{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T07:20:10Z","timestamp":1787642410954,"version":"build-2736575974"},"reference-count":13,"publisher":"Springer Science and Business Media LLC","issue":"3","license":[{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,8,10]],"date-time":"2026-08-10T00:00:00Z","timestamp":1786320000000},"content-version":"vor","delay-in-days":9,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"NIH","award":["K76 AG074918"],"award-info":[{"award-number":["K76 AG074918"]}]},{"DOI":"10.13039\/100001006","name":"Breast Cancer Research Foundation","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100001006","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Breast Cancer Res Treat"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>Patient-reported outcomes (PROs) inform benefit-risk tradeoffs in breast cancer treatment, yet reporting quality across registration trials remains incompletely characterized.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We conducted a scoping review of PRO reporting in randomized trials supporting FDA breast cancer drug approvals (January 2011\u2013December 2024), identified via the FDA Oncology Approval Notifications database. Associated manuscripts were retrieved through systematic PubMed and EBSCO searches using trial-specific NCT identifiers. We assessed PRO endpoint prespecification status, instruments used, PRO publication delay (defined as the interval in months between the primary trial manuscript and corresponding PRO-dedicated manuscript publication date), and missing data reporting across eligible primary trial, PRO-dedicated, and subpopulation-specific PRO manuscripts.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>We identified 34 FDA breast cancer drug approvals supported by 36 unique randomized trials, yielding 45 eligible manuscripts. No trial designated PROs as a primary or co-primary endpoint; nine (25%) did not explicitly prespecify them. Median PRO publication delay was 18 months, with eight trials experiencing a delay of two or more years. Missing data handling methods were described in 33% of manuscripts and reasons for missingness in 11%.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>In this scoping review, PROs were commonly collected but inconsistently prespecified, often delayed, and incompletely reported. Registration trials should strengthen PRO prespecification, reduce publication delay, and adhere to missing data reporting standards.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical trial number<\/jats:title>\n                    <jats:p>Not applicable.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s10549-026-08051-y","type":"journal-article","created":{"date-parts":[[2026,8,10]],"date-time":"2026-08-10T08:07:59Z","timestamp":1786349279000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Patient-reported outcomes in clinical trials leading to breast cancer drug approvals: are we making them count?"],"prefix":"10.1007","volume":"218","author":[{"given":"Samuel","family":"Margolis","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andre Naguib","family":"Guirguis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Lee","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Saiya","family":"Smith","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexis","family":"LeVee","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marla D.","family":"Lipsyc-Sharf","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aditya","family":"Bardia","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8379-391X","authenticated-orcid":false,"given":"Mina S.","family":"Sedrak","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,8,10]]},"reference":[{"key":"8051_CR1","doi-asserted-by":"publisher","first-page":"1553","DOI":"10.1158\/1078-0432.CCR-15-2035","volume":"22","author":"PG Kluetz","year":"2016","unstructured":"Kluetz PG, Slagle A, Papadopoulos EJ, Johnson LL, Donoghue M, Kwitkowski VE et al (2016) Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials: Symptomatic Adverse Events, Physical Function, and Disease-Related Symptoms. Clin Cancer Res 22:1553\u20131558. https:\/\/doi.org\/10.1158\/1078-0432.CCR-15-2035","journal-title":"Clin Cancer Res"},{"key":"8051_CR2","doi-asserted-by":"publisher","first-page":"dju244","DOI":"10.1093\/jnci\/dju244","volume":"106","author":"E Basch","year":"2014","unstructured":"Basch E, Reeve BB, Mitchell SA, Clauser SB, Minasian LM, Dueck AC et al (2014) Development of the National Cancer Institute\u2019s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). JNCI J Natl Cancer Inst 106:dju244\u2013dju244. https:\/\/doi.org\/10.1093\/jnci\/dju244","journal-title":"JNCI J Natl Cancer Inst"},{"key":"8051_CR3","doi-asserted-by":"publisher","first-page":"123","DOI":"10.1007\/s40268-024-00478-2","volume":"24","author":"S Bellino","year":"2024","unstructured":"Bellino S, La Salvia A (2024) The Importance of Patient Reported Outcomes in Oncology Clinical Trials and Clinical Practice to Inform Regulatory and Healthcare Decision-Making. Drugs R D 24:123\u2013127. https:\/\/doi.org\/10.1007\/s40268-024-00478-2","journal-title":"Drugs R D"},{"key":"8051_CR4","doi-asserted-by":"publisher","first-page":"3459","DOI":"10.1002\/cncr.23968","volume":"113","author":"NJ Meropol","year":"2008","unstructured":"Meropol NJ, Egleston BL, Buzaglo JS, Benson AB, Cegala DJ, Diefenbach MA et al (2008) Cancer patient preferences for quality and length of life. Cancer 113:3459\u20133466. https:\/\/doi.org\/10.1002\/cncr.23968","journal-title":"Cancer"},{"key":"8051_CR5","doi-asserted-by":"publisher","first-page":"1170","DOI":"10.1093\/jnci\/djz038","volume":"111","author":"D Kyte","year":"2019","unstructured":"Kyte D, Retzer A, Ahmed K, Keeley T, Armes J, Brown JM et al (2019) Systematic Evaluation of Patient-Reported Outcome Protocol Content and Reporting in Cancer Trials. JNCI: J Natl Cancer Inst 111:1170\u20131178. https:\/\/doi.org\/10.1093\/jnci\/djz038","journal-title":"JNCI: J Natl Cancer Inst"},{"key":"8051_CR6","doi-asserted-by":"publisher","first-page":"814","DOI":"10.1001\/jama.2013.879","volume":"309","author":"M Calvert","year":"2013","unstructured":"Calvert M, Blazeby J, Altman DG, Revicki DA, Moher D, Brundage MD et al (2013) Reporting of Patient-Reported Outcomes in Randomized Trials: The CONSORT PRO Extension. JAMA 309:814. https:\/\/doi.org\/10.1001\/jama.2013.879","journal-title":"JAMA"},{"key":"8051_CR7","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1016\/j.jclinepi.2023.07.012","volume":"162","author":"D Krepper","year":"2023","unstructured":"Krepper D, Giesinger JM, Dirven L, Efficace F, Martini C, Thurner AMM et al (2023) Information about missing patient-reported outcome data in breast cancer trials is frequently not documented: a scoping review. J Clin Epidemiol 162:1\u20139. https:\/\/doi.org\/10.1016\/j.jclinepi.2023.07.012","journal-title":"J Clin Epidemiol"},{"key":"8051_CR8","doi-asserted-by":"publisher","first-page":"36","DOI":"10.1186\/s41687-021-00308-y","volume":"5","author":"K Hong","year":"2021","unstructured":"Hong K, Majercak KR, Villalonga-Olives E, Perfetto EM (2021) Patient-reported outcomes in breast cancer FDA drug labels and review documents. J Patient Rep Outcomes 5:36. https:\/\/doi.org\/10.1186\/s41687-021-00308-y","journal-title":"J Patient Rep Outcomes"},{"key":"8051_CR9","doi-asserted-by":"publisher","first-page":"483","DOI":"10.1001\/jama.2017.21903","volume":"319","author":"M Calvert","year":"2018","unstructured":"Calvert M, Kyte D, Mercieca-Bebber R, Slade A, Chan A-W, King MT et al (2018) Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension. JAMA 319:483. https:\/\/doi.org\/10.1001\/jama.2017.21903","journal-title":"JAMA"},{"issue":"5","key":"8051_CR10","doi-asserted-by":"publisher","first-page":"622","DOI":"10.1080\/0284186X.2017.1400683","volume":"57","author":"M Rautalin","year":"2018","unstructured":"Rautalin M, F\u00e4rkkil\u00e4 N, Sintonen H, Saarto T, Taari K, Jahkola T, Roine RP (2018) Health-related quality of life in different states of breast cancer - comparing different instruments. Acta Oncol (Stockholm Sweden) 57(5):622\u2013628. https:\/\/doi.org\/10.1080\/0284186X.2017.1400683","journal-title":"Acta Oncol (Stockholm Sweden)"},{"issue":"3","key":"8051_CR11","doi-asserted-by":"publisher","first-page":"449","DOI":"10.1016\/j.jval.2024.12.003","volume":"28","author":"S Pangestu","year":"2025","unstructured":"Pangestu S, Purba FD, Setyowibowo H, Azhar Y, Mukuria C, Rencz F (2025) The Psychometric Properties of the EQ-HWB and EQ-HWB-S in Patients With Breast Cancer: A Comparative Analysis With EQ-5D-5L, FACT-8D, and SWEMWBS. Value health: J Int Soc Pharmacoeconomics Outcomes Res 28(3):449\u2013459. https:\/\/doi.org\/10.1016\/j.jval.2024.12.003","journal-title":"Value health: J Int Soc Pharmacoeconomics Outcomes Res"},{"key":"8051_CR12","doi-asserted-by":"publisher","first-page":"1176","DOI":"10.1200\/JCO-24-02021","volume":"43","author":"EC Blackstone","year":"2025","unstructured":"Blackstone EC, Efficace F, Meyerhardt JA, Abel GA (2025) Timely Reporting of Patient-Reported Outcomes in Cancer Clinical Trials: An Ethical Imperative. JCO 43:1176\u20131179. https:\/\/doi.org\/10.1200\/JCO-24-02021","journal-title":"JCO"},{"key":"8051_CR13","doi-asserted-by":"publisher","first-page":"e83","DOI":"10.1016\/S1470-2045(19)30790-9","volume":"21","author":"C Coens","year":"2020","unstructured":"Coens C, Pe M, Dueck AC, Sloan J, Basch E, Calvert M et al (2020) International standards for the analysis of quality-of-life and patient-reported outcome endpoints in cancer randomised controlled trials: recommendations of the SISAQOL Consortium. Lancet Oncol 21:e83\u201396. https:\/\/doi.org\/10.1016\/S1470-2045(19)30790-9","journal-title":"Lancet Oncol"}],"container-title":["Breast Cancer Research and Treatment"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10549-026-08051-y.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s10549-026-08051-y","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10549-026-08051-y.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T06:49:14Z","timestamp":1787640554000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s10549-026-08051-y"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8]]},"references-count":13,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2026,8]]}},"alternative-id":["8051"],"URL":"https:\/\/doi.org\/10.1007\/s10549-026-08051-y","relation":{},"ISSN":["0167-6806","1573-7217"],"issn-type":[{"value":"0167-6806","type":"print"},{"value":"1573-7217","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8]]},"assertion":[{"value":"5 June 2026","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"2 August 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"10 August 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"Not applicable. This manuscript analyzed previously published trial reports and did not involve new human participant recruitment, intervention, or access to identifiable individual participant data.","order":1,"name":"Ethics","label":"Ethical approval","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The authors report no other disclosures.","order":2,"name":"Ethics","label":"Disclosures","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The authors declare no competing interests.","order":3,"name":"Ethics","label":"Competing interests","group":{"name":"EthicsHeading","label":"Declarations"}}],"article-number":"35"}}