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OT1-02-09 : A phase 2 randomized, double-blinded, controlled study of ONT-380 vs. placebo in combination with capecitabine (C) and trastuzumab (T) in patients with pretreated HER2+ unresectable locally advanced or metastatic breast carcinoma (MBC) (HER2CLIMB)

Researchers

Presenter

  • E Hamilton

Principal Investigators

  • V Borges

  • R Murthy

  • C Anders

  • D Cameron

  • L Carey

  • V Müller

  • G Curigliano

  • K Gelmon

  • G Hortobagy

  • I Krop

  • S Loibl

  • X Pivort

  • M Pegram

  • D Slamon

  • S Hurvitz

  • M Tsai

  • E Winer

Medical Centers

  • Service Oncologie Medicale, University Hospital Jean Minjoz, Besancon, France

  • BC Cancer - Vancouver Centre, Vancouver, BC, Canada

  • Drug Development, Istituto Europeo di Oncologia, Milano, Italy

  • University of Colorado Cancer Center, Aurora, CO

  • University of California, Los Angeles, Los Angeles, CA

  • UCLA School of Medicine, Los Angeles, CA

  • University of California, Los Angeles, Los Angeles, CA

  • Medicine and Research, German Breast Group, Neu-Isenburg, Germany

  • The University of Texas MD Anderson Cancer Canter, Houston, TX

  • Dana-Farber Cancer Institute, Boston, MA

  • University Medical Center Hamburg Eppendorf, Hamburg, Germany

  • Virginia Piper Cancer Institute, Minneapolis, MN

  • University of North Carolina, Chapel Hill, NC

  • Oncology, Edinburgh Cancer Centre Western General Hospital, Edinburgh, United Kingdom

Locations

  • Canada

  • Italy

  • Germany

  • United Kingdom

  • United States

  • France

Companies

  • Tennessee Onc PLLC

Study Components

Therapeutic Area

  • Oncology (ONC)

Disease

  • Breast cancer

  • Brain metastasis

  • Solid malignancies

Biomarkers

  • erb-b2 receptor tyrosine kinase 2

Drug/Treatment

  • Trastuzumab emtansine

  • Capecitabine

  • Trastuzumab

  • Pertuzumab

  • Lapatinib

  • ONT380

  • taxane

Outcome

  • N/A

Study Design

  • randomized

  • double blind/blinded

Phase

  • II

Study Id's

  • N/A

Sponsors

  • N/A

Result

  • Interim

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