Fenretinide in Healthy Young Women at Genetic and Familial Risk

NCT01479192 | Terminated Phase 3

• 2 other identifiers: IEO S462/1092009-010260-41
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

High-Risk Cancer

Keywords

breast; cancer; prevention; fenretinide

Outcome Measures

Primary Outcomes (1)

• Breast cancer incidence

  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.

  every 6 months for 15 years

Secondary Outcomes (1)

• Incidence of other non-invasive breast disorders, ovarian cancers and other cancers.

  every 6 months for 15 years

Study Arms (2)

Fenretinide

EXPERIMENTAL

100mg: 2cps/day for 5 years followed by

Drug: Fenretinide

Placebo

PLACEBO COMPARATOR

matched placebo 2 cps/day for 5 years

Other: Placebo

Interventions

Fenretinide DRUG

100mg (2cps/day) for 5 years

Fenretinide

Placebo OTHER

2 cpr/day of matched placebo for 5 years

Placebo

Eligibility Criteria

• Age: 20 Years - 46 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, Italy

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Fenretinide

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Umberto Veronesi

  European Institute of Oncology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: November 24, 2011
• Study Start: December 1, 2009
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 7, 2018

Record last verified: 2015-12

Locations

IT (1)