NCT02730429

Trial of Letrozole + Palbociclib/Placebo in Metastatic Endometrial Cancer

ENGOT-EN3-NSGO/PALEO: A Randomized, Double-blind, Placebo-controlled, Phase II Trial of Palbociclib in Combination With Letrozole Versus Placebo in Combination With Letrozole for Patients With Estrogen Receptor Positive Advanced or Recurrent Endometrial Cancer.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Nordic Society of Gynaecological Oncology - Clinical Trials Unit · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized double-blind, placebo-controlled phase 2 trial is evaluating superiority of Letrozole-palbociclib combination versus letrozole-placebo combination in ER positive endometrioid adenocarcinoma of endometrium

Detailed description

This multicenter, prospective, randomized, double-blind, placebo-controlled phase 2 study is evaluating the efficacy of letrozole-palbociclib combination against letrozole-placebo combination in women with ER+ advanced or relapsed endometrial cancer. Stratification Patients are stratified according to: 1. Number of prior lines of therapy (primary advanced disease vs. 1st relapse vs. ≥2 relapses) 2. Measurable vs. evaluable disease 3. Prior use of MPA/Megace Randomization 1:1 randomization The patients with prior MPA/Megace treatment will be capped to a maximum of 50%. Study arms Patients are randomized to one of the two treatment arms: * Arm A: (comparator) letrozole-placebo combination therapy until progression. * Arm B: (experimental arm): Letrozole- palbociclib combination therapy until progression

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	Palbociclib/placebo	Palbociclib or a placebo is administered together with standard of care letrozole
DRUG	Letrozole	Letrozole is standard of care in both arms

Timeline

• Start date: 2017-02-15
• Primary completion: 2020-12-15
• Completion: 2021-12-15
• First posted: 2016-04-06
• Last updated: 2025-07-31

Locations

1 site across 1 country: Denmark