The Italian breast cancer prevention trial with tamoxifen: Findings and new perspectives

Aliana Guerrieri-Gonzaga, Arianna Galli, Nicole Rotmensz, Andrea Decensi

Research output: Contribution to journalArticle

21 Citations (Scopus)

Abstract

The Italian Tamoxifen Prevention Study includes 5408 healthy hysterectomized women aged 35-70 years who have been randomized to 20 mg/day of tamoxifen or placebo for 5 years. After 46 months median follow-up, an increased risk of venous vascular events (38 women on tamoxifen vs. 18 women on placebo, P = 0.0053), mainly consisting of superficial phlebitis, has been observed and 41 breast cancers have occurred (19 on tamoxifen vs. 22 on placebo, P = 0.64). However, subgroup analyses indicated a borderline significant reduction of breast cancer among women continuously on estrogen replacement therapy (ERT, mostly transdermal) and receiving tamoxifen, with 8 cases of breast cancer among 390 ERT users on placebo versus 1 case among 362 ERT users on tamoxifen (RR = 0.13, 95% CI = 0.02-1.02). Withdrawal rate (mainly due to menopausal symptoms) differed according to ERT use, with compliance being 78% and 75% at 3 and 5 years, respectively, for women who never took ERT, and 92% and 88% at 3 and 5 years, respectively, for women not on ERT at baseline, but who took ERT at some time during the trial. Pharmacokinetic and pharmacodynamic (surrogate end point biomarkers) studies showed that a lower dose of tamoxifen (such as 5 mg/day) does not affect the drug's activity on several biomarkers of both cardiovascular and breast cancer risk. We are therefore planning a multicenter placebo-controlled phase III trial in postmenopausal healthy women on hormone replacement therapy (HRT) to test whether the combination of HRT and low-dose tamoxifen retains the benefits while reducing the risks of either agent maintaining a high compliance rate.

Original languageEnglish
Pages (from-to)113-122
Number of pages10
JournalAnnals of the New York Academy of Sciences
Volume949
Publication statusPublished - 2001

Fingerprint

Tamoxifen
Breast Neoplasms
Placebos
Biomarkers
Hormone Replacement Therapy
Pharmacodynamics
Hormones
Phlebitis
Estrogen Replacement Therapy
Pharmacokinetics
Breast Cancer
Compliance
Blood Vessels
Placebo
Estrogens
Planning
Pharmaceutical Preparations

Keywords

  • Breast cancer prevention
  • Estrogen replacement therapy (ERT)
  • Selective estrogen receptor modulator (SERM)
  • Tamoxifen

ASJC Scopus subject areas

  • Biochemistry, Genetics and Molecular Biology(all)

Cite this

The Italian breast cancer prevention trial with tamoxifen : Findings and new perspectives. / Guerrieri-Gonzaga, Aliana; Galli, Arianna; Rotmensz, Nicole; Decensi, Andrea.

In: Annals of the New York Academy of Sciences, Vol. 949, 2001, p. 113-122.

Research output: Contribution to journalArticle

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