Senologie - Zeitschrift für Mammadiagnostik und -therapie 2025; 22(02): e7
DOI: 10.1055/s-0045-1807647
Abstracts

Real world mutational landscape detected by ctDNA analysis in patients with metastatic breast cancer (MBC) progressing on/after CDK4/6i & aromatase inhibitor (AI) based therapies, DRKS00035139

M Dimpfl
1   University Medical Center Mannheim, Medical Faculty Mannheim, University of Heidelberg, Department of Obstetrics and Gynecology, Mannheim, Germany
,
B Ataseven
2   Universität Bielefeld, Medizinische Fakultät und Universitätsklinikum OWL, Klinikum Lippe, Universitätsklinik für Frauenheilkunde und Geburtshilfe, Lippe, Germany
,
V Bjelic-Radisic
3   Helios Universitätsklinikum Wuppertal, Universität Witten/Herdecke, Wuppertal, Germany
,
T Decker
4   MVZ für Onkologie Ravensburg, Ravensburg, Germany
,
T Dimpfl
5   Klinikum Kassel, Kassel, Germany
,
M Eichbaum
6   Helios Dr. Horst-Schmidt-Kliniken Wiesbaden, Wiesbaden, Germany
,
J Ettl
7   Klinikverbund Allgaeu, Kempten, Germany
,
O Gluz
8   Ev. Bethesda Hospital, Breast Center Niederrhein, Moenchengladbach, Germany
,
V Haselmann
9   Institute for Clinical Chemistry, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany
,
F Klauschen
10   Pathology Institute, Ludwig Maximilians University of Munich, Munich, Germany
,
A Mavratzas
1   University Medical Center Mannheim, Medical Faculty Mannheim, University of Heidelberg, Department of Obstetrics and Gynecology, Mannheim, Germany
,
T-W Park-Simon
11   Hannover Medical School, Hannover, Germany
,
M Reinisch
1   University Medical Center Mannheim, Medical Faculty Mannheim, University of Heidelberg, Department of Obstetrics and Gynecology, Mannheim, Germany
,
C Schem
12   Mammazentrum Hamburg, Hamburg, Germany
,
E Sperk
13   University Medical Center Mannheim, Medical Faculty Mannheim, University of Heidelberg, Mannheim Cancer Center, Mannheim, Germany
,
M Sütterlin
1   University Medical Center Mannheim, Medical Faculty Mannheim, University of Heidelberg, Department of Obstetrics and Gynecology, Mannheim, Germany
,
M Thill
14   Agaplesion Markus Krankenhaus, Department of Gynecology and Gynecological Oncology, Frankfurt, Germany
,
K Tiemann
15   Institute for Hematopathology Hamburg, Hamburg, Germany
,
B Tuschy
1   University Medical Center Mannheim, Medical Faculty Mannheim, University of Heidelberg, Department of Obstetrics and Gynecology, Mannheim, Germany
,
P Wild
16   Goethe University Frankfurt, University Hospital, Dr. Senckenberg Institute of Pathology, Frankfurt, Germany
,
R Würstlein
17   LMU University Hospital, Breast Center, Department of Obstetrics and Gynecology and CCC Munich, Munich, Germany
,
F Marmè
1   University Medical Center Mannheim, Medical Faculty Mannheim, University of Heidelberg, Department of Obstetrics and Gynecology, Mannheim, Germany
› Author Affiliations
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    Introduction: In treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer (mBC), selecting therapy after first-line endocrine treatment combined with CDK4/6 inhibitors increasingly relies on biomarkers. Recently, biomarker-driven treatments gained regulatory approval. These include Elacestrant for patients with ESR1 mutations, detected via liquid biopsies, and Capivasertib for those with alterations in PIK3CA/AKT1 and/or PTEN. For patients with co-occurring genetic alterations, this development offers multiple therapeutic options. Given the heterogeneity of mBC, varying over time and between as well as within different metastases, there is still relatively limited knowledge about the evolution and impact of co-occurring genetic alterations in real-world settings.

    Objective: Our goal is to assess the mutational landscape detected through ctDNA analysis in a real-world setting, focusing on patients with HR+/HER2- mBC who are progressing on or after therapies based on CDK4/6 inhibitors and aromatase inhibitors. We will examine how these mutations correlate with clinicopathologic factors and previous treatments.

    Materials & Methods: We plan to enroll 250 patients from approximately 12 study centers across Germany. Liquid biopsy testing will be conducted in IVD-certified laboratories using NGS panels. The primary inclusion criterion is HR+/HER2- mBC in patients who have been treated with CDK4/6 inhibitors and aromatase inhibitors.

    Results: Enrollment began in the fourth quarter of 2024 at the University Hospital Mannheim. In 2025 additional study centers start enrolling patients.

    Summary: This study is among the first in Germany to explore the real-world mutational landscape in patients with HR+/HER2- mBC, as detected through liquid biopsies, and to correlate these findings with clinicopathologic factors.


     

    Interessenskonflikt

    Ich erkläre als korrespondierende/r AutorIn, dass ich oder einer bzw. mehrere meiner Ko-AutorenInnen während der letzten 3 Jahre wirtschaftliche oder persönliche Verbindungen im oben genannten Sinne hatten: Interessenskonflikt Details: Moritz Dimpfl: received financial support from the Berlin Chemie AG for the conduct of the study. Frederik Marmé: received financial support from the Berlin Chemie AG for the conduct of the study.

    Publication History

    Article published online:
    04 June 2025

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