Gut bacteria and diarrhea in breast cancer patients on pyrotinib

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will examine the gut microbiota of HER2-positive breast cancer patients being treated with pyrotinib. Researchers will compare those who experience diarrhea with those who do not to identify bacteria that might be linked to the side effect. The goal is to uncover patterns in gut microbiota that could lead to future prevention or treatment approaches. Participants must be adults aged 18-75 on pyrotinib for at least two weeks and able to provide informed consent. Exclusion criteria include significant GI disease, recent antibiotic or probiotic use, pregnancy, or unwillingness to participate.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hubei Cancer Hospital
  Wuhan, Hubei, China Recruiting

Study contacts

• Study coordinator: Xinhong Wu Wu, Principal Investigator
• Email: wuxinhong_9@sina.com
• Phone: 18602726300

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  Recruiting Phase 1 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT06770296

• Evaluating Pyrotinib dosing for advanced HER2-positive breast cancer

  This study is testing if a lower dose of Pyrotinib is safer and just as effective as the standard dose for people with advanced HER2-positive breast cancer.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT06254690

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.