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TPS624 : Phase III study of ribociclib (LEE011) plus fulvestrant for the treatment of postmenopausal patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2) advanced breast cancer (aBC) who have received no or only one line of prior endocrine treatment (ET): MONALEESA-3.

Researchers

Presenter

  • Peter A. Fasching

Principal Investigators

  • Guy Heinrich Maria Jerusalem

  • Xavier Pivot

  • Miguel Martin

  • Michele De Laurentiis

  • Kimberly L. Blackwell

  • Francisco J. Esteva

  • Stephen K. L. Chia

  • Caroline Germa

  • Zhongwen Tang

  • Shyeilla V. Dhuria

  • Dennis J. Slamon

Medical Centers

  • Universitatsklinikum Erlangen, Erlangen, Germany

  • Centre Hospitalier Universitaire du Sart Tilman Liege and Liege University, Liege, Belgium

  • CHU Besancon, Besancon, France

  • Hospital Universitario Quiron Madrid, Madrid, Spain

  • National Cancer Institute "Fondazione Pascale", Naples, Italy

  • Duke University Medical Center, Durham, NC

  • Laura and Isaac Perlmutter Cancer Center, NYU Langone Medical Center, New York, NY

  • BC Cancer Agency, Vancouver, BC, Canada

  • Novartis Pharmaceutical Corporation, East Hanover, NJ

  • University of California Los Angeles Medical Center, Santa Monica, CA

Locations

  • Canada

  • Italy

  • Germany

  • Spain

  • United States

  • France

  • Belgium

Companies

  • Novartis AG

Study Components

Therapeutic Area

  • Oncology (ONC)

Disease

  • Secondary liver cancer

  • Breast cancer

  • Solid malignancies

Biomarkers

  • Cyclin-dependent kinase 4

  • erb-b2 receptor tyrosine kinase 2

Drug/Treatment

  • Fulvestrant

  • Ribociclib

Outcome

  • N/A

Study Design

  • Randomized

  • Placebo Control

  • Pharmacokinetics

  • Double Blind/Blinded

Phase

  • III

Study Id's

  • NCT02422615

Sponsors

  • N/A

Result

  • N/A

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