Investigating CRP Levels in Triple-Negative Breast Cancer During Immunotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore the prognostic significance of C-reactive protein (CRP) kinetics in patients with early and metastatic triple-negative breast cancer (TNBC) undergoing immune checkpoint inhibitor therapy. By measuring CRP levels through routine blood samples, the study seeks to determine if changes in these inflammatory markers can predict treatment response and disease progression. The research will focus on both pathological complete response in early TNBC and various survival outcomes in advanced cases. The findings could enhance understanding of immunotherapy effectiveness in TNBC patients.

Why it matters

Who can join: the full rules

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)

Where it's running

• Department of Women's Health
  Tübingen, Germany Recruiting

Study contacts

• Principal investigator: Tobias Engler, Dr. — Department of Women's Health Tübingen
• Study coordinator: Tobias Engler, Dr.
• Email: Tobias.Engler@med.uni-tuebingen.de
• Phone: 07071 29 82211

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.