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

NCT04385433 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-08-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

EXPERIMENTAL ARM

Patients in the experimental arm will receive: * Daily pravastatin (40mg/d) during 12 months (pravastatin initiation: first day of radiotherapy). * Standard adjuvant whole breast radiotherapy (50Gy/ 25 fractions to whole breast) followed or not by a boost to tumor bed (16Gy/ 8 fractions).

OTHER

CONTROL GROUP

Patients in the standard arm will receive: * Daily placebo during 12 months (placebo initiation: first day of radiotherapy) * Standard adjuvant whole breast radiotherapy (50Gy/ 25 fractions to whole breast) followed or not by a boost to tumor bed (16Gy/ 8 fractions).

RADIATION

Standard adjuvant whole breast radiotherapy (50Gy/ 25 fractions to whole breast) followed or not by a boost to tumor bed (16Gy/ 8 fractions)

Radiotherapy will last 5 weeks during treatment by Pravastatine or Placebo

Sponsors & Collaborators

  • Institut du Cancer de Montpellier - Val d'Aurelle

    lead OTHER

Principal Investigators

  • Céline Bourgier, MD · ICM Co. Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • France
  • Monaco

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 NCT04385433 on ClinicalTrials.gov