160
Participants
Start Date
December 19, 2018
Primary Completion Date
February 24, 2020
Study Completion Date
October 12, 2022
Pertuzumab and Trastuzumab Fixed-Dose Combination for Subcutaneous Administration (PH FDC SC)
PH FDC SC will be administered subcutaneously (SC) at a fixed non-weight-based dose. A loading dose of 1200 mg pertuzumab and 600 mg trastuzumab is then followed by a maintenance dose of 600 mg pertuzumab and 600 mg trastuzumab once every 3 weeks (Q3W).
Pertuzumab IV
Pertuzumab will be administered intravenously (IV) as a fixed non-weight-based dose of 840-mg IV loading dose and then 420-mg IV maintenance dose Q3W.
Trastuzumab IV
Trastuzumab will be administered intravenously (IV) as an 8-mg/kg IV loading dose and then 6 mg/kg IV maintenance dose Q3W.
Bellevue Medical Center, El-Metn
Hammoud Hospital, Saida
Hospital Hermanos Ameijeiras, La Habana
Instituto Nacional de Oncología y Radiología (INOR), La Habana
Institute of Oncology and Radiology of Serbia, Belgrade
King Fahad Medical City; Gastroentrology, Riyadh
King Hussein Cancer Center, Amman
National Center for Cancer Care and Research, Doha
Clinical Centre Nis, Clinic for Oncology, Niš
Maryland Oncology Hematology, Rockville
Hospital Universitario de Canarias;servicio de Oncologia, San Cristóbal de La Laguna
Illinois Cancer Care, Peoria
VAASAN KESKUSSAIRAALA; Onkologian poliklinikka, Vaasa
Centro Médico Zambrano Hellion, Monterrey
KYS Sadesairaala; Syopatautien poliklinikka, Kuopio
Västmanlands sjukhus Västerås, Onkologkliniken, Västerås
Texas Oncology - Dallas Presbyterian Hospital, Dallas
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas
Texas Oncology- Northeast Texas, Tyler
Cuidados oncologicos, Querétaro City
Texas Oncology - Memorial City, Houston
USOR - Texas Oncology - San Antonio Northeast, San Antonio
Rocky Mountain Cancer Center - Lakewood (West), Lakewood
Bradford Hill Centro de Investigaciones Clinicas, Recoleta
Cancer Center of Kansas, Wichita
Hospital Britanico de Buenos Aires, Ciudad Autonoma Buenos Aires
Instituto de Câncer E Transplante, Curitiba
Clinicas Oncologicas Integradas - COI, Rio de Janeiro
Instituto de Ensino e Pesquisa Sao Lucas - IEP, São Paulo
Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA, São Paulo
Princess Margaret Hospital, Oncology; Department of Oncology, Hong Kong
Prince of Wales Hosp; Dept. Of Clinical Onc, Shatin
Consultorio Privado (José Luis González Trujillo), León
Centro Oncológico de Panamá, Panama City
Centro Hemato Oncologico Panama, Panama City
Hospital da Luz; Departamento de Oncologia Medica, Lisbon
Hospital de Santa Maria; Servico de Oncologia Medica, Lisbon
IPO do Porto; Servico de Oncologia Medica, Porto
Hospital General Universitario de Elche; Servicio de Oncologia, Elche
Sodersjukhuset; Onkologkliniken, Stockholm
Hoffmann-La Roche
INDUSTRY