Gut and Intratumoral Microbiome Effect on the Neoadjuvant Chemotherapy-induced Immunosurveillance in Triple Negative Breast Cancer

Completed

Conditions studied: Triple Negative Breast Cancer

In brief

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.

Key facts

Study ID

NCT03586297

Run by

Hackensack Meridian Health

People needed

49

Starts

2017-08-27

Expected to finish

2025-09-15

Last updated by the study team

2026-03-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Yale University - Yale Cancer Center — New Haven, Connecticut, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• Hackensack Meridian Health — Hackensack, New Jersey, United States

Full record on ClinicalTrials.gov

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