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
52 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
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 system's 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 therapy's experimental nature.
CONDITIONS
Brief 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 by local lab assessment as IHC 0, 1+, or 2+ and ISH non-amplified (HER2 to CEP17 ratio <2.0 or HER2 gene copy number <4 signals/cell)
- No prior chemotherapy, endocrine therapy, or immunotherapy
- Willingness and ability to comply with scheduled visits, standard of care drug plan, lab tests, study procedures, and restrictions
- Signed informed consent and awareness of study details including experimental nature and potential risks
You will not qualify if you...
- Pregnant, breastfeeding, or unwilling to use birth control during the study
- Receiving other investigational agents or devices within 21 days before study drug
- Use of steroid medications not part of the study's standard pre-medications
- History of allergic reactions to similar compounds as study agents
- Uncontrolled illnesses such as active infections, heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
- HIV-positive patients on combination antiretroviral therapy due to potential drug interactions and infection risk
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to the time of surgery
Participants undergoing standard of care neoadjuvant chemo-immunotherapy are observed to assess immune and clinical responses, including changes in blood cytokine levels and tissue transcriptomic signatures.
Regular visits as part of standard of care treatment
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
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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