NCT03586297Completed
Gut and Intratumoral Microbiome Effect on the Neoadjuvant Chemotherapy-induced Immunosurveillance in Triple Negative Breast Cancer
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 49 (actual)
- First submitted
- 11 Jun 2018
- Start date
- 27 Aug 2017
- Primary completion date
- 15 Sept 2025
- Lead sponsor
- Hackensack Meridian Health
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT03586297
What you commit to
- Study type: Observational
- Participants enrolled: 49
- From 27 Aug 2017 to the primary completion date, 15 Sept 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- chronic anticoagulation therapy
- prior ipsilateral breast surgery, ipsilateral radiotherapy, hormonal therapy or systemic chemotherapy
Other illness
- Prolonged antibiotic treatment \> 10 days within 1 month of neoadjuvant chemotherapy as prevention or suppression of an ongoing infection
Other
- lactating
- pregnant
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hackensack Meridian Health Coordinator of this site? Confirm its status | Hackensack | United States | Unknown status |
| Yale University, Yale Cancer Center Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Georgetown University Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.