Breast cancer prevention with fenretinide in young women at genetic and familial risk. A phase III randomized clinical trial - ND
- Conditions
- prevention in patients with high risk for breast cancer
- Registration Number
- EUCTR2009-010260-41-IT
- Lead Sponsor
- ISTITUTO EUROPEO DI ONCOLOGIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
women 25-44 years old with a known BRCA1/2 mutation or with a risk of being a mutation carrier ≥ 20% (BRCAPRO program), performance status=0, avoid pregnancy during treatment and for 12 months after drug cessation, no clinical and radiological evidence of breast and ovarian cancer, signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
History of breast cancer or any other malignancy with the exclusion of CIN and non- melanoma skin cancer, child bearing or breast feeding, previous or current use of SERMs for more than 12 months; if less a two-months wash-out is requested before entering the study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Assessment of the efficacy of fenretinide (4-HPR), a vitamin A derivate, in reducing the incidence of breast cancer in healthy young premenopausal women at increased familial/genetic risk;Secondary Objective: incidence of other non- invasive breast cancers (intralobular neoplasia, atypical hyperplasia), ovarian cancer and other cancers;Primary end point(s): invasive breast cancer and ductal intraepithelial neoplasia
- Secondary Outcome Measures
Name Time Method