{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,8]],"date-time":"2026-09-08T06:53:21Z","timestamp":1788850401421,"version":"build-2803163510"},"reference-count":15,"publisher":"Springer Science and Business Media LLC","issue":"4","license":[{"start":{"date-parts":[[2024,4,10]],"date-time":"2024-04-10T00:00:00Z","timestamp":1712707200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,4,10]],"date-time":"2024-04-10T00:00:00Z","timestamp":1712707200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Breast Cancer"],"published-print":{"date-parts":[[2024,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Sacituzumab govitecan (SG) has been approved by FDA in April 2021 for pre-treated metastatic triple-negative breast cancer (mTNBC), following the ASCENT trial results.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>We set up an ambispective bicentric cohort study to assess the real-world effectiveness and safety of SG in patients with mTNBC treated at Institut Curie Hospitals, with a focus on patients with brain metastases.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>This study included 99 patients treated through the French Early Access Program to SG from May 2021 to January 2023. Median age was 55 years [26\u201389], <jats:italic>N<\/jats:italic>\u2009=\u20098 patients (8%) had <jats:italic>BRCA1\/2<\/jats:italic> mutation, <jats:italic>N<\/jats:italic>\u2009=\u200912 (12%) de novo stage IV disease and <jats:italic>N<\/jats:italic>\u2009=\u200931 (31%) brain metastases. Patients had previously received a median of two [1\u201310] lines of treatment in advanced setting. After a median follow-up of 9.7\u00a0months, the median progression-free survival (PFS) and overall survival (OS) were 3.9\u00a0months (95%CI[3.4\u20135.0]) and 8.6\u00a0months (95%CI[7.1\u201311.9]), respectively, while objective response rate was 29% (95%CI[21\u201339]). Among patients with brain metastases, median PFS and OS were 3.7\u00a0months (95%CI[2.6\u20136.2]) and 6.7\u00a0months (95%CI[6.3\u2013NR]), respectively, with intracranial tumor responses. Dose reductions were required in <jats:italic>N<\/jats:italic>\u2009=\u200917 patients (17%) within a median of three [2\u201311] cycles, due to gastrointestinal toxicity (<jats:italic>N<\/jats:italic>\u2009=\u20096; 6%), hematological toxicity (<jats:italic>N<\/jats:italic>\u2009=\u20099; 9%) including febrile neutropenia (<jats:italic>N<\/jats:italic>\u2009=\u20092; 2%), liver enzyme elevation (<jats:italic>N<\/jats:italic>\u2009=\u20091; 1%), and physical deterioration (<jats:italic>N<\/jats:italic>\u2009=\u20091; 1%). There was no related death to SG.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>The observed response rate and safety of SG are consistent with the results of the ASCENT trial, with efficacy observed in patients with brain metastases, but observed PFS and OS are numerically shorter.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s12282-024-01565-7","type":"journal-article","created":{"date-parts":[[2024,4,10]],"date-time":"2024-04-10T17:01:35Z","timestamp":1712768495000},"page":"572-580","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":38,"title":["Sacituzumab govitecan in metastatic triple-negative breast cancer patients treated at Institut Curie Hospitals: efficacy, safety, and impact of brain metastases"],"prefix":"10.1007","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5888-6399","authenticated-orcid":false,"given":"Alexandre","family":"De Moura","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Delphine","family":"Loirat","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Vaillant","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sinen","family":"Korbi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicolas","family":"Kiavue","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diana","family":"Bello Roufai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurence","family":"Escalup","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Romain","family":"Desmaris","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pauline","family":"Vaflard","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Cottu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean-Yves","family":"Pierga","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fran\u00e7ois-Cl\u00e9ment","family":"Bidard","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luc","family":"Cabel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandre","family":"Acramel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,4,10]]},"reference":[{"key":"1565_CR1","doi-asserted-by":"publisher","first-page":"4429","DOI":"10.1158\/1078-0432.CCR-06-3045","volume":"13","author":"R Dent","year":"2007","unstructured":"Dent R, et al. Triple-negative breast cancer: clinical features and patterns of recurrence. Clin Cancer Res. 2007;13:4429\u201334.","journal-title":"Clin Cancer Res"},{"key":"1565_CR2","doi-asserted-by":"publisher","first-page":"44","DOI":"10.1016\/S1470-2045(19)30689-8","volume":"21","author":"P Schmid","year":"2020","unstructured":"Schmid P, et al. Atezolizumab plus nab-paclitaxel as first-line treatment for unresectable, locally advanced or metastatic triple-negative breast cancer (IMpassion130): updated efficacy results from a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2020;21:44\u201359.","journal-title":"Lancet Oncol"},{"key":"1565_CR3","doi-asserted-by":"publisher","first-page":"1817","DOI":"10.1016\/S0140-6736(20)32531-9","volume":"396","author":"J Cortes","year":"2020","unstructured":"Cortes J, et al. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (KEYNOTE-355): a randomised, placebo-controlled, double-blind, phase 3 clinical trial. The Lancet. 2020;396:1817\u201328.","journal-title":"The Lancet"},{"key":"1565_CR4","doi-asserted-by":"publisher","first-page":"1529","DOI":"10.1056\/NEJMoa2028485","volume":"384","author":"A Bardia","year":"2021","unstructured":"Bardia A, et al. Sacituzumab govitecan in metastatic triple-negative breast cancer. N Engl J Med. 2021;384:1529\u201341.","journal-title":"N Engl J Med"},{"key":"1565_CR5","doi-asserted-by":"publisher","first-page":"60","DOI":"10.1016\/j.ejca.2020.01.016","volume":"129","author":"E Deluche","year":"2020","unstructured":"Deluche E, et al. Contemporary outcomes of metastatic breast cancer among 22,000 women from the multicentre ESME cohort 2008\u20132016. Eur J Cancer. 2020;129:60\u201370.","journal-title":"Eur J Cancer"},{"key":"1565_CR6","doi-asserted-by":"publisher","first-page":"4951","DOI":"10.1158\/0008-5472.CAN-09-0099","volume":"69","author":"J Lu","year":"2009","unstructured":"Lu J, et al. Breast cancer metastasis: challenges and opportunities. Cancer Res. 2009;69:4951\u20133.","journal-title":"Cancer Res"},{"key":"1565_CR7","doi-asserted-by":"publisher","first-page":"2638","DOI":"10.1002\/cncr.23930","volume":"113","author":"NU Lin","year":"2008","unstructured":"Lin NU, et al. Sites of distant recurrence and clinical outcomes in patients with metastatic triple-negative breast cancer: high incidence of central nervous system metastases. Cancer. 2008;113:2638\u201345.","journal-title":"Cancer"},{"key":"1565_CR8","doi-asserted-by":"publisher","first-page":"127","DOI":"10.1007\/s10549-022-06602-7","volume":"195","author":"J O\u2019Shaughnessy","year":"2022","unstructured":"O\u2019Shaughnessy J, et al. Analysis of patients without and with an initial triple-negative breast cancer diagnosis in the phase 3 randomized ASCENT study of sacituzumab govitecan in metastatic triple-negative breast cancer. Breast Cancer Res Treat. 2022;195:127\u201339.","journal-title":"Breast Cancer Res Treat"},{"key":"1565_CR9","doi-asserted-by":"publisher","first-page":"PD13-07","DOI":"10.1158\/1538-7445.SABCS20-PD13-07","volume":"81","author":"V Di\u00e9ras","year":"2021","unstructured":"Di\u00e9ras V, et al. Abstract PD13\u201307: Subgroup analysis of patients with brain metastases from the phase 3 ASCENT study of sacituzumab govitecan versus chemotherapy in metastatic triple-negative breast cancer. Cancer Res. 2021;81:PD13-07.","journal-title":"Cancer Res"},{"key":"1565_CR10","doi-asserted-by":"publisher","first-page":"1840","DOI":"10.1038\/s41591-022-01935-8","volume":"28","author":"R Bartsch","year":"2022","unstructured":"Bartsch R, et al. Trastuzumab deruxtecan in HER2-positive breast cancer with brain metastases: a single-arm, phase 2 trial. Nat Med. 2022;28:1840\u20137.","journal-title":"Nat Med"},{"key":"1565_CR11","doi-asserted-by":"publisher","DOI":"10.1016\/j.ctrv.2023.102597","volume":"119","author":"N Epaillard","year":"2023","unstructured":"Epaillard N, Bassil J, Pistilli B. Current indications and future perspectives for antibody-drug conjugates in brain metastases of breast cancer. Cancer Treat Rev. 2023;119: 102597.","journal-title":"Cancer Treat Rev"},{"key":"1565_CR12","doi-asserted-by":"publisher","first-page":"1139372","DOI":"10.3389\/fonc.2023.1139372","volume":"13","author":"P di Mauro","year":"2023","unstructured":"di Mauro P, et al. Sacituzumab govitecan and radiotherapy in metastatic, triple-negative, and BRCA-mutant breast cancer patient with active brain metastases: a case report. Front Oncol. 2023;13:1139372.","journal-title":"Front Oncol"},{"key":"1565_CR13","doi-asserted-by":"publisher","first-page":"1729","DOI":"10.1001\/jamaoncol.2023.4492","volume":"9","author":"ES Lebow","year":"2023","unstructured":"Lebow ES, et al. Symptomatic necrosis with antibody-drug conjugates and concurrent stereotactic radiotherapy for brain metastases. JAMA Oncol. 2023;9:1729\u201333.","journal-title":"JAMA Oncol"},{"key":"1565_CR14","doi-asserted-by":"publisher","first-page":"1951","DOI":"10.1038\/s41388-022-02585-3","volume":"42","author":"D Bello Roufai","year":"2023","unstructured":"Bello Roufai D, et al. Alpelisib and fulvestrant in PIK3CA-mutated hormone receptor-positive HER2-negative advanced breast cancer included in the French early access program. Oncogene. 2023;42:1951\u20136.","journal-title":"Oncogene"},{"issue":"1","key":"1565_CR15","doi-asserted-by":"publisher","first-page":"13427","DOI":"10.1038\/s41598-023-40569-9","volume":"13","author":"A De Moura","year":"2023","unstructured":"De Moura A, et al. Atezolizumab and paclitaxel as first line therapy in advanced triple-negative breast cancer patients included in the French early access program. Sci Rep. 2023;13(1):13427.","journal-title":"Sci Rep."}],"container-title":["Breast Cancer"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s12282-024-01565-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s12282-024-01565-7\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s12282-024-01565-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,6,23]],"date-time":"2024-06-23T06:06:57Z","timestamp":1719122817000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s12282-024-01565-7"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,4,10]]},"references-count":15,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2024,7]]}},"alternative-id":["1565"],"URL":"https:\/\/doi.org\/10.1007\/s12282-024-01565-7","relation":{},"ISSN":["1340-6868","1880-4233"],"issn-type":[{"value":"1340-6868","type":"print"},{"value":"1880-4233","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,4,10]]},"assertion":[{"value":"29 November 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"4 March 2024","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"10 April 2024","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Delphine Loirat declared support for attending meetings from Gilead and participation in Gilead advisory board. Diana Bello-Roufai declared support for attending meetings from Gilead. Pauline Vaflard declared consulting fees from Gilead. Jean-Yves Pierga declared consulting fees from Gilead and participation in Gilead advisory board. Fran\u00e7ois-Cl\u00e9ment Bidard declared consulting fees from Gilead and participation in Gilead advisory board. Other authors declared no competing interests with this research.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and\/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. This study was approved by the Institut Curie review board (DATA230222) in accordance with relevant guidelines and regulations. This article does not contain any studies with animals performed by any of the authors.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Informed consent was obtained from all individual participants included in the study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}