Clinical Trial 21452

• Overview

  Study Title:

  Evaluating Gut Microbiome As A Biomarker Of Pathological Complete Response In Patients With Early Triple Negative Breast Cancer - A Pilot Study (TCC)

  Summary:

  The purpose of the study is to is to obtain information on the microbiome – bacteria and other microbes living all over the outside and inside the human body. Specifically, investigators would like to know more about the gut microbiome of participants with breast cancer who plan to receive chemotherapy at Moffitt Cancer Center

  Objective:

  In patients with non-metastatic triple negative breast cancer, eligible for neoadjuvant chemotherapy+/- immunotherapy: 1. Characterize gut microbiota and microbial metabolite of patients starting standard neoadjuvant treatment. 2. Compare differences in gut microbiota/metabolite between pathological complete responders vs non-responders.

• Inclusion Criteria

  • Age >18 years, any gender
  • Longitudinal study will be conducted in patients confirmed to have: Patients with non-metastatic resectable triple negative breast cancer starting treatment with standard of care neoadjuvant therapy
  • Patients must have had at least one measurable lesion as per RECIST 1.1. at start of therapy
  • Ability to understand and the willingness to sign a written informed consent document
  • Patient will be consented through the TCC consent process or the PI initiated consent

• Exclusion Criteria

  • Patients on antibiotics in the last 30 days prior to starting neoadjuvant treatment, GI surgery including colectomy, small intestinal surgery, history of inflammatory bowel disease

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