Gut microbiome's role in predicting treatment response for HER2-positive breast cancer

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 investigates the characteristics and changes in the gut microbiome of patients with HER2-positive breast cancer undergoing neoadjuvant therapy. It aims to correlate gut microbiome composition with the likelihood of achieving a pathologic complete response (pCR) after treatment. By enrolling 100 participants, the study will collect stool and blood samples at various treatment stages to assess the relationship between microbiome alterations and treatment outcomes. The goal is to identify predictive factors that could enhance treatment efficacy and minimize side effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Female, presenting for the first time with operable breast cancer, who had not received any previous treatment for an invasive malignancy.
2. Primary tumor greater than (\>) 2 cm in diameter.
3. Age ≥ 18 years and \< 70 years.
4. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\</=) 1.
5. Baseline left ventricular ejection fraction (LVEF) greater than or equal to (\>/=) 55%
6. Availability of tumor tissue specimen after surgery.
7. Histologically proven diagnosis of breast cancer.
8. Patients have HER2-positive disease. HER2-positive disease was defined as follows: disease which overexpresses HER-2 by immunohistochemistry (IHC) 3+ and/or has HER2 amplification according to fluorescence in situ hybridization (FISH).
9. Had hormonal receptors (ER and PgR) assessed.
10. Signed informed consent.
11. Able to comply with the protocol.

Exclusion Criteria:

1. prior ipsilateral breast surgery, ipsilateral radiotherapy, hormonal therapy or systemic chemotherapy
2. Prolonged antibiotic treatment \> 10 days within 1 month of neoadjuvant chemotherapy as prevention or suppression of an ongoing infection
3. Uncontrolled inflammatory bowel disease
4. pregnant

Where it's running

• Jiangsu Provincial People's Hospital
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Wei Li, Ph.D
• Email: real.lw@163.com
• Phone: 025-68307102

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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.