Fenretinide in Healthy Young Women at Genetic and Familial Risk
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||Breast Cancer Prevention With Fenretinide in Young Women at Genetic and Familil Risk. A Phase III Randomized Clinical Trial|
- Breast cancer incidence [ Time Frame: every 6 months for 15 years ] [ Designated as safety issue: No ]The aim of the proposed trial is to assess the efficacy of fenretinide, (4 hydroxyphenilretinamide, 4-HPR), a vitamin A derivative, in reducing the incidence of breast cancer (BC) in healthy young premenopausal women at increased familial/genetic risk for BC (i.e. BRCA1 or BRCA2 mutation carriers or subjects at high risk of being carriers). The primary endpoint is the incidence of invasive BC and ductal intraepithelial neoplasia (DIN), histologically diagnosed.
- Incidence of other non-invasive breast disorders, ovarian cancers and other cancers. [ Time Frame: every 6 months for 15 years ] [ Designated as safety issue: No ]
Incidence of other non-invasive breast disorders, ovarian cancers and other cancers.
Early intermediate biomarkers of efficacy after 12, 36, and 60 months of treatment. We will also evaluate the percent change in circulating biomarkers of the IGF system, androgens, retinol binding protein (RBP-4), insulin, blood glucose and VEGF, after 12, 36 and 60 months of treatment.
|Study Start Date:||December 2009|
|Estimated Study Completion Date:||December 2024|
|Estimated Primary Completion Date:||December 2024 (Final data collection date for primary outcome measure)|
100mg: 2cps/day for 5 years followed by
100mg (2cps/day) for 5 years
Placebo Comparator: Placebo
matched placebo 2 cps/day for 5 years
2 cpr/day of matched placebo for 5 years
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01479192
|European Institute of Oncology|
|Study Chair:||Umberto Veronesi||European Institute of Oncology|