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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

Primary Objectives: Safety run-in: Safety and tolerability of AZD4547 as assessed by Dose Limiting Toxicities (DLTs). Phase IIa: To assess the efficacy of AZD4547 based on the change in tumour size at 12 weeks (or progression if prior to week 12), when used in combination with either anastrozole or letrozole in ER+ breast cancer patients who have progressed on treatment with either anastrozole or letrozole in any setting.

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