{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T04:16:36Z","timestamp":1792815396238,"version":"4.5.0"},"reference-count":28,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"12","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["J Clin Oncol"],"published-print":{"date-parts":[[2026,4,20]]},"abstract":"<jats:sec>\n                    <jats:title>PURPOSE<\/jats:title>\n                    <jats:p>Gedatolisib potently targets all four class I PI3K isoforms and mTORC1 and mTORC2 to comprehensively block the PI3K\/AKT\/mTOR pathway and has shown compelling activity in early clinical trials with palbociclib and fulvestrant.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>\n                      This phase III randomized trial (VIKTORIA-1; ClinicalTrials.gov identifier:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT05501886\">NCT05501886<\/jats:ext-link>\n                      ) evaluated the efficacy of gedatolisib-based therapy, comparing gedatolisib, palbociclib, and fulvestrant (gedatolisib triplet) and gedatolisib plus fulvestrant (gedatolisib doublet) with fulvestrant monotherapy in patients with hormone receptor\u2013positive, human epidermal growth factor receptor 2\u2013negative (HER2\u2212),\n                      <jats:italic toggle=\"yes\">PIK3CA<\/jats:italic>\n                      wild-type (WT) advanced breast cancer. Eligible patients had disease progression during or after CDK4\/6 inhibitor and aromatase inhibitor treatment. Comparison of progression-free survival as assessed by blinded independent central review for gedatolisib triplet versus fulvestrant and gedatolisib doublet versus fulvestrant was the primary objective.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>\n                      A total of 392 patients were randomly assigned 1:1:1. The median study follow-up was 10.1 months. The median progression-free survival was 9.3 months in the gedatolisib-triplet group, 2.0 months in the fulvestrant group (hazard ratio [HR] for progression or death, 0.24 [95% CI, 0.17 to 0.35];\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      &lt; .001), and 7.4 months in the gedatolisib-doublet group (HR, 0.33 [95% CI, 0.24 to 0.48];\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      &lt; .001\n                      <jats:italic toggle=\"yes\">v<\/jats:italic>\n                      fulvestrant). Grade \u22653 treatment-related adverse events (TRAEs) reported in the gedatolisib-triplet and gedatolisib-doublet groups, respectively, included neutropenia (62.3%, 0.8%), stomatitis (19.2%, 12.3%), rash (4.6%, 5.4%), hyperglycemia (2.3%, 2.3%), and diarrhea (1.5%, 0.8%). Study treatment discontinuation because of TRAEs was reported in 2.3% (triplet) and 3.1% (doublet) of patients.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>\n                      The addition of gedatolisib to fulvestrant, with or without palbociclib, significantly reduced the risk of disease progression or death in patients with hormone receptor\u2013positive\/HER2\u2212,\n                      <jats:italic toggle=\"yes\">PIK3CA<\/jats:italic>\n                      WT advanced breast cancer.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/jco-25-02643","type":"journal-article","created":{"date-parts":[[2026,3,9]],"date-time":"2026-03-09T20:59:20Z","timestamp":1773089960000},"page":"1108-1119","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":22,"title":["VIKTORIA-1 Trial of Gedatolisib Plus Fulvestrant With or Without Palbociclib in Hormone Receptor\u2013Positive\/HER2\u2212\/PIK3CA Wild-Type Advanced Breast Cancer"],"prefix":"10.1200","volume":"44","clinical-trial-number":[{"clinical-trial-number":"nct05501886","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7808-7191","authenticated-orcid":false,"given":"Sara A.","family":"Hurvitz","sequence":"first","affiliation":[{"name":"Fred Hutchinson Cancer Center, University of Washington, Seattle, WA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8663-0331","authenticated-orcid":false,"given":"Rachel M.","family":"Layman","sequence":"additional","affiliation":[{"name":"The University of Texas MD Anderson Cancer Center, Houston, 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