Trial of Letrozole + Palbociclib/Placebo in Metastatic Endometrial Cancer

Endometrial Cancer Clinical Trial

Official title: 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

Clinical Trial 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

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

• NCT number: NCT02730429
• Study type: Interventional
• Source: Nordic Society of Gynaecological Oncology - Clinical Trials Unit
• Status: Completed
• Phase: Phase 2
• Start date: February 15, 2017
• Completion date: December 15, 2021