ARomatase Inhibition +- SaracaTinib as Advanced breast CAncer Therapy
Research type
Research Study
Full title
ARomatase Inhibition plus minus SaracaTinib as Advanced breast CAncer Therapy: a randomised phase II study of aromatase inhibition plus/minus the src-inhibitor AZD0530 in post-menopausal women with advanced breast cancer.
IRAS ID
94184
Contact name
David Cameron
Contact email
Sponsor organisation
Common Services Agency
Eudract number
2011-002157-64
ISRCTN Number
ISRCTN23804370
Research summary
Post-menopausal women who have advanced breast cancer that is sensitive to the estrogen hormone are commonly treated with a type of drug called an aromatase inhibitor. However for most of these patients the drug eventually stops working (known as developing a resistance to the drug). Ultimately this leads to their disease getting worse and in many this leads to early death. There are many ways in which this resistance may develop but one route may be through the activation of a regulator protein called Src. The presence in breast cancer cells of large amounts of this activated protein is linked with a poorer outcome for the patients. There is also evidence from laboratory work that if this protein is de-activated (switched off) in breast cancer cells, hormone therapy is more effective.There is a new drug called saracatinib which works by inhibiting the Src protein. This study is looking to see if there is benefit in adding this new drug saracatinib to the conventional aromatase inhibitor drug when given to post-menopausal with advanced/metastatic breast cancer to see if it will delay the onset of drug resistance. This study is a phase II randomised study of 140 patients who are post menopausal women with hormone sensitive advanced breast cancer. Recruitment will take place over 2 years.
REC name
West of Scotland REC 1
REC reference
11/WS/0114
Date of REC Opinion
7 Feb 2012
REC opinion
Further Information Favourable Opinion