RecruitingNCT05877859
Evaluating and Monitoring Immune and Clinical Responses in Early-Stage Triple Negative Breast Cancer Undergoing Neoadjuvant Chemo-immunotherapy With Pembrolizumab
Sponsor
Emory University
Enrollment
10 participants
Start Date
May 30, 2023
Study Type
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Sex: FEMALEMin Age: 18 Years
Plain Language Summary
Simplified for easier understanding
This study closely monitors how the immune system responds in women with early-stage triple-negative breast cancer (TNBC) who are receiving standard chemo-immunotherapy with pembrolizumab before surgery. It collects blood and tissue samples to better understand which patients benefit most from this treatment.
**You may be eligible if...**
- You have newly diagnosed, previously untreated stage II or III invasive breast cancer
- Your cancer is triple-negative (ER-negative, PR-negative, HER2-negative)
- You have not received any prior chemotherapy, hormone therapy, or immunotherapy for this cancer
- You are willing and able to follow the study schedule
**You may NOT be eligible if...**
- You are pregnant, breastfeeding, or unwilling to use birth control
- You are taking steroids (such as prednisone or dexamethasone) beyond what is prescribed as part of the study regimen
- You are enrolled in another experimental treatment study
- You have HIV on antiretroviral therapy
- You have an uncontrolled infection, heart problem, or psychiatric condition that affects compliance
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05877859
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