Matches in SemOpenAlex for { <https://semopenalex.org/work/W2891432330> ?p ?o ?g. }
Showing items 1 to 84 of
84
with 100 items per page.
- W2891432330 abstract "TPS5612 Background: Endometrial cancer (EC) patients with advanced or recurrent disease and endometrioid histology have a short progression-free survival (PFS). These malignancies are hormone dependent and endocrine therapy with aromatase inhibitors is well established. Palbociclib is an oral and selective inhibitor of cyclin-dependent kinases CDK4 and CDK6. Studies in breast cancer have demonstrated superiority of letrozole treatment in combination with palbociclib vs. letrozole monotherapy in oestrogen receptor positive (ER+) HER2- advanced disease. The combination is generally well tolerated with an acceptable toxicity profile. This multicenter, prospective, double-blind, placebo-controlled, randomized, phase II trial is evaluating the efficacy of letrozole when combined with palbociclib against letrozole-placebo combination therapy in women with ER+ advanced or recurrent EC. Methods: The primary objective of this trial is to demonstrate superiority of palbociclib against placebo in combination with letrozole, as defined by investigator-assessed progression-free survival (PFS). Key eligibility criteria include: histologically confirmed ER+ EC of endometrioid type; stage 4 or recurrent disease; prior surgery, adjuvant chemotherapy, radiation therapy, hormonal therapy (e.g. megestrol acetate) is permitted; measurable/evaluable disease according to RECIST 1.1. 78 patients will be randomized 1:1 to receive palbociclib 125mg daily or placebo on days 1-21 and letrozole 2.5mg daily on days 1-28 in a 28 days cycle until disease progression, unacceptable toxicity, or withdrawal. Secondary endpoints include PFS in sub-populations, overall response rate, disease control rate, PFS2, time to first subsequent therapy, time to second subsequent therapy, overall survival, safety & tolerability, patient reported outcomes (assessed via EORTC QLQ-C30 and EORTC QLQ-EN24) and PFS in patients with or without retinoblastoma protein-expressing tumors. The following cooperative groups are participating: NSGO (DK, FIN, NOR), MITO (ITA), GEICO (SPA) & NOGGO (GER). Clinical trial information: NCT02730429." @default.
- W2891432330 created "2018-09-27" @default.
- W2891432330 creator A5002555374 @default.
- W2891432330 creator A5004936382 @default.
- W2891432330 creator A5005455563 @default.
- W2891432330 creator A5005578310 @default.
- W2891432330 creator A5007674739 @default.
- W2891432330 creator A5011353416 @default.
- W2891432330 creator A5012666639 @default.
- W2891432330 creator A5019754075 @default.
- W2891432330 creator A5029127743 @default.
- W2891432330 creator A5040656664 @default.
- W2891432330 creator A5046771682 @default.
- W2891432330 creator A5061129999 @default.
- W2891432330 creator A5061939825 @default.
- W2891432330 creator A5067234296 @default.
- W2891432330 creator A5069482220 @default.
- W2891432330 creator A5073578749 @default.
- W2891432330 creator A5079485962 @default.
- W2891432330 creator A5083659627 @default.
- W2891432330 creator A5085757871 @default.
- W2891432330 date "2017-05-20" @default.
- W2891432330 modified "2023-10-08" @default.
- W2891432330 title "Palbociclib versus placebo in combination with letrozole for patients with advanced or recurrent endometrial cancer: The NSGO ENGOT-EN3/PALEO trial." @default.
- W2891432330 doi "https://doi.org/10.1200/jco.2017.35.15_suppl.tps5612" @default.
- W2891432330 hasPublicationYear "2017" @default.
- W2891432330 type Work @default.
- W2891432330 sameAs 2891432330 @default.
- W2891432330 citedByCount "0" @default.
- W2891432330 crossrefType "journal-article" @default.
- W2891432330 hasAuthorship W2891432330A5002555374 @default.
- W2891432330 hasAuthorship W2891432330A5004936382 @default.
- W2891432330 hasAuthorship W2891432330A5005455563 @default.
- W2891432330 hasAuthorship W2891432330A5005578310 @default.
- W2891432330 hasAuthorship W2891432330A5007674739 @default.
- W2891432330 hasAuthorship W2891432330A5011353416 @default.
- W2891432330 hasAuthorship W2891432330A5012666639 @default.
- W2891432330 hasAuthorship W2891432330A5019754075 @default.
- W2891432330 hasAuthorship W2891432330A5029127743 @default.
- W2891432330 hasAuthorship W2891432330A5040656664 @default.
- W2891432330 hasAuthorship W2891432330A5046771682 @default.
- W2891432330 hasAuthorship W2891432330A5061129999 @default.
- W2891432330 hasAuthorship W2891432330A5061939825 @default.
- W2891432330 hasAuthorship W2891432330A5067234296 @default.
- W2891432330 hasAuthorship W2891432330A5069482220 @default.
- W2891432330 hasAuthorship W2891432330A5073578749 @default.
- W2891432330 hasAuthorship W2891432330A5079485962 @default.
- W2891432330 hasAuthorship W2891432330A5083659627 @default.
- W2891432330 hasAuthorship W2891432330A5085757871 @default.
- W2891432330 hasConcept C121608353 @default.
- W2891432330 hasConcept C126322002 @default.
- W2891432330 hasConcept C142724271 @default.
- W2891432330 hasConcept C143998085 @default.
- W2891432330 hasConcept C204787440 @default.
- W2891432330 hasConcept C27081682 @default.
- W2891432330 hasConcept C2775930923 @default.
- W2891432330 hasConcept C2777088508 @default.
- W2891432330 hasConcept C2777176818 @default.
- W2891432330 hasConcept C2778812593 @default.
- W2891432330 hasConcept C2779744173 @default.
- W2891432330 hasConcept C29456083 @default.
- W2891432330 hasConcept C530470458 @default.
- W2891432330 hasConcept C71924100 @default.
- W2891432330 hasConceptScore W2891432330C121608353 @default.
- W2891432330 hasConceptScore W2891432330C126322002 @default.
- W2891432330 hasConceptScore W2891432330C142724271 @default.
- W2891432330 hasConceptScore W2891432330C143998085 @default.
- W2891432330 hasConceptScore W2891432330C204787440 @default.
- W2891432330 hasConceptScore W2891432330C27081682 @default.
- W2891432330 hasConceptScore W2891432330C2775930923 @default.
- W2891432330 hasConceptScore W2891432330C2777088508 @default.
- W2891432330 hasConceptScore W2891432330C2777176818 @default.
- W2891432330 hasConceptScore W2891432330C2778812593 @default.
- W2891432330 hasConceptScore W2891432330C2779744173 @default.
- W2891432330 hasConceptScore W2891432330C29456083 @default.
- W2891432330 hasConceptScore W2891432330C530470458 @default.
- W2891432330 hasConceptScore W2891432330C71924100 @default.
- W2891432330 hasLocation W28914323301 @default.
- W2891432330 hasOpenAccess W2891432330 @default.
- W2891432330 hasPrimaryLocation W28914323301 @default.
- W2891432330 isParatext "false" @default.
- W2891432330 isRetracted "false" @default.
- W2891432330 magId "2891432330" @default.
- W2891432330 workType "article" @default.