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

Sponsor

University Hospital Tuebingen (Other)

Overall Status

Recruiting

CT.gov ID

NCT05914961

Collaborator

University Hospital Ulm (Other), University Hospital Freiburg (Other)

225

Enrollment

Location

142

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
TNBC - Triple-Negative Breast Cancer

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 Design

Study Type:

Observational

Anticipated Enrollment :

225 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2025

Anticipated Study Completion Date :

Apr 1, 2035

Arms and Interventions

Arm	Intervention/Treatment
Control Group Chemotherapy without immunotherapy
Experimental Group Chemotherapy in combination with immunotherapy

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Women's Health	Tuebingen		Germany	72076

Sponsors and Collaborators

University Hospital Tuebingen
University Hospital Ulm
University Hospital Freiburg

Investigators

Principal Investigator: Tobias Engler, Dr., Department of Women's Health Tübingen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital Tuebingen

ClinicalTrials.gov Identifier:

NCT05914961

Other Study ID Numbers:

ICK-Breast

First Posted:

Jun 22, 2023

Last Update Posted:

Jun 22, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breast Neoplasms

Triple Negative Breast Neoplasms

Study Results

No Results Posted as of Jun 22, 2023