Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| TNBC - Triple-Negative Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Control Group
- description
- Chemotherapy without immunotherapy
- label
- Experimental Group
- description
- Chemotherapy in combination with immunotherapy
Primary outcomes (1)
- measure
- Prognostic value of CRP kinetics under ICI therapy on pathologic complete response (PCR)
- timeFrame
- duration of therapy and follow-up data (10 years)
- description
- Evaluation of CRP kinetics to predict pCR in early (pathologic complete response) TNBC treated with ICI in combination with chemotherapy. The CRP value is determined from blood samples.
Secondary outcomes (1)
- measure
- Prognostic value of CRP kinetics under ICI therapy on objective response rate (ORR), progression free survival (PFS), event-free survival (EFS), invasive recurrence free survival and overall survival (OS)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available