Fenretinide in Healthy Young Women at Genetic and Familial Risk
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|ClinicalTrials.gov Identifier: NCT01479192|
Recruitment Status : Terminated (very low rate of patient accrual)
First Posted : November 24, 2011
Last Update Posted : January 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|High-Risk Cancer||Drug: Fenretinide Other: Placebo||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Breast Cancer Prevention With Fenretinide in Young Women at Genetic and Familil Risk. A Phase III Randomized Clinical Trial|
|Study Start Date :||December 2009|
|Estimated Primary Completion Date :||December 2024|
|Estimated Study Completion Date :||December 2024|
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
- Breast cancer incidence [ Time Frame: every 6 months for 15 years ]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 ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01479192
|European Institute of Oncology|
|Study Chair:||Umberto Veronesi||European Institute of Oncology|