Phase Ib Trial of LEE011 With Everolimus (RAD001) and Exemestane in the Treatment of Hormone Receptor Positive HER2 Negative Advanced Breast Cancer

PHASE1CompletedINTERVENTIONAL
Enrollment

132

Participants

Timeline

Start Date

September 6, 2013

Primary Completion Date

March 14, 2018

Study Completion Date

April 16, 2020

Conditions
Breast Cancer
Interventions
DRUG

ribociclib (LEE011)

LEE011 is taken orally once per day for 21 days of each 28 day cycle. LEE011 comes in 50 mg and 200 mg capsules.

DRUG

Exemestane

Exemestane is taken orally once per day. Exemestane comes in 25 mg tablets.

DRUG

Everolimus (RAD001)

Everolimus is taken orally once per day. Everolimus comes in 1 mg, 2.5 mg, 5mg, and 7.5 mg tablets

Trial Locations (13)

2610

Novartis Investigative Site, Wilrijk

10017

Memorial Sloan Kettering Oncology Dept., New York

33136

Sylvester Comprehensive Cancer Center Main Center, Miami

44805

Novartis Investigative Site, Saint-Herblain

48201

Karmanos Cancer Institute Dept of Onc, Detroit

72703

Highlands Oncology Group, Fayetteville

77030

University of Texas MD Anderson Cancer Center Onc Dept, Houston

97239

Oregon Health and Science University SC-5, Portland

98405

Northwest Medical Specialties, Tacoma

02114

Massachusetts General Hospital Onc Dept, Boston

Unknown

Novartis Investigative Site, Hong Kong

08035

Novartis Investigative Site, Barcelona

08907

Novartis Investigative Site, L'Hospitalet de Llobregat

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY