Spots Global Cancer Trial Database for A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer
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Trial Identification
Brief Title: A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer
Official Title: A Phase III, Randomized, Multicenter, Open-Label, Two-Arm Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Patients With HER2-Positive Early Breast Cancer
Study ID: NCT03493854
Conditions
Study Description
Brief Summary: This is a global Phase III, two-arm, open-label, multicenter, randomized study to investigate the pharmacokinetics, efficacy, and safety of the fixed-dose combination (FDC) of pertuzumab and trastuzumab for subcutaneous (SC) administration in combination with chemotherapy in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer in the neoadjuvant/adjuvant setting.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Maryland Oncology Hematology, Rockville, Maryland, United States
San Juan Oncology Associates, Farmington, New Mexico, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
Northwest Medical Specialties, Lakewood, Washington, United States
Fundación CENIT para la Investigación en Neurociencias, Buenos Aires, , Argentina
Centro Oncologico Riojano Integral (CORI), La Rioja, , Argentina
COIBA, Provincia De Buenos Aires, , Argentina
Institut Jules Bordet, Anderlecht, , Belgium
GHdC Site Notre Dame, Charleroi, , Belgium
UZ Antwerpen, Edegem, , Belgium
Jessa Zkh (Campus Virga Jesse), Hasselt, , Belgium
UZ Leuven Gasthuisberg, Leuven, , Belgium
Clinique Ste-Elisabeth, Namur, , Belgium
Hospital Araujo Jorge; Departamento de Ginecologia E Mama, Goiania, GO, Brazil
Hospital Nossa Senhora da Conceicao, Porto Alegre, RS, Brazil
Hospital Perola Byington, Sao Paulo, SP, Brazil
Royal Victoria Hospital, Barrie, Ontario, Canada
Lakeridge Health Center; R. S. MacLaughlin Durham Regional Cancer Center, Oshawa, Ontario, Canada
The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada
Jewish General Hospital, Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont, Sherbrooke, Quebec, Canada
Masarykuv onkologicky ustav, Brno, , Czechia
Multiscan s.r.o., Pardubice, , Czechia
ICO Paul Papin; Oncologie Medicale., Angers, , France
Institut Sainte Catherine, Avignon, , France
CHRU Besançon, Besançon, , France
Institut Bergonie; Oncologie, Bordeaux, , France
Centre Léon Bérard, Lyon, , France
Institut Curie; Oncologie Medicale, Paris, , France
APHP - Hospital Saint Louis, Paris, , France
ICO - Site René Gauducheau, Saint Herblain, , France
Klinikum Augsburg; Frauenklinik, Augsburg, , Germany
Hochwaldkrankenhaus; Abt.Gynäkologie Geburtshilfe u.Senologie, Bad Nauheim, , Germany
Onkologische Schwerpunktpraxis Kurfürstendamm, Berlin, , Germany
St. Johannes-Hospital, Dortmund, , Germany
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum, Essen, , Germany
Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem, Hamburg, , Germany
Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe, Offenbach, , Germany
Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher, Stralsund, , Germany
Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica, Napoli, Campania, Italy
Università degli Studi Federico II; Clinica di Oncologia Medica, Napoli, Campania, Italy
Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica, Aviano, Friuli-Venezia Giulia, Italy
Uni Degli Studi Di Genova ; Clinica Di Medicina Interna Ad Indirizzo Oncologico, Genova, Liguria, Italy
ASST DI LECCO; Oncologia Medica, Lecco, Lombardia, Italy
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II, Padova, Veneto, Italy
National Hospital Organization Kyushu Cancer Center, Fukuoka, , Japan
Fukushima Medical University Hospital, Fukushima, , Japan
Gifu University Hospital, Gifu, , Japan
Hiroshima City Hiroshima Citizens Hospital, Hiroshima, , Japan
Hiroshima University Hospital, Hiroshima, , Japan
National Hospital Organization Hokkaido Cancer Center, Hokkaido, , Japan
Hyogo Medical University Hospital, Hyogo, , Japan
Sagara Hospital, Kagoshima, , Japan
Kanagawa Cancer Center, Kanagawa, , Japan
Tokai University Hospital, Kanagawa, , Japan
Niigata Cancer Center Hospital, Niigata, , Japan
Okayama University Hospital, Okayama, , Japan
Osaka International Cancer Institute, Osaka, , Japan
Saitama Medical University International Medical Center, Saitama, , Japan
St. Luke's International Hospital, Tokyo, , Japan
The Cancer Institute Hospital of JFCR, Tokyo, , Japan
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Ulsan University Hosiptal, Ulsan, , Korea, Republic of
Iem-Fucam, D.f., Mexico CITY (federal District), Mexico
Centro Médico Zambrano Hellion, Monterrey, Nuevo LEON, Mexico
Oncologico Potosino, San Luis Potosí, SAN LUIS Potosi, Mexico
Bialostockie Centrum Onkologii im. Marii Sklodowskiej - Curie, Bialystok, , Poland
Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; Centr.Diagn.i Lecz.Chor.Piersi, Gliwice, , Poland
Szpital Uniwersytecki w Krakowie; Oddzial Kliniczny Onkologii i Poradnia Onkologiczna, Kraków, , Poland
Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych, Szczecin, , Poland
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr, Warszawa, , Poland
Dolnoslaskie Centrum Onkologii, Wroclaw, , Poland
Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Arhangelsk, Russian Federation
Moscow City Oncology Hospital #62, Moscovskaya Oblast, Moskovskaja Oblast, Russian Federation
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological), Saint-Petersburg, Sankt Petersburg, Russian Federation
Clinical Oncology Dispensary of Ministry of Health of Tatarstan, Kazan, Tatarstan, Russian Federation
Ivanovo Regional Oncology Dispensary, Ivanovo, , Russian Federation
Omsk Region Clinical Oncology Dispensary; 1St Sergical Department, Omsk, , Russian Federation
Hospital Universitario Reina Sofia; Servicio de Oncologia, Córdoba, Cordoba, Spain
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia, Santiago de Compostela, LA Coruña, Spain
Hospital de Cruces; Servicio de Oncología Médica, Barakaldo, Vizcaya, Spain
Hospital del Mar; Servicio de Oncologia, Barcelona, , Spain
Institut Catala d Oncologia Hospital Duran i Reynals, Barcelona, , Spain
Hospital Universitario La Princesa, Madrid, , Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia, Sevilla, , Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia, Valencia, , Spain
China Medical University Hospital; Surgery, Taichung, , Taiwan
VETERANS GENERAL HOSPITAL; Department of General Surgery, Taipei, , Taiwan
Chang Gung Medical Foundation - Linkou; Dept of Surgery, Taoyuan, , Taiwan
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology, Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial, Chiang Mai, , Thailand
Songklanagarind Hospital; Department of Surgery, Songkla, , Thailand
Municipal Noncommercial Institution Regional Center of Oncology, Kharkiv, Kharkiv Governorate, Ukraine
Chemotherapy SI Dnipropetrovsk MA of MOHU, Dnipropetrovsk, , Ukraine
National Cancer Institute MOH of Ukraine, Kiev, , Ukraine
Lviv State Oncology Regional Treatment and Diagnostic Centre, Lviv, , Ukraine
RCI Sumy Regional Clinical Oncological Dispensary, Sumy, , Ukraine
Brighton and Sussex Univ Hosp, Brighton, , United Kingdom
Velindre Cancer Centre, Cardiff, , United Kingdom
St Georges University Hospitals NHS Foundation Trust, London, , United Kingdom
Christie Hospital NHS Trust, Manchester, , United Kingdom
Freeman Hospital, Newcastle upon Tyne, , United Kingdom
Nottingham City Hospital, Nottingham, , United Kingdom
Peterborough City Hospital, Peterborough, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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