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
University Hospital Tuebingen
225 participants
Jun 1, 2024
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
Inclusion Criteria6
- 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 Criteria6
- 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)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05914961