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TPS211 : BREAKWATER: Randomized phase 3 study of encorafenib (enco) + cetuximab (cet) ± chemotherapy for first-line treatment (tx) of BRAF V600E-mutant (BRAFV600) metastatic colorectal cancer (mCRC).

Researchers

Presenter

  • Scott Kopetz

Principal Investigators

  • Axel Grothey

  • Rona Yaeger

  • Fortunato Ciardiello

  • Jayesh Desai

  • Tae Won Kim

  • Tim Maughan

  • Eric Van Cutsem

  • Harpreet Singh Wasan

  • Takayuki Yoshino

  • Michelle L. Edwards

  • Adele Golden

  • Ashwin Gollerkeri

  • Josep Tabernero

Medical Centers

  • 1.MD Anderson Cancer Center, Houston, TX

  • West Cancer Center, OneOncology, Germantown, TN

  • Memorial Sloan Kettering Cancer Center, Port Washington, NY

  • Universita Della Campania "Luigi Vanvitelli", Napoli, Italy

  • Peter MacCallum Cancer Centre, East Melbourne, Australia

  • Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea

  • Oxford Institute for Radiation Oncology, University of Oxford, Oxford, United Kingdom

  • University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Leuven, Belgium

  • Hammersmith Hospital, Division of Cancer, Imperial College London, London, United Kingdom

  • National Cancer Center, EPOC, Chiba, Japan

  • Pfizer Inc, New York, NY

  • Pfizer Inc., Cambridge, MA

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

Locations

  • United States

  • Italy

  • Australia

  • Republic of South Korea

  • United Kingdom

  • Belgium

  • Japan

  • Spain

Companies

  • Pfizer Inc.

Study Components

Therapeutic Area

  • Gastroenterology (GU)

  • Oncology (ONC)

Disease

  • Colorectal Cancer

Biomarkers

  • B-Raf proto-oncogene, serine/threonine kinase

  • Epidermal growth factor receptor

Drug/Treatment

  • Encorafenib

  • Oxaliplatin

  • Irinotecan

  • Erbitux

Outcome

  • N/A


Study Design

  • Randomized

  • Open Label

  • Multicenteric

Phase

  • III

Study Id's

  • NCT04607421

Sponsors

  • N/A

Result

  • N/A