Status:
TERMINATED
Fenretinide in Healthy Young Women at Genetic and Familial Risk
Lead Sponsor:
European Institute of Oncology
Conditions:
High-Risk Cancer
Eligibility:
FEMALE
20-46 years
Phase:
PHASE3
Brief 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/geneti...
Detailed Description
Retinoids have been studied as chemo preventive compounds in clinical trials because of their acknowledged role in regulating cell growth, differentiation and apoptosis in preclinical models. Inductio...
Eligibility Criteria
Inclusion
- 20-46 years old women with a known BRCA ½ mutation or with a risk of being a mutation carrier ≥20%.
- Performance status =0
- Willingness to avoid pregnancy during treatment and 12 months after drug cessation
- No clinical and radiological evidence of breast cancer and ovarian disease
- Signed informed consent
Exclusion
- History of breast cancer or any other malignancy with the exclusion of CIN and non-melanoma skin cancer
- Child bearing or breast feeding
- Genetic test result (BRCA)=true negative
- Blood test alterations (grade ≥2 based on the NCI Common Toxicity Criteria)
- Previous or concurrent use of SERMs, e.g. tamoxifen (for more than 12 months; if less, a two-months wash-out is required before entering the study)
- Severe psychiatric disorders or inability to comply to the protocol procedures
- Any other factor that, at the investigator's discretion, contraindicates the use of fenretinide
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01479192
Start Date
December 1 2009
End Date
December 1 2015
Last Update
November 7 2018
Active Locations (1)
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1
European Institute of Oncology
Milan, Italy