drugset / Trial / NCT04385433

A Comparative Study of Pravastatin vs Placebo as Primary Prevention of Severe Subcutaneous Breast Fibrosis in Hyper-radiosensitive Identified Patients With Breast Cancer

NCT04385433

Phase 3 Terminated 15 enrolled Institut du Cancer de Montpellier - Val d'Aurelle
RandomizedParallel-groupDouble-blindTreatment

Summary

-Interventional trials aim at preventing severe RIF occurrence in BC patients selected by individual radiosensitivity: PRAVAPREV-01 will be the first interventional double blind trial that will offer a personalised strategy to breast cancer patients who will be treated with adjuvant RT after breast conserving surgery: * By assessing individual risk of severe RIF development * By offering a statin targeted therapy to the high-risk patients identified.

Timeline

Start
2020-12-04
Primary completion
2023-04-27
Completion
2023-04-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Pravastatin Small molecule 40 mg

Indications