Monitoring Immune and Clinical Responses in Women with Early-Stage Triple Negative Breast Cancer Receiving Pembrolizumab and Chemotherapy

What this Trial Is About

Researchers are studying the immune and clinical responses in women with untreated Stage II-III triple negative breast cancer TNBC who are undergoing standard neoadjuvant chemo-immunotherapy. This pilot study aims to evaluate how the treatment affects inflammatory markers in the blood and tissue, and whether these changes are linked to how well the cancer responds to therapy. The research also focuses on specific gene activity in tumor tissue related to immune response and treatment outcomes. Participants will receive the standard neoadjuvant chemo-immunotherapy, including pembrolizumab, as part of their treatment plan. The study observes the immune systems reaction, particularly looking at certain cytokines in the blood within 24 hours of starting therapy and throughout the treatment course. Tissue samples will also be analyzed to assess gene signatures associated with treatment response or resistance. During the study, participants will have scheduled visits to monitor their blood and tissue changes, including laboratory tests and other study procedures. Researchers will track changes in inflammatory markers in the blood and gene activity in tumor tissue to understand their association with treatment success. The study requires participants to comply with all visits and procedures, and participation involves informed consent and understanding of the therapys experimental nature.

Evaluating and Monitoring Immune and Clinical Responses in Early-Stage Triple Negative Breast Cancer Undergoing Neoadjuvant Chemo-immunotherapy With Pembrolizumab