A Study of LEE011 in combination with Fulvestrant and BYL719 or BKM120

• Research type

  Research Study

• Full title

  A phase Ib/II study of LEE011 in combination with fulvestrant and BYL719 or BKM120 in the treatment of postmenopausal women with hormone receptor positive, HER2 negative locally recurrent or advanced metastatic breast cancer.

• IRAS ID

  149375

• Contact name

  Samreen Ahmed

• Contact email

  Samreen.Ahmed@uhl-tr.nhs.uk

• Sponsor organisation

  Novartis Pharmaceuticals Corporation

• Eudract number

  2013-004587-65

• Research summary

  This study is a Phase 1b dose escalation study, followed by a randomised Phase II expansion study.

  The purpose of this open label dose escalation study is to determine the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of LEE011, BKM120 and BYL719 when administered in combination with a standard dose of fulvestrant in patients with oestrogen receptor positive, HER 2 negative breast cancer.

  The purpose of the dose expansion study is to gain further safety information of the maximum tolerated doses of LEE011, BKM120 and BYL719 in combination with fulvestrant and look at the anticancer effects the combination demonstrates.

• REC name

  West of Scotland REC 1

• REC reference

  14/WS/0103

• Date of REC Opinion

  18 Jun 2014

• REC opinion

  Further Information Favourable Opinion