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IRIS

Trial Details

  • Trial statusAnalysis
  • Study email contactiris-trial@imperial.ac.uk
  • Chief InvestigatorCarlo Palmieri
  • SponsorImperial College London
  • PhaseII

A Phase II study to assess the safety and efficacy of the steroid sulfatase inhibitor Irosustat when added to an aromatase inhibitor in ER positive locally advanced or metastatic breast cancer patient

Design and Objective

This is a multicentre, single arm, open label phase II trial. 27 postmenopausal women with oestrogen receptor positive locally advanced or metastatic breast cancer who has progressed during first line treatment with an AI will be recruited. Eligible patients will receive Irosustat once daily in addition to the class of AI on which they progressed, until disease progression or the development of unacceptable toxicities.

Key inclusion criteria

Written informed consent prior to admission to this study Aged ≥ 25 years of age Histologically confirmed ER+ve primary or metastatic breast cancer according to local criteria Locally advanced or metastatic breast cancer treated with 1st line AI treatment Postmenopausal ECOG performance status 0 to 2 Life expectancy of ≥ 3 months

Study Disclaimer Statement