BreastPub Date : 2025-03-17DOI: 10.1016/j.breast.2025.104448
Rachel M. Layman , Xianchen Liu , Benjamin Li , Lynn McRoy , Adam Brufsky
{"title":"Real-world palbociclib dose modifications and clinical outcomes in patients with HR+/HER2− metastatic breast cancer: A Flatiron Health database analysis","authors":"Rachel M. Layman , Xianchen Liu , Benjamin Li , Lynn McRoy , Adam Brufsky","doi":"10.1016/j.breast.2025.104448","DOIUrl":"10.1016/j.breast.2025.104448","url":null,"abstract":"<div><h3>Purpose</h3><div>To examine the associations of palbociclib dose modifications with clinical outcomes of patients with HR+/HER2− metastatic breast cancer (MBC) treated with first-line (1L) palbociclib + aromatase inhibitor (AI) in routine practice.</div></div><div><h3>Methods</h3><div>Using the Flatiron Health Analytic Database, we conducted a retrospective analysis of HR+/HER2− MBC patients who started 1L palbociclib + AI February 2015–March 2020. Kaplan−Meier analyses were used to estimate treatment duration, real-world progression-free survival (rwPFS), and overall survival (OS) by palbociclib dose adjustments (any change in palbociclib daily dose while on treatment) and dose reductions (starting dose <125 mg/day or dose reduced while on treatment). Cox proportional hazard regression models were performed to compute unadjusted/adjusted hazard ratios (HRs).</div></div><div><h3>Results</h3><div>Of 1302 patients with documented starting dose, 524 (40.2 %) had palbociclib dose adjustments; 778 (59.8 %) had none. Median treatment duration was significantly longer in patients with dose adjustments versus those with none (27.4 vs 21.4 months; adjusted HR = 0.80 [95 % CI, 0.69–0.93]; <em>P</em> = 0.004). Patients with and without dose adjustments showed similar median rwPFS (20.5 vs 19.6 months; adjusted HR = 0.89 [95 % CI, 0.76–1.04]; <em>P</em> = 0.133). Median OS was significantly prolonged in patients with versus without dose adjustments (57.8 vs 51.4 months; adjusted HR = 0.73 [95 % CI, 0.59–0.89]; <em>P</em> = 0.002). Similar findings were observed in patients with and without dose reductions.</div></div><div><h3>Conclusions</h3><div>In this real-world study, rwPFS in HR+/HER2− MBC patients was maintained irrespective of dose adjustments. However, dose adjustments were associated with extended treatment duration and OS.</div></div><div><h3>Clinical trial registration</h3><div><span><span>NCT05361655</span><svg><path></path></svg></span> (<span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>)</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"81 ","pages":"Article 104448"},"PeriodicalIF":5.7,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143695963","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BreastPub Date : 2025-03-17DOI: 10.1016/j.breast.2025.104449
Min Jung Lee , Ji-Jung Jung , Jong-Ho Cheun , Eunhye Kang , Hong-Kyu Kim , Han-Byoel Lee , Hyeong-Gon Moon , Wonshik Han
{"title":"Comparison of oncological outcomes of premenopausal with ovarian function suppression versus postmenopausal women in ER+/HER2- breast cancer","authors":"Min Jung Lee , Ji-Jung Jung , Jong-Ho Cheun , Eunhye Kang , Hong-Kyu Kim , Han-Byoel Lee , Hyeong-Gon Moon , Wonshik Han","doi":"10.1016/j.breast.2025.104449","DOIUrl":"10.1016/j.breast.2025.104449","url":null,"abstract":"<div><h3>Background</h3><div>The Rx for positive node endocrine-responsive breast cancer trial highlighted that premenopausal (PRE) women who underwent chemotherapy exhibited superior survival rates compared to postmenopausal (POST) counterparts, but showed worse survival without chemotherapy. This raises the question whether application of ovarian function suppression (OFS) in PRE women aligns with their cancer biology, treatment response, and outcomes observed in POST women.</div></div><div><h3>Methods</h3><div>Data from the Seoul National University Hospital breast cancer cohort focusing on patients with stage pT1-3, pN0-1, estrogen receptor-positive (ER+), and HER2-negative breast cancer were analyzed. Survival outcomes, including invasive disease-free survival (iDFS) and distant relapse-free survival (DRFS), were compared between PRE women receiving OFS and POST women, with chemotherapy usage as a stratification factor. Propensity score matching was performed.</div></div><div><h3>Result</h3><div>We analyzed 3483 patients, comprising 2901 POST and 582 PRE women with OFS. In the cohort without chemotherapy, the 10-year iDFS rates were 90.3 % and 88.3 % (hazard ratio [HR], 1.32; p = 0.16), and 10-year DRFS rates were 94.3 % and 96.1 % (HR, 0.78; p = 0.41) for POST and PRE women with OFS, respectively. Among women treated with chemotherapy, 10-year iDFS rates were 83.0 % and 79.5 % (HR, 1.21; p = 0.37), and DRFS rates were 86.7 % and 85.7 % (HR, 1.14; p = 0.58) for POST and PRE women with OFS, respectively. These results remained consistent after PSM.</div></div><div><h3>Conclusion</h3><div>Oncological outcomes of PRE women receiving OFS were comparable to those of POST women with ER+ and HER2-early breast cancer, irrespective of chemotherapy administration.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"81 ","pages":"Article 104449"},"PeriodicalIF":5.7,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143685432","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Corrigendum to “Metronomic chemotherapy using capecitabine and cyclophosphamide in metastatic breast cancer – efficacy, tolerability and quality of life results from the phase II METRO trial” [The Breast 78 (2004) 103795]","authors":"Karolina Larsson F , Jamila Adra , Leif Klint , Barbro Linderholm","doi":"10.1016/j.breast.2025.104420","DOIUrl":"10.1016/j.breast.2025.104420","url":null,"abstract":"","PeriodicalId":9093,"journal":{"name":"Breast","volume":"80 ","pages":"Article 104420"},"PeriodicalIF":5.7,"publicationDate":"2025-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143630084","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BreastPub Date : 2025-03-13DOI: 10.1016/j.breast.2025.104440
Marta Bonotto , Giulia De Pieri , Rocco Esposto , Ludovica Lay , Silvia Buriolla , Giuseppe Aprile , Fabio Puglisi , Alessandro Marco Minisini
{"title":"Corrigendum to “Antibody-Drug conjugates in elderly patients with breast cancer” [The Breast 80 (2025) 104428]","authors":"Marta Bonotto , Giulia De Pieri , Rocco Esposto , Ludovica Lay , Silvia Buriolla , Giuseppe Aprile , Fabio Puglisi , Alessandro Marco Minisini","doi":"10.1016/j.breast.2025.104440","DOIUrl":"10.1016/j.breast.2025.104440","url":null,"abstract":"","PeriodicalId":9093,"journal":{"name":"Breast","volume":"80 ","pages":"Article 104440"},"PeriodicalIF":5.7,"publicationDate":"2025-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143630082","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BreastPub Date : 2025-03-13DOI: 10.1016/j.breast.2025.104441
Yi Kuang , Jiajia Qiu , Ye Liu , Sijin Guo , Ting Chen , Lichen Tang , Winnie K.W. So , Weijie Xing
{"title":"Trajectories and predictors of financial toxicity in breast cancer patients: A multicenter longitudinal study in China","authors":"Yi Kuang , Jiajia Qiu , Ye Liu , Sijin Guo , Ting Chen , Lichen Tang , Winnie K.W. So , Weijie Xing","doi":"10.1016/j.breast.2025.104441","DOIUrl":"10.1016/j.breast.2025.104441","url":null,"abstract":"<div><h3>Background</h3><div>Patients with breast cancer experience varying levels of financial toxicity (FT), but the factors contributing to sustained financial toxicity remain poorly understood.</div></div><div><h3>Methods</h3><div>This longitudinal study was conducted from November 2022 to March 2024 in China. Participants were recruited from four Tertiary Level A hospitals using convenient sampling. FT was assessed using the Comprehensive Score for Financial Toxicity (COST) at baseline (T1), 3 months (T2), 6 months (T3), and 12 months (T4) post-surgery. Growth Mixture Modeling was used to identify the different trajectories of the FT. Multivariable logistic regression were employed to explore the predictive factors with different trajectory categories.</div></div><div><h3>Results</h3><div>Among 378 participants (all women; median [SD] age, 48.9 [9.97] years), the COST score was lowest at T2. Three distinct FT trajectories were identified: 91 patients <strong>(24 %)</strong> in the \"Severe FT with Gradual Relief\" group (trajectory 1), 190 patients <strong>(50 %)</strong> in the \"Persistently Low-Level FT\" group (trajectory 2), and 97 patients <strong>(</strong>26 %<strong>)</strong> in the \"Moderate FT with Gradual Worsening\" group (trajectory 3). Using trajectory 2 as the reference, predictors for trajectory 1 included symptom burden, location, cancer stage, cost-related health literacy, resilience, and difficulty affording basic expenses. For trajectory 3, predictors included monthly household income, symptom burden, location, and cancer stage.</div></div><div><h3>Conclusions</h3><div>The FT experienced by breast cancer patients changes over time and follows distinct dynamic trajectories, influenced by multiple factors. In future clinical practice, early identification and intervention for high-risk FT groups should be prioritized.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"81 ","pages":"Article 104441"},"PeriodicalIF":5.7,"publicationDate":"2025-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143632035","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Identifying germline pathogenic variants in breast cancer using tumor sequencing","authors":"Mara Cruellas , Andri Papakonstantinou , Adrià López-Fernández , Ester Castillo , Judit Matito , Marina Gómez , Alejandra Rezqallah , Sharela Vega , Víctor Navarro , Maite Torres , Alejandro Moles-Fernández , Cristina Saura , Ana Vivancos , Judith Balmaña , Mafalda Oliveira","doi":"10.1016/j.breast.2025.104439","DOIUrl":"10.1016/j.breast.2025.104439","url":null,"abstract":"<div><h3>Purpose</h3><div>To investigate the performance of an in-house tumor sequencing panel to identify patients with breast cancer and a germline pathogenic variant (gPV).</div></div><div><h3>Patients and methods</h3><div>Retrospective and blinded tumor sequencing analysis in 90 patients with breast cancer and prior germline genetic testing (45 non-carriers and 45 carriers of a gPV) using an in-house panel (VHIO-300). Sensitivity (S), specificity (Sp), positive predictive value (PPV), and negative predictive value (NPV) of tumor sequencing were calculated. A Cohen's kappa coefficient ≥0.80 was predefined as minimum to be reliably acceptable for clinical implementation.</div></div><div><h3>Results</h3><div>The cohort included 84 women and 6 men with a median age of 48 years (29–84). Tumors of germline carriers were mainly stage II (47 % vs 31 %, P = 0.047), luminal B-like (56 % vs 31 %, p = 0.037) or triple negative (22 % vs 16 %, = 0.037). The in-house tumor panel identified 91 % (40/44) of the gPV. The analysis did not detect any of the 2 patients with germline large rearrangement alterations nor 2 of the 7 patients with intronic variants included. The tumor sequencing panel yielded 7 % of false positive results (ie, genetic alterations suggestive of germline origin). Hence, S was 91 %, Sp 93 % and Cohen's kappa coefficient between tumor and germline testing was 0.84 (95 % CI 0.73–0.95).</div></div><div><h3>Conclusion</h3><div>Tumor tissue sequencing with our in-house panel demonstrated an acceptable performance to identify patients with breast cancer carriers of a gPV.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"81 ","pages":"Article 104439"},"PeriodicalIF":5.7,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143629065","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BreastPub Date : 2025-03-10DOI: 10.1016/j.breast.2025.104438
Quynh T.N. Nguyen , Shwu-Jiuan Lin , Phung-Anh Nguyen , Phan Thanh Phuc , Min-Huei Hsu , Chun-Yao Huang , Chin-Sheng Hung , Christine Y. Lu , Jason C. Hsu
{"title":"Early prediction of cardiovascular events following treatments in female breast cancer patients: Application of real-world data and artificial intelligence","authors":"Quynh T.N. Nguyen , Shwu-Jiuan Lin , Phung-Anh Nguyen , Phan Thanh Phuc , Min-Huei Hsu , Chun-Yao Huang , Chin-Sheng Hung , Christine Y. Lu , Jason C. Hsu","doi":"10.1016/j.breast.2025.104438","DOIUrl":"10.1016/j.breast.2025.104438","url":null,"abstract":"","PeriodicalId":9093,"journal":{"name":"Breast","volume":"81 ","pages":"Article 104438"},"PeriodicalIF":5.7,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143703956","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BreastPub Date : 2025-03-07DOI: 10.1016/j.breast.2025.104437
Joyce O'Shaughnessy , Sara M. Tolaney , Denise A. Yardley , Lowell Hart , Pedram Razavi , Peter A. Fasching , Wolfgang Janni , Lee Schwartzberg , Julia Kim , Murat Akdere , Courtney McDermott , Aamir Khakwani , Purnima Pathak , Stephanie L. Graff
{"title":"Real-world risk of recurrence and treatment outcomes with adjuvant endocrine therapy in patients with stage II-III HR+/HER2- early breast cancer","authors":"Joyce O'Shaughnessy , Sara M. Tolaney , Denise A. Yardley , Lowell Hart , Pedram Razavi , Peter A. Fasching , Wolfgang Janni , Lee Schwartzberg , Julia Kim , Murat Akdere , Courtney McDermott , Aamir Khakwani , Purnima Pathak , Stephanie L. Graff","doi":"10.1016/j.breast.2025.104437","DOIUrl":"10.1016/j.breast.2025.104437","url":null,"abstract":"<div><h3>Background</h3><div>Despite adjuvant endocrine therapy (ET), recurrence is still a concern for patients with HR+/HER2- early breast cancer (EBC). We assessed recurrence risk in real-world patients with stage II/III HR+/HER2- EBC treated with adjuvant ET.</div></div><div><h3>Methods</h3><div>A retrospective analysis was conducted using the ConcertAI Patient360 database (January 1995 to April 2021) of patients with stage II/III HR+/HER2- EBC ≥18 years who underwent surgery and received adjuvant ET. Risk of recurrence was assessed using invasive disease-free survival (iDFS) with adapted STEEP criteria. An ET subanalysis evaluated iDFS, distant disease-free survival, and overall survival in patients receiving adjuvant non-steroidal aromatase inhibitors (NSAI) vs tamoxifen.</div></div><div><h3>Results</h3><div>In the full analysis cohort (N = 3133), the risk of an iDFS event was 26.1 % at 5 years, rising to 45.0 % at 10 years. Among patients with stage II disease, the risk of an iDFS event at 5 and 10 years was 22.7 % and 40.5 %, respectively; stage III 5- and 10-year risk was 40.4 % and 62.9 %. Patients with node-negative disease had 5- and 10-year risks of 22.1 % and 36.9 %, respectively; node-positive 5- and 10-year risk was 28.9 % and 49.4 %. ET subanalysis showed improved iDFS with NSAI ± ovarian function suppression vs tamoxifen ± ovarian function suppression (HR, 0.83; 95 % CI, 0.69–0.98; p = 0.031); this trend was observed regardless of menopausal status.</div></div><div><h3>Conclusions</h3><div>This real-world study highlights the considerable risk of recurrence with adjuvant ET in patients with stage II or III HR+/HER2- EBC (including node-negative disease) and confirms the need for improved treatment options.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"81 ","pages":"Article 104437"},"PeriodicalIF":5.7,"publicationDate":"2025-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143714552","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BreastPub Date : 2025-03-06DOI: 10.1016/j.breast.2025.104431
G. Giannone , P. Lombardi , M. Filetti , J. Paparo , C. Rognone , S. Stefanizzi , A.A. Valsecchi , L. Zumstein , I.A. McNeish , D.J. Pinato , A. Gennari , G. Daniele , M. Di Maio
{"title":"Integration of translational research in phase III trials: A systematic review of breast cancer studies in a 5-year period","authors":"G. Giannone , P. Lombardi , M. Filetti , J. Paparo , C. Rognone , S. Stefanizzi , A.A. Valsecchi , L. Zumstein , I.A. McNeish , D.J. Pinato , A. Gennari , G. Daniele , M. Di Maio","doi":"10.1016/j.breast.2025.104431","DOIUrl":"10.1016/j.breast.2025.104431","url":null,"abstract":"<div><h3>Background</h3><div>Samples' collection for translational analyses in phase III trials requires a huge effort and there is no evidence on how it translates into new knowledge on tumour biology or optimization of patients’ selection. We systematically reviewed phase III trials in breast cancer (BC) to evaluate how frequently a translational project has been integrated into their design and how this integration translated into new translational evidence.</div></div><div><h3>Methods</h3><div>Interventional phase III trials evaluating anticancer drugs in BC published in 11 major journals between 2014 and 2018 were included.</div></div><div><h3>Results</h3><div>89 BC phase III trials were identified, 3 had no sample collection. Among the others, in 36 % the information on sample collection for research purposes was not clear while more than half of the samples had definitive evidence of it.</div><div>After a median follow-up of 87.9 months, 55.8 % studies published translational data with a mean number of 1.31 (SD 1.7) and 1.07 (SD 1.8), congress abstracts and secondary papers, respectively.</div><div>There was a higher probability of published translational results for studies with positive outcomes (68.6 % vs 47.1 %), clear evidence of sample collection (72.2 % vs 28.1 %), well-established translational endpoint (73 % vs 42.9 %) and higher impact factor journal (IF) for the clinical publications (64.5 % vs 33.3 %). Secondary translational papers were usually published in lower IF journals with a significant delay from the clinical publication.</div></div><div><h3>Conclusions</h3><div>Although extremely resource-demanding, sample collections for translational analyses in phase III trials are frequently not well defined, and only 50 % produce new translational evidence, which is delayed in time and published in lower IF journals.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"81 ","pages":"Article 104431"},"PeriodicalIF":5.7,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143685420","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BreastPub Date : 2025-03-05DOI: 10.1016/j.breast.2025.104429
Wolfgang Janni , Michael Untch , Nadia Harbeck , Joseph Gligorov , William Jacot , Stephen Chia , Jean-François Boileau , Subhajit Gupta , Namita Mishra , Murat Akdere , Andriy Danyliv , Giuseppe Curigliano
{"title":"Systematic literature review and trial-level meta-analysis of aromatase inhibitors vs tamoxifen in patients with HR+/HER2− early breast cancer","authors":"Wolfgang Janni , Michael Untch , Nadia Harbeck , Joseph Gligorov , William Jacot , Stephen Chia , Jean-François Boileau , Subhajit Gupta , Namita Mishra , Murat Akdere , Andriy Danyliv , Giuseppe Curigliano","doi":"10.1016/j.breast.2025.104429","DOIUrl":"10.1016/j.breast.2025.104429","url":null,"abstract":"<div><h3>Background</h3><div>Current standard of care for patients with HR+/HER2− early breast cancer (EBC) includes adjuvant endocrine therapy with an aromatase inhibitor (AI) or tamoxifen (TAM). We present a trial-level meta-analysis on efficacy of AI vs TAM in patients with HR+/HER2− EBC.</div></div><div><h3>Methods</h3><div>A systematic literature review was conducted using key medical literature databases (eg, PubMed; inception to October 2023) and data from conferences (to December 2023). Phase 3 randomized controlled trials (RCTs) that had ≥80 % of patients with HR+/HER2− EBC (or available subgroup data) and reported a disease-free survival (DFS) hazard ratio for AI vs TAM were included in the meta-analysis, regardless of menopausal status and ovarian function suppression (OFS) use. The generic invariance method was used to calculate a pooled effect estimate of DFS hazard ratios and 95 % CIs. A base-case analysis (all RCTs) and scenario analyses for NSAI-only, premenopausal, and postmenopausal RCTs were conducted.</div></div><div><h3>Results</h3><div>Five RCTs were identified for inclusion in the meta-analysis. In the base-case analysis, DFS significantly favored AI ± OFS vs TAM ± OFS (pooled hazard ratio, 0.68; 95 % CI, 0.61–0.76; <em>P</em> < .0001). Results from scenario analyses were consistent with the base case; NSAI-only (pooled hazard ratio, 0.68; 95 % CI, 0.59–0.78; <em>P</em> < .0001), premenopausal (pooled hazard ratio, 0.65; 95 % CI, 0.56–0.76; <em>P</em> < .0001), and postmenopausal (pooled hazard ratio, 0.72; 95 % CI, 0.61–0.86; <em>P</em> = .001) RCTs favored AI ± OFS over TAM ± OFS.</div></div><div><h3>Conclusions</h3><div>This trial-level meta-analysis demonstrated a significant DFS benefit with AI vs TAM for patients with HR+/HER2− EBC, which was more pronounced in premenopausal women.</div></div>","PeriodicalId":9093,"journal":{"name":"Breast","volume":"81 ","pages":"Article 104429"},"PeriodicalIF":5.7,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143704592","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}