High-Risk Cancer Clinical Trial
Official title:
Breast Cancer Prevention With Fenretinide in Young Women at Genetic and Familil Risk. A Phase III Randomized Clinical Trial
Verified date | December 2015 |
Source | European Institute of Oncology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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/genetic risk for breast cancer
Status | Terminated |
Enrollment | 20 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 46 Years |
Eligibility |
Inclusion Criteria: 1. 20-46 years old women with a known BRCA ½ mutation or with a risk of being a mutation carrier =20%. 2. Performance status =0 3. Willingness to avoid pregnancy during treatment and 12 months after drug cessation 4. No clinical and radiological evidence of breast cancer and ovarian disease 5. Signed informed consent Exclusion Criteria: 1. History of breast cancer or any other malignancy with the exclusion of CIN and non-melanoma skin cancer 2. Child bearing or breast feeding 3. Genetic test result (BRCA)=true negative 4. Blood test alterations (grade =2 based on the NCI Common Toxicity Criteria) 5. 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) 6. Severe psychiatric disorders or inability to comply to the protocol procedures 7. Any other factor that, at the investigator's discretion, contraindicates the use of fenretinide |
Country | Name | City | State |
---|---|---|---|
Italy | European Institute of Oncology | Milan |
Lead Sponsor | Collaborator |
---|---|
European Institute of Oncology |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Breast cancer incidence | 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. | every 6 months for 15 years | |
Secondary | Incidence of other non-invasive breast disorders, ovarian cancers and other cancers. | 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. |
every 6 months for 15 years |
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