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.
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
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
University Hospital Tuebingen
Lead sponsor
University Hospital Ulm
Collaborator
University Hospital Freiburg
Collaborator