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TPS1103 : persevERA Breast Cancer (BC): Phase III study evaluating the efficacy and safety of giredestrant (GDC-9545) + palbociclib versus letrozole + palbociclib in patients (pts) with estrogen-receptor-positive, HER2-negative locally advanced or metastatic BC (ER+/HER2– LA/mBC).

Researchers

Presenter

  • Nicholas C. Turner

Principal Investigators

  • Komal L. Jhaveri

  • Aditya Bardia

  • Naoki Niikura

  • Veronique Dieras

  • Carlos H. Barrios

  • Seock-Ah Im

  • Volkmar Mueller

  • Meritxell Bellet

  • Ching-Wei Chang

  • Graham A Ross

  • Monika Patre

  • Sherene Loi

Medical Centers

  • The Royal Marsden Hospital, London, United Kingdom

  • Memorial Sloan Kettering Cancer Center, New York, NY, Massachusetts General Hospital Cancer Center, Boston, MA

  • Showa University, Tokyo, Japan

  • Centre Eugene-Marquis, Rennes, France

  • Centro de Hematologia e Oncologia, Porto Alegre, Brazil

  • Seoul National University College of Medicine, Seoul, Korea

  • University Hospital Eppendorf Frauenklinik, Hamburg, Germany

  • Vall d Hebron University Hospital (HUVH) and Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain

  • Genentech, Inc., South San Francisico, CA

  • F. Hoffmann-La Roche Ltd., Basel, Switzerland

  • Peter MacCallum Cancer Centre, East Melbourne, Australia

Locations

  • United Kingdom

  • Japan

  • France

  • Brazil

  • Germany

  • Spain

  • Switzerland

  • Australia

Companies

  • F. Hoffmann-La Roche

Study Components

Therapeutic Area

  • Oncology (ONC)

Disease

  • Breast cancer

Biomarkers

  • Cyclin-dependent kinase 4

  • Human epidermal growth factor receptor 2

Drug/Treatment

  • Fulvestrant

  • Palbociclib

  • Letrozole

  • Tamoxifen

  • LHRH

Outcome

  • N/A


Study Design

  • Randomized

  • Placebo Control

  • Double Blind/Blinded

  • Multicenteric

  • Controlled

Phase

  • III

Study Id's

  • NCT04546009

Sponsors

  • N/A

Result

  • N/A