Evaluating and Monitoring Immune and Clinical Responses in Early-Stage Triple Negative Breast Cancer Undergoing Neoadjuvant Chemo-immunotherapy With Pembrolizumab
Trial Parameters
Brief Summary
This research study is a prospective, single arm, pilot study, designed to evaluate the correlation between the immune and clinical responses of subjects with untreated Stage II-III triple negative breast cancer (TNBC) undergoing standard of care neoadjuvant chemo- immunotherapy.
Eligibility Criteria
Inclusion Criteria: * Newly diagnosed, previously untreated, non-metastatic Stage II-III invasive breast cancer * Estrogen receptor IHC expression ≤10%; progesterone receptor IHC expression ≤ 10%; HER2 negative * HER2 negativity is defined as either of the following by local laboratory assessment: * IHC 0, 1+, or 2+ and In situ hybridization (ISH) non-amplified (ratio of HER2 to CEP17 \<2.0 or single probe average HER2 gene copy number \<4 signals/cell) * No prior chemotherapy, endocrine therapy, or immunotherapy * Willingness and ability of the subject to comply with scheduled visits, standard of care drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions. * Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potentia