Fenretinide in Healthy Young Women at Genetic and Familial Risk
This study is currently recruiting participants.
Verified September 2012 by European Institute of Oncology
Sponsor:
European Institute of Oncology
Information provided by (Responsible Party):
European Institute of Oncology
ClinicalTrials.gov Identifier:
NCT01479192
First received: November 22, 2011
Last updated: September 10, 2012
Last verified: September 2012
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
High-Risk Cancer |
Drug: Fenretinide Other: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Breast Cancer Prevention With Fenretinide in Young Women at Genetic and Familil Risk. A Phase III Randomized Clinical Trial |
Resource links provided by NLM:
Further study details as provided by European Institute of Oncology:
Primary Outcome Measures:
- Breast cancer incidence [ Time Frame: every 6 months for 15 years ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Incidence of other non-invasive breast disorders, ovarian cancers and other cancers. [ Time Frame: every 6 months for 15 years ] [ Designated as safety issue: No ]
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.
| Estimated Enrollment: | 764 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | December 2024 |
| Estimated Primary Completion Date: | December 2024 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Fenretinide
100mg: 2cps/day for 5 years followed by
|
Drug: Fenretinide
100mg (2cps/day) for 5 years
|
|
Placebo Comparator: Placebo
matched placebo 2 cps/day for 5 years
|
Other: Placebo
2 cpr/day of matched placebo for 5 years
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 20 Years to 46 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 20-46 years old women with a known BRCA ½ mutation or with a risk of being a mutation carrier ≥20%.
- Performance status =0
- Willingness to avoid pregnancy during treatment and 12 months after drug cessation
- No clinical and radiological evidence of breast cancer and ovarian disease
- Signed informed consent
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
- Genetic test result (BRCA)=true negative
- Blood test alterations (grade ≥2 based on the NCI Common Toxicity Criteria)
- 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)
- Severe psychiatric disorders or inability to comply to the protocol procedures
- Any other factor that, at the investigator's discretion, contraindicates the use of fenretinide
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01479192
Contacts
| Contact: Umberto veronesi | Umberto.Veronesi@ieo.it | |
| Contact: Bernardo Bonanni | Bernardo.Bonanni@ieo.it |
Locations
| Italy | |
| European Institute of Oncology | Recruiting |
| Milan, Italy | |
| Contact: Umberto Veronesi Umberto.Veronesi@ieo.it | |
| Contact: Bernardo Bonani Bernardo.Bonanni@ieo.it | |
| Principal Investigator: Umberto Veronesi | |
Sponsors and Collaborators
European Institute of Oncology
Investigators
| Study Chair: | Umberto Veronesi | European Institute of Oncology |
More Information
No publications provided
| Responsible Party: | European Institute of Oncology |
| ClinicalTrials.gov Identifier: | NCT01479192 History of Changes |
| Other Study ID Numbers: | IEO S462/109, 2009-010260-41 |
| Study First Received: | November 22, 2011 |
| Last Updated: | September 10, 2012 |
| Health Authority: | Italy: The Italian Medicines Agency |
Keywords provided by European Institute of Oncology:
|
breast cancer prevention fenretinide |
Additional relevant MeSH terms:
|
Fenretinide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Anticarcinogenic Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013