Actively Recruiting
Immunotherapy-related CRP Kinetics in Early and Metastatic Triple-negative Breast Cancer
Led by University Hospital Tuebingen · Updated on 2026-02-12
225
Participants Needed
1
Research Sites
565 weeks
Total Duration
On this page
Sponsors
U
University Hospital Tuebingen
Lead Sponsor
U
University Hospital Ulm
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Immunotherapy-related CRP Kinetics in Early and Metastatic Triple-negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 years or older
- Histologically confirmed early, advanced, or metastatic invasive breast cancer
- Breast cancer must be estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and HER2-negative (IHC 0-2+, FISH negative)
- For advanced or metastatic disease in the experimental group, PD-L1 positivity is required (IC 65 1 or CPS 65 10)
- Planned treatment with immune checkpoint inhibitor therapy combined with chemotherapy in the experimental group
- Provided written informed consent to participate in ICK-breast
You will not qualify if you...
- Estrogen receptor (ER)-positive or progesterone receptor (PR)-positive breast cancer
- HER2-positive breast cancer (IHC 2+, FISH positive or IHC 3+)
- Prior systemic breast cancer therapy before trial inclusion for early breast cancer patients
- Previous immune checkpoint inhibitor therapy before trial inclusion
- Pregnant or breastfeeding patients
- Poor general health condition not suitable for chemotherapy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Women's Health
Tübingen, Germany, 72076
Actively Recruiting
Research Team
T
Tobias Engler, Dr.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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