Real-world utilization of aromatase inhibitors, tamoxifen, and ovarian function suppression in premenopausal patients with early hormone receptor-positive, HER2-negative breast cancer with increased recurrence risk
Background: The optimal adjuvant endocrine treatment in premenopausal patients with hormone receptor-positive, HER2-negative (HRpos/HER2neg) early breast cancer (eBC) remains debated, particularly the choice between aromatase inhibitors plus ovarian function suppression (AI + OFS) or tamoxifen (TAM)...
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2025-06-01
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| author | Volkmar Müller Manuel Hörner Marc Thill Maggie Banys-Paluchowski Sabine Schmatloch Peter A. Fasching Nadia Harbeck Dagmar Langanke Sabrina Uhrig Lothar Häberle Dorothea Fischer Alexander Hein Tanja N. Fehm Chloë Goossens Jürgen Terhaag Uwe Heilenkötter Peter Dall Christian Rudlowski Rachel Wuerstlein Mustafa Aydogdu Mignon-Denise Keyver-Paik Carolin Hammerle Natalija Deuerling Elmar Stickeler Bahriye Aktas Erik Belleville Martin Thoma Nina Ditsch Yasmin Baila Christian Roos Christian Mann Caterina Iuliano Sara Y. Brucker Andreas Schneeweiss Andreas D. Hartkopf |
| author_facet | Volkmar Müller Manuel Hörner Marc Thill Maggie Banys-Paluchowski Sabine Schmatloch Peter A. Fasching Nadia Harbeck Dagmar Langanke Sabrina Uhrig Lothar Häberle Dorothea Fischer Alexander Hein Tanja N. Fehm Chloë Goossens Jürgen Terhaag Uwe Heilenkötter Peter Dall Christian Rudlowski Rachel Wuerstlein Mustafa Aydogdu Mignon-Denise Keyver-Paik Carolin Hammerle Natalija Deuerling Elmar Stickeler Bahriye Aktas Erik Belleville Martin Thoma Nina Ditsch Yasmin Baila Christian Roos Christian Mann Caterina Iuliano Sara Y. Brucker Andreas Schneeweiss Andreas D. Hartkopf |
| author_sort | Volkmar Müller |
| collection | DOAJ |
| description | Background: The optimal adjuvant endocrine treatment in premenopausal patients with hormone receptor-positive, HER2-negative (HRpos/HER2neg) early breast cancer (eBC) remains debated, particularly the choice between aromatase inhibitors plus ovarian function suppression (AI + OFS) or tamoxifen (TAM) with or without additional OFS. This study assessed the use of adjuvant endocrine therapies for premenopausal patients with intermediate/high-risk HRpos/HER2neg eBC. Methods: CLEAR-B (AGO-B-059; NCT05870813) was a retrospective study analyzing data, collected from January 2016 to June 2019 and from January 2022 to December 2023 during the certification process of breast centers in Germany. Premenopausal patients with HRpos/HER2neg intermediate/high-risk eBC were eligible. Patient and disease characteristics, in addition to recommended and received adjuvant treatments, were evaluated. Results: The number of registered patients was 3137, of whom 2789 had complete information on endocrine treatments (1717 for 2016–2019 and 1072 for 2022–2023). In 2016–2019, 8.4 % of the patients were recommended to be treated with AI + OFS, whereas in 2022–2023, the proportion of patients with a treatment recommendation for AI + OFS rose to 42.1 %. In 2016–2019, TAM monotherapy was most frequently recommended (80.8 %). Conversely, TAM + OFS was not commonly recommended (9.3 % in 2016–2019 and 16.5 % in 2022–2023). While no clear association between tumor stage and chosen endocrine therapy was found in 2016–2019, most patients with ≥stage IIA were recommended to be treated with AI + OFS in 2022–2023. Conclusion: This analysis shows that treatment recommendation for AI + OFS in premenopausal patients with HRpos/HER2neg eBC increased relevantly in the past years, reflecting latest guideline recommendations. |
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| id | doaj-art-713f2a8e54924335bdff59cd1e6a5ef7 |
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| issn | 1532-3080 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Elsevier |
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| series | Breast |
| spelling | doaj-art-713f2a8e54924335bdff59cd1e6a5ef72025-08-20T01:49:58ZengElsevierBreast1532-30802025-06-018110445810.1016/j.breast.2025.104458Real-world utilization of aromatase inhibitors, tamoxifen, and ovarian function suppression in premenopausal patients with early hormone receptor-positive, HER2-negative breast cancer with increased recurrence riskVolkmar Müller0Manuel Hörner1Marc Thill2Maggie Banys-Paluchowski3Sabine Schmatloch4Peter A. Fasching5Nadia Harbeck6Dagmar Langanke7Sabrina Uhrig8Lothar Häberle9Dorothea Fischer10Alexander Hein11Tanja N. Fehm12Chloë Goossens13Jürgen Terhaag14Uwe Heilenkötter15Peter Dall16Christian Rudlowski17Rachel Wuerstlein18Mustafa Aydogdu19Mignon-Denise Keyver-Paik20Carolin Hammerle21Natalija Deuerling22Elmar Stickeler23Bahriye Aktas24Erik Belleville25Martin Thoma26Nina Ditsch27Yasmin Baila28Christian Roos29Christian Mann30Caterina Iuliano31Sara Y. Brucker32Andreas Schneeweiss33Andreas D. Hartkopf34Department of Gynecology, Hamburg-Eppendorf University Medical Center, Hamburg, GermanyDepartment of Gynecology and Obstetrics, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany; Comprehensive Cancer Center Erlangen-EMN (CCC ER-EMN), Erlangen, GermanyDepartment of Gynecology and Gynecological Oncology, Agaplesion Markus Krankenhaus, Frankfurt, GermanyDepartment of Gynecology and Obstetrics, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, GermanyFrauenklinik, Elisabeth-Krankenhaus Kassel, Kassel, GermanyDepartment of Gynecology and Obstetrics, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany; Comprehensive Cancer Center Erlangen-EMN (CCC ER-EMN), Erlangen, Germany; Corresponding author. Department of Gynecology and Obstetrics, Universitätsklinikum Erlangen, Comprehensive Cancer Center Erlangen EMN; Friedrich-Alexander-Universität Erlangen-Nürnberg, Universitätsstrasse 21/23, 91054 Erlangen, Germany.Breast Center, Department of Gynecology and Obstetrics and CCC Munich LMU, LMU University Hospital, Munich, GermanyFrauenklinik, St. Elisabeth-Krankenhaus Leipzig, Leipzig, GermanyDepartment of Gynecology and Obstetrics, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany; Comprehensive Cancer Center Erlangen-EMN (CCC ER-EMN), Erlangen, GermanyDepartment of Gynecology and Obstetrics, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany; Comprehensive Cancer Center Erlangen-EMN (CCC ER-EMN), Erlangen, Germany; Biostatistics Unit, Department of Gynecology and Obstetrics, Universitätsklinikum Erlangen, Erlangen, GermanyFrauenklinik, Klinikum Ernst von Bergmann, Potsdam, GermanyFrauenklinik, Klinikum Esslingen GmbH, Esslingen GermanyDepartment of Gynecology and Obstetrics, University Hospital Düsseldorf, Center for Integrated Oncology (CIO Aachen, Bonn, Cologne, Düsseldorf), Düsseldorf, GermanyDepartment of Gynecology and Obstetrics, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany; Comprehensive Cancer Center Erlangen-EMN (CCC ER-EMN), Erlangen, GermanyDepartment of Gynecology and Obstetrics, Rottal Inn Kliniken, Eggenfelden, GermanyKlinik für Frauenheilkunde und Geburtshilfe, Klinikum Itzehoe, Itzehoe, GermanyFrauenklinik, Städtisches Klinikum Lüneburg, Lüneburg, GermanyFrauenklinik, Evangelisches Krankenhaus Bergisch Gladbach, Bergisch-Gladbach, GermanyBreast Center, Department of Gynecology and Obstetrics and CCC Munich LMU, LMU University Hospital, Munich, GermanyKlinik für Gynäkologie, Gynäkoonkologie und Senologie Klinikum Bremen-Mitte, Bremen, GermanyFrauenklinik des Klinikums der Stadt Wolfsburg, Wolfsburg, GermanyFrauenklinik, St. Josefs- Hospital Wiesbaden, Wiesbaden, GermanyFrauenklinik und Brustzentrum, Klinikum Fichtelgebirge gGmbH, Marktredwitz, GermanyDepartment of Obstetrics and Gynecology, Center for Integrated Oncology (CIO Aachen, Bonn, Cologne, Düsseldorf), University Hospital of RWTH Aachen, Aachen, GermanyDepartment of Gynecology, University of Leipzig Medical Center, Leipzig, GermanyClinSol GmbH & Co KG, Würzburg, GermanyBrustzentrum, Ammerland-Klinik, Westerstede, GermanyDepartment of Gynecology and Obstetrics, University Hospital Augsburg, Augsburg, GermanyFrauenklinik, Klinikum Kassel, Kassel, GermanyNovartis Pharma GmbH, Sophie-Germain-Str. 10, 90443 Nuermberg, GermanyNovartis Pharma GmbH, Sophie-Germain-Str. 10, 90443 Nuermberg, GermanyNovartis Pharma GmbH, Sophie-Germain-Str. 10, 90443 Nuermberg, GermanyDepartment of Gynecology and Obstetrics, Tübingen University Hospital, Tübingen, GermanyNational Center for Tumor Diseases, University Hospital and German Cancer Research Center, Heidelberg, GermanyDepartment of Gynecology and Obstetrics, Tübingen University Hospital, Tübingen, GermanyBackground: The optimal adjuvant endocrine treatment in premenopausal patients with hormone receptor-positive, HER2-negative (HRpos/HER2neg) early breast cancer (eBC) remains debated, particularly the choice between aromatase inhibitors plus ovarian function suppression (AI + OFS) or tamoxifen (TAM) with or without additional OFS. This study assessed the use of adjuvant endocrine therapies for premenopausal patients with intermediate/high-risk HRpos/HER2neg eBC. Methods: CLEAR-B (AGO-B-059; NCT05870813) was a retrospective study analyzing data, collected from January 2016 to June 2019 and from January 2022 to December 2023 during the certification process of breast centers in Germany. Premenopausal patients with HRpos/HER2neg intermediate/high-risk eBC were eligible. Patient and disease characteristics, in addition to recommended and received adjuvant treatments, were evaluated. Results: The number of registered patients was 3137, of whom 2789 had complete information on endocrine treatments (1717 for 2016–2019 and 1072 for 2022–2023). In 2016–2019, 8.4 % of the patients were recommended to be treated with AI + OFS, whereas in 2022–2023, the proportion of patients with a treatment recommendation for AI + OFS rose to 42.1 %. In 2016–2019, TAM monotherapy was most frequently recommended (80.8 %). Conversely, TAM + OFS was not commonly recommended (9.3 % in 2016–2019 and 16.5 % in 2022–2023). While no clear association between tumor stage and chosen endocrine therapy was found in 2016–2019, most patients with ≥stage IIA were recommended to be treated with AI + OFS in 2022–2023. Conclusion: This analysis shows that treatment recommendation for AI + OFS in premenopausal patients with HRpos/HER2neg eBC increased relevantly in the past years, reflecting latest guideline recommendations.http://www.sciencedirect.com/science/article/pii/S0960977625004758Early breast cancerEndocrine therapyTamoxifenAromatase inhibitorHormone receptor-positive |
| spellingShingle | Volkmar Müller Manuel Hörner Marc Thill Maggie Banys-Paluchowski Sabine Schmatloch Peter A. Fasching Nadia Harbeck Dagmar Langanke Sabrina Uhrig Lothar Häberle Dorothea Fischer Alexander Hein Tanja N. Fehm Chloë Goossens Jürgen Terhaag Uwe Heilenkötter Peter Dall Christian Rudlowski Rachel Wuerstlein Mustafa Aydogdu Mignon-Denise Keyver-Paik Carolin Hammerle Natalija Deuerling Elmar Stickeler Bahriye Aktas Erik Belleville Martin Thoma Nina Ditsch Yasmin Baila Christian Roos Christian Mann Caterina Iuliano Sara Y. Brucker Andreas Schneeweiss Andreas D. Hartkopf Real-world utilization of aromatase inhibitors, tamoxifen, and ovarian function suppression in premenopausal patients with early hormone receptor-positive, HER2-negative breast cancer with increased recurrence risk Breast Early breast cancer Endocrine therapy Tamoxifen Aromatase inhibitor Hormone receptor-positive |
| title | Real-world utilization of aromatase inhibitors, tamoxifen, and ovarian function suppression in premenopausal patients with early hormone receptor-positive, HER2-negative breast cancer with increased recurrence risk |
| title_full | Real-world utilization of aromatase inhibitors, tamoxifen, and ovarian function suppression in premenopausal patients with early hormone receptor-positive, HER2-negative breast cancer with increased recurrence risk |
| title_fullStr | Real-world utilization of aromatase inhibitors, tamoxifen, and ovarian function suppression in premenopausal patients with early hormone receptor-positive, HER2-negative breast cancer with increased recurrence risk |
| title_full_unstemmed | Real-world utilization of aromatase inhibitors, tamoxifen, and ovarian function suppression in premenopausal patients with early hormone receptor-positive, HER2-negative breast cancer with increased recurrence risk |
| title_short | Real-world utilization of aromatase inhibitors, tamoxifen, and ovarian function suppression in premenopausal patients with early hormone receptor-positive, HER2-negative breast cancer with increased recurrence risk |
| title_sort | real world utilization of aromatase inhibitors tamoxifen and ovarian function suppression in premenopausal patients with early hormone receptor positive her2 negative breast cancer with increased recurrence risk |
| topic | Early breast cancer Endocrine therapy Tamoxifen Aromatase inhibitor Hormone receptor-positive |
| url | http://www.sciencedirect.com/science/article/pii/S0960977625004758 |
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