Evaluating and Monitoring Immune and Clinical Responses in Early-Stage Triple Negative Breast Cancer Undergoing Neoadjuvant Chemo-immunotherapy With Pembrolizumab
Part of paid clinical trials in Atlanta, Georgia.
- Sponsor
- Emory University
- Study ID
- NCT05877859
- Status
- Recruiting
Conditions
- Breast Cancer Invasive
- Breast Cancer Stage II
- Breast Cancer Stage III
- Breast Cancer Triple Negative
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Study Details
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.
Key Dates
- Start date
- May 30, 2023
- Status verified
- May 2026
- Primary completion
- Feb 20, 2027
- Completion
- Feb 20, 2028
Study Design
- Enrollment
- 10 participants (estimated)
Primary Outcome Measure
Change in the cytokine milieu in the blood [ Time Frame: From baseline within 24 hours of surgery ]
Central Contacts
- Ruth Sacks, MD404-778-1900
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Emory University/Winship Cancer Institute | Atlanta | Georgia | 30322 | Ruth Sacks, MD (PRINCIPAL_INVESTIGATOR) |
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