Spots Global Cancer Trial Database for A Study To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Early Her2-Positive Breast Cancer
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Trial Identification
Brief Title: A Study To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Early Her2-Positive Breast Cancer
Official Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Early Her2-Positive Breast Cancer
Study ID: NCT03726879
Conditions
Study Description
Brief Summary: This study (also known as IMpassion050) will evaluate the efficacy and safety of atezolizumab compared with placebo when given in combination with neoadjuvant dose-dense anthracycline (doxorubicin) + cyclophosphamide followed by paclitaxel + trastuzumab + pertuzumab (ddAC-PacHP) in patients with early HER2-positive breast cancer (T2-4, N1-3, M0).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
HCA Midwest Division, Kansas City, Missouri, United States
New York University Medical Center PRIME; NYU Langone Medical Center, New York, New York, United States
Tennessee Oncology, Nashville, Tennessee, United States
Hospital Sao Rafael - HSR, Salvador, BA, Brazil
Hospital Araujo Jorge; Departamento de Ginecologia E Mama, Goiania, GO, Brazil
Hospital Sao Lucas - PUCRS, Porto Alegre, RS, Brazil
Hospital Nossa Senhora da Conceicao, Porto Alegre, RS, Brazil
Hospital Perola Byington, Sao Paulo, SP, Brazil
Tom Baker Cancer Centre-Calgary, Calgary, Alberta, Canada
BCCA-Vancouver Cancer Centre, Vancouver, British Columbia, Canada
Jewish General Hospital, Montreal, Quebec, Canada
Hopital du Saint Sacrement, Quebec City, Quebec, Canada
Masarykuv onkologicky ustav, Brno, , Czechia
Fakultni nemocnice Olomouc; Onkologicka klinika, Olomouc, , Czechia
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum, Essen, , Germany
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR, Freiburg, , Germany
Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem, Hamburg, , Germany
Sankt Elisabeth Krankenhaus; Gynaekology, Leipzig, , Germany
Rotkreuzklinikum München; Frauenklinik, Muenchen, , Germany
Universitätsklinikum Münster; Klinik für Frauenheilkunde und Geburtshilfe, Münster, , Germany
St. Vincenz-Krankenhaus Paderborn; Haus 3 Frauenklinik, Paderborn, , Germany
Universitätsfrauenklinik Ulm; Abteilung Gynäkologie, Ulm, , 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
Policlinico Universitario Agostino Gemelli, Roma, Lazio, Italy
ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica, Brescia, Lombardia, Italy
ASST DI MONZA; Oncologia Medica, Monza, Lombardia, Italy
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia, Rozzano, Lombardia, Italy
Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico, Candiolo, Piemonte, Italy
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II, Padova, Veneto, Italy
National Hospital Organization Shikoku Cancer Center, Ehime, , Japan
Fukushima Medical University Hospital, Fukushima, , Japan
Hiroshima City Hiroshima Citizens Hospital, Hiroshima, , Japan
Hiroshima University Hospital, Hiroshima, , Japan
National Hospital Organization Hokkaido Cancer Center, Hokkaido, , Japan
Hyogo Cancer Center, Hyogo, , Japan
Kanagawa Cancer Center, Kanagawa, , Japan
Tokai University Hospital, Kanagawa, , Japan
Kumamoto Shinto General Hospital, Kumamoto, , Japan
Niigata Cancer Center Hospital, Niigata, , Japan
Saitama Medical University International Medical Center, Saitama, , Japan
Toranomon Hospital, Tokyo, , Japan
Showa University Hospital, Tokyo, , Japan
Gachon University Gil Medical Center, Incheon, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Samsung Medical Centre; Oncology, Seoul, , Korea, Republic of
Instytut "Centrum Zdrowia Matki Polki"; Klinika Onkologii, ?ód?, , Poland
Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; Centr.Diagn.i Lecz.Chor.Piersi, Gliwice, , Poland
Regionalny Szpital Specjalistyczny im. W. Bieganskiego; Oddzial Onkologii Klinicznej, Grudzi?dz, , Poland
Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii, Kraków, , Poland
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr, Warszawa, , Poland
FSBI National Medical Research Radiological Center; A. TSYB MEDICAL RADIOLOGICAL RESEARCH CENTER, Obninsk, Kaluga, Russian Federation
City Clinical Oncology Hospital, Moscow, Moskovskaja Oblast, Russian Federation
SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM", Moskva, Moskovskaja Oblast, Russian Federation
Blokhin Cancer Research Center; Combined Treatment, Moskva, Moskovskaja Oblast, Russian Federation
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic, Kazan, Tatarstan, Russian Federation
Petrov Research Inst. of Oncology, Sankt Petersburg, , Russian Federation
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia, Badalona, Barcelona, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia, Sant Andreu de La Barca, Barcelona, Spain
Hospital Universitario Virgen de La Arrixaca; Servicio De Oncologia, El Palmar, Murcia, Spain
Clinica Universitaria de Navarra; Servicio de Oncologia, Pamplona, Navarra, Spain
Hospital Clínic i Provincial; Servicio de Hematología y Oncología, Barcelona, , Spain
Complejo Asistencial Universitario De Burgos; Servicio de Oncologia, Burgos, , Spain
Hospital Clinico de Granada; Servicio de Oncologia, Granada, , Spain
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia, Jaen, , Spain
Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Oncologia, Lerida, , Spain
Clinica Universidad de Navarra Madrid; Servicio de Oncología, Madrid, , Spain
Centro Integral Oncologico Clara Campal; Servicio de Oncología, Madrid, , Spain
Hospital Universitario Virgen Macarena; Servicio de Oncologia, Sevilla, , Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia, Sevilla, , Spain
China Medical University Hospital; Surgery, Taichung, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology, Taipei City, , Taiwan
Mackay Memorial Hospital; Dept of Surgery, Taipei, , Taiwan
Chang Gung Medical Foundation - Linkou; Dept of Surgery, Taoyuan, , Taiwan
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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