title: Chemoprevention trial of contralateral breast cancer with fenretinide. Rationale, design, methodology, organization, data management, statistics and accrual.
abstract: The Fenretinide (4-HPR) Breast Cancer Study is a randomized multicenter clinical trial originally designed and conducted by the investigators of the Istituto Nazionale Tumori of Milan. The study is sponsored by the National Cancer Institute of Bethesda and by the Italian National Research Council. The trial was designed to evaluate the effectiveness of the synthetic retinoid 4-HPR, at a dose of 200 mg per os every day for 5 years, in reducing the incidence of contralateral breast cancer in a population of patients previously operated on for breast cancer. Between 1987 and 1993, the Istituto Nazionale Tumori of Milan and 9 other collaborating Centers enrolled 2,972 women between the ages of 30 and 70 years who had been previously operated on for T1-T2 N- M0 breast cancer. This paper describes the rationale, design, methodology, organization, data management, statistics and accrual of the participating population.
authors.affiliation: Istituto Nazionale Tumori, University of Milan, Italy.
authors.forename: G
authors.initials: G
authors.lastname: De Palo
authors.forename: T
authors.initials: T
authors.lastname: Camerini
authors.forename: E
authors.initials: E
authors.lastname: Marubini
authors.forename: A
authors.initials: A
authors.lastname: Costa
authors.forename: F
authors.initials: F
authors.lastname: Formelli
authors.forename: M
authors.initials: M
authors.lastname: Del Vecchio
authors.forename: L
authors.initials: L
authors.lastname: Mariani
authors.forename: R
authors.initials: R
authors.lastname: Miceli
authors.forename: G
authors.initials: G
authors.lastname: Mascotti
authors.forename: A
authors.initials: A
authors.lastname: Magni
authors.forename: T
authors.initials: T
authors.lastname: Campa
authors.forename: M G
authors.initials: MG
authors.lastname: Di Mauro
authors.forename: A
authors.initials: A
authors.lastname: Attili
authors.forename: C
authors.initials: C
authors.lastname: Maltoni
authors.forename: M R
authors.initials: MR
authors.lastname: Del Turco
authors.forename: A
authors.initials: A
authors.lastname: Decensi
authors.forename: G
authors.initials: G
authors.lastname: D'Aiuto
authors.forename: U
authors.initials: U
authors.lastname: Veronesi
mesh_terms: D000328:Adult; D000368:Aged; D016588:Anticarcinogenic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000503:physiopathology / Q000517:prevention & control*; D004334:Drug Administration Schedule; D005260:Female; D017313:Fenretinide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008875:Middle Aged; D012008:Recurrence; D016896:Treatment Outcome
chemical_list: D016588:Anticarcinogenic Agents; D017313:Fenretinide