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

University Hospital Tuebingen

Status

Enrolling

Conditions

TNBC - Triple-Negative Breast Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT05914961

ICK-Breast

Details and patient eligibility

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.

Full 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.

Enrollment

225 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)