CompletedNot Applicable

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

United States49 participantsStarted 2017-08-27

Plain-language summary

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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Pathologic Complete Response

Timeframe: completion of chemotherapy, approximately 18 weeks.

Trial details

NCT IDNCT03586297

SponsorHackensack Meridian Health

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-09-15

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