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TPS1111 : A phase 3 study of alpelisib (ALP) plus fulvestrant (FUL) in men and postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) ABC progressing on or after aromatase inhibitor (AI) therapy: SOLAR-1.

Researchers

Presenter

  • Hope S. Rugo

Principal Investigators

  • Fabrice Andre

  • Gabor Rubovszky

  • Bella Kaufman

  • Kenichi Inoue

  • Masato Takahashi

  • Satoru Shimizu

  • Eva M. Ciruelos

  • Mario Campone

  • Pier Franco Conte

  • Hiroji Iwata

  • Sibylle Loibl

  • Ingrid A. Mayer

  • Dejan Juric

  • Anne-Sophie Longin

  • David Mills

  • Celine Wilke

  • Dalila B. Sellami

Medical Centers

  • University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA

  • Gustave Roussy, Universite Paris-Saclay, Villejuif, France

  • Orszagos Onkologiai Intezet, Budapest, Hungary

  • Saitama Cancer Center, Ina, Japan

  • National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan

  • Department of Breast and Endocrine Surgery, Kanagawa Cancer Center, Yokohama, Japan

  • Hospital Universitario Doce de Octubre, Madrid, Spain

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

  • Department of Surgery, Oncology and Gastroenterology, University of Padua, Medical Oncology 2, Instituto Oncologico Veneto IRCCS, Padova, Italy

  • Aichi Cancer Center Hospital, Nagoya, Japan

  • German Breast Group (GBG), Neu-Isenbug, Germany

  • Vanderbilt-Ingram Cancer Center, Nashville, TN

  • Massachusetts General Hospital Cancer Center, Boston, MA

  • Novartis Pharma, Paris, France

  • Novartis Pharmaceuticals AG, Basel, Switzerland

  • Novartis Pharmaceuticals AG, Basel, Switzerland

  • Novartis Pharmaceutical Corporation, East Hanover, NJ

Locations

  • Japan

  • Italy

  • Spain

  • Germany

  • Switzerland

  • United States

  • Israel

  • France

  • Hungary

Companies

  • Novartis AG

Study Components

Therapeutic Area

  • N/A

Disease

  • N/A

Biomarkers

  • Alkaline phosphatase

  • Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha isoform

  • Cyclin-dependent kinase 4

  • erb-b2 receptor tyrosine kinase 2

  • Serine/threonine-protein kinase mTOR

  • PI3K/AKT

  • Circulating DNA

Drug/Treatment

  • Fulvestrant

  • Alpelisib

Outcome

  • N/A

Study Design

  • Randomized

  • Placebo Control

  • Double Blind/Blinded

  • Cohort

Phase

  • III

Study Id's

  • NCT02437318

Sponsors

  • N/A

Result

  • N/A

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