drugset
drugset / Trial / NCT04460807

Exemestane in Hormone Receptor Positive High Grade Ovarian Cancer

NCT04460807 ↗

Phase 3 Terminated 23 enrolled Ente Ospedaliero Ospedali Galliera Federation of Italian Cooperative Oncology Groups · collabFondazione Policlinico Universitario Agostino Gemelli IRCCS · collabIstituto Di Ricerche Farmacologiche Mario Negri · collab
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

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

Outcome

Outcome not reported

Stopped (Enrollment): “low accrual, COVID 19 emergency and the modification of the standard of care for ovarian cancer treatment”

Drugs

EvaluationDrugModalityDoseRoute
Subject Exemestane Small molecule 25 mg Oral

Indications

ovarian cancer