhea Group

Description:

This cohort consists of HER2-positive breast cancer patients receiving pyrotinib treatment who do not develop diarrhea (Grade 0 according to CTCAE v5.0) during the observation period. Participants in this group will provide stool samples and clinical data, serving as a control for comparison with the diarrhea group. No study intervention is administered; all patients receive standard medical care.