LEE011 + BYL719 with Letrozole in patients with ER+ breast cancer
Research type
Research Study
Full title
A phase Ib/II, multicenter, study of the combination of LEE011 and BYL719 with letrozole in adult patients with advanced ER+ breast cancer.
IRAS ID
141705
Contact name
Iain Macpherson
Contact email
Sponsor organisation
Novartis Institutes for BioMedical Research Inc
Eudract number
2013-001219-57
Duration of Study in the UK
2 years, 4 months, 11 days
Research summary
This study is a Phase 1b dose escalation and expansion study, followed by a randomised Phase II 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 and / or BYL719 when administered in combination with a standard dose of letrozole 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 or BYL719 in combination with letrozole and look at the anti-cancer effects the combination demonstrates.
The purpose of the randomised Phase II portion of the study is to further investigate the LEE011 and / or BYL719 in combination with letrozole, focusing on patient safety and tumour response.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
14/NW/0010
Date of REC Opinion
21 Jan 2014
REC opinion
Favourable Opinion