Chemoprevention trial of contralateral breast cancer with fenretinide. Rationale, design, methodology, organization, data management, statistics and accrual

Giuseppe De Palo, Tiziana Camerini, Ettore Marubini, Alberto Costa, Franca Formelli, Marcella Del Vecchio, Luigi Mariani, Rosalba Miceli, Gustavo Mascotti, Andrea Magni, Tiziana Campa, Maria Gaetana Di Mauro, Angelo Attili, Cesare Maltoni, Marco Rosselli Del Turco, Andrea Decensi, Giuseppe D'Aiuto, Umberto Veronesi

Research output: Contribution to journalArticle

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.

Original languageEnglish
Pages (from-to)884-894
Number of pages11
JournalTumori
Volume83
Issue number6
Publication statusPublished - Nov 1997

Keywords

  • Breast cancer
  • Chemoprevention
  • Clinical trial
  • Fenretinide

ASJC Scopus subject areas

  • Cancer Research

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  • Cite this

    De Palo, G., Camerini, T., Marubini, E., Costa, A., Formelli, F., Del Vecchio, M., Mariani, L., Miceli, R., Mascotti, G., Magni, A., Campa, T., Di Mauro, M. G., Attili, A., Maltoni, C., Del Turco, M. R., Decensi, A., D'Aiuto, G., & Veronesi, U. (1997). Chemoprevention trial of contralateral breast cancer with fenretinide. Rationale, design, methodology, organization, data management, statistics and accrual. Tumori, 83(6), 884-894.