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Exemestane in Hormone Receptor Positive High Grade Ovarian Cancer

NCT04460807 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2024-02-12

No results posted yet for this study

Summary

In this Italian, multicenter, randomized, double-blind, placebo controlled, phase III study the efficacy of exemestane will be evaluated in addition to the standard front line treatment in patients with hormone-receptor-positive high grade serous or endometrioid Epithelian Ovarian Cancer (EOC). The patients enrolled in the EXPERT trial will receive exemestane or placebo in addition to standard treatment. Patients and investigators will be blinded to study treatment.

The hypothesis underlying the proposed clinical trial is that exemestane added to standard first line therapy will significantly prolong median progression free survival (PFS).

Conditions

Interventions

DRUG

Exemestane

Exemestane in addition to standard therapy, in Experimental arm.

OTHER

Placebo oral tablet

Placebo in addition to standard therapy, in Control arm.

Sponsors & Collaborators

  • Istituto Di Ricerche Farmacologiche Mario Negri

    collaborator OTHER

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    collaborator OTHER

  • Federation of Italian Cooperative Oncology Groups

    collaborator OTHER

  • Ente Ospedaliero Ospedali Galliera

    lead OTHER

Principal Investigators

  • Andrea DeCensi · E.O. Ospedali Galliera Genova

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-13
Primary Completion
2023-04-27
Completion
2023-04-27

Countries

  • Italy

Study Locations

More Related Trials

Entities

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 NCT04460807 on ClinicalTrials.gov