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UNIRAD

Randomised, double blind, multicentre phase III trial evaluating the safety and benefit of adding everolimus to adjuvant hormone therapy in women with high risk of relapse, ER+ and HER2- primary breast cancer who remain free of disease after receiving at least 1 year of adjuvant hormone therapy.

Disease site: Breast cancer

Treatment modality: Systemic therapy

Status: Open to recruitment

Trial details

UNIRAD is an international, double blind, multicentre, phase III randomised trial to evaluate the benefit of adding 2 years of everolimus to standard endocrine treatments for patients with high risk of relapse, ER+, HER2- primary, non-metastatic breast cancer, who remain disease free after 1–4 years of adjuvant endocrine therapy.

1,984 patients will be recruited from participating sites in France, Belgium and the UK to receive either everolimus or placebo for 2 years, in addition to ongoing standard care endocrine therapy lasting up to a total of 5 years. Following completion of treatment, participants will be followed up for a further 5 years. 

Further information

Global Chief Investigator: Dr Fabrice Andre, Institut Gustave Roussy and Dr Thomas Bachelot, Centre Léon Bérard

UK National Coordinating Investigator: Professor David Cameron, NHS Lothian/University of Edinburgh

ICR-CTSU Scientific Lead: Professor Judith Bliss

Trial management contact: UNIRAD is coordinated in the UK by ICR-CTSU and in the rest of Europe by UNICANCER. The UK trial management contact is [email protected]

ISRCTN: To be confirmed

Sponsor: UNICANCER

Funding: Cancer Research UK (CRUK/13/010) and Novartis Pharmaceuticals UK Limited

Further information including recruitment progress is available from the following link:

UKCRN portfolio 

Patient friendly information is available from the following link:

CancerHelp UK

Publications and presentations

There have been no presentations or publications to date.

Clinical trials

Division of Clinical Studies

The division carries out or coordinates high-quality trials and translational research at both an early phase – typically to test new targeted drugs – and a later stage.