RecruitingNCT05914961

Immunotherapy-related CRP Kinetics in Early and Metastatic Triple-negative Breast Cancer

ICK-Breast: Immunotherapy-related CRP Kinetics in Early and Metastatic Triple-negative Breast Cancer


Sponsor

University Hospital Tuebingen

Enrollment

225 participants

Start Date

Jun 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

ICK-breast is a prospective, multicentric, non-interventional investigator-initiated trial (IIT) that aims to investigate the prognostic value of CRP kinetics in early and advanced or metastatic triple negative breast cancer (TNBC) under immune checkpoint inhibitor (ICI) therapy on pathological complete response (pCR) and event-free survival in early TNBC patients, and objective response rate (ORR), progression-free survival (PFS) and overall survival (OS) in advanced or metastatic TNBC.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking a blood protein called CRP (C-reactive protein) in women with triple-negative breast cancer (TNBC) who are receiving immunotherapy, to see if CRP levels can predict who responds well to treatment. **You may be eligible if...** - You are a woman 18 or older - You have confirmed triple-negative breast cancer (ER, PR, and HER2 negative) at any stage - You are receiving or about to receive immunotherapy (checkpoint inhibitor) as part of your treatment **You may NOT be eligible if...** - You have a different breast cancer subtype (not triple-negative) - You are not receiving immunotherapy as part of your treatment - You have a condition that causes chronically elevated CRP unrelated to cancer (e.g., active serious infection) 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)

Department of Women's Health

Tübingen, Germany

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NCT05914961


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