NCT05914961Recruiting
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
Source: ClinicalTrials.gov · Last updated 12 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 225 (estimated)
- First submitted
- 13 Jun 2023
- Start date
- 1 Jun 2024
- Primary completion date
- Apr 2027
- Lead sponsor
- University Hospital Tuebingen
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT05914961
What you commit to
- Study type: Observational
- Planned participants: 225
- From 1 Jun 2024 to the primary completion date, Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- any ICI therapy before inclusion into the trial
Other illness
- any systemic breast cancer therapy before inclusion into the trial for early breast cancer patients
- inadequate general condition (not fit for chemotherapy)
Other
- ER-positive or PR-positive
- HER2-positive (IHC 2+, FISH pos or IHC 3+)
- pregnant or lactating patients
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Women's Health Coordinator of this site? Confirm its status | Tübingen | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.