Исследование, посвященное оценке эффективности и безопасности адъюванта атезолизумаба или плацебо и трастузумаба эмтанзина для участников с HER2-положительным раком молочной железы с высоким риском рецидива после предоперационной терапии

Название протокола
Клинические исследование Рак молочной железы: Atezolizumab, Трастузумаб эмтанзин, Плацебо, Трастузумаб - Реестр клинических исследований
Платное
Нет
Дата начала и окончания КИ
2022-02-06 - 2022-02-06
Спонсоры

Ведущий спонсор: Hoffmann-La Roche

Источник Hoffmann-La Roche
Краткое содержание

Это рандомизированное двойное слепое плацебо-контролируемое исследование фазы III в двух группах. участники с HER2-положительным первичным раком молочной железы, получившие дооперационные химиотерапия и HER2-направленная терапия, включая трастузумаб с последующим хирургическим вмешательством, с обнаружение резидуальной инвазивной болезни в груди и / или подмышечных лимфатических узлах.

Общий статус Рекрутинг
Дата начала 2021-05-04
Дата завершения 2034-10-26
Дата первичного завершения 2025-12-18
Фаза Фаза 3
Тип исследования Интервенционный
Первичный результат
Мера Временное ограничение
Выживание без инвазивных заболеваний (IDFS) От рандомизации до примерно 6 лет
Вторичный результат
Мера Временное ограничение
IDFS Including Second Primary Non-breast Invasive Cancer From baseline up to 10 years
Выживание без болезней (DFS) От исходного до 10 лет
Общее выживание (ОС) От исходного до 10 лет
Дистанционный интервал без рецидивов (DRFI) От исходного до 10 лет
Количество участников с клинически значимым ухудшением глобального состояния здоровья / качества жизни (GHS / QoL): физические, ролевые и когнитивные функции От исходного уровня до 2 лет после визита для завершения / прекращения исследуемого лечения (приблизительно 3 года)
Средние абсолютные баллы по GHS / QoL, физическим, ролевым и когнитивным функциям, оцененные с помощью EORTC QLQ-C30 От исходного уровня до 2 лет после визита для завершения / прекращения исследуемого лечения (приблизительно 3 года)
Среднее изменение по сравнению с исходными показателями GHS / QoL, физических, ролевых и когнитивных функций, оцененных с помощью EORTC QLQ-C30 От исходного уровня до 2 лет после визита для завершения / прекращения исследуемого лечения (приблизительно 3 года)
Процент участников с нежелательными явлениями (НЯ) в соответствии с критериями общей терминологии для нежелательных явлений Национального института рака, версия 5.0 (NCI CTCAE v5.0) От исходного до 10 лет
Максимальные концентрации атезолизумаба в сыворотке крови (Cmax) День 1 циклов 1 и 4 перед инфузией, День 1 циклов 1 и 4 через 30 минут после инфузии, День 1 циклов 2, 3 и 8 перед инфузией (цикл = 21 день) и при завершении / прекращении исследуемого лечения визит (примерно через 11 месяцев после цикла 1, день 1)
Cmax для трастузумаба эмтанзина День 1 циклов 1 и 4 перед инфузией, День 1 циклов 1 и 4 через 30 минут после инфузии (цикл = 21 день) и визит при завершении / прекращении исследуемого лечения (примерно через 11 месяцев после цикла 1, день 1)
Cmax для общего трастузумаба День 1 циклов 1 и 4 перед инфузией, День 1 циклов 1 и 4 через 30 минут после инфузии (цикл = 21 день) и визит при завершении / прекращении исследуемого лечения (примерно через 11 месяцев после цикла 1, день 1)
Cmax для DM1 День 1 циклов 1 и 4 перед инфузией, День 1 циклов 1 и 4 через 30 минут после инфузии (цикл = 21 день) и визит при завершении / прекращении исследуемого лечения (примерно через 11 месяцев после цикла 1, день 1)
Минимальные сывороточные концентрации (Cmin) атезолизумаба День 1 циклов 1 и 4 перед инфузией, День 1 циклов 1 и 4 через 30 минут после инфузии, День 1 циклов 2, 3 и 8 (цикл = 21 день) и при посещении завершения / прекращения исследуемого лечения (приблизительно 11 месяцев после цикла 1, день 1)
Процент участников с антителами против лекарственных препаратов (АДА) к атезолизумабу День 1 циклов 1 и 4 перед инфузией, День 1 циклов 1 и 4 через 30 минут после инфузии, День 1 циклов 2, 3 и 8 (цикл = 21 день) и при посещении завершения / прекращения исследуемого лечения (приблизительно 11 месяцев после цикла 1, день 1)
Процент участников с ADA к трастузумабу эмтанзину День 1 циклов 1 и 4 перед инфузией, День 1 циклов 1 и 4 через 30 минут после инфузии (цикл = 21 день) и визит при завершении / прекращении исследуемого лечения (примерно через 11 месяцев после цикла 1, день 1)
Регистрация 1700
Состояние
  • Рак молочной железы
Вмешательство

Тип вмешательства: Drug

Название вмешательства: Atezolizumab

Описание: Atezolizumab will be administered at a dose of 1200 mg every three weeks (Q3W) for 14 cycles.

Этикетка Arm Group: Arm B: Atezolizumab + Trastuzumab Emtansine

Другое имя: Tecentriq, RO5541267, MPDL3280A

Тип вмешательства: Препарат, средство, медикамент

Название вмешательства: Трастузумаб эмтанзин

Описание: Трастузумаб эмтанзин будет вводиться в дозе 3,6 мг / кг каждые 3 недели в течение 14 недель.

Другое имя: Кадсила, Т-ДМ1, РО5304020

Тип вмешательства: Препарат, средство, медикамент

Название вмешательства: Плацебо

Описание: Плацебо, сопоставимое с атезолизумабом, будет вводиться в дозе 1200 мг каждые 3 недели в течение 14 циклов.

Этикетка Arm Group: Группа А: плацебо + трастузумаб эмтанзин

Тип вмешательства: Препарат, средство, медикамент

Название вмешательства: Трастузумаб

Описание: Трастузумаб будет использоваться для завершения 14 циклов исследуемого лечения, если трастузумаб эмтанзин будет прекращен из-за токсичности, не связанной с компонентом трастузумаба в лекарственном средстве.

Другое имя: Герцептин

Приемлемость

Критерии:

Критерии включения: - Гистологически подтвержденная инвазивная карцинома груди - Централизованно подтвержденный инвазивный рецептор 2 эпидермального фактора роста человека (HER2) рак молочной железы - Централизованно подтвержденный статус PD-L1 и рецепторов гормонов - Клиническая стадия при проявлении заболевания: cT4 / anyN / M0, любой cT / N2-3 / M0 или cT1-3 / N0-1 / M0 (участники с cT1mi / T1a / T1b / N0 не допускаются) - Завершение предоперационной системной химиотерапии, включая не менее 9 недель приема таксана и 9 недель трастузумаба (антрациклин и / или дополнительные препараты, нацеленные на HER2, являются разрешенный) - = 50% и отсутствие снижения ФВЛЖ на > 15% от предхимиотерапевтического ФВЛЖ. Если без предварительной химиотерапии ФВЛЖ, скрининг ФВЛЖ> = 55% - Ожидаемая продолжительность жизни> = 6 месяцев - Адекватная гематологическая функция и функция конечных органов Критерий исключения: - рак груди IV стадии - Общий ответ на прогрессирование заболевания по мнению исследователя заключение предоперационной системной терапии - Предварительное лечение T-DM1, атезолизумабом или другими ингибиторами иммунных контрольных точек - История воздействия различных кумулятивных доз антрациклинов - История других злокачественных новообразований в течение 5 лет до скрининга, за исключением надлежащим образом пролеченная карцинома in situ шейки матки, немеланомная карцинома кожи, Рак матки I стадии или протоковая карцинома in situ (DCIS) - Текущая степень> = 2 периферической невропатии - Идиопатический легочный фиброз в анамнезе, органическая пневмония или пневмонит - История активного аутоиммунного заболевания или иммунодефицита - Лечение иммуностимулирующими или иммунодепрессивными средствами - Сердечно-легочная дисфункция - Любое известное активное заболевание печени

Пол:

Все

Минимальный возраст:

18 лет

Максимальный возраст:

N / A

Здоровые волонтеры:

Нет

Общий Официальный
Фамилия Роль Присоединение
Clinical Trials Study Director Hoffmann-La Roche
Общий контакт

Фамилия: Reference Study ID Number: WO42633 www.roche.com/about_roche/roche_worldwide.htm

Телефон: 888-662-6728 (U.S. and Canada)

Расположение
Объект: Положение дел:
Alabama Oncology | Alabaster, Alabama, 35007, United States Recruiting
Roy and Patricia Disney Family Cancer Center- Providence Saint Joseph Medical Center | Burbank, California, 91505, United States Not yet recruiting
California Cancer Associate for Research & Excellence | Fresno, California, 93720, United States Recruiting
Glendale Adventist Medical Ctr | Glendale, California, 91206, United States Not yet recruiting
UCLA Medical Center | Santa Monica, California, 90404, United States Recruiting
Kaiser Permanente - Vallejo | Vallejo, California, 94589, United States Not yet recruiting
Innovation Clinical Research Institute | Whittier, California, 90603, United States Recruiting
Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy) | Jacksonville, Florida, 32256, United States Recruiting
Florida Cancer Specialists | West Palm Beach, Florida, 33401, United States Recruiting
University Cancer & Blood Center, LLC; Research | Athens, Georgia, 30607, United States Recruiting
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital | Carrollton, Georgia, 30117, United States Recruiting
Elmhurst Memorial Healthcare | Elmhurst, Illinois, 60126, United States Not yet recruiting
Edward Cancer Center Naperville | Naperville, Illinois, 60540, United States Not yet recruiting
Edward Cancer Center Plainfield | Plainfield, Illinois, 60585, United States Not yet recruiting
University of Iowa | Iowa City, Iowa, 52242, United States Not yet recruiting
Pontchartrain Cancer Center | Covington, Louisiana, 70433, United States Recruiting
New England Cancer Specialists | Scarborough, Maine, 04074, United States Not yet recruiting
University of Maryland Medical Center | Baltimore, Maryland, 21201, United States Not yet recruiting
Mercy Medical Center | Baltimore, Maryland, 21202, United States Recruiting
Greater Baltimore Med Ctr; Dept Berman Cancer Institute | Baltimore, Maryland, 21204, United States Not yet recruiting
Henry Ford Health System; Dept of Transplantation Surgery | Detroit, Michigan, 48202-2689, United States Not yet recruiting
Jackson Oncology Associates, PLLC | Jackson, Mississippi, 39202, United States Recruiting
Central Care Cancer Center; NC | Bolivar, Missouri, 65613, United States Recruiting
MD Anderson Cancer Center at Cooper | Camden, New Jersey, 08103, United States Not yet recruiting
Jersey Shore University Medical Centre | Neptune, New Jersey, 07753, United States Not yet recruiting
The Valley Hospital | Paramus, New Jersey, 07652, United States Recruiting
Cooper Cancer Institute | Voorhees, New Jersey, 08043, United States Not yet recruiting
Mount Sinai Medical Center | New York, New York, 10029, United States Not yet recruiting
Great Lakes Cancer Center | Williamsville, New York, 14221, United States Not yet recruiting
Messino Cancer Centers | Asheville, North Carolina, 28806, United States Recruiting
Levine Cancer Institute | Charlotte, North Carolina, 28204, United States Not yet recruiting
Providence Health & Services - Oregon | Portland, Oregon, 97213, United States Recruiting
Abramson Cancer Center; Univ of Pennsylvania; Clinical Research Unit | Philadelphia, Pennsylvania, 19106, United States Not yet recruiting
Lankenau Hospital | Wynnewood, Pennsylvania, 19096, United States Not yet recruiting
Charleston Oncology, P .A | Charleston, South Carolina, 29414, United States Recruiting
Avera Cancer Institute | Sioux Falls, South Dakota, 57105, United States Recruiting
SCRI Tennessee Oncology Chattanooga | Chattanooga, Tennessee, 37404, United States Recruiting
The West Clinic; West Cancer Center | Germantown, Tennessee, 38138, United States Recruiting
Thompson Cancer Survival Center | Knoxville, Tennessee, 37916-2305, United States Recruiting
Tennessee Oncology; Sarah Cannon Research Institute | Nashville, Tennessee, 37203, United States Recruiting
Joe Arrington Cancer Research & Treatment Center | Lubbock, Texas, 79410, United States Not yet recruiting
Cancer Therapy and Research Center CTRC at UTHSCSA | San Antonio, Texas, 78229, United States Not yet recruiting
Utah Cancer Specialists | Salt Lake City, Utah, 84106, United States Not yet recruiting
Hematology Oncology Associates of Fredericksburg, Inc. | Fredericksburg, Virginia, 22408, United States Recruiting
Virginia Oncology Associates - New Port News | Newport News, Virginia, 23606, United States Recruiting
Virginia Oncology Associates | Norfolk, Virginia, 23502, United States Recruiting
Virginia Cancer Institute | Richmond, Virginia, 23226, United States Recruiting
Virginia Oncology Associates - Virginia Beach | Virginia Beach, Virginia, 23456, United States Recruiting
Providence Regional Cancer Partnership | Everett, Washington, 98201, United States Not yet recruiting
Kadlec Regional Medical Center | Kennewick, Washington, 99336, United States Not yet recruiting
Northwest Medical Specialties | Tacoma, Washington, 98405, United States Recruiting
Macarthur Cancer Therapy Centre | Campbelltown, New South Wales, 2560, Australia Not yet recruiting
Kinghorn Cancer Centre; St Vincents Hospital | Darlinghurst, New South Wales, 2010, Australia Not yet recruiting
Royal North Shore Hospital; Department of Medical Oncology | St Leonards, New South Wales, 2065, Australia Not yet recruiting
Princess Alexandra Hospital; Cancer Trials Unit | Woolloongabba, Queensland, 4102, Australia Recruiting
Peter MacCallum Cancer Centre; Medical Oncology | Melbourne, Victoria, 3000, Australia Not yet recruiting
Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie | Innsbruck, 6020, Austria Not yet recruiting
Ordensklinikum Linz Barmherzige Schwestern; Interne 1 - Hämato-Onkologie | Linz, 4010, Austria Not yet recruiting
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt. | Salzburg, 5020, Austria Not yet recruiting
AKH - Medizinische Universität Wien; Department of Oncology | Vienna, 1090, Austria Not yet recruiting
Cliniques Universitaires St-Luc | Bruxelles, 1200, Belgium Recruiting
Jessa Zkh (Campus Virga Jesse) | Hasselt, 3500, Belgium Recruiting
Clinique St. Elizabeth | Namur, 5000, Belgium Recruiting
Hospital Sao Rafael - HSR | Salvador, BA, 41253-190, Brazil Not yet recruiting
Crio - Centro Regional Integrado de Oncologia | Fortaleza, CE, 60336-550, Brazil Not yet recruiting
Hospital Araujo Jorge; Departamento de Ginecologia E Mama | Goiania, GO, 74605-070, Brazil Not yet recruiting
Hospital de Caridade de Ijui; Oncologia | Ijui, RS, 98700-000, Brazil Not yet recruiting
Hospital Nossa Senhora da Conceicao | Porto Alegre, RS, 91350-200, Brazil Not yet recruiting
Hospital de Base de Sao Jose do Rio Preto | Sao Jose do Rio Preto, SP, 15090-000, Brazil Not yet recruiting
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda | Sao Paulo, SP, 01317-001, Brazil Not yet recruiting
Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA | Sao Paulo, SP, 04014-002, Brazil Not yet recruiting
KOC Plovdiv; First Medical Oncology Department | Plovdiv, 4004, Bulgaria Not yet recruiting
Multiprofile Hospital for Active Treatment "Nadezhda"; Medical Oncology Department | Sofia, 1330, Bulgaria Not yet recruiting
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD | Sofia, 1527, Bulgaria Not yet recruiting
Sichuan Cancer Hospital | Chengdu City, 610041, China Not yet recruiting
West China Hospital - Sichuan University | Chengdu City, 610047, China Not yet recruiting
Chongqing Cancer Hospital | Chongqing, 400030, China Not yet recruiting
The First Affilicated Hospital, Sun Yat-sen University | Guangzhou City, 510080, China Not yet recruiting
Guangdong Provincial People's Hospital; Breast | Guangzhou City, 510245, China Not yet recruiting
Sun Yat-sen Memorial Hospital | Guangzhou, 510000, China Recruiting
Harbin Medical University Cancer Hospital | Harbin, 150081, China Not yet recruiting
The Affiliated Hospital of Medical College Qingdao University | Qingdao, 266003, China Not yet recruiting
Zhongshan Hospital Fudan University | Shanghai, 200032, China Not yet recruiting
Tianjin Medical University Cancer Institute & Hospital | Tianjing, 300060, China Not yet recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan City, 430023, China Recruiting
First Affiliated Hospital of Medical College of Xi'an Jiaotong University | Xi'an, 710061, China Recruiting
Zhejiang Cancer Hospital | Zhejiang, 310022, China Not yet recruiting
Henan Cancer Hospital | Zhengzhou, 450008, China Not yet recruiting
Masarykův onkologický ústav; Klinika komplexní onkologické péče | Brno, 656 53, Czechia Recruiting
Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology | Hradec Kralove, 500 05, Czechia Recruiting
Nemocnice AGEL Novy Jicin a.s.; Oddeleni radioterapie a onkologie | Novy Jicin, 741 01, Czechia Recruiting
Fakultni nemocnice Olomouc; Onkologicka klinika | Olomouc, 779 00, Czechia Recruiting
Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika | Praha 2, 128 08, Czechia Recruiting
Thomayerova nemocnice; Onkologicka klinika 1. LF UK A TN | Praha 4 - Krc, 140 59, Czechia Recruiting
Fakultni nemocnice v Motole; Onkologicka klinika 2. LF UK a FN Motol | Praha 5, 150 06, Czechia Recruiting
Herlev Hospital; Afdeling for Kræftbehandling | Herlev, 2730, Denmark Recruiting
Vejle Sygehus; Onkologisk Afdeling | Vejle, 7100, Denmark Not yet recruiting
Institut Sainte Catherine | Avignon, 84918, France Recruiting
CHRU Besançon | Besançon, 25030, France Not yet recruiting
Polyclinique Bordeaux Nord Aquitaine | Bordeaux, 33300, France Recruiting
Hopital Morvan | Brest, 29200, France Not yet recruiting
Centre Francois Baclesse; Comite Sein | Caen, 14076, France Not yet recruiting
Groupe Hospitalier Public Du Sud De L'Oise GHPSO; Oncologie | Creil Cedex 1, 60109, France Not yet recruiting
CLCC Leon Berard Lyon | Lyon, 69008, France Recruiting
Centre Hospitalier Uni Ire Caremeau; Radiotherapie & Oncologie | Nimes, 30029, France Recruiting
Groupe Hospitalier Diaconesses | Paris, 75020, France Not yet recruiting
Institut Curie; Oncologie Medicale | Paris, 75231, France Not yet recruiting
Pole Regional De Cancerologie | Poitiers, 86021, France Not yet recruiting
HOPITAL RENE HUGUENIN, Institut Curie; Service d'Oncologie Médicale. | Saint-Cloud, 92210, France Not yet recruiting
Klinikum Augsburg; Frauenklinik | Augsburg, 86156, Germany Not yet recruiting
Hochtaunus-Kliniken gGmbH; Krankenhaus Bad Homburg; Frauenklinik | Bad Homburg vdH, 61352, Germany Recruiting
Hochwaldkrankenhaus; Abt.Gynäkologie Geburtshilfe u.Senologie | Bad Nauheim, 61231, Germany Recruiting
Onkologische Schwerpunktpraxis Kurfürstendamm | Berlin, 10707, Germany Recruiting
Vivantes Klinikum Am Urban; Zentrum für Brusterkrankungen | Berlin, 10967, Germany Recruiting
Städtisches Klinikum Dessau | Dessau-Roßlau, 06847, Germany Recruiting
Frauenarztpraxis Dr. Apel, Dr. Kolpin | Erfurt, 99084, Germany Recruiting
Universitätsklinikum Erlangen; Frauenklinik | Erlangen, 91054, Germany Recruiting
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum | Essen, 45136, Germany Recruiting
AGAPLESION Markus-Krankenhaus | Frankfurt, 60431, Germany Recruiting
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR | Freiburg, 79110, Germany Recruiting
St. Barbara-Klinik Hamm-Heessen GmbH; Frauenklinik | Hamm, 59073, Germany Recruiting
Diakovere Henriettenstift, Frauenklinik | Hannover, 30559, Germany Recruiting
UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe | Kiel, 24105, Germany Recruiting
Universitätsklinikum Leipzig; Klinik und Poliklinik für Frauenheilkunde | Leipzig, 04103, Germany Recruiting
Städtische Klinik Lüneburg; Frauenklinik | Lüneburg, 21339, Germany Recruiting
Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt | München, 80337, Germany Recruiting
Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe | Offenbach, 63069, Germany Recruiting
Klinikum Ernst von Bergmann; Frauenklinik | Potsdam, 14467, Germany Recruiting
Leopoldina Krankenhaus der Stadt Schweinfurt GmbH | Schweinfurt, 97422, Germany Recruiting
Johanniter-Krankenhaus Genthin-Stendal; Klinik Für Frauenheilkunde & Geburtshilfe | Stendal, 39576, Germany Recruiting
Metropolitan General Hospital | Cholargos, 155 62, Greece Recruiting
University General Hospital of Heraklion | Crete, 711 10, Greece Not yet recruiting
University Hospital of Larissa;Department of Medical Oncology | Larissa, 411 10, Greece Not yet recruiting
Metropolitan Hospital; 2Nd Oncology Clinic | Piraeus, 185 47, Greece Recruiting
Euromedical General Clinic of Thessaloniki; Oncology Department | Thessaloniki, 546450, Greece Not yet recruiting
Queen Mary Hospital; Surgery | Hong Kong, 852, Hong Kong Recruiting
Pamela Youde Nethersole Eastern Hospital; Clinical Oncology | Hong Kong, Hong Kong Not yet recruiting
Tuen Mun Hospital; Clinical Oncology | Hong Kong, Hong Kong Not yet recruiting
Szent Margit Hospital | Budapest, 1032, Hungary Not yet recruiting
Honvédelmi Minisztérium Állami Egészségügyi Központ; Onkológiai Osztály; Oncology department | Budapest, 1062, Hungary Not yet recruiting
Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly | Budapest, 1122, Hungary Not yet recruiting
Debreceni Egyetem Klinikai Kozpont ; Department of Oncology | Debrecen, 4032, Hungary Recruiting
Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly | Miskolc, 3501, Hungary Recruiting
Rajiv Gandhi Cancer Institute & Research Center | New Delhi, Delhi, 110085, India Not yet recruiting
Max Super Speciality Hospital; Medical Oncology | North WEST Delhi, Delhi, 110088, India Not yet recruiting
Vedant Institute of Medical Sciences | Ahmedabad, Gujarat, 380009, India Not yet recruiting
Manipal Hospital; Department of Oncology | Bangalore, Karnataka, 560017, India Not yet recruiting
Tata Memorial Hospital; Dept of Medical Oncology | Mumbai, Maharashtra, 400012, India Not yet recruiting
HCG Manavata Cancer Centre | Nashik, Maharashtra, 422002, India Not yet recruiting
Sahyadri Super Specialty Hospital Hadapsar | Pune, Maharashtra, 411028, India Not yet recruiting
TATA Medical Centre; Medical Oncology | Kolkata, WEST Bengal, 700156, India Not yet recruiting
Christian Med Clg & Hspt | Vellore, 632004, India Not yet recruiting
AORN'S.G.Moscati; Oncologia | Avellino, Campania, 83100, Italy Recruiting
U.O.C. Oncologia Medica Senologica | Napoli, Campania, 80131, Italy Recruiting
Università degli Studi Federico II; Clinica di Oncologia Medica | Napoli, Campania, 80131, Italy Not yet recruiting
Policlinico S.Orsola-Malpighi; Istituto Oncologia R. Addarii | Bologna, Emilia-Romagna, 40138, Italy Recruiting
A.O. Universitaria Policlinico Di Modena; Oncologia | Modena, Emilia-Romagna, 41100, Italy Not yet recruiting
Irccs Centro Di Riferimento Oncologico (CRO) | Aviano, Friuli-Venezia Giulia, 33081, Italy Recruiting
ASU FC S. M. DELLA MISERICORDIA; Oncologia | Udine, Friuli-Venezia Giulia, 33100, Italy Recruiting
Policlinico Universitario Agostino Gemelli | Roma, Lazio, 00168, Italy Not yet recruiting
ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica | Brescia, Lombardia, 25123, Italy Recruiting
Ospedale San Raffaele; Medical Oncology | Milano, Lombardia, 20132, Italy Recruiting
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1 | Milano, Lombardia, 20133, Italy Not yet recruiting
Ospedale Civile - Livorno | Livorno, Toscana, 57124, Italy Recruiting
Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2 | Pisa, Toscana, 56100, Italy Not yet recruiting
University of Eastern Piedmont - Maggiore della Carità University Hospital | Novara, Umbria, 28100, Italy Recruiting
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda | Padova, Veneto, 35128, Italy Not yet recruiting
International Cancer Institute (ICI) | Eldoret, 30100, Kenya Not yet recruiting
Aga Khan University Hospital | Nairobi, 00100, Kenya Not yet recruiting
Kyungpook National University Medical Center | Daegu, 41404, Korea, Republic of Recruiting
National Cancer Center | Goyang-si, 10408, Korea, Republic of Recruiting
Seoul National University Bundang Hospital | Seongnam-si, 13605, Korea, Republic of Recruiting
Korea University Anam Hospital | Seoul, 02841, Korea, Republic of Recruiting
Seoul National University Hospital | Seoul, 03080, Korea, Republic of Recruiting
Severance Hospital, Yonsei University Health System | Seoul, 03722, Korea, Republic of Recruiting
Asan Medical Center | Seoul, 05505, Korea, Republic of Active, not recruiting
Gangnam Severance Hospital | Seoul, 06273, Korea, Republic of Recruiting
Samsung Medical Center | Seoul, 06351, Korea, Republic of Recruiting
Seoul St Mary's Hospital | Seoul, 06591, Korea, Republic of Recruiting
Korea University Guro Hospital | Seoul, 08308, Korea, Republic of Recruiting
Investigacion Oncofarmaceutica | La Paz, BAJA California SUR, 23040, Mexico Recruiting
Health Pharma Professional Research | Cdmx, Mexico CITY (federal District), 03100, Mexico Recruiting
Centro Medico Dalinde | Cdmx, Mexico CITY (federal District), 06760, Mexico Recruiting
Christus Muguerza Clinica Vidriera | Monterrey, Nuevo LEON, 64570, Mexico Recruiting
Centro de Investigacion Clinica de Oaxaca | Oaxaca de Juárez, Oaxaca, 68020, Mexico Recruiting
Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios | Distrito Federal, 14000, Mexico Not yet recruiting
Auckland City Hospital, Cancer and Blood Research | Auckland, 1023, New Zealand Recruiting
Tauranga Hospital, Clinical Trials Unit; BOP Clinical School | Tauranga, 3112, New Zealand Recruiting
Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej | Bialystok, 15-027, Poland Recruiting
Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii | Gdańsk, 80-214, Poland Not yet recruiting
Narodowy Instytut Onkologii Odział w Gliwicach; Centrum Diagnostyki i Leczenia Chorób Piersi | Gliwice, 44-102, Poland Not yet recruiting
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii | Kraków, 30-688, Poland Recruiting
Wielkopolskie Centrum Onkologii; Oddzial Chemioterapii | Poznan, 61-866, Poland Recruiting
Centrum Onkologii Instytut im.M. Sklodowskiej-Curie; Klin. Nowot. Piersii i Chirurgii Rekonstruk | Warszawa, 02-781, Poland Recruiting
Hospital de Santa Maria; Servico de Oncologia Medica | Lisboa, 1649-035, Portugal Not yet recruiting
Hospital Beatriz Angelo; Departamento de Oncologia | Loures, 2674-514, Portugal Recruiting
Centro Hospitalar do Porto - Hospital de Santo António; Oncologia | Porto, 4099-001, Portugal Not yet recruiting
IPO do Porto; Servico de Oncologia Medica | Porto, 4200-072, Portugal Recruiting
Filantropia Clinical Hospital; Medical oncology | Bucuresti, 021164, Romania Not yet recruiting
Prof.dr. Alexandru Trestioreanu, The Oncology Institute; Medical oncology I | Bucuresti, 022328, Romania Not yet recruiting
Amethyst Cluj; Medical Oncology | Cluj County, 407280, Romania Not yet recruiting
Cluj-Napoca Emergency Clinical County Hospital; Medical Oncology | Cluj-Napoca, 400006, Romania Not yet recruiting
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca; Radioterapie I - Oncologie | Cluj-Napoca, 400015, Romania Not yet recruiting
Sf. Nectarie Oncology Center; Medical oncology | Craiova, 200347, Romania Recruiting
Oncomed SRL | Timisoara, 300239, Romania Not yet recruiting
Republican Clinical Oncological Dispensary of the Ministry of Healthcare; Chemotherapy department | Kazan, Karelija, 420029, Russian Federation Not yet recruiting
FSBI"National Medical Research Center of Oncology named after N.N.Petrov" MHRF | St Petersburg, Leningrad, 197758, Russian Federation Recruiting
MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy | Moscow, Moskovskaja Oblast, 143422, Russian Federation Recruiting
SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM" | Moskva, Moskovskaja Oblast, 111123, Russian Federation Not yet recruiting
Nizhny Novgorod Regional Clinical Oncology Center | Nizhny Novgorod, Niznij Novgorod, 603126, Russian Federation Recruiting
Medical Clinic "AB Medical group" | Saint Petersburg, Sankt Petersburg, Russian Federation Not yet recruiting
SBIH Kaluga Region Clinical Oncology Dispensary | Kaluga, 248007, Russian Federation Not yet recruiting
Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy | Krasnoyarsk, 660133, Russian Federation Not yet recruiting
Oncology Dispensary#1; Out-Patient Oncology Dept | Moscow, 105005, Russian Federation Not yet recruiting
FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF | Moscow, 115478, Russian Federation Recruiting
LLC Medical and Sanitary Unit "Clinician" | Novosibirsk, 630099, Russian Federation Recruiting
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological) | Saint-Petersburg, 197758, Russian Federation Not yet recruiting
SBI of Healthcare Samara Regional Clinical Oncology Dispensary | Samara, 443031, Russian Federation Not yet recruiting
State Healthcare Institution "Regional Clinical Oncology Dispensary" | Saratov, 410053, Russian Federation Not yet recruiting
SBI of Healthcare Leningrad Regional Oncology Dispensary | St Petersburg, 191104, Russian Federation Not yet recruiting
Regional Oncology Dispensary | Tomsk, 634063, Russian Federation Recruiting
Regional Clinical Oncology Hospital | Yaroslavl, 150040, Russian Federation Recruiting
National University Hospital; National University Cancer Institute, Singapore (NCIS) | Singapore, 119228, Singapore Not yet recruiting
National Cancer Centre; Medical Oncology | Singapore, 169610, Singapore Recruiting
Hospital General Universitario de Elche; Servicio de Oncologia | Elche, Alicante, 03203, Spain Not yet recruiting
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia | Badalona, Barcelona, 08916, Spain Not yet recruiting
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia | Sabadell, Barcelona, 8208, Spain Recruiting
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia | A Coruña, LA Coruña, 15006, Spain Recruiting
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia | Santiago de Compostela, LA Coruña, 15706, Spain Recruiting
Hospital Quiron de Madrid; Servicio de Oncologia | Pozuelo de Alarcon, Madrid, 28223, Spain Recruiting
Hospital Alvaro Cunqueiro; Servicio de Oncologia | Vigo, Pontevedra, 36213, Spain Not yet recruiting
Hospital Universitario de Canarias;servicio de Oncologia | La Laguna, Tenerife, 38320, Spain Recruiting
Hospital de Basurto; Servicio de Oncologia | Bilbao, Vizcaya, 48013, Spain Recruiting
Hospital del Mar; Servicio de Oncologia | Barcelona, 08003, Spain Not yet recruiting
Hospital Univ Vall d'Hebron; Servicio de Oncologia | Barcelona, 08035, Spain Not yet recruiting
Hospital Clinic Barcelona; Servicio de oncologia | Barcelona, 08036, Spain Recruiting
Hospital Universitario Clínico San Cecilio; Servicio de oncologia | Granada, 18016, Spain Recruiting
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia | Jaen, 23007, Spain Recruiting
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia | Madrid, 28007, Spain Recruiting
Hospital Ramon y Cajal; Servicio de Oncologia | Madrid, 28034, Spain Not yet recruiting
Hospital Clinico San Carlos; Servicio de Oncologia | Madrid, 28040, Spain Not yet recruiting
Hospital Universitario La Paz; Servicio de Oncologia | Madrid, 28046, Spain Not yet recruiting
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia | Malaga, 29010, Spain Recruiting
Hospital Clinico Universitario de Salamanca; Servicio de Oncologia | Salamanca, 37007, Spain Recruiting
Hospital Universitario Virgen Macarena; Servicio de Oncologia | Sevilla, 41009, Spain Recruiting
Hospital Universitario Virgen del Rocio; Servicio de Oncologia | Sevilla, 41013, Spain Recruiting
Hospital Clínico Universitario de Valencia; Servicio de Oncología | Valencia, 46010, Spain Not yet recruiting
Hospital Universitario Dr. Peset; Servicio de Oncologia | Valencia, 46017, Spain Not yet recruiting
Hospital Universitario Miguel Servet; Servicio Oncologia | Zaragoza, 50009, Spain Not yet recruiting
China Medical University Hospital; Surgery | Taichung, 404, Taiwan Not yet recruiting
National Cheng Kung Uni Hospital; Dept of Hematology and Oncology | Tainan, 704, Taiwan Not yet recruiting
National Taiwan University Hospital ; Dept of Surgery & Hepatitis Research Center | Taipei 100, 100, Taiwan Not yet recruiting
Taipei Veterans General Hospital; Department of Clinical Trial Pharmacy | Taipei, 00112, Taiwan Recruiting
Mackay Memorial Hospital; Dept of Surgery | Taipei, 104, Taiwan Not yet recruiting
Chulalongkorn Hospital; Medical Oncology | Bangkok, 10330, Thailand Recruiting
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc | Bangkok, 10400, Thailand Recruiting
Srinagarind Hospital; Department of Surgery | Khon Kaen, 40002, Thailand Recruiting
Songklanagarind Hospital; Department of Surgery | Songkla, 90110, Thailand Recruiting
Adana Baskent University Hospital; Medical Oncology | Adana, 01120, Turkey Not yet recruiting
Hacettepe University Medical Faculty | Ankara, 06100, Turkey Not yet recruiting
Ankara City Hospital | Ankara, 06490, Turkey Not yet recruiting
Memorial Ankara Hastanesi | Ankara, 06520, Turkey Not yet recruiting
Antalya Training and Research Hospital ; Oncology Department | Antalya, 07100, Turkey Not yet recruiting
Ege University Medical Faculty; Medical Oncology Department | Bornova, İ̇zmi̇r, 35100, Turkey Not yet recruiting
Dicle University Faculty of Medicine | Diyarbakir, 21280, Turkey Not yet recruiting
Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi | Edirne, 22030, Turkey Not yet recruiting
Istanbul Faculty of Medicine | Istanbul, 34093, Turkey Not yet recruiting
Istanbul University Cerrahpasa Faculty of Medicine | Istanbul, 34098, Turkey Not yet recruiting
Acıbadem Altunizade Hastanesi; Oncology | Istanbul, 34662, Turkey Not yet recruiting
Katip Celebi University Ataturk Training and Research Hospital; Oncology | Izmir, 35360, Turkey Not yet recruiting
Medeniyet University Goztepe Training and Research Hospital. | Kadiköy, 34722, Turkey Not yet recruiting
Inonu University Medical Faculty of Medicine; Medical Oncology Department | Malatya, 44280, Turkey Not yet recruiting
Uganda Cancer Institute | Kampala, 99999, Uganda Not yet recruiting
Uzhgorod Central City Clinical Hospital | Uzhhorod, Katerynoslav Governorate, 88000, Ukraine Not yet recruiting
Municipal Noncommercial Institution Regional Center of Oncology | Kharkiv, Kharkiv Governorate, 61070, Ukraine Recruiting
Municipal non profit enterprise of Sumy Regional Council Sumy Regional Clinical Oncology Disp | Sumy, Kholm Governorate, 40005, Ukraine Not yet recruiting
MI "Clinical Oncological Dispensary" of Dnipro Reg Council; chemotherapy department | Dnipro, KIEV Governorate, 49100, Ukraine Not yet recruiting
Innovacia Cancer Center | Liutizh, KIEV Governorate, 07352, Ukraine Recruiting
Municipal Institution Odesa Regional Oncology Dispensary | Odesa, KIEV Governorate, 65055, Ukraine Not yet recruiting
CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC SI Dnipropetrovsk MA of MOHU Ch of Oncology and MR | Dnipropetrovsk, 49102, Ukraine Not yet recruiting
Municipal Institution Kirovograd Regional Oncology Dispensary | Kirovograd, 25011, Ukraine Not yet recruiting
Kyiv City Clinical Oncological Center | Kyiv, 03115, Ukraine Not yet recruiting
Belfast City Hospital | Belfast, BT9 7AB, United Kingdom Not yet recruiting
Blackpool Victoria Hospital | Blackpool, FY3 8NR, United Kingdom Recruiting
Bradford Royal Infirmary; Oncology Department | Bradford, BD9 6RJ, United Kingdom Not yet recruiting
Royal Sussex County Hospital | Brighton, BN2 5BE, United Kingdom Recruiting
Addenbrookes Hospital | Cambridge, CB2 0QQ, United Kingdom Not yet recruiting
Velindre Cancer Centre; Clinical Trials Unit | Cardiff, CF14 2TL, United Kingdom Not yet recruiting
Cheltenham General Hospital | Cheltenham, GL53 7AN, United Kingdom Recruiting
Hairmyres Hospital | East Kilbride, G75 8RG, United Kingdom Not yet recruiting
Raigmore Hospital | Inverness, IV2 3UV, United Kingdom Not yet recruiting
Barts & London School of Med; Medical Oncology | London, EC1A 7BE, United Kingdom Not yet recruiting
University College London Hospital | London, NW1 - 2PG, United Kingdom Recruiting
Royal Free Hospital | London, NW3 2QS, United Kingdom Not yet recruiting
Royal Marsden Hospital - London | London, SW3 6JJ, United Kingdom Not yet recruiting
Christie Hospital NHS Trust | Manchester, M20 4BX, United Kingdom Recruiting
Mount Vernon Cancer Centre | Northwood, HA6 2RN, United Kingdom Not yet recruiting
Nottingham City Hospital | Nottingham, NG5 1PB, United Kingdom Recruiting
Royal Preston Hospital | Preston, PR2 9HT, United Kingdom Recruiting
Glan Clywd Hospital | Rhyl, LL18 5UJ, United Kingdom Recruiting
Musgrove Park Hospital | Somerset, TA1 5DA, United Kingdom Not yet recruiting
Royal Marsden Hospital - Surrey | Surrey, SM2 5PT, United Kingdom Not yet recruiting
Royal Cornwall Hospital; Dept of Clinical Oncology | Truro, TR1 3LJ, United Kingdom Active, not recruiting
Walsall Manor Hospital | Walsall, WS2 9PS, United Kingdom Not yet recruiting
Расположение Страны

Australia

Austria

Belgium

Brazil

Bulgaria

China

Czechia

Denmark

France

Germany

Greece

Hong Kong

Hungary

India

Italy

Kenya

Korea, Republic of

Mexico

New Zealand

Poland

Portugal

Romania

Russian Federation

Singapore

Spain

Taiwan

Thailand

Turkey

Uganda

Ukraine

United Kingdom

United States

Дата проверки

2021-09-01

Ответственная сторона

Тип: Спонсор

Имеет расширенный доступ Нет
Количество рук 2
Группа вооружений

Метка: Arm A: Placebo + Trastuzumab Emtansine

Тип: Active Comparator

Описание: Participants will receive an intravenous (IV) infusion of placebo prior to the IV infusion of trastuzumab emtansine on Day 1 of each 21-day cycle for a total of 14 cycles.

Метка: Группа B: атезолизумаб + трастузумаб эмтанзин

Тип: Экспериментальный

Описание: Участники получат внутривенную инфузию атезолизумаба перед внутривенной инфузией трастузумаба эмтанзина в день 1 каждого 21-дневного цикла, всего 14 циклов.

Акроним Astefania
Информация о дизайне исследования

Распределение: Рандомизированный

Модель вмешательства: Параллельное присвоение

Первичное назначение: Уход

Маскировка: Двойник (участник, исследователь)