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:
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
  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:

  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
  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 April 22, 2014