RADICAL, v1.0

• Research type

  Research Study

• Full title

  A randomised phase IIa study (with combination safety run-in) to assess the safety and efficacy of AZD4547 in combination with either anastrozole or letrozole versus exemestane alone in ER positive breast cancer patients who are progressing on current tratment with anastrozole or letrozole.

• IRAS ID

  79514

• Contact name

  Michael Seckl

• Sponsor organisation

  Imperial College

• Eudract number

  2011-000454-32

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This study is looking at a new drug called AZD4547 which is being tested for the treatment of oestrogen receptor positive breast cancer. AZD4547 is a drug which specifically ??blocks? proteins called fibroblast growth factor receptors (FGFR1) that are involved in the processes that help cancer cells to grow. These proteins may also be responsible for the development of resistance to hormonal therapies used to treat some breast cancers. AZD4547 is not yet approved for use in breast cancer and is therefore being used in this study as a research drug.We will also test the theory that it is not necessary for high levels of FGFR1 to be present in the body to see benefit from AZD4547. The study will be carried out in two stages. Stage 1 is to find a suitable dose of AZD4547 which can be used together with a class of drugs called non-steroidal aromatase inhibitors (e.g. anastrozole or letrozole) i.e. a dose which does not cause too many unacceptable side effects. Stage 2 will then compare this new treatment of AZD4547 and non-steroidal aromatase inhibitor against the current standard treatment using a steroidal aromatase inhibitor (exemestane) to see if the new treatment can either stop the cancer from growing or cause a reduction in the size of the tumour. Patients will be randomly selected to receive either: 1) Exemestane (control arm) or 2) AZD4547闫殣㨥 or anastrozole (experimental arm).In both stages, the study will look at how well the new treatment is tolerated. Each patient is only allowed to take part in either stage 1 or 2. Patients with hormone sensitive (oestrogen receptor positive) breast cancer, whose current treatment with anastrozole or letrozole has recently stopped working properly will be eligible for this study. The study will be run in 9 Hospitals across England and Scotland.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  11/EM/0393

• Date of REC Opinion

  23 Dec 2011

• REC opinion

  Further Information Favourable Opinion