BKM120 + fulvestrant in patients with HR+ HER2- after mTOR

• Research type

  Research Study

• Full title

  A phase III randomized, double blind placebo controlled study of BKM120 with fulvestrant, in postmenopausal women with hormone receptorpositive HER2negative AI treated, locally advanced or metastatic breast cancer which progressed on or after mTOR inhibitor based treatment.

• IRAS ID

  110180

• Contact name

  Stephen Johnston

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2012-002571-34

• ISRCTN Number

  xx

• Research summary

  This study is a phase III randomized, double blind placebo controlled study of oral BKM120 in combination with fulvestrant. The patients treated will be postmenopausal women with hormone receptor positive, HER2 negative locally advanced or metastatic breast cancer that have been pre-treated with aromatase inhibitor and whose disease has relapsed on or after mTORi treatment. Approximately 615 patients with a minimum of 246 patients with PI3K pathway activated status will be randomised in a 2:1 ratio of BKM120 plus fulvestrant or placebo plus fulvestrant. Pre-screening will determine the PI3K activations status. Patients will receive treatment until the disease progresses.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  12/LO/1540

• Date of REC Opinion

  10 Dec 2012

• REC opinion

  Further Information Favourable Opinion