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Trial of Letrozole + Palbociclib/Placebo in Metastatic Endometrial Cancer

NCT02730429 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2025-07-31

No results posted yet for this study

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

Conditions

Interventions

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

Sponsors & Collaborators

  • European Network of Gynaecological Oncological Trial Groups (ENGOT)

    collaborator OTHER

  • Gynecologic Cancer Intergroup (GCIG)

    collaborator OTHER

  • North Eastern German Society of Gynaecological Oncology

    collaborator OTHER

  • Multicenter Italian Trials in Ovarian cancer and gynecologic malignancies (MITO)

    collaborator UNKNOWN

  • Grupo Español de Investigación en Cáncer de Ovario

    collaborator OTHER

  • Nordic Society of Gynaecological Oncology - Clinical Trials Unit

    lead OTHER

Principal Investigators

  • Mansoor R Mirza, MD · NSGO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-15
Primary Completion
2020-12-15
Completion
2021-12-15

Countries

  • Denmark

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02730429 on ClinicalTrials.gov