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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) 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 endocrineBackground 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.show moreshow less

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Author:Volkmar Müller, Manuel Hörner, Marc Thill, Maggie Banys-Paluchowski, Sabine Schmatloch, Peter A. FaschingORCiD, 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 DitschORCiDGND, Yasmin Baila, Christian Roos, Christian Mann, Caterina Iuliano, Sara Y. Brucker, Andreas Schneeweiss, Andreas D. Hartkopf
URN:urn:nbn:de:bvb:384-opus4-1213894
Frontdoor URLhttps://opus.bibliothek.uni-augsburg.de/opus4/121389
ISSN:0960-9776OPAC
Parent Title (English):The Breast
Publisher:Elsevier BV
Type:Article
Language:English
Year of first Publication:2025
Publishing Institution:Universität Augsburg
Release Date:2025/04/23
Volume:81
First Page:104458
DOI:https://doi.org/10.1016/j.breast.2025.104458
Institutes:Medizinische Fakultät
Medizinische Fakultät / Universitätsklinikum
Medizinische Fakultät / Professur für Operative und Konservative Senologie
Dewey Decimal Classification:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Licence (German):CC-BY 4.0: Creative Commons: Namensnennung (mit Print on Demand)