ICTUImperial Clinical Trials Unit

Welcome to Imperial Clinical Trials Unit (ICTU)

This website is intended for commercial trial sponsors engaged in the area of pharmaceuticals, medical devices or diagnostic devices

Clinical Trials Search

OR

CurrentAll Trials

RADICAL

Trial Details

  • Trial statusFollowup
  • Study email contactradical@imperial.ac.uk
  • Chief InvestigatorMichael Seckl
  • SponsorImperial College London
  • ISRCTN number80307982
  • PhaseIIa

A single arm phase IIa study (with combination safety run-in) to assess the safety and efficacy of AZD4547 in combination with either anastrozole or letrozole in ER positive breast cancer patients

Design and Objective

This is a phase IIa (with safety run-in), multi-centre, open label, single arm study of AZD4547 administered orally together with anastrozole or letrozole in ER+ breast cancer patients who have progressed on treatment with anastrozole or letrozole; in adjuvant or first line metastatic (safety run-in only) or any setting (phase IIa only). There are two parts to this study: an initial safety run-in followed by a phase IIa study

Key inclusion criteria

Written informed consent and ability to comply with study protocol Aged ≥ 25 years of age Post menopausal women with histological confirmation of breast cancer with documented positive oestrogen receptor status (ER+) of primary or metastatic tumour tissue Fulfils criteria for previous treatment of breast cancer

Study Disclaimer Statement