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

Recruitingn/aAges 18 Years - anyFemaleUniversity Hospital Tuebingen
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * women ≥ 18 years of age * histologically proven early or advanced or metastatic invasive breast cancer irrespective of therapy line * ER-negative and progesterone receptor (PR)-negative and human epidermal growth factor receptor 2 (HER2)-negative (IHC 0-2+, Fluorescence In Situ Hybridization (FISH) neg.) * patients with advanced or metastatic disease must be programmed cell death ligand 1 (PD-L1)-positive (IC ≥ 1 or combined positive score (CPS) ≥ 10) in the experimental group * planned ICI therapy in combination with chemotherapy in the experimental group * written informed consent into ICK-breast Exclusion Criteria: * ER-positive or PR-positive * HER2-positive (IHC 2+, FISH pos or IHC 3+) * any systemic breast cancer therapy before inclusion into the trial for early breast cancer patients * any ICI therapy before inclusion into the trial * pregnant or lactating patients * inadequate general condition (not fit for chemotherapy)
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What it tests

  • Not listed
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Where

1 site
Department of Women's Health
Tübingen, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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