Immunotherapy-related CRP Kinetics in Early and Metastatic Triple-negative Breast Cancer

Recruiting

• Conditions: TNBC - Triple-Negative Breast Cancer

• Registration Number: NCT05914961
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

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.

Detailed Description

Immunotherapy, which involves activating the body's immune system for cancer treatment, has already been widely incorporated into the standard care of breast cancer patients with early and metastatic triple-negative breast cancer (TNBC).

This study aims to investigate how inflammatory markers such as C-reactive protein (CRP) change during and after immunotherapy. Study findings from other tumor types (kidney, lung, bladder) suggest that immunotherapy is particularly effective when a mild inflammatory response is triggered in the body. The investigators want to examine this using CRP measurement. CRP measurement can easily be integrated into clinical routine as it only requires a blood sample. And since the patients already need a blood draw for chemotherapy, CRP measurement can be performed directly from the blood sample.

The goal of this prospective study is to determine whether changes in CRP levels in the blood can predict the disease progression or response to immunotherapy.

Study Timeline

• Study First Submitted: 2023-06-13
• Study First Submitted QC: 2023-06-13
• Study First Posted: 2023-06-22
• Study Start: 2024-06-01
• Status Verified: 2025-04
• Primary Completion: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-13
• Study Completion: 2035-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 225

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prognostic value of CRP kinetics under ICI therapy on pathologic complete response (PCR)	duration of therapy and follow-up data (10 years)	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 Outcome Measures

Name	Time	Method
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)	duration of therapy and follow-up data (10 years)	* evaluation of CRP kinetics to predict objective response in patients with metastatic TNBC receiving ICI in combination with chemotherapy; * evaluation of CRP kinetics to predict progression free survival in patients with metastatic TNBC receiving ICI in combination with chemotherapy; * evaluation of CRP kinetics to predict overall survival in patients with metastatic TNBC receiving ICI in combination with chemotherapy; * evaluation of CRP kinetics to predict event-free survival in patients with early TNBC receiving ICI in combination with chemotherapy; * evaluation of CRP kinetics to predict distant invasive recurrence free survival in patients with early TNBC receiving ICI in combination with chemotherapy The CRP value is determined from blood samples.

Trial Locations

Locations (1)

Department of Women's Health; 🇩🇪 Tuebingen, Germany