{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T19:16:12Z","timestamp":1789154172448,"version":"build-2803163510"},"reference-count":21,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2023,3,23]],"date-time":"2023-03-23T00:00:00Z","timestamp":1679529600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,5,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Talazoparib is a poly (adenosine diphosphate-ribose) polymerase inhibitor approved for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative, locally advanced or metastatic breast cancer (LA\/mBC), with approval based on the EMBRACA trial. To date, there are no published data on talazoparib use in the real-world United States (USA) setting.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Patients and Methods<\/jats:title>\n                  <jats:p>Characteristics, treatment patterns, and clinical outcomes of real-world US patients with gBRCAm HER2-negative LA\/mBC treated with talazoparib monotherapy were collected via retrospective chart review and summarized using descriptive statistics.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Among 84 eligible patients, 35.7% had hormone receptor-positive tumors and 64.3% had triple-negative LA\/mBC (TNBC). At talazoparib initiation, 29.8% had ECOG PS of \u22652 and 19.0% had brain metastasis. Mutations in gBRCA1 or 2 were detected among 64.3% and 35.7% of patients, respectively. Talazoparib was given as 1st-line therapy in 14.3% of patients, 2nd-line in 40.5%, and 3rd- or 4th-line in 45.2%. Median time to talazoparib treatment failure was 8.5\u2009months (95% CI, 8.0-9.7), median progression-free survival was 8.7\u2009months (95% CI, 8.0-9.9), the median time from initiation to chemotherapy was 12.2\u2009months (95% CI, 10.5-20.1), and the overall response rate was 63.1%. No differences in clinical outcomes were observed between patients with HR-positive\/HER2-negative LA\/mBC and patients with TNBC by using unadjusted statistical comparisons. Brain metastasis and ECOG PS \u22652 at talazoparib initiation were associated with treatment failure and progression or mortality.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>Overall, talazoparib clinical outcomes in this real-world population are consistent with findings from EMBRACA.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/oncolo\/oyad021","type":"journal-article","created":{"date-parts":[[2023,3,23]],"date-time":"2023-03-23T18:27:52Z","timestamp":1679596072000},"page":"414-424","source":"Crossref","is-referenced-by-count":12,"title":["Characteristics, Treatment, and Outcomes of Real-World Talazoparib-Treated Patients With Germline <i>BRCA<\/i>-Mutated Advanced HER2-Negative Breast Cancer"],"prefix":"10.1093","volume":"28","author":[{"given":"Kristin M Zimmerman","family":"Savill","sequence":"first","affiliation":[{"name":"Department of Real World Evidence and Insights, Cardinal Health Specialty Solutions, Cardinal Health , Dublin, OH , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jasmina","family":"Ivanova","sequence":"additional","affiliation":[{"name":"Department of Patient Health & Impact, Pfizer Inc. , New York, NY , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Parisa","family":"Asgarisabet","sequence":"additional","affiliation":[{"name":"Department of Real World Evidence and Insights, Cardinal Health Specialty Solutions, Cardinal Health , Dublin, OH , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angelica","family":"Falkenstein","sequence":"additional","affiliation":[{"name":"Department of Real World Evidence and Insights, Cardinal Health Specialty Solutions, Cardinal Health , Dublin, OH , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandrina","family":"Balanean","sequence":"additional","affiliation":[{"name":"Department of Real World Evidence and Insights, Cardinal Health Specialty Solutions, Cardinal Health , Dublin, OH , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"Niyazov","sequence":"additional","affiliation":[{"name":"Department of Patient Health & Impact, Pfizer Inc. , New York, NY , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joanne C","family":"Ryan","sequence":"additional","affiliation":[{"name":"Department of US Medical Affairs, Pfizer Inc. , New York, NY , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan","family":"Kish","sequence":"additional","affiliation":[{"name":"Department of Real World Evidence and Insights, Cardinal Health Specialty Solutions, Cardinal Health , Dublin, OH , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ajeet","family":"Gajra","sequence":"additional","affiliation":[{"name":"Department of Real World Evidence and Insights, Cardinal Health Specialty Solutions, Cardinal Health , Dublin, OH , USA"},{"name":"Hematology-Oncology Associates of CNY , Syracuse, NY , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7711-8627","authenticated-orcid":false,"given":"Reshma L","family":"Mahtani","sequence":"additional","affiliation":[{"name":"Miami Cancer Institute , Miami, FL , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2023,3,23]]},"reference":[{"key":"2023050815251345600_CIT0001","article-title":"Cancer statistics center: breast","author":"American Cancer Society (ACS).","year":"2022"},{"key":"2023050815251345600_CIT0002","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1016\/j.semcancer.2019.08.012","article-title":"Metastatic heterogeneity of breast cancer: molecular mechanism and potential therapeutic targets","volume":"60","author":"Liang","year":"2020","journal-title":"Semin Cancer Biol"},{"issue":"40","key":"2023050815251345600_CIT0003","first-page":"e4975","article-title":"Effect of BRCA germline mutations on breast cancer prognosis: a systematic review and meta-analysis","volume":"95","author":"Baretta","year":"2016","journal-title":"Am J L & Med."},{"issue":"V94","key":"2023050815251345600_CIT0004","first-page":"v74","article-title":"4458 - real-life study of BRCA genetic screening in metastatic breast cancer, European Society for Medical Oncology (ESMO) 2017 Congress","volume":"28 (suppl 5)","author":"Meynard","year":"2017","journal-title":"Ann Oncol"},{"issue":"Suppl_4","key":"2023050815251345600_CIT0005","first-page":"PD1PD1-02","article-title":"Abstract PD1-02: cancer predisposition genes in metastatic breast cancer \u2013 association with metastatic pattern, prognosis, patient and tumor characteristics","volume":"78","author":"Fasching","year":"2018","journal-title":"Cancer Res"},{"issue":"6","key":"2023050815251345600_CIT0006","doi-asserted-by":"crossref","first-page":"523","DOI":"10.1056\/NEJMoa1706450","article-title":"Olaparib for metastatic breast cancer in patients with a germline BRCA mutation","volume":"377","author":"Robson","year":"2017","journal-title":"N Engl J Med"},{"issue":"3","key":"2023050815251345600_CIT0007","doi-asserted-by":"crossref","first-page":"255","DOI":"10.1007\/s11523-021-00796-4","article-title":"An overview of parp inhibitors for the treatment of breast cancer","volume":"16","author":"Cortesi","year":"2021","journal-title":"Target Oncol"},{"key":"2023050815251345600_CIT0008","article-title":"FDA approves olaparib for germline BRCA-mutated metastatic breast cancer","author":"United States Food and Drug Administration (FDA)","year":"2018"},{"key":"2023050815251345600_CIT0009","article-title":"FDA approves talazoparib for gBRCAm HER2-negative locally advanced or metastatic breast cancer","author":"United States Food and Drug Administration (FDA)","year":"2018"},{"key":"2023050815251345600_CIT0010","article-title":"A study evaluating talazoparib (BMN 673), a PARP inhibitor, in advanced and\/or metastatic breast cancer patients with BRCA mutation (EMBRACA Study) (EMBRACA)","author":"Clinical Trials.gov","year":"2022"},{"issue":"8","key":"2023050815251345600_CIT0011","doi-asserted-by":"crossref","first-page":"753","DOI":"10.1056\/NEJMoa1802905","article-title":"Talazoparib in patients with advanced breast cancer and a germline BRCA mutation","volume":"379","author":"Litton","year":"2018","journal-title":"N Engl J Med"},{"issue":"5","key":"2023050815251345600_CIT0012","doi-asserted-by":"crossref","first-page":"21","DOI":"10.1007\/s11864-018-0540-2","article-title":"Update on PARP inhibitors in breast cancer","volume":"19","author":"Zimmer","year":"2018","journal-title":"Curr Treat Options Oncol"},{"issue":"11","key":"2023050815251345600_CIT0013","doi-asserted-by":"crossref","first-page":"1526","DOI":"10.1016\/j.annonc.2020.08.2098","article-title":"Talazoparib versus chemotherapy in patients with germline BRCA1\/2-mutated HER2-negative advanced breast cancer: final overall survival results from the EMBRACA trial","volume":"31","author":"Litton","year":"2020","journal-title":"Ann Oncol"},{"issue":"Suppl_4","key":"2023050815251345600_CIT0014","first-page":"P1P118","article-title":"Abstract P1-18-28: phase IV study evaluating effectiveness and safety of talazoparib in patients with locally advanced or metastatic HER2 negative breast cancer and a BRCA1 or BRCA2 mutation (ViTAL)","volume":"82","author":"Loirat","year":"2022","journal-title":"Cancer Res"},{"issue":"Suppl_2","key":"2023050815251345600_CIT0015","doi-asserted-by":"crossref","first-page":"S74","DOI":"10.1016\/j.annonc.2021.03.138","article-title":"124P talazoparib in locally advanced or metastatic breast cancer patients: Experience from an early access program in Turkey","volume":"32","author":"Sendur","year":"2021","journal-title":"Ann Oncol Elsevier"},{"issue":"20","key":"2023050815251345600_CIT0016","first-page":"143","article-title":"Russian multicenter experience of using talazoparib in the treatment of patients with BRCA-associated metastatic breast cancer","volume":"0","author":"Semiglazova","year":"2020","journal-title":"\u041c\u0415\u0414\u0418\u0426\u0418\u041d\u0421\u041a\u0418\u0419 \u0421\u041e\u0412\u0415\u0422"},{"issue":"3.5","key":"2023050815251345600_CIT0017","doi-asserted-by":"crossref","first-page":"HSR21-062","DOI":"10.6004\/jnccn.2020.7760","article-title":"HSR21-062: real-world study of BRCA1\/2 mutation (BRCA1\/2mut) testing among adult patients (pts) with HER2\u2014advanced breast cancer (ABC) in the US","volume":"19","author":"Mahtani","year":"2021","journal-title":"J Natl Compr Canc Netw"},{"issue":"1","key":"2023050815251345600_CIT0018","doi-asserted-by":"crossref","first-page":"112","DOI":"10.1016\/j.jval.2020.09.015","article-title":"Replication of randomized, controlled trials using real-world data: what could go wrong?","volume":"24","author":"Thompson","year":"2021","journal-title":"Value Health"},{"key":"2023050815251345600_CIT0019","article-title":"Considerations for use of real-world evidence in oncology","author":"Friends of Cancer Research Collaborations.","year":"2020"},{"key":"2023050815251345600_CIT0020","doi-asserted-by":"crossref","first-page":"185","DOI":"10.1200\/EDBK_156686","article-title":"The role of clinical trial participation in cancer research: barriers, evidence, and strategies","volume":"35","author":"Unger","year":"2016","journal-title":"Am Soc Clin Oncol Educ Book"},{"key":"2023050815251345600_CIT0021","article-title":"November oncology virtual summit: change factor post-ASCO_new era of value-based care 2021.","author":"Cardinal Health Specialty Solutions.","year":"2021"}],"container-title":["The Oncologist"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/oncolo\/article-pdf\/28\/5\/414\/50247573\/oyad021.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/oncolo\/article-pdf\/28\/5\/414\/50247573\/oyad021.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,5,8]],"date-time":"2023-05-08T16:36:33Z","timestamp":1683563793000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/oncolo\/article\/28\/5\/414\/7084883"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,3,23]]},"references-count":21,"journal-issue":{"issue":"5","published-online":{"date-parts":[[2023,3,23]]},"published-print":{"date-parts":[[2023,5,8]]}},"URL":"https:\/\/doi.org\/10.1093\/oncolo\/oyad021","relation":{},"ISSN":["1083-7159","1549-490X"],"issn-type":[{"value":"1083-7159","type":"print"},{"value":"1549-490X","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2023,5,1]]},"published":{"date-parts":[[2023,3,23]]}}}