Immunotherapy-related CRP Kinetics in Early and Metastatic Triple-negative Breast Cancer
Recruiting now
Conditions studied: TNBC - Triple-Negative Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT05914961
- Run by
- University Hospital Tuebingen
- People needed
- 225
- Starts
- 2024-06-01
- Expected to finish
- 2035-04-01
- Last updated by the study team
- 2026-02-12
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Department of Women's Health — Tübingen, Germany (enrolling)
Full record on ClinicalTrials.gov
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