Investigating CRP Levels in Triple-Negative Breast Cancer During Immunotherapy
ICK-Breast: Immunotherapy-related CRP Kinetics in Early and Metastatic Triple-negative Breast Cancer
This study is testing if changes in a blood marker called CRP can help predict how well immunotherapy works for people with triple-negative breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 225 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital Tuebingen Academic / other |
| Drugs / interventions | chemotherapy, Immunotherapy |
| Locations | 1 site (Tübingen) |
| Trial ID | NCT05914961 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 and older with histologically confirmed early or metastatic TNBC who are ER-negative, PR-negative, and HER2-negative.
Not a fit: Patients with ER-positive, PR-positive, or HER2-positive breast cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new predictive tool for assessing treatment response in triple-negative breast cancer patients undergoing immunotherapy.
How similar studies have performed: Previous studies in other cancer types have shown that inflammatory responses can correlate with immunotherapy effectiveness, suggesting potential success for this approach in TNBC.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Tübingen
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.