{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,6]],"date-time":"2026-07-06T10:16:25Z","timestamp":1783332985309,"version":"3.54.6"},"reference-count":27,"publisher":"Oxford University Press (OUP)","issue":"7","license":[{"start":{"date-parts":[[2026,3,27]],"date-time":"2026-03-27T00:00:00Z","timestamp":1774569600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100005564","name":"Gilead Sciences, Inc.","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005564","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,7,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Sacituzumab govitecan (SG), a Trop-2-directed antibody-drug conjugate, is approved outside Japan for previously treated hormone receptor-positive\/human epidermal growth factor receptor 2-negative (HR+\/HER2\u2212) unresectable locally advanced or metastatic BC (mBC) based on the global, phase III TROPiCS-02 study. ASCENT-J02 (NCT05101096; jRCT2031210346), an open-label, phase I\/II study, evaluated efficacy and safety of SG in Japanese participants with advanced solid tumors. We report phase II HR+\/HER2\u2013 mBC cohort primary results.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Participants with previously treated HR+\/HER2\u2013 mBC received SG 10\u00a0mg\/kg intravenously on days 1 and 8, every 21\u00a0days until progression\/unacceptable toxicity. Primary endpoint: confirmed independent review committee (IRC)-assessed objective response rate (ORR; Response Evaluation Criteria in Solid Tumors v1.1), with 10% threshold (H0: ORR \u226410% vs H1: ORR &amp;gt;10%; one-sided P &amp;lt; .025). Key secondary endpoints: investigator-assessed ORR, IRC and investigator-assessed progression-free survival (PFS), overall survival (OS), safety.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Forty-two participants received SG. At the 7.5-month median follow-up, ORR (95% CI) was 16.7% (7.0\u201331.4; P =\u00a0.1214) by IRC and 28.6% (15.7\u201344.6) by investigator. Median PFS (95% CI) was 4.4\u00a0months (2.7\u20138.5) by IRC and 5.6\u00a0months (3.3\u20137.1) by investigator. Median OS (95% CI) was 13.0\u00a0months (11.0-not reached). Treatment-emergent adverse events (TEAEs) occurred in 41 (98%) participants (grade\u00a0\u2265\u00a03, 35 [83%]). No TEAE-related deaths reported; one participant discontinued treatment due to neutropenia.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Although the primary endpoint (ORR by IRC) was not met (P &amp;gt;\u00a0.025), overall efficacy results were generally similar to TROPiCS-02, supporting access to SG in Japanese patients with HR+\/HER2\u2013 mBC. Safety was consistent with the known and manageable SG safety profile.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/jjco\/hyag043","type":"journal-article","created":{"date-parts":[[2026,3,27]],"date-time":"2026-03-27T00:31:35Z","timestamp":1774571495000},"page":"816-826","source":"Crossref","is-referenced-by-count":0,"title":["Sacituzumab govitecan in Japanese participants with HR+\/HER2\u2212 metastatic breast cancer: primary results from the phase II ASCENT-J02 study"],"prefix":"10.1093","volume":"56","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2557-8170","authenticated-orcid":false,"given":"Akihiko","family":"Shimomura","sequence":"first","affiliation":[{"name":"Department of Breast and Medical Oncology, National Center for Global Health and Medicine , 1-21-1 Toyama Shinjuku-ku, Tokyo 162-8655 ,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takahiro","family":"Kogawa","sequence":"additional","affiliation":[{"name":"Department of Advanced Medical Development, The Cancer Institute Hospital of JFCR , 3-8-31, Ariake, Koto, Tokyo 135-8550 ,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1907-0247","authenticated-orcid":false,"given":"Koji","family":"Matsumoto","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Hyogo Cancer Center , Kitaojicho 13-70, Akashi City, Hyogo Pref. 673-8558 ,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9226-895X","authenticated-orcid":false,"given":"Junichiro","family":"Watanabe","sequence":"additional","affiliation":[{"name":"Department of Breast Oncology, Juntendo University Hospital , 3 Chome-1-3 Hongo, Bunky\u014d City, Tokyo 113-0033 ,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenichi","family":"Watanabe","sequence":"additional","affiliation":[{"name":"Department of Breast Surgery, National Hospital Organization, Hokkaido Cancer Center , 003-0804 Sapporo-shi, Shiroishi-ku, Kikusui 4-3-54, Sapporo ,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takahiro","family":"Nakayama","sequence":"additional","affiliation":[{"name":"Department of Breast and Endocrine Surgery, Osaka International Cancer Institute , 3-ch\u014dme-1-69 \u014ctemae, Chuo Ward, Osaka 540-0008 ,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3202-5512","authenticated-orcid":false,"given":"Tadahiko","family":"Shien","sequence":"additional","affiliation":[{"name":"Department of Breast and Endocrine Surgery, Okayama University Hospital , 2-5-1 Shikata-cho, Kitaku, Okayama 700-8558 ,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tsutomu","family":"Iwasa","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Kindai University Faculty of Medicine , 377-2, Minamihanadacho, Sakai, Osaka 591-8011 ,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sunita","family":"Padman","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc. , 333 Lakeside Dr, Foster City, CA 94404 ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Danh","family":"Huynh","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc. , 333 Lakeside Dr, Foster City, CA 94404 ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiang","family":"Shao","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc. , 333 Lakeside Dr, Foster City, CA 94404 ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joyce","family":"Kwan","sequence":"additional","affiliation":[{"name":"Gilead Sciences, Inc. , 333 Lakeside Dr, Foster City, CA 94404 ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuki","family":"Iwahori","sequence":"additional","affiliation":[{"name":"Gilead Sciences, K.K. , 1-9-2, Marunouchi Grand Tokyo South Tower 16F, Chiyoda-ku, Tokyo 100-6616 ,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8490-9064","authenticated-orcid":false,"given":"Yoichi","family":"Naito","sequence":"additional","affiliation":[{"name":"Department of General Internal Medicine, National Cancer Center Hospital East , 6-5-1 Kashiwanoha, Kashiwa-shi Chiba, 277-8577, Kashiwa ,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0242-4718","authenticated-orcid":false,"given":"Hiroji","family":"Iwata","sequence":"additional","affiliation":[{"name":"Department of Advanced Clinical Research and Development, Nagoya City University , 65 Tsurumai-cho, Showa-ku, Nagoya 466-8560 ,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2026,3,27]]},"reference":[{"key":"2026070605423023500_ref1","doi-asserted-by":"publisher","first-page":"229","DOI":"10.3322\/caac.21834","article-title":"Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries","volume":"74","author":"Bray","year":"2024","journal-title":"CA Cancer J Clin"},{"key":"2026070605423023500_ref2","article-title":"Global cancer observatory: Cancer today","author":"Ferlay","journal-title":"Japan fact sheet"},{"key":"2026070605423023500_ref3","doi-asserted-by":"publisher","first-page":"102670","DOI":"10.1016\/j.ctrv.2023.102670","article-title":"Current and emerging treatment approaches for hormone receptor-positive\/human epidermal growth factor receptor 2-negative metastatic breast cancer","volume":"123","author":"Jhaveri","year":"2024","journal-title":"Cancer Treat Rev"},{"key":"2026070605423023500_ref4","doi-asserted-by":"publisher","first-page":"1709","DOI":"10.1016\/j.annonc.2020.09.004","article-title":"Sacituzumab govitecan in previously treated hormone receptor-positive\/HER2-negative metastatic breast cancer: final results from a phase I\/II, single-arm, basket trial","volume":"31","author":"Kalinsky","year":"2020","journal-title":"Ann Oncol"},{"key":"2026070605423023500_ref5","doi-asserted-by":"publisher","first-page":"3175","DOI":"10.1080\/14796694.2025.2558280","article-title":"Real-world treatment outcomes of abemaciclib in older patients with HR+, HER2- metastatic breast cancer in Japan","volume":"21","author":"Shimoi","year":"2025","journal-title":"Future Oncol"},{"key":"2026070605423023500_ref6","doi-asserted-by":"publisher","first-page":"132","DOI":"10.1007\/s12282-024-01640-z","article-title":"Capivasertib and fulvestrant for patients with HR-positive\/HER2-negative advanced breast cancer: analysis of the subgroup of patients from Japan in the phase 3 CAPItello-291 trial","volume":"32","author":"Tokunaga","year":"2025","journal-title":"Breast Cancer"},{"key":"2026070605423023500_ref7","doi-asserted-by":"publisher","first-page":"285","DOI":"10.1200\/JCO.24.00920","article-title":"Datopotamab deruxtecan versus chemotherapy in previously treated inoperable\/metastatic hormone receptor-positive human epidermal growth factor receptor 2-negative breast cancer: primary results from TROPION-Breast01","volume":"43","author":"Bardia","year":"2025","journal-title":"J Clin Oncol"},{"key":"2026070605423023500_ref8","doi-asserted-by":"publisher","first-page":"1390","DOI":"10.1158\/1078-0432.CCR-24-1525","article-title":"The mode of action and clinical outcomes of sacituzumab govitecan in solid tumors","volume":"31","author":"Tolaney","year":"2025","journal-title":"Clin Cancer Res"},{"key":"2026070605423023500_ref9","doi-asserted-by":"publisher","first-page":"1529","DOI":"10.1056\/NEJMoa2028485","article-title":"Sacituzumab govitecan in metastatic triple-negative breast cancer","volume":"384","author":"Bardia","year":"2021","journal-title":"N Engl J Med"},{"key":"2026070605423023500_ref10","volume-title":"Everest\u2019s Trodelvy receives approval for breast cancer in China","author":"Pharmaceutical Technology"},{"key":"2026070605423023500_ref11","volume-title":"TRODELVY (sacituzumab govitecan) [summary of product characteristics]","author":"Europeans Medicines Agency"},{"key":"2026070605423023500_ref12","volume-title":"(sacituzumab govitecan-hziy) [prescribing information]","author":"TRODELVY","year":"2023"},{"key":"2026070605423023500_ref13","doi-asserted-by":"publisher","first-page":"3365","DOI":"10.1200\/JCO.22.01002","article-title":"Sacituzumab govitecan in hormone receptor-positive\/human epidermal growth factor receptor 2-negative metastatic breast cancer","volume":"40","author":"Rugo","year":"2022","journal-title":"J Clin Oncol"},{"key":"2026070605423023500_ref14","doi-asserted-by":"publisher","first-page":"1423","DOI":"10.1016\/S0140-6736(23)01245-X","article-title":"Overall survival with sacituzumab govitecan in hormone receptor-positive and human epidermal growth factor receptor 2-negative metastatic breast cancer (TROPiCS-02): a randomised, open-label, multicentre, phase 3 trial","volume":"402","author":"Rugo","year":"2023","journal-title":"Lancet"},{"key":"2026070605423023500_ref15","doi-asserted-by":"publisher","first-page":"3709","DOI":"10.1038\/s41591-024-03269-z","article-title":"Sacituzumab govitecan in HR(+)HER2(\u2212) metastatic breast cancer: the randomized phase 3 EVER-132-002 trial","volume":"30","author":"Xu","year":"2024","journal-title":"Nat Med"},{"key":"2026070605423023500_ref16","doi-asserted-by":"publisher","first-page":"1684","DOI":"10.1007\/s10147-024-02589-x","article-title":"Preliminary results from ASCENT-J02: a phase 1\/2 study of sacituzumab govitecan in Japanese patients with advanced solid tumors","volume":"29","author":"Naito","year":"2024","journal-title":"Int J Clin Oncol"},{"key":"2026070605423023500_ref17","doi-asserted-by":"publisher","first-page":"1775","DOI":"10.1007\/s10147-024-02644-7","article-title":"PMDA regulatory update on approval and revision of the precautions for use of anticancer drugs; approval of sacituzumab govitecan for breast cancer, fruquintinib for colorectal cancer, amivantamab for lung cancer, repotrectinib for lung cancer, tasurgratinib for biliary tract cancer, enfortumab vedotin plus pembrolizumab for urothelial cancer, and dabrafenib plus trametinib for glioma in Japan","volume":"29","author":"Matsumura","year":"2024","journal-title":"Int J Clin Oncol"},{"key":"2026070605423023500_ref18","doi-asserted-by":"publisher","first-page":"228","DOI":"10.1016\/j.ejca.2008.10.026","article-title":"New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1)","volume":"45","author":"Eisenhauer","year":"2009","journal-title":"Eur J Cancer"},{"key":"2026070605423023500_ref19","doi-asserted-by":"publisher","first-page":"594","DOI":"10.1200\/JCO.2013.52.4892","article-title":"Phase III open-label randomized study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and a taxane","volume":"33","author":"Kaufman","year":"2015","journal-title":"J Clin Oncol"},{"key":"2026070605423023500_ref20","doi-asserted-by":"publisher","first-page":"914","DOI":"10.1016\/S0140-6736(11)60070-6","article-title":"Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study","volume":"377","author":"Cortes","year":"2011","journal-title":"Lancet"},{"key":"2026070605423023500_ref21","doi-asserted-by":"publisher","first-page":"2567","DOI":"10.1200\/JCO.1995.13.10.2567","article-title":"Randomized comparison of vinorelbine and melphalan in anthracycline-refractory advanced breast cancer","volume":"13","author":"Jones","year":"1995","journal-title":"J Clin Oncol"},{"key":"2026070605423023500_ref22","doi-asserted-by":"publisher","first-page":"497","DOI":"10.1111\/cas.12647","article-title":"Pharmacokinetics, dynamics and toxicity of docetaxel: why the Japanese dose differs from the Western dose","volume":"106","author":"Kenmotsu","year":"2015","journal-title":"Cancer Sci"},{"key":"2026070605423023500_ref23","doi-asserted-by":"publisher","first-page":"1165","DOI":"10.21037\/gs.2020.03.26","article-title":"Does ethnicity matter in chemotherapy for breast cancer?","volume":"9","author":"Komorowski","year":"2020","journal-title":"Gland Surg"},{"key":"2026070605423023500_ref24","doi-asserted-by":"publisher","first-page":"268","DOI":"10.1016\/j.ejca.2008.10.031","article-title":"Lessons learned from independent central review","volume":"45","author":"Ford","year":"2009","journal-title":"Eur J Cancer"},{"key":"2026070605423023500_ref25","doi-asserted-by":"publisher","first-page":"810","DOI":"10.1002\/jcph.1790","article-title":"Local investigators significantly overestimate overall response rates compared to blinded independent central reviews in phase 2 oncology trials","volume":"61","author":"Dello Russo","year":"2021","journal-title":"J Clin Pharmacol"},{"key":"2026070605423023500_ref26","doi-asserted-by":"publisher","first-page":"19","DOI":"10.1093\/annonc\/mdp478","article-title":"Influence of an independent review committee on assessment of response rate and progression-free survival in phase III clinical trials","volume":"21","author":"Tang","year":"2010","journal-title":"Ann Oncol"},{"key":"2026070605423023500_ref27","doi-asserted-by":"publisher","first-page":"120","DOI":"10.1038\/tpj.2013.10","article-title":"Association of UGT1A1*28 polymorphisms with irinotecan-induced toxicities in colorectal cancer: a meta-analysis in Caucasians","volume":"14","author":"Liu","year":"2014","journal-title":"Pharmacogenomics J"}],"container-title":["Japanese Journal of Clinical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/jjco\/article-pdf\/56\/7\/816\/67514452\/hyag043.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/jjco\/article-pdf\/56\/7\/816\/67514452\/hyag043.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,6]],"date-time":"2026-07-06T09:42:37Z","timestamp":1783330957000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/jjco\/article\/56\/7\/816\/8540933"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,3,27]]},"references-count":27,"journal-issue":{"issue":"7","published-online":{"date-parts":[[2026,3,27]]},"published-print":{"date-parts":[[2026,7,6]]}},"URL":"https:\/\/doi.org\/10.1093\/jjco\/hyag043","relation":{},"ISSN":["1465-3621"],"issn-type":[{"value":"1465-3621","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2026,7]]},"published":{"date-parts":[[2026,3,27]]}}}