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

ConditionTNBC - Triple-Negative Breast Cancer

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age18+

SponsorUniversity Hospital Tuebingen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

225 patients will be included in the study after written informed consent. Of 75 patients in the control group, which will undergo chemotherapy of physician's choice, 50 patients will be diagnosed with early TNBC and 25 patients will be diagnosed with advanced or metastatic TNBC. Of 150 patients in the experimental group, which will undergo chemotherapy in combination with ICIs, 100 patients will be diagnosed with early TNBC and 50 patients will be diagnosed with advanced or metastatic TNBC.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

225 Participants

are grouped into 2 trial groups

Group A: Control Group

Group B: Experimental Group

Trial outcomes

Primary outcomes

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.

Time frame

duration of therapy and follow-up data (10 years)

Secondary outcomes

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.

Time frame

duration of therapy and follow-up data (10 years)

Sponsors and contacts

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University Hospital Tuebingen

Lead sponsor

University Hospital Ulm

Collaborator

University Hospital Freiburg