Clinical Trial

Predicting Response to Immunochemotherapy in Early Triple Negative Breast Cancer

Study acronym: PRIME-TNBC
Recruiting
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Summary
The goal of this clinical trial is to identify cellular and molecular determinants of response to neoadjuvant immunochemotherapy in women aged 18 or older with early-stage triple-negative breast cancer (TNBC). The main questions it aims to answer are: * Can detailed immune profiling of the tumor and its microenvironment predict pathological complete response (pCR, RCB-0) versus partial/non-response (RCB-I, II, III) to neoadjuvant immunochemotherapy? * Are there specific immune or molecular biomarkers (e.g., TILs, CD3/8/20, FoxP3, PDL1, transcriptomic signatures) associated with progression-free survival and overall survival in this population? Researchers will compare patients achieving pCR (RCB-0) to those with residual disease (RCB-I, II, III) to determine if immune and molecular profiles can discriminate responders from non-responders and guide personalized treatment strategies.
Protocol Amendment History 1 change
critical Recruitment opened 2026-07-11
Trial Details
NCT Number NCT07570524
Lead Sponsor Center Eugene Marquis
Conditions Triple-negative Breast Cancer (TNBC)
Enrollment 200 participants
Start Date 2026-06-25
Primary Completion 2036-06-25 (estimated)
Study Completion 2036-06-25 (estimated)
Updated on ClinicalTrials.gov 2026-07-10