Clinical trial · Observational
Gut Microbiome Components Predict Response to Neoadjuvant Therapy in HER2-positive Breast Cancer Patients : A Prospective Study
NCT05444647CI-TRIAL-00059509unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this study the characteristics and alterations of the gut microbiome during neoadjuvant therapy for HER2-positive breast cancer patients are studied, as well as the relation between the gut microbiome and probability of pCR.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| stool and blood collection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- HER2-positive
- description
- patients with newly diagnosed early stage HER2-positive breast cancer with an indication for standard trastuzumab-containing neoadjuvant treatment.
- interventionNames
- Procedure: stool and blood collection
Primary outcomes (1)
- measure
- Pathologic complete response in the breast and lymph nodes (ypT0/Tis ypN0)
- timeFrame
- 2 years
- description
- The primary objective of this study is to determine if the probability of pCR (pathologic complete response) in HER2-positive breast cancer patients treated with standard of care neoadjuvant therapy is correlated with variability in the composition of intestinal microbiota and subsequent short-term alterations in that composition.
Secondary outcomes (2)
- measure
- Correlations between Pathologic complete Response
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.