Clinical trial · Observational
Gut and Intratumoral Microbiome Effect on the Neoadjuvant Chemotherapy-induced Immunosurveillance in Triple Negative Breast Cancer
NCT03586297CI-TRIAL-00106642completedClinicalTrials.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)
The probability of pCR in TNBC patients receiving standard of care neoadjuvant chemotherapy treatment is associated with the dominance of specific intestinal and intratumoral microbiota that promote anti-tumor immunosurveillance.
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 |
|---|---|---|---|
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Pathologic Complete Response
- timeFrame
- completion of chemotherapy, approximately 18 weeks.
- description
- The primary objective of this study is to determine if the probability of pCR (pathologic complete response) in TNBC (triple negative breast cancer) patients treated with standard of care neoadjuvant chemotherapy is correlated with variability in the composition of intestinal and intratumoral microbiota and subsequent short-term alterations in that composition.
Secondary outcomes (3)
- measure
- Other Correlations between Pathologic complete Response
- timeFrame
- completion of chemotherapy, approximately 18 weeks.
- description
- Determine whether the correlation between specific microbiota and the probability of pCR is predictive for the resolution of T cell exhaustion.
- measure
- Other Correlations between Pathologic complete Response
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed new diagnosis of TNBC (\<5% of ER and PR immunoreactivity and HER2- by FISH or IHC staining 0 or 1+) * \>18 years * 1.5 cm mass lesion or greater * Tumor amenable to percutaneous core biopsy Exclusion Criteria: * chronic anticoagulation therapy * prior ipsilateral breast surgery, ipsilateral radiotherapy, hormonal therapy or systemic chemotherapy * Prolonged antibiotic treatment \> 10 days within 1 month of neoadjuvant chemotherapy as prevention or suppression of an ongoing infection * lactating * pregnant
References
Publications (0)
Data not yet available
No reference posted for this study.