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)

Emory University/Winship Cancer Institute

Atlanta, Georgia, United States

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NCT05877859


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