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TPS1100 : acelERA Breast Cancer (BC): Phase II study evaluating efficacy and safety of giredestrant (GDC-9545) versus physician’s choice of endocrine monotherapy in patients (pts) with estrogen receptor-positive, HER2-negative (ER+/HER2-) locally advanced or metastatic breast cancer (LA/mBC).

Researchers

Presenter

  • Miguel Martin

Principal Investigators

  • Elgene Lim

  • Mariana Chavez Mac Gregor

  • Mahesh Shivhare

  • Graham Ross

  • Monika Patre

  • Laura Roncoroni

  • Maria Louka

  • Joohyuk Sohn

Medical Centers

  • Hospital Universitario Quiron Madrid, Madrid, Spain

  • Connie Johnson Breast Cancer Research Laboratory, Garvan Institute of Medical Research, UNSW Sydney, Sydney, NSW, Australia

  • 1.MD Anderson Cancer Center, Houston, TX

  • Roche Products Ltd., Welwyn Garden City, United Kingdom

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

  • Yonsei Cancer Center, Yonsei University College of Medicine, Seoul,...

Locations

  • Spain

  • Australia

  • United Kingdom

  • Switzerland

  • Republic of South Korea

Companies

  • Feng Chi Biotech Cor

  • F. Hoffmann-La Roche

Study Components

Therapeutic Area

  • Oncology (ONC)

Disease

  • Breast cancer

  • Solid malignancies

Biomarkers

  • Cyclin-dependent kinase 4

  • Estrogen Receptor 1

  • Human epidermal growth factor receptor 2

Drug/Treatment

  • LHRH

  • Fulvestrant

Outcome

  • N/A


Study Design

  • Randomized

  • Pharmacokinetics

  • Open Label

  • Multicenteric

Phase

  • II

Study Id's

  • NCT04576455

Sponsors

  • N/A

Result

  • N/A