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TPS653 : A phase II randomized, double-blind, placebo-controlled multicenter trial evaluating the efficacy and safety of enzalutamide in combination with exemestane in estrogen or progesterone receptor-positive and HER2-normal advanced breast cancer.

Researchers

Presenter

  • Denise A. Yardley

Principal Investigators

  • Ahmad Awada

  • Iulia Cristina Tudor

  • Shanna Stopatschinskaja

  • Joyce Leta Steinberg

  • Luca Gianni

  • Kathy D. Miller

  • Eric P. Winer

  • Javier Cortes

  • Howard A. Burris

  • Amy C. Peterson

Medical Centers

  • Astellas Pharma Global Development, Inc., Northbrook, IL

  • Sarah Cannon Research Institute/Tennessee Oncology, PLLC, Nashville, TNIndiana University Simon Cancer Center, Indianapolis, INSan Raffaele Scientific Institute, Milan, Italy

  • Dana-Farber Cancer Institute, Boston, MA

  • University Hospital Vall d'Hebron, Barcelona, Spain

  • Medication, Inc., San Francisco, CA

  • Medication, Inc., San Francisco, CA

  • Institut Jules Bordet, Universite libre de Bruxelles, Brussels, Belgium

Locations

  • United States

  • Spain

  • Belgium

  • Italy

Companies

  • N/A

Study Components

Therapeutic Area

  • Oncology (ONC)

Disease

  • Breast cancer

  • Epilepsy

  • Solid malignancies

Biomarkers

  • Human epidermal growth factor receptor 2

Drug/Treatment

  • Enzalutamide

  • Exemestane

Outcome

  • Unknown

Study Design

  • randomized

Phase

  • II

Study Id's

  • NCT02007512

Sponsors

  • Astellas Pharma

  • Medivation

Result

  • Interim

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