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

Gut Microbiome Components Predict Response to Neoadjuvant Therapy in HER2-positive Breast Cancer Patients : A Prospective Study

This study is trying to see if changes in the gut bacteria of women with HER2-positive breast cancer can help predict how well they respond to their treatment.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (other)
• Drugs / interventions: chemotherapy, trastuzumab
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT05444647 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are females aged 18 to 70 with newly diagnosed operable HER2-positive breast cancer who have not received prior treatment.

Not a fit: Patients with a history of prior breast surgery or treatment for invasive malignancy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved personalized treatment strategies for HER2-positive breast cancer patients.

How similar studies have performed: While the role of the gut microbiome in cancer treatment is an emerging field, this specific approach is relatively novel and has not been extensively tested in similar studies.

Eligibility criteria

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 this trial is running

Nanjing, Jiangsu

• Jiangsu Provincial People's Hospital — Nanjing, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Wei Li, Ph.D

Conditions: Breast Cancer, HER2-positive, neoadjuvant, microbiome