JOURNAL ONKOLOGIE – STUDIE

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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme

Rekrutierend

NCT-Nummer:
NCT05914961

Studienbeginn:
Juni 2024

Letztes Update:
01.02.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Breast Neoplasms, Triple Negative Breast Neoplasms

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital Tuebingen

Collaborator:
University Hospital Ulm, University Hospital Freiburg,

Studienleiter

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

Kontakt

Tobias Engler, Dr.
Kontakt:
Phone: 07071 29 82211
E-Mail: Tobias.Engler@med.uni-tuebingen.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Department of Women's Health
72076 Tuebingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Tobias Engler, Dr.
Phone: 07071 29 82211
E-Mail: Tobias.Engler@med.uni-tuebingen.de» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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)

Studien-Rationale

Primary outcome:

1. Prognostic value of CRP kinetics under ICI therapy on pathologic complete response (PCR) (Time Frame - 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:

1. 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) (Time Frame - 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.

Studien-Arme

Control Group
Chemotherapy without immunotherapy
Experimental Group
Chemotherapy in combination with immunotherapy

Quelle: ClinicalTrials.gov

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