Actively Recruiting
Evaluating and Monitoring Immune and Clinical Responses in Early-Stage Triple Negative Breast Cancer Undergoing Neoadjuvant Chemo-immunotherapy With Pembrolizumab
Led by Emory University · Updated on 2026-05-07
10
Participants Needed
1
Research Sites
246 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluating and Monitoring Immune and Clinical Responses in Early-Stage Triple Negative Breast Cancer Undergoing Neoadjuvant Chemo-immunotherapy With Pembrolizumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed, previously untreated, non-metastatic Stage II-III invasive breast cancer
- Estrogen receptor IHC expression 60;10%; progesterone receptor IHC expression 60;10%; HER2 negative
- HER2 negativity defined as IHC 0, 1+, or 2+ and In situ hybridization non-amplified
- No prior chemotherapy, endocrine therapy, or immunotherapy
- Willingness and ability to comply with visits, drug administration, lab tests, procedures, and restrictions
- Signed informed consent showing awareness of disease, procedures, risks, benefits, and alternatives
You will not qualify if you...
- Pregnant, breastfeeding, or unwilling to practice birth control during the study
- Receiving other investigational agents or devices within 21 days before first dose
- Using steroid medications not part of standard pre-medications for chemo-immunotherapy
- History of allergic reactions to similar compounds used in the study
- Uncontrolled illnesses such as active infection, heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
- HIV-positive on combination antiretroviral therapy due to interaction risks and infection susceptibility
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
R
Ruth Sacks, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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