{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,23]],"date-time":"2026-06-23T06:49:44Z","timestamp":1782197384811,"version":"3.54.5"},"reference-count":54,"publisher":"MDPI AG","issue":"12","license":[{"start":{"date-parts":[[2026,6,20]],"date-time":"2026-06-20T00:00:00Z","timestamp":1781913600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancers"],"abstract":"<jats:p>Background\/Objectives: Metastatic triple-negative breast cancer (mTNBC) carries a poor prognosis and limited treatment options. Sacituzumab govitecan (SG), an anti-Trop-2 antibody\u2013drug conjugate, has shown activity in this setting, but a quantitative synthesis integrating randomized and real-world evidence\u2014particularly in underrepresented subgroups\u2014was lacking. We aimed to summarize the comparative benefit of SG, which derives from a single randomized trial, and to assess whether trial-level efficacy is consistent with the activity observed in routine practice. Methods: Following PRISMA 2020, we searched PubMed\/MEDLINE and Web of Science (January 2017\u2013April 2026) for trials and observational cohorts of SG monotherapy in mTNBC. Comparative effects were taken from randomized data; single-arm efficacy (objective response rate [ORR], clinical benefit rate [CBR], median progression-free [PFS], and overall survival [OS]) was pooled using random-effects models. Risk of bias was assessed with RoB 2 and ROBINS-I. The review was registered in the Open Science Framework. Results: Nine studies (1242 patients; 980 SG-treated) were included: one randomized trial (ASCENT), two single-arm trials, and six real-world cohorts. In ASCENT, SG improved PFS (hazard ratio [HR] 0.41, 95% CI 0.33\u20130.63) and OS (HR 0.51, 0.42\u20130.64). Pooled ORR was 31.1% (28.0\u201334.4), and CBR was 42.2% (37.7\u201346.8), with the median PFS being 4.8 months (4.4\u20135.3) and OS being 11.0 months (9.3\u201313.0); trial-derived and real-world estimates were concordant. The benefit persisted in older patients (HR 0.25) and Black women (HR 0.44) but not in those with brain metastases (HR 0.68, 0.38\u20131.23). Conclusions: SG shows clinically meaningful activity in mTNBC that is broadly consistent between controlled trials and routine practice. Comparative superiority over chemotherapy rests on a single randomized trial (ASCENT); the pooled single-arm estimates describe activity and its consistency rather than a comparative effect.<\/jats:p>","DOI":"10.3390\/cancers18122005","type":"journal-article","created":{"date-parts":[[2026,6,23]],"date-time":"2026-06-23T06:13:37Z","timestamp":1782195217000},"page":"2005","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer: A Systematic Review with Meta-Analysis of Single-Arm Efficacy and Integration of Randomized and Real-World Evidence"],"prefix":"10.3390","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5027-4785","authenticated-orcid":false,"given":"Marcelino","family":"P\u00e9rez-Bermejo","sequence":"first","affiliation":[{"name":"SONEV Research Group, Faculty of Medicine and Health Sciences, Catholic University of Valencia San Vicente M\u00e1rtir, C\/Quevedo No. 2, 46001 Valencia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcelo","family":"Maz\u00f3n-Albalate","sequence":"additional","affiliation":[{"name":"Faculty of Medicine and Health Sciences, Catholic University of Valencia San Vicente M\u00e1rtir, C\/Quevedo No. 2, 46001 Valencia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9905-0443","authenticated-orcid":false,"given":"Mar\u00eda Teresa","family":"Murillo-Llorente","sequence":"additional","affiliation":[{"name":"SONEV Research Group, Faculty of Medicine and Health Sciences, Catholic University of Valencia San Vicente M\u00e1rtir, C\/Quevedo No. 2, 46001 Valencia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Javier","family":"P\u00e9rez-Murillo","sequence":"additional","affiliation":[{"name":"SONEV Research Group, Faculty of Medicine and Health Sciences, Catholic University of Valencia San Vicente M\u00e1rtir, C\/Quevedo No. 2, 46001 Valencia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5468-4434","authenticated-orcid":false,"given":"Mar\u00eda Ester","family":"Legidos-Garc\u00eda","sequence":"additional","affiliation":[{"name":"SONEV Research Group, Faculty of Medicine and Health Sciences, Catholic University of Valencia San Vicente M\u00e1rtir, C\/Quevedo No. 2, 46001 Valencia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9515-180X","authenticated-orcid":false,"given":"Francisco","family":"Tom\u00e1s-Aguirre","sequence":"additional","affiliation":[{"name":"SONEV Research Group, Faculty of Medicine and Health Sciences, Catholic University of Valencia San Vicente M\u00e1rtir, C\/Quevedo No. 2, 46001 Valencia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3660-2516","authenticated-orcid":false,"given":"Alma Mar\u00eda","family":"Palau-Ferr\u00e9","sequence":"additional","affiliation":[{"name":"SONEV Research Group, Faculty of Medicine and Health Sciences, Catholic University of Valencia San Vicente M\u00e1rtir, C\/Quevedo No. 2, 46001 Valencia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miriam","family":"Mart\u00ednez-Peris","sequence":"additional","affiliation":[{"name":"SONEV Research Group, Faculty of Medicine and Health Sciences, Catholic University of Valencia San Vicente M\u00e1rtir, C\/Quevedo No. 2, 46001 Valencia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6426-2999","authenticated-orcid":false,"given":"Ignacio","family":"Ventura","sequence":"additional","affiliation":[{"name":"Faculty of Medicine and Health Sciences, Catholic University of Valencia San Vicente M\u00e1rtir, C\/Quevedo No. 2, 46001 Valencia, Spain"},{"name":"Translational Research Center San Alberto Magno CITSAM, Catholic University of Valencia San Vicente M\u00e1rtir, C\/Quevedo No 2, 46001 Valencia, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2026,6,20]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"181","DOI":"10.1146\/annurev-pathol-042420-093238","article-title":"Pathogenesis of triple-negative breast cancer","volume":"17","author":"Derakhshan","year":"2022","journal-title":"Annu. 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