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Fenretinide in Healthy Young Women at Genetic and Familial Risk

NCT01479192 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-11-07

No results posted yet for this study

Summary

The purpose of this trial is to assess the effect of fenretinide (4-HPR), a vitamin A derivative, in reducing the incidence of breast cancer in healthy premenopausal women at increased familial/genetic risk for breast cancer

Conditions

  • High-Risk Cancer

Interventions

DRUG

Fenretinide

100mg (2cps/day) for 5 years

OTHER

Placebo

2 cpr/day of matched placebo for 5 years

Sponsors & Collaborators

  • European Institute of Oncology

    lead OTHER

Principal Investigators

  • Umberto Veronesi · European Institute of Oncology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
46 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Italy

Study Locations

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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 NCT01479192 on ClinicalTrials.gov