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323TiP : EarLEE-1: A phase 3 study of ribociclib + endocrine therapy (ET) for adjuvant treatment of patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–), high-risk, early breast cancer (EBC)

Researchers

Presenter

  • M.Martin Jimenez

Principal Investigators

  • T.Bachelot

  • C.Barrios

  • K.Blackwell

  • S.Chia

  • M.De Laurentiis

  • S.Hurvitz

  • W.Janni

  • B.Kaufman

  • S.Loi

  • P.Schmid

  • D.Slamon

  • K.Hazell

  • S.Mondal

  • M.Shilkrut

  • C.Germa

  • G.Hortobagyi

Medical Centers

  • Medical Oncology Service, Hospital General Universitario Gregorio Maranon, Madrid, Spain

  • Departement d'Oncologie Medicale, Centre Leon Berard, Lyon, France

  • Pontifical Catholic University of Rio Grande do Sul School of Medicine, Porto Alegre, Brazil

  • Multidisciplinary Breast Program, Duke University Medical Center, Durham, NC, USA

  • Medical Oncology, BCCA Vancouver Cancer Centre, Vancouver, BC, Canada

  • Breast Oncology, IRCCS Fondazione G. Pascale, Naples, Italy

  • Translational Research in Oncology, University of California, Los Angeles, CA, USA

  • Department of Gynecology and Obstetrics University Ulm, Ulm, Germany

  • Breast Medical Oncology, Sheba Medical Center at Tel HaShomer, Ramat Gan, Israel

  • Dept. of Hematology, Peter MacCallum Cancer Center, Melbourne, Australia

  • Breast Center, Barts Cancer Institute, London, UK

  • Breast Oncology Program, UCLA - School of Medicine, Los Angeles, CA, USA

  • Department of Oncology, Novartis Pharmaceuticals Corporation, East Hanover, USA

Locations

  • Spain

  • France

  • Brazil

  • United States

  • Canada

  • Italy

  • Germany

  • Israel

  • Australia

  • United Kingdom

Companies

  • N/A

Study Components

Therapeutic Area

  • Oncology (ONC)

Disease

  • N/A

Biomarkers

  • BCL2 Binding Component 3

  • erb-b2 receptor tyrosine kinase 2

Drug/Treatment

  • Anastrozole

  • Exemestane

  • Ribociclib

  • Letrozole

  • Tamoxifen

  • Sandolase

Outcome

  • N/A

Study Design

  • Randomized

  • Placebo Control

  • Double Blind/Blinded

  • Controlled

Phase

  • III

Study Id's

  • N/A

Sponsors

  • N/A

Result

  • N/A

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