UNIRAD V5.0 14/02/2014
Research type
Research Study
Full title
Randomized, double-blind, multicentre phase III trial evaluating the safety and benefit of adding everolimus to adjuvant hormone therapy in women with poor prognosis, ER+ and HER2- primary breast cancer who remain free of disease after receiving at least 1 year of adjuvant hormone therapy.
IRAS ID
142447
Contact name
David Cameron
Contact email
Sponsor organisation
UNICANCER
Eudract number
2012-003187-44
Clinicaltrials.gov Identifier
Duration of Study in the UK
20 years, 0 months, 1 days
Research summary
In 2010 there were 49,564 new cases of breast cancer in the UK. In ≈80% of these cases, breast cancer cells express a marker called ‘oestrogen receptor’ (ER). Cancers which express this marker are called 'ER positive' breast cancers. ER positive breast cancers are treated with drugs called 'hormone therapies' which stop the oestrogen receptor from working, slowing down the growth of ER positive breast cancer cells.
In standard practice, patients with ER positive breast cancer will have surgery (with or without neo-adjuvant chemotherapy/radiotherapy) plus 5 or more years of hormone therapy. In many cases, this treatment will cure the patient’s cancer.
However, if the cancer has started to spread beyond the breast there is an increased risk that the cancer will return (disease relapse). The first place that breast cancer spreads to is the lymph nodes of the armpit. If breast cancer spreads to 4 or more lymph nodes, patients have a 30% chance that their breast cancer will return in the 5 years after diagnosis, while they are still receiving hormone therapy. It is thought these cancers have become 'resistant' to hormone therapy and are no longer dependent on the oestrogen receptor to grow and divide. Scientists have identified an alternative pathway called the 'PI3K/AKT/mTOR signalling pathway' which they think may be involved in the cancer cells becoming resistant to hormone therapies.
Everolimus is a drug which blocks the activity of mTOR, a molecule which forms one of the steps in this alternative pathway. It is thought that blocking the activity of mTOR will stop the whole pathway working, and in turn will stop cancer cells growing again.
The UNIRAD study will investigate whether the addition of everolimus treatment to standard of care hormone therapy, in patients with a high risk of disease relapse, will reduce the risk of breast cancer returning.
REC name
Scotland B REC
REC reference
14/SS/1043
Date of REC Opinion
1 Oct 2014
REC opinion
Favourable Opinion