Spots Global Cancer Trial Database for Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer
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Trial Identification
Brief Title: Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer
Official Title: A Phase Ib/II, Multicenter Study of the Combination of LEE011 and BYL719 With Letrozole in Adult Patients With Advanced ER+ Breast Cancer
Study ID: NCT01872260
Conditions
Study Description
Brief Summary: The purpose of this trial is to inform the future clinical development of the two investigational agents in ER+ breast cancer, LEE011 (CDK4/6 inhibitor) and BYL719 (PI3K-alpha inhibitor). This is a multi-center, open-label Phase Ib study. The Phase Ib dose escalation will estimate the MTD and/or RP2D for three regimens: two double combinations, LEE011 with letrozole and BYL719 with letrozole, followed by triple combinations of LEE011 + BYL719 with letrozole (Arms 3 and 4). The Phase Ib dose escalation part will be followed by Phase Ib dose expansions to further characterize the safety, tolerability, PK and preliminary clinical anti-tumor activity of the combinations. Optional crossover for patients who have progressed while on dose escalation or dose expansion with doublet treatment on Arms 1 or 2 to be treated with the triplet combination (Arm 3) after the determination of the RP2D for Arm 3; is no longer permitted after protocol amendment 6. Approximately 270 adult women with ER+/HER2- locally advanced or metastatic breast cancer will be enrolled.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of California at San Diego, Moores Cancer Ctr Dept of Moores Cancer Center, San Diego, California, United States
UCSF Medical Center ., San Francisco, California, United States
H Lee Moffitt Cancer Center and Research Institute H. Lee Moffitt Cancer Center, Tampa, Florida, United States
Massachusetts General Hospital SC-5, Boston, Massachusetts, United States
Sarah Cannon Research Institute SCRI SC, Nashville, Tennessee, United States
Vanderbilt University Medical Ctr Vanderbilt Thompson Ln, Nashville, Tennessee, United States
Texas Oncology Texas Oncology - Sammons, Dallas, Texas, United States
Mays Cancer Ctr Uthsa Mdacc Dept of Onc, San Antonio, Texas, United States
Northwest Medical Specialties Northwest Medical Specialties, Tacoma, Washington, United States
Novartis Investigative Site, Westmead, New South Wales, Australia
Novartis Investigative Site, Parkville, Victoria, Australia
Novartis Investigative Site, Nedlands, Western Australia, Australia
Novartis Investigative Site, Marseille, , France
Novartis Investigative Site, Paris 10, , France
Novartis Investigative Site, Saint Herblain, , France
Novartis Investigative Site, Pisa, PI, Italy
Novartis Investigative Site, Seoul, , Korea, Republic of
Novartis Investigative Site, Sevilla, Andalucia, Spain
Novartis Investigative Site, Valencia, Comunidad Valenciana, Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Bellinzona, , Switzerland
Novartis Investigative Site, Glasgow, , United Kingdom
Novartis Investigative Site, Manchester, , United Kingdom
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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