Fenretinide in Healthy Young Women at Genetic and Familial Risk

• Status: Terminated
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: Female

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/genetic risk for breast cancer

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Institute of Oncology
• Treatments: Fenretinide

Criteria

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