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Fenretinide in Healthy Young Women at Genetic and Familial Risk

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ClinicalTrials.gov Identifier: NCT01479192
Recruitment Status : Terminated (very low rate of patient accrual)
First Posted : November 24, 2011
Last Update Posted : January 22, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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

Condition or disease Intervention/treatment Phase
High-Risk Cancer Drug: Fenretinide Other: Placebo Phase 3

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : December 2009
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Breast cancer incidence [ Time Frame: every 6 months for 15 years ]
    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 :
  1. Incidence of other non-invasive breast disorders, ovarian cancers and other cancers. [ Time Frame: every 6 months for 15 years ]

    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.



Eligibility Criteria

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Ages Eligible for Study:   20 Years to 46 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01479192


Locations
Italy
European Institute of Oncology
Milan, Italy
Sponsors and Collaborators
European Institute of Oncology
Investigators
Study Chair: Umberto Veronesi European Institute of Oncology
More Information

Responsible Party: European Institute of Oncology
ClinicalTrials.gov Identifier: NCT01479192     History of Changes
Other Study ID Numbers: IEO S462/109
2009-010260-41 ( EudraCT Number )
First Posted: November 24, 2011    Key Record Dates
Last Update Posted: January 22, 2016
Last Verified: December 2015

Keywords provided by European Institute of Oncology:
breast
cancer
prevention
fenretinide