Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:39 PM
Ignite Modification Date:
2025-12-24 @ 3:39 PM
NCT ID:
NCT01479192
Eligibility 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
46 Years
Study:
NCT01479192
Study Brief:
Protocol Section:
NCT01479192