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Tumor Prevention and Genetics pp 104–111Cite as

HRT Opposed to Low-Dose Tamoxifen (HOT Study): Rationale and Design

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Part of the book series: Recent Results in Cancer Research ((RECENTCANCER,volume 163))

Abstract

The rationale for the HOT study is mainly based on the findings of the Italian Tamoxifen Prevention Study, where 5,408 healthy hysterectomized women aged 35–70 years were randomized to 20 mg/day of tamoxifen or placebo for 5 years. After 81.2 months median follow-up, 79 breast cancers occurred (34 on tamoxifen versus 45 on placebo, p=0.215). In the subgroup of 1,580women who used estrogen replacement therapy (ERT) at some point during the study, 23 breast cancers were observed: 17 on placebo and 6 on tamoxifen (hazard ratio=0.35, 95% CI, 0.14–0.89). Pharmacokinetic and pharmacodynamic (surrogate endpoint 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 therefore propose a multicenter placebo-controlled phase III trial in postmenopausal healthy women on hormone replacement therapy (HRT) to assess whether the combination of HRTand low-dose tamoxifen retains the benefits while reducing the risks of either.

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Authors and Affiliations

  1. European Institute of Oncology, Via Ripamonti 435, 20141, Milan, Italy

    Andrea Decensi, Arianna Galli & Umberto Veronesi

Authors
  1. Andrea Decensi
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  2. Arianna Galli
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  3. Umberto Veronesi
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Editors and Affiliations

  1. Zentrum für Tumordiagnostik und Prävention, Rorschacherstr. 150, 9006, St. Gallen, Switzerland

    Hans-Jörg Senn  & Rudolf Morant  & 

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© 2003 Springer-Verlag Berlin Heidelberg

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Decensi, A., Galli, A., Veronesi, U. (2003). HRT Opposed to Low-Dose Tamoxifen (HOT Study): Rationale and Design. In: Senn, HJ., Morant, R. (eds) Tumor Prevention and Genetics. Recent Results in Cancer Research, vol 163. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-55647-0_10

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  • DOI: https://doi.org/10.1007/978-3-642-55647-0_10

  • Publisher Name: Springer, Berlin, Heidelberg

  • Print ISBN: 978-3-642-62892-4

  • Online ISBN: 978-3-642-55647-0

  • eBook Packages: Springer Book Archive

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