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

TNBC - Triple-Negative Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05914961
• Other study ID #: ICK-Breast
• Status: Recruiting
• Start date: June 2024
• Est. completion date: April 2035

Study information

• Verified date: January 2024
• Source: University Hospital Tuebingen
• Contact: Tobias Engler, Dr.
• Phone: 07071 29 82211
• Email: Tobias.Engler[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: April 2035
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Neoplasms
• TNBC - Triple-Negative Breast Cancer
• Triple Negative Breast Neoplasms

Locations

Country	Name	City	State
Germany	Department of Women's Health	Tuebingen

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Tuebingen	University Hospital Freiburg, University Hospital Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prognostic value of CRP kinetics under ICI therapy on pathologic complete response (PCR)	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.	duration of therapy and follow-up data (10 years)
Secondary	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)	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.	duration of therapy and follow-up data (10 years)