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

Launched by UNIVERSITY HOSPITAL TUEBINGEN · Jun 13, 2023

Keywords

ClinConnect Summary

This clinical trial, called ICK-breast, is studying how changes in a blood marker called CRP (C-reactive protein) relate to treatment outcomes for women with triple-negative breast cancer (TNBC). The trial aims to understand how CRP levels can predict how well patients respond to a specific type of therapy known as immune checkpoint inhibitors (ICIs), both in early-stage and advanced or metastatic cases of TNBC. Researchers want to see if CRP levels can help determine if patients achieve a complete response to treatment and how long they remain free from disease or alive after starting therapy.

To participate in this trial, women must be at least 18 years old and have been diagnosed with invasive breast cancer that is negative for hormone receptors (like estrogen and progesterone) and HER2. For those with advanced cancer, they also need to have a certain level of a protein called PD-L1. Participants will receive planned treatment with ICIs alongside chemotherapy. The trial is currently recruiting, and all participants will need to give their written consent to join. This study could help improve treatment strategies for women facing this challenging type of breast cancer.

Gender

FEMALE

Eligibility 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)