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: In follow-up
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.
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
Funding: Cancer Research UK (CRUK/13/010) and Novartis Pharmaceuticals UK Limited
Patient friendly information is available from the following link:
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