Neoadjuvant TIL- and Response-Adapted Chemoimmunotherapy for TNBC
Trial Parameters
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Brief Summary
This study will assess if the presence of immune system cells in and around the tumor impacts tumor shrinkage in patients receiving neoadjuvant chemoimmunotherapy for triple-negative breast cancer.
Eligibility Criteria
Inclusion Criteria: * Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent * Female subjects 18 years of age or older * Histologically confirmed cT1c-T3N0, cT1-T3N1-N2, cTxN1-2 TNBC * The invasive tumor must be hormone receptor poor, defined as both estrogen receptor (ER) and progesterone receptor staining in ≤ 10% of invasive cancer cells by IHC * The invasive tumor must be HER2-negative based on the current ASCO-CAP guidelines * No previous ipsilateral breast surgery for the current breast cancer * No previous chemotherapy, immunotherapy, endocrine therapy, or radiotherapy for the current breast cancer * ECOG Performance Status 0 - 1 documented within 21 days prior to the start of study treatment * Breast and axillary imaging (including ultrasound and MRI) within 42 days (6 weeks) prior to treatment initiation * Subjects with clinically and/or radiographically abnormal axillar