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PD4-07 : Subcutaneous administration of the fixed-dose combination of trastuzumab and pertuzumab in combination with chemotherapy in HER2-positive early breast cancer: Primary analysis of the phase III, multicenter, randomized, open-label, two-arm FeDeriCa study

Researchers

Presenter

  • Antoinette R Tan

Principal Investigators

  • Seock-Ah Im

  • Andre Mattar

  • Ramon Colomer

  • Daniil Stroyakovskii

  • Zbigniew Nowecki

  • Michelino De Laurentiis

  • Jean-Yves Pierga

  • Kyung Hae Jung

  • Christian Schem

  • Sarah Heeson

  • Mahesh Shivhare

  • Whitney P. Kirschbrown

  • Eleonora Restuccia

  • Tanja Badovinac Crnjevic

  • Christian Jackisch

Medical Centers

  • Levine Cancer Institute, Atrium Health, Charlotte, NC

  • Chonbuk National University Medical School, Jeonju, Korea, Republic of

  • Hospital Perola Byington, Sao Paulo, Brazil

  • Hospital Universitario La Paz, Madrid, Spain

  • City Clinical Oncology Hospital 62, Moscow, Russia

  • Centrum Onkologii - Instytut, Warszawa, Poland

  • National Cancer Institute, Aviano, Italy

  • Institut Curie; Oncologie Medicale, Paris, France

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

  • Mammazentrum-Hamburg, Hamburg, Germany

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

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

  • Genentech, Inc., South San Francisico, CA

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

  • Sana Klinikum Offenbach GmbH, Offenbach, Germany

Locations

  • United States

  • Republic of South Korea

  • Brazil

  • Spain

  • Russia

  • Poland

  • Italy

  • France

  • Germany

  • United Kingdom

  • Switzerland

Companies

  • Feng Chi Biotech Cor

  • F. Hoffmann-La Roche

  • Genentech, Inc.

  • Sana Klinikum Offenb

Study Components

Therapeutic Area

  • Oncology (ONC)

Disease

  • Breast cancer

  • Congestive heart failure

  • Solid malignancies

Biomarkers

  • Human epidermal growth factor receptor 2

Drug/Treatment

  • Cyclophosphamide

  • Cyclophosphamide Injection

  • Trastuzumab

  • Doxorubicin

  • Paclitaxel

  • Pertuzumab

  • Docetaxel

Outcome

  • N/A

Study Design

  • Randomized

  • Fixed Dose

  • Open Label

  • Non Inferiority

  • Multiple Arm

  • Multicenteric

Phase

  • III

Study Id's

  • NCT00950300

  • NCT02738970

  • NCT03493854

Sponsors

  • N/A

Result

  • N/A

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