PARP inhibition with olaparib and talazoparib for HER2-negative advanced breast cancer—Results from the prospective PRAEGNANT registry

Germline BRCA1 and BRCA2 mutations enable targeted therapies in human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (ABC). The two poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitors olaparib and talazoparib were introduced into clinical practice in 2018. Limited evidence about their routine clinical use highlights the importance of this analysis. We provide a real-world analysis for PARP-inhibitor use in ABC patients treated within the prospective German PRAEGNANT registry (NCT02338167). 152 patients with ABC receiving a PARP-inhibitor were included. Real-world progression-free survival (rwPFS) and real-world overall survival (rwOS) were calculated for all patients using the Kaplan-Meier method. Subgroups (line of therapy, metastasis timing, hormone receptor (HR) status, treatment: olaparib, talazoparib, among others), germline BRCA1, BRCA2 and PALB2 mutations and adverse events (AEs) were analyzed. The median rwPFS was 6.2 months (95% CI, 4.8-7.9) and the median rwOS was 17.1 months (95% CI, 14.4-22.3). Line of therapy, HR status and treatment (olaparib versus talazoparib) appeared to especially affect both rwPFS and rwOS. Among patients with a reported germline mutation, 36.1% had a BRCA1, 62.9% a BRCA2 and 1.0% a PALB2 mutation. In summary, outcomes were comparable to those reported in pivotal trials despite later-line use of PARP-inhibitors in this analysis.

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Journal
npj Breast Cancer
Published
2026-04-11
DOI
https://doi.org/10.1038/s41523-026-00947-8
Primary Topic
PARP inhibition in cancer therapy
Type
article
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0.00

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article

PARP inhibition with olaparib and talazoparib for HER2-negative advanced breast cancer—Results from the prospective PRAEGNANT registry

D. Lüftner, Carolin C. Hack, M. Wallwiener, Nikolas Tauber et al.
npj Breast Cancer
PARP inhibition in cancer therapy
article

PARP inhibition with olaparib and talazoparib for HER2-negative advanced breast cancer—Results from the prospective PRAEGNANT registry

D. Lüftner, Carolin C. Hack, M. Wallwiener, Nikolas Tauber, Jan‐Philipp Cieslik, Dominik Dannehl, L Häberle, Melitta B. Köpke, D. Wallwiener, Achim Rody, Erik Belleville, Nelson John, Thomas Maximilian Deutsch, L. Michel, Alexander Englisch, Catharina Wichmann, Henriette Princk, Sabrina Uhrig, Peyman Hadji, Hans Tesch, Kerstin Eichstädt, Annika Krückel, Christian M. Tegeler, Jonas Roth, Alexander Hein, Max Ehlert, Christian Maurer, Niklas Amann, Stephan Seitz, Lara Meike Tretschock, M. P. Lux, F. Taran, Lea Sych, Annika Müller, Philipp Ziegler, T Link, Nina Ditsch, Maggie Banys-Paluchowski, Volkmar Müller, Andreas Schneeweiss, Wolfgang W. Janni, Tanja Fehm, Manuel Hörner, Henning Schäffler, Sara Y. Brucker, Kristin Reinhardt, Frederik Marmé, Johannes Ettl, Andreas Hartkopf, Moritz Dimpfl, Peter A. Fasching, Chloë Goossens, Hans-Christian Kolberg
article en

Abstract

Germline BRCA1 and BRCA2 mutations enable targeted therapies in human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (ABC). The two poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitors olaparib and talazoparib were introduced into clinical practice in 2018. Limited evidence about their routine clinical use highlights the importance of this analysis. We provide a real-world analysis for PARP-inhibitor use in ABC patients treated within the prospective German PRAEGNANT registry (NCT02338167). 152 patients with ABC receiving a PARP-inhibitor were included. Real-world progression-free survival (rwPFS) and real-world overall survival (rwOS) were calculated for all patients using the Kaplan-Meier method. Subgroups (line of therapy, metastasis timing, hormone receptor (HR) status, treatment: olaparib, talazoparib, among others), germline BRCA1, BRCA2 and PALB2 mutations and adverse events (AEs) were analyzed. The median rwPFS was 6.2 months (95% CI, 4.8-7.9) and the median rwOS was 17.1 months (95% CI, 14.4-22.3). Line of therapy, HR status and treatment (olaparib versus talazoparib) appeared to especially affect both rwPFS and rwOS. Among patients with a reported germline mutation, 36.1% had a BRCA1, 62.9% a BRCA2 and 1.0% a PALB2 mutation. In summary, outcomes were comparable to those reported in pivotal trials despite later-line use of PARP-inhibitors in this analysis.

npj Breast CancerVol. 12(1)
Universität Hamburg (DE), German Cancer Research Center (DE), University of Cologne (DE), Heidelberg University (DE), University Hospital Augsburg (DE), University Hospital Heidelberg (DE), TUM Klinikum (DE), Kempten University of Applied Sciences (DE), University Hospital Regensburg (DE), Cardiovascular Center Bethanien (DE), Düsseldorf University Hospital (DE), Integrated Oncology (United States) (US), University Medical Center Hamburg-Eppendorf (DE), National Center for Tumor Diseases (DE), University Hospital Schleswig-Holstein (DE), Marienhospital Bottrop (DE), Klinikum Esslingen (DE), Cardiovascular Center Frankfurt (DE), Brüderkrankenhaus St. Josef Paderborn (DE), St. Vincenz-Krankenhaus Limburg (DE), Comprehensive Cancer Center Erlangen (DE), University Hospital in Halle (DE), University Hospital Cologne (DE), Immanuel Krankenhaus (DE), University Hospital Ulm (DE), University Medical Centre Mannheim (DE), University Hospital Carl Gustav Carus (DE), Heinrich Heine University Düsseldorf (DE), Technical University of Munich (DE), Technische Universität Dresden (DE), University of Tübingen (DE), University of Lübeck (DE)
Pfizer, AstraZeneca, Celgene, Helsinn, Deutsches Krebsforschungszentrum, Friedrich-Alexander-Universität Erlangen-Nürnberg, Technische Universität Dresden, Eisai, Universität Regensburg, Technische Universität München, Universität zu Köln, Universitätsklinikum Köln, Universitätsklinikum Erlangen, Universitätsklinikum Hamburg-Eppendorf, Daiichi Sankyo Europe
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PARP inhibition in cancer therapy
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