BEZ235 in patients with HER2 negative metastatic breast cancer.
Research type
Research Study
Full title
A phase II study of orally administered BEZ235 monotherapy in patients with hormone receptor positive, HER2 negative, metastatic breast cancer, with or without PI3K activated pathway.
IRAS ID
74363
Contact name
Iain Macpherson
Eudract number
2010-024394-39
Research summary
This is a multi-centre phase II study of a new drug called BEZ235. The aim of this study is to determine whether BEZ235 may be a safe and effective treatment in woman with metastatic breast cancer. The new drug acts by interfering with two proteins called PI3-K and mTOR which have been shown to be involved in the growth and survival of cancer cells in the laboratory. BEZ235 is developed and manufactured by the company Novartis Pharmaceuticals; it is experimental and therefore only available for use in clinical trials. This trial is an open label study, which means that everyone participating in the study will receive BEZ235. BEZ235 is taken orally once daily on a continuous basis. Women who have metastatic breast cancer which is hormone-receptor positive and HER2-negative and who have disease which has progressed despite hormonal therapy and chemotherapy may be eligible to participate. All potential patients will have the presence of PI3-K and mTOR assessed in their tumour and will be assigned to one of three groups depending on the status of these proteins. In each group 20 patients will be treated initially and if there is evidence of benefit in a predetermined number of patients a further 20 patients will be recruited to that group. The principle objective of this trial is to assess the activity of BEZ235 defined as the proportion of patients continuing treatment at 16 weeks without progression of their cancer. 120 patients will take part in approximately 70 centres worldwide.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
11/AL/0172
Date of REC Opinion
12 Apr 2011
REC opinion
Favourable Opinion