BKM120 with fulvestrant in patients with HER-2 negative breast cancer.

• Research type

  Research Study

• Full title

  A phase III randomized, double blind placebo controlled study of BKM120 with fulvestrant, in postmenopausal women with hormone receptor-positive HER2-negative locally advanced or metastatic breast cancer which progressed on or after aromatase inhibitor treatment.

• IRAS ID

  107982

• Contact name

  Andrew Wardley

• Sponsor organisation

  Novartis Pharmaceuticals UK Ltd

• Eudract number

  2011-005524-17

• ISRCTN Number

  1

• Research summary

  This study is a phase III randomized, double blind placebo controlled study of oral BKM120 in combination with fulvestrant, in the treatment of postmenopausal women with hormone receptor-positive HER2-negative locally advanced or metastatic breast cancer whose disease has progressed on or after aromatase inhibitor treatment. Approximately 842 patients with a minimum of 334 patients with PI3K pathway activated status will be randomised in a 1:1 ratio.

• REC name

  Wales REC 2

• REC reference

  12/WA/0220

• Date of REC Opinion

  13 Sep 2012

• REC opinion

  Further Information Favourable Opinion