Clinical trial · Interventional
Fenretinide in Healthy Young Women at Genetic and Familial Risk
Breast Cancer Prevention With Fenretinide in Young Women at Genetic and Familil Risk. A Phase III Randomized Clinical Trial
NCT01479192CI-TRIAL-00035682terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): very low rate of patient accrual
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High-Risk Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fenretinide | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fenretinide
- description
- 100mg: 2cps/day for 5 years followed by
- interventionNames
- Drug: Fenretinide
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- matched placebo 2 cps/day for 5 years
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Breast cancer incidence
- timeFrame
- every 6 months for 15 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 46 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.