Study of LEE011 With Fulvestrant and BYL719 or BKM120 in Advanced Breast Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

May 19, 2014

Primary Completion Date

April 17, 2018

Study Completion Date

April 17, 2018

Conditions
Breast Cancer
Interventions
DRUG

LEE011

LEE011: supplied as capsules of dosage strength of 50 mg or 200 mg. The capsules will be differentiated through different sizes

DRUG

BYL719

BYL719: supplied as tablets of dosage strength of 10 mg, 50 mg or 200 mg. Tablets will be differentiated through different sizes and/or colors.

DRUG

fulvestrant

Fulvestrant will be supplied according to local practice and regulation. Fulvestrant is a commercially available product, comes in 500 mg dose and is an injection for intramuscular (i.m.) administration.

DRUG

BKM120

BKM120: supplied as 10 mg or 50 mg capsules. The capsules will be differentiated through different sizes.

Trial Locations (11)

10041

Novartis Investigative Site, Taipei

20132

Novartis Investigative Site, Milan

28050

Novartis Investigative Site, Madrid

37203

Sarah Cannon Research Institute Onc Dept, Nashville

41124

Novartis Investigative Site, Modena

69373

Novartis Investigative Site, Lyon

119228

Novartis Investigative Site, Singapore

35294-0006

University of Alabama at Birmingham/ Kirklin Clinic Dept Onc, Birmingham

02215

Dana Farber Cancer Institute Onc. Dept., Boston

06351

Novartis Investigative Site, Seoul

LE1 5WW

Novartis Investigative Site, Leicester

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY