FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W4379285846> ?p ?o ?g. }

• W4379285846 endingPage "TPS1118" @default.
• W4379285846 startingPage "TPS1118" @default.
• W4379285846 abstract "TPS1118 Background: Patients who receive frontline CDK4/6 inhibitor (CDK4/6i) therapy eventually experience disease progression. Resistance to CDK4/6i is likely a transient adaptive mechanism that may be reversed by inhibition of the PI3K/mTOR pathway. Thus, combination of CDK4/6i and PI3K/mTORi after disease progression on CDK4/6i could restore sensitivity to CDK4/6i and prevent activation of the PI3K/mTOR pathway. This hypothesis was evaluated in a Phase 1b study (Layman SABCS 2021) of gedatolisib (geda), a potent inhibitor of PI3K and mTOR. Subjects with HR+/HER2- ABC with prior CDK4/6i received geda (180 mg IV weekly for 3 weeks, then one week off) with palbociclib (palbo) and fulvestrant (FUL). Median PFS was 12.9 months with 63% overall response rate. Efficacy was observed regardless of PIK3CA mutation status (Wesolowski SABCS 2022). Geda was well tolerated, with few discontinuations due to treatment-related adverse events (4%). The most common AE was stomatitis; hyperglycemia of any grade occurred in 26% of patients. This preliminary data, dosing schedule, and study population characteristics form the basis for the Phase 3 trial, VIKTORIA-1 (NCT05501886). Methods: This Phase 3 multinational clinical trial will evaluate geda and FULwith or without palboin patients with HR+/HER2- ABC previously treated with any CDK4/6i in combination with a non-steroidal aromatase inhibitor (AI) therapy. Those without tumor PIK3CA mutations will be assigned to Study 1 (n=351) and randomized to Arm A (geda, palbo, and FUL), Arm B (geda and FUL), or Arm C (FUL). Those with PIK3CA mutations will be assigned to Study 2 (n=350) and randomized to Arm D (geda, palbo, and FUL), Arm E (alpelisib and FUL), or Arm F (geda and FUL). Key eligibility criteria include adults with confirmed metastatic or locally advanced breast cancer, any menopausal status, radiologically evaluable disease, and prior CDK4/6i treatment in combination with a non-steroidal AI. Prior hormonal therapy, including SERDs, is allowed. Key exclusion criteria include prior treatment with a PI3K, Akt, or mTOR inhibitor, prior treatment with chemotherapy for advanced disease, more than two lines of prior endocrine therapy, bone only disease with no soft tissue components, active CNS metastases, and type 1 diabetes or uncontrolled type 2 diabetes. The primary endpoint is PFS assessed by blinded independent central review per RECIST v1.1. Secondary endpoints included overall survival, safety and tolerability, ORR, duration of response, time to response, CBR, quality of life, and pharmacokinetics. The trial is open for enrollment. Clinical trial information: NCT05501886 ." @default.
• W4379285846 created "2023-06-05" @default.
• W4379285846 creator A5003897511 @default.
• W4379285846 creator A5009030272 @default.
• W4379285846 creator A5012367014 @default.
• W4379285846 creator A5022517601 @default.
• W4379285846 creator A5030653735 @default.
• W4379285846 creator A5032987754 @default.
• W4379285846 creator A5035054317 @default.
• W4379285846 creator A5037212641 @default.
• W4379285846 creator A5059240684 @default.
• W4379285846 creator A5065548608 @default.
• W4379285846 creator A5068059897 @default.
• W4379285846 creator A5076028497 @default.
• W4379285846 creator A5090188675 @default.
• W4379285846 creator A5091169382 @default.
• W4379285846 date "2023-06-01" @default.
• W4379285846 modified "2023-09-26" @default.
• W4379285846 title "A phase 3 study of gedatolisib plus fulvestrant with and without palbociclib in patients with HR+/ HER2- advanced breast cancer previously treated with a CDK4/6 inhibitor plus a nonsteroidal aromatase inhibitor (VIKTORIA-1)." @default.
• W4379285846 doi "https://doi.org/10.1200/jco.2023.41.16_suppl.tps1118" @default.
• W4379285846 hasPublicationYear "2023" @default.
• W4379285846 type Work @default.
• W4379285846 citedByCount "0" @default.
• W4379285846 crossrefType "journal-article" @default.
• W4379285846 hasAuthorship W4379285846A5003897511 @default.
• W4379285846 hasAuthorship W4379285846A5009030272 @default.
• W4379285846 hasAuthorship W4379285846A5012367014 @default.
• W4379285846 hasAuthorship W4379285846A5022517601 @default.
• W4379285846 hasAuthorship W4379285846A5030653735 @default.
• W4379285846 hasAuthorship W4379285846A5032987754 @default.
• W4379285846 hasAuthorship W4379285846A5035054317 @default.
• W4379285846 hasAuthorship W4379285846A5037212641 @default.
• W4379285846 hasAuthorship W4379285846A5059240684 @default.
• W4379285846 hasAuthorship W4379285846A5065548608 @default.
• W4379285846 hasAuthorship W4379285846A5068059897 @default.
• W4379285846 hasAuthorship W4379285846A5076028497 @default.
• W4379285846 hasAuthorship W4379285846A5090188675 @default.
• W4379285846 hasAuthorship W4379285846A5091169382 @default.
• W4379285846 hasConcept C121608353 @default.
• W4379285846 hasConcept C126322002 @default.
• W4379285846 hasConcept C143998085 @default.
• W4379285846 hasConcept C185592680 @default.
• W4379285846 hasConcept C190283241 @default.
• W4379285846 hasConcept C197934379 @default.
• W4379285846 hasConcept C2775930923 @default.
• W4379285846 hasConcept C2777176818 @default.
• W4379285846 hasConcept C2778504769 @default.
• W4379285846 hasConcept C2779744173 @default.
• W4379285846 hasConcept C2780482068 @default.
• W4379285846 hasConcept C530470458 @default.
• W4379285846 hasConcept C55493867 @default.
• W4379285846 hasConcept C71924100 @default.
• W4379285846 hasConcept C86554907 @default.
• W4379285846 hasConcept C98274493 @default.
• W4379285846 hasConceptScore W4379285846C121608353 @default.
• W4379285846 hasConceptScore W4379285846C126322002 @default.
• W4379285846 hasConceptScore W4379285846C143998085 @default.
• W4379285846 hasConceptScore W4379285846C185592680 @default.
• W4379285846 hasConceptScore W4379285846C190283241 @default.
• W4379285846 hasConceptScore W4379285846C197934379 @default.
• W4379285846 hasConceptScore W4379285846C2775930923 @default.
• W4379285846 hasConceptScore W4379285846C2777176818 @default.
• W4379285846 hasConceptScore W4379285846C2778504769 @default.
• W4379285846 hasConceptScore W4379285846C2779744173 @default.
• W4379285846 hasConceptScore W4379285846C2780482068 @default.
• W4379285846 hasConceptScore W4379285846C530470458 @default.
• W4379285846 hasConceptScore W4379285846C55493867 @default.
• W4379285846 hasConceptScore W4379285846C71924100 @default.
• W4379285846 hasConceptScore W4379285846C86554907 @default.
• W4379285846 hasConceptScore W4379285846C98274493 @default.
• W4379285846 hasIssue "16_suppl" @default.
• W4379285846 hasLocation W43792858461 @default.
• W4379285846 hasOpenAccess W4379285846 @default.
• W4379285846 hasPrimaryLocation W43792858461 @default.
• W4379285846 hasRelatedWork W2292433415 @default.
• W4379285846 hasRelatedWork W2762467781 @default.
• W4379285846 hasRelatedWork W2790660600 @default.
• W4379285846 hasRelatedWork W2804365213 @default.
• W4379285846 hasRelatedWork W2915354113 @default.
• W4379285846 hasRelatedWork W2931385471 @default.
• W4379285846 hasRelatedWork W2972634993 @default.
• W4379285846 hasRelatedWork W3203690439 @default.
• W4379285846 hasRelatedWork W4226356606 @default.
• W4379285846 hasRelatedWork W4297984276 @default.
• W4379285846 hasVolume "41" @default.
• W4379285846 isParatext "false" @default.
• W4379285846 isRetracted "false" @default.
• W4379285846 workType "article" @default.