prevention in patients with high risk for breast cancer
Conditions
Interventions
Product Name: 4-hydroxyphenylretinamide 4-HPR
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: retinamide
CAS Number: 65646-68-6
Concentration unit: mg milligram(s)
Concentration type: equal
C
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed