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P1-19-46 : A phase Ib dose escalation study evaluating the mutant selective PI3K-alpha inhibitor GDC-0077 (G) in combination with letrozole (L) with and without palbociclib (P) in patients with PIK3CA-mutant HR+/HER2- breast cancer

Researchers

Presenter

  • Komal Jhaveri

Principal Investigators

  • Philippe Bedard

  • Andres Cervantes

  • Cristina Saura

  • Ian Krop

  • Erika Hamilton

  • Peter Schmid

  • Andrea Varga

  • Nick Turner

  • Antoine Italiano

  • Valentina Gambardella

  • Zachary Veitch

  • Mafalda Oliveira

  • Leslie Dickmann

  • Naoki Kotani

  • Amy Kapp

  • Katie Hutchinson

  • Stephanie Royer-Joo

  • Anjali Vaze

  • Jennifer Schutzman

  • Dejan Juric

Medical Centers

  • Memorial Sloan Kettering Cancer Center, Port Washington, NY

  • Columbia University Medical Center, New York, NY

  • Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada

  • University of Valencia, Valencia, Spain

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

  • Dana-Farber Cancer Institute, Boston, MA

  • Sarah Cannon Research Institute/Tennessee Oncology, PLLC, Nashville, TN

  • Barts Cancer Institute, Queen Mary University of London, London, United Kingdom

  • Gustave Roussy Cancer Campus, Villejuif, France

  • Institute for Cancer Research, London, United Kingdom

  • Institut Bergonie, Bordeaux, France

  • Genentech, Inc., South San Francisico, CA

  • Massachusetts General Hospital Cancer Center, Boston, MA

Locations

  • United States

  • Canada

  • Spain

  • United Kingdom

  • France

Companies

  • Genentech, Inc.

Study Components

Therapeutic Area

  • Oncology (ONC)

Disease

  • Breast cancer

Biomarkers

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

  • Cyclin-dependent kinase 4

  • erb-b2 receptor tyrosine kinase 2

  • Circulating DNA

Drug/Treatment

  • Palbociclib

  • Letrozole

  • NSC-163501

Outcome

  • N/A

Study Design

  • Pharmacokinetics

  • Pharmacodynamics

  • Dose Escalation

Phase

  • I

Study Id's

  • NCT03006172

Sponsors

  • N/A

Result

  • N/A

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