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Alpelisib and fulvestrant in PIK3CA-mutated hormone receptor-positive HER2-negative advanced breast cancer included in the German PRAEGNANT trial

Mutations in PIK3CA are one of several actionable mutations for patients with hormone receptor positive, human epidermal growth factor receptor 2 negative breast cancer. Alpelisib in combination with fulvestrant was the first approved PI3K inhibitor and was introduced in clinical practice in 2019. A...

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Main Authors: Hörner, Manuel (Author) , Tretschock, Lara M. (Author) , John, Nelson (Author) , Ziegler, Philipp (Author) , Häberle, Lothar (Author) , Uhrig, Sabrina (Author) , Goossens, Chloë (Author) , Amann, Niklas (Author) , Cieslik, Jan-Philipp (Author) , Dannehl, Dominik (Author) , Deutsch, Thomas M. (Author) , Dimpfl, Moritz (Author) , Ehlert, Max (Author) , Eichstädt, Kathleen (Author) , Englisch, Alexander (Author) , Köpke, Melitta B. (Author) , Krückel, Annika (Author) , Link, Theresa (Author) , Müller, Annika (Author) , Reinhardt, Kristin (Author) , Roth, Jonas (Author) , Schäffler, Henning (Author) , Sych, Lea (Author) , Tegeler, Christian M. (Author) , Wichmann, Catharina (Author) , Banys-Paluchowski, Maggie (Author) , Princk, Henriette (Author) , Rody, Achim (Author) , Brucker, Sara Y. (Author) , Ditsch, Nina (Author) , Ettl, Johannes (Author) , Fehm, Tanja (Author) , Hack, Carolin C. (Author) , Hadji, Peyman (Author) , Hein, Alexander (Author) , Janni, Wolfgang W. (Author) , Kolberg, Hans-Christian (Author) , Lüftner, Diana (Author) , Lux, Michael P. (Author) , Müller, Volkmar (Author) , Schneeweiss, Andreas (Author) , Taran, Florin-Andrei (Author) , Tesch, Hans (Author) , Wallwiener, Diethelm (Author) , Marmé, Frederik (Author) , Seitz, Stephan (Author) , Belleville, Erik (Author) , Hartkopf, Andreas (Author) , Michel, Laura L. (Author) , Wallwiener, Markus (Author) , Fasching, Peter A. (Author) , Tauber, Nikolas (Author)
Format: Article (Journal)
Language:English
Published: May 2026
In: Breast cancer research and treatment
Year: 2026, Volume: 217, Issue: 1, Pages: 1-15
ISSN:1573-7217
DOI:10.1007/s10549-026-07939-z
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1007/s10549-026-07939-z
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Author Notes:Manuel Hörner, Lara M. Tretschock, Nelson John, Philipp Ziegler, Lothar Häberle, Sabrina Uhrig, Chloë Goossens, Niklas Amann, Jan-Philipp Cieslik, Dominik Dannehl, Thomas M. Deutsch, Moritz Dimpfl, Max Ehlert, Kathleen Eichstädt, Alexander Englisch, Melitta B. Köpke, Annika Krückel, Theresa Link, Annika Müller, Kristin Reinhardt, Jonas Roth, Henning Schäffler, Lea Sych, Christian M. Tegeler, Catharina Wichmann, Maggie Banys-Paluchowski, Henriette Princk, Achim Rody, Sara Y. Brucker, Nina Ditsch, Johannes Ettl, Tanja Fehm, Carolin C. Hack, Peyman Hadji, Alexander Hein, Wolfgang W. Janni, Hans-Christian Kolberg, Diana Lüftner, Michael P. Lux, Volkmar Müller, Andreas Schneeweiss, Florin-Andrei Taran, Hans Tesch, Diethelm Wallwiener, Frederik Marmé, Stephan Seitz, Erik Belleville, Andreas Hartkopf, Laura L. Michel, Markus Wallwiener, Peter A. Fasching, Nikolas Tauber
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Summary:Mutations in PIK3CA are one of several actionable mutations for patients with hormone receptor positive, human epidermal growth factor receptor 2 negative breast cancer. Alpelisib in combination with fulvestrant was the first approved PI3K inhibitor and was introduced in clinical practice in 2019. A lack of evidence for the use of alpelisib in the context of current treatment options like cyclin-dependent 4/6 inhibitor (CDK4/6i), highlights the importance of this analysis. We provide a real-world analysis of the use of alpelisib with the prospective German PRAEGNANT registry (NCT02338167).
Item Description:Online veröffentlicht: 2. April 2026
Gesehen am 20.04.2026
Physical Description:Online Resource
ISSN:1573-7217
DOI:10.1007/s10549-026-07939-z

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