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568 : Ribociclib (LEE011) and letrozole in estrogen receptor-positive (ER+), HER2-negative (HER2) advanced breast cancer (aBC): Phase Ib safety, preliminary efficacy and molecular analysis.

Researchers

Presenter

  • Dejan Juric

Principal Investigators

  • Pamela N. Munster

  • Mario Campone

  • Roohi Ismail-Khan

  • Laura Garcia-Estevez

  • Erika Paige Hamilton

  • Carlos Becerra

  • Richard H. De Boer

  • Rina Hui

  • Anthony Goncalves

  • Yingbo Wang

  • Shyeilla V. Dhuria

  • Ghulam H. Kalimi

  • Karen Cristina Rodriguez Lorenc

  • Ingrid A. Mayer

Medical Centers

  • Massachusetts General Hospital Cancer Center, Boston, MA

  • University of California, San Francisco, San Francisco, CA

  • Institut de Cancerologie de l'Ouestsite Rene Gauducheau, Saint Herblain, France

  • H. Lee Moffitt Cancer Center and Research Institute, Department of Women's Oncology, Tampa, FL

  • START Department, Centro Integral Oncologico Clara Campal, Madrid, Spain

  • Sarah Cannon Research Institute/Tennessee Oncology, PLLC, Nashville, TN

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, TX

  • Department of Medical Oncology, Royal Melbourne Hospital, Melbourne, Australia

  • Westmead Hospital and University of Sydney, Sydney, Australia

  • Department of Medical Oncology, Institut Paoli-Calmettes, Marseille, France

  • Novartis AG, Basel, Switzerland

  • Novartis Pharmaceutical Corporation, East Hanover, NJ

  • Novartis Pharmaceutical Corporation, East Hanover, NJ

  • Breast Cancer Program, Vanderbilt-Ingram Cancer Center, Nashville, TN

Locations

  • Spain

  • Switzerland

  • Australia

  • United States

  • France

Companies

  • Novartis AG

Study Components

Therapeutic Area

  • Oncology (ONC)

Disease

  • Breast cancer

Biomarkers

  • Human epidermal growth factor receptor 2

Drug/Treatment

  • Ribociclib

  • Letrozole

Outcome

  • Unknown


Study Design

  • Pharmacokinetics

Phase

  • I

Study Id's

  • NCT01872260

Sponsors

  • N/A

Result

  • Interim