Evaluating and Monitoring Immune and Clinical Responses in Early-Stage Triple Negative Breast Cancer Undergoing Chemo-Immunotherapy with Pembrolizumab Before Surgery

Active:	Yes
Cancer Type:	Breast Cancer	NCT ID:	NCT05877859
Trial Phases:		Protocol IDs:	WINSHIP5818-22 (primary) NCI-2023-02943 STUDY00005452
Eligibility:	18 Years and older, Female	Study Type:	Other
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT05877859

Summary

This study evaluates immune and clinical responses in patients with early stage triple negative breast cancer undergoing combination chemotherapy and immunotherapy. Using blood and tissue samples may explain what changes occur in the immune system and the breast cancer when a patient receives standard of care chemotherapy and immunotherapy prior to surgery and how these changes are associated with response (how much cancer is still present) at the time of surgery.

Objectives

PRIMARY OBJECTIVE:
I. To determine whether standard of care neoadjuvant chemo-immunotherapy leads to the induction of a pro-inflammatory cytokine milieu in the blood, which is induced with 24 hours of treatment initiation, persists through the course of the therapy and is associated with pathologic complete response in the tissue.

OUTLINE: This is an observational study.

Patients undergo collection of blood and tissue samples on study. Patients also have their medical records reviewed on study.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.