Astefania: A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04873362
Collaborator
(none)
1,700
296
2
161.7
5.7
0

Study Details

Study Description

Brief Summary

This is a Phase III, two-arm, randomized, double-blind placebo-controlled study in participants with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease in the breast and/or axillary lymph nodes.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1700 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy
Actual Study Start Date :
May 4, 2021
Anticipated Primary Completion Date :
Dec 18, 2025
Anticipated Study Completion Date :
Oct 26, 2034

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm A: Placebo + Trastuzumab Emtansine

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.

Drug: Trastuzumab Emtansine
Trastuzumab emtansine will be administered at a dose of 3.6 mg/kg Q3W for 14 weeks.
Other Names:
  • Kadcyla, T-DM1, RO5304020
  • Drug: Placebo
    Placebo matched to atezolizumab will be administered at a dose of 1200 mg Q3W for 14 cycles.

    Drug: Trastuzumab
    Trastuzumab will be used to complete 14 cycles of study treatment if trastuzumab emtansine is discontinued for toxicity not considered to be related to the trastuzumab component of the drug.
    Other Names:
  • Herceptin
  • Experimental: Arm B: Atezolizumab + Trastuzumab Emtansine

    Participants will receive an IV infusion of atezolizumab prior to the IV infusion of trastuzumab emtansine on Day 1 of each 21-day cycle for a total of 14 cycles.

    Drug: Atezolizumab
    Atezolizumab will be administered at a dose of 1200 mg every three weeks (Q3W) for 14 cycles.
    Other Names:
  • Tecentriq, RO5541267, MPDL3280A
  • Drug: Trastuzumab Emtansine
    Trastuzumab emtansine will be administered at a dose of 3.6 mg/kg Q3W for 14 weeks.
    Other Names:
  • Kadcyla, T-DM1, RO5304020
  • Drug: Trastuzumab
    Trastuzumab will be used to complete 14 cycles of study treatment if trastuzumab emtansine is discontinued for toxicity not considered to be related to the trastuzumab component of the drug.
    Other Names:
  • Herceptin
  • Outcome Measures

    Primary Outcome Measures

    1. Invasive Disease-free Survival (IDFS) [From randomization up to approximately 6 years]

      IDFS event is defined as the time from randomization to the first occurrence of the following events: ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, contralateral invasive breast cancer, distant recurrence, death from any cause.

    Secondary Outcome Measures

    1. IDFS Including Second Primary Non-breast Invasive Cancer [From baseline up to 10 years]

    2. Disease-free Survival (DFS) [From baseline up to 10 years]

    3. Overall Survival (OS) [From baseline up to 10 years]

    4. Distant Recurrence-free Interval (DRFI) [From baseline up to 10 years]

    5. Number of Participants with Clinically Meaningful Deterioration in Global Health Status/Quality of Life (GHS/QoL) Physical, Role, and Cognitive Function [From baseline until 2 years after study treatment completion/discontinuation visit (approximately 3 years)]

      Clinically Meaningful Deterioration will be Measured by Scales of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer (EORTC QLQ C30)

    6. Mean Absolute Scores in GHS/QoL, Physical, Role, and Cognitive Function, as Assessed Using the EORTC QLQ-C30 [From baseline until 2 years after study treatment completion/discontinuation visit (approximately 3 years)]

      The European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30) is a self-reported measure. Functioning and symptoms items are scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. GHS and QoL items are scored on a 7-point scale: 1=Very poor, 2, 3, 4, 5, 6, 7=Excellent. Scores will be transformed to a range of 0 to 100, with higher scores (i.e. closer to 100) reflecting better functioning, better GHS/QoL, and worse symptoms.

    7. Mean Change From Baseline Scores in GHS/QoL, Physical, Role, and Cognitive Function, as Assessed Using the EORTC QLQ-C30 [From baseline until 2 years after study treatment completion/discontinuation visit (approximately 3 years)]

      The European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30) is a self-reported measure. Functioning and symptoms items are scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. GHS and QoL items are scored on a 7-point scale: 1=Very poor, 2, 3, 4, 5, 6, 7=Excellent. Scores will be transformed to a range of 0 to 100, with higher scores (i.e. closer to 100) reflecting better functioning, better GHS/QoL, and worse symptoms.

    8. Percentage of Participants with Adverse Events (AEs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0) [From baseline up to 10 years]

    9. Maximum Serum Concentrations (Cmax) for Atezolizumab [Day 1 of Cycles 1 and 4 pre-infusion, Day 1 of Cycles 1 and 4 after 30 minutes post-infusion, Day 1 of Cycles 2, 3 and 8 pre-infusion (cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after Cycle 1 Day 1)]

    10. Cmax for Trastuzumab Emtansine [Day 1 of Cycles 1 and 4 pre-infusion, Day 1 of Cycles 1 and 4 after 30 minutes post-infusion, (cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after Cycle 1 Day 1)]

    11. Cmax for Total Trastuzumab [Day 1 of Cycles 1 and 4 pre-infusion, Day 1 of Cycles 1 and 4 after 30 minutes post-infusion, (cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after Cycle 1 Day 1)]

    12. Cmax for DM1 [Day 1 of Cycles 1 and 4 pre-infusion, Day 1 of Cycles 1 and 4 after 30 minutes post-infusion, (cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after Cycle 1 Day 1)]

      DM1 = a thiol-containing maytansinoid anti-microtubule agent; N2'-deacetyl-N2'-(3-mercapto-1-oxopropyl)-maytansine

    13. Minimum Serum Concentrations (Cmin) for Atezolizumab [Day 1 of Cycles 1 and 4 pre-infusion, Day 1 of Cycles 1 and 4 after 30 minutes post-infusion, Day 1 of Cycles 2, 3 and 8 (cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after Cycle 1 Day 1)]

    14. Percentage of Participants with Anti-drug Antibodies (ADAs) to Atezolizumab [Day 1 of Cycles 1 and 4 pre-infusion, Day 1 of Cycles 1 and 4 after 30 minutes post-infusion, Day 1 of Cycles 2, 3 and 8 (cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after Cycle 1 Day 1)]

    15. Percentage of Participants with ADAs to Trastuzumab Emtansine [Day 1 of Cycles 1 and 4 pre-infusion, Day 1 of Cycles 1 and 4 after 30 minutes post-infusion, (cycle=21 days) and at study treatment completion/discontinuation visit (approximately 11 months after Cycle 1 Day 1)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Histologically confirmed invasive breast carcinoma

    • Centrally-confirmed human epidermal growth factor receptor 2 (HER2)-positive invasive breast cancer

    • Centrally confirmed PD-L1 and hormone receptor status

    • Clinical stage at disease presentation: cT4/anyN/M0, any cT/N2-3/M0, or cT1-3/N0-1/M0 (participants with cT1mi/T1a/T1b/N0 are not eligible)

    • Completion of pre-operative systemic chemotherapy including at least 9 weeks of taxane and 9 weeks of trastuzumab (anthracycline and/or additional HER2-targeted agents are permitted)

    • <=12 weeks between primary surgery and randomization

    • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

    • Screening left ventricular ejection fraction (LVEF) >= 50% and no decrease in LVEF by

    15% from the pre-chemotherapy LVEF. If no pre-chemotherapy LVEF, screening LVEF >= 55%

    • Life expectancy >= 6 months

    • Adequate hematologic and end organ function

    Exclusion Criteria:
    • Stage IV breast cancer

    • An overall response of disease progression according to the investigator at the conclusion of preoperative systemic therapy

    • Prior treatment with T-DM1, or atezolizumab, or other immune checkpoint inhibitors

    • History of exposure to various cumulative doses of anthracyclines

    • History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or ductal carcinoma in situ (DCIS)

    • Current grade >=2 peripheral neuropathy

    • History of idiopathic pulmonary fibrosis, organizing pneumonia, or pneumonitis

    • History of or active autoimmune disease or immune deficiency

    • Treatment with immunostimulatory or immunosuppressive agents

    • Cardiopulmonary dysfunction

    • Any known active liver disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alabama Oncology Alabaster Alabama United States 35007
    2 Roy and Patricia Disney Family Cancer Center- Providence Saint Joseph Medical Center Burbank California United States 91505
    3 California Cancer Associate for Research & Excellence Fresno California United States 93720
    4 Glendale Adventist Medical Ctr Glendale California United States 91206
    5 UCLA Medical Center Santa Monica California United States 90404
    6 Innovation Clinical Research Institute Whittier California United States 90603
    7 Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy) Jacksonville Florida United States 32256
    8 Florida Cancer Specialists West Palm Beach Florida United States 33401
    9 University Cancer & Blood Center, LLC; Research Athens Georgia United States 30607
    10 Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital Carrollton Georgia United States 30117
    11 Elmhurst Memorial Healthcare Elmhurst Illinois United States 60126
    12 Edward Cancer Center Naperville Naperville Illinois United States 60540
    13 Edward Cancer Center Plainfield Plainfield Illinois United States 60585
    14 University of Iowa Iowa City Iowa United States 52242
    15 Pontchartrain Cancer Center Covington Louisiana United States 70433
    16 New England Cancer Specialists Scarborough Maine United States 04074
    17 University of Maryland Medical Center Baltimore Maryland United States 21201
    18 Mercy Medical Center Baltimore Maryland United States 21202
    19 Henry Ford Health System; Dept of Transplantation Surgery Detroit Michigan United States 48202-2689
    20 Jackson Oncology Associates, PLLC Jackson Mississippi United States 39202
    21 Central Care Cancer Center; NC Bolivar Missouri United States 65613
    22 Cooper Cancer Institute Camden New Jersey United States 08103
    23 MD Anderson Cancer Center at Cooper Camden New Jersey United States 08103
    24 Jersey Shore University Medical Centre Neptune New Jersey United States 07753
    25 The Valley Hospital Paramus New Jersey United States 07652
    26 Mount Sinai Medical Center New York New York United States 10029
    27 Great Lakes Cancer Center Williamsville New York United States 14221
    28 Messino Cancer Centers Asheville North Carolina United States 28806
    29 Providence Health & Services - Oregon Portland Oregon United States 97213
    30 Abramson Cancer Center; Univ of Pennsylvania; Clinical Research Unit Philadelphia Pennsylvania United States 19106
    31 Lankenau Hospital Wynnewood Pennsylvania United States 19096
    32 Charleston Oncology, P .A Charleston South Carolina United States 29414
    33 Avera Cancer Institute Sioux Falls South Dakota United States 57105
    34 SCRI Tennessee Oncology Chattanooga Chattanooga Tennessee United States 37404
    35 The West Clinic; West Cancer Center Germantown Tennessee United States 38138
    36 Thompson Cancer Survival Center Knoxville Tennessee United States 37916-2305
    37 Tennessee Oncology; Sarah Cannon Research Institute Nashville Tennessee United States 37203
    38 Joe Arrington Cancer Research & Treatment Center Lubbock Texas United States 79410
    39 Mays Cancer Center at UT Health San Antonio MD Anderson Cancer San Antonio Texas United States 78229
    40 Hematology Oncology Associates of Fredericksburg, Inc. Fredericksburg Virginia United States 22408
    41 Virginia Oncology Associates - New Port News Newport News Virginia United States 23606
    42 Virginia Oncology Associates Norfolk Virginia United States 23502
    43 Virginia Cancer Institute Richmond Virginia United States 23229
    44 Virginia Oncology Associates - Virginia Beach Virginia Beach Virginia United States 23456
    45 Providence Regional Cancer Partnership Everett Washington United States 98201
    46 Kadlec Regional Medical Center Kennewick Washington United States 99336
    47 Northwest Medical Specialties Tacoma Washington United States 98405
    48 Macarthur Cancer Therapy Centre Campbelltown New South Wales Australia 2560
    49 Kinghorn Cancer Centre; St Vincents Hospital Darlinghurst New South Wales Australia 2010
    50 Royal North Shore Hospital; Department of Medical Oncology St Leonards New South Wales Australia 2065
    51 Princess Alexandra Hospital; Cancer Trials Unit Woolloongabba Queensland Australia 4102
    52 Peter MacCallum Cancer Centre; Medical Oncology Melbourne Victoria Australia 3000
    53 Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie Innsbruck Austria 6020
    54 Ordensklinikum Linz Barmherzige Schwestern; Interne 1 - Hämato-Onkologie Linz Austria 4010
    55 Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt. Salzburg Austria 5020
    56 AKH - Medizinische Universität Wien; Department of Oncology Vienna Austria 1090
    57 Cliniques Universitaires St-Luc Bruxelles Belgium 1200
    58 Jessa Zkh (Campus Virga Jesse) Hasselt Belgium 3500
    59 Clinique St. Elizabeth Namur Belgium 5000
    60 Hospital Sao Rafael - HSR Salvador BA Brazil 41253-190
    61 Crio - Centro Regional Integrado de Oncologia Fortaleza CE Brazil 60336-550
    62 Hospital Araujo Jorge; Departamento de Ginecologia E Mama Goiania GO Brazil 74605-070
    63 Hospital Nossa Senhora da Conceicao Porto Alegre RS Brazil 91350-200
    64 Hospital de Base de Sao Jose do Rio Preto Sao Jose do Rio Preto SP Brazil 15090-000
    65 Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda Sao Paulo SP Brazil 01317-001
    66 Núcleo de Pesquisa São Camilo; ONCOLOGIA CLINICA / QUIMIOTERAPIA Sao Paulo SP Brazil 04014-002
    67 COC Plovdiv; First Medical Oncology Department Plovdiv Bulgaria 4004
    68 Medical Center "Nadezhda Clinical" EOOD; Medical Oncology Department Sofia Bulgaria 1330
    69 University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD Sofia Bulgaria 1527
    70 Sichuan Cancer Hospital Chengdu City China 610041
    71 West China Hospital - Sichuan University Chengdu City China 610047
    72 Chongqing Cancer Hospital Chongqing China 400030
    73 The First Affilicated Hospital, Sun Yat-sen University Guangzhou City China 510080
    74 Guangdong Provincial People's Hospital; Breast Guangzhou City China 510180
    75 Sun Yat-sen Memorial Hospital Guangzhou China 510000
    76 Harbin Medical University Cancer Hospital Harbin China 150081
    77 Zhongshan Hospital Fudan University Shanghai China 200032
    78 Tianjin Medical University Cancer Institute & Hospital Tianjing China 300060
    79 Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan City China 430023
    80 First Affiliated Hospital of Medical College of Xi'an Jiaotong University Xi'an China 710061
    81 Zhejiang Cancer Hospital Zhejiang China 310022
    82 Henan Cancer Hospital Zhengzhou China 450008
    83 Masarykův onkologický ústav; Klinika komplexní onkologické péče Brno Czechia 656 53
    84 Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology Hradec Kralove Czechia 500 05
    85 Nemocnice AGEL Novy Jicin a.s.; Oddeleni radioterapie a onkologie Novy Jicin Czechia 741 01
    86 Fakultni nemocnice Olomouc; Onkologicka klinika Olomouc Czechia 779 00
    87 Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika Praha 2 Czechia 128 08
    88 Thomayerova nemocnice; Onkologicka klinika 1. LF UK A TN Praha 4 - Krc Czechia 140 59
    89 Fakultni nemocnice v Motole; Onkologicka klinika 2. LF UK a FN Motol Praha 5 Czechia 150 06
    90 Herlev Hospital; Afdeling for Kræftbehandling Herlev Denmark 2730
    91 Vejle Sygehus; Onkologisk Afdeling Vejle Denmark 7100
    92 Institut Sainte Catherine Avignon France 84082
    93 CHRU Besançon Besançon France 25030
    94 Polyclinique Bordeaux Nord Aquitaine Bordeaux France 33300
    95 Hopital Morvan Brest France 29200
    96 Centre Francois Baclesse; Comite Sein Caen France 14076
    97 Groupe Hospitalier Public Du Sud De L'Oise GHPSO; Oncologie Creil Cedex 1 France 60109
    98 CLCC Leon Berard Lyon Lyon France 69008
    99 Centre Hospitalier Uni Ire Caremeau; Radiotherapie & Oncologie Nimes France 30029
    100 Groupe Hospitalier Diaconesses Paris France 75020
    101 Institut Curie; Oncologie Medicale Paris France 75231
    102 Pole Regional De Cancerologie Poitiers France 86021
    103 HOPITAL RENE HUGUENIN, Institut Curie; Service d'Oncologie Médicale. Saint-Cloud France 92210
    104 Klinikum Augsburg; Frauenklinik Augsburg Germany 86156
    105 Gemeinschaftspraxis für Hämatologie und Onkologie Dr. Reichert/Dr.Janssen Aurich Germany 26603
    106 Hochtaunus-Kliniken gGmbH; Krankenhaus Bad Homburg; Frauenklinik Bad Homburg vdH Germany 61352
    107 Hochwaldkrankenhaus; Abt.Gynäkologie Geburtshilfe u.Senologie Bad Nauheim Germany 61231
    108 Onkologische Schwerpunktpraxis Kurfürstendamm Berlin Germany 10707
    109 Vivantes Klinikum Am Urban; Zentrum für Brusterkrankungen Berlin Germany 10967
    110 Gynäkologisches Zentrum Bonn Bonn Germany 53111
    111 Marienhospital Bottrop Bottrop Germany 46236
    112 Städtisches Klinikum Dessau Dessau-Roßlau Germany 06847
    113 Gynonco Düsseldorf, MVZ Medical Center GmbH Düsseldorf Germany 40235
    114 Frauenarztpraxis Dr. Apel, Dr. Kolpin Erfurt Germany 99084
    115 Universitätsklinikum Erlangen; Frauenklinik Erlangen Germany 91054
    116 Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum Essen Germany 45136
    117 AGAPLESION Markus-Krankenhaus Frankfurt Germany 60431
    118 Klinik Johann Wolfgang von Goethe Uni; Klinik für Frauenheilkunde und Geburtshilfe Frankfurt Germany 60596
    119 Praxis für Interdisziplinäre Onkologie und Hämatologie GbR Freiburg Germany 79110
    120 St. Barbara-Klinik Hamm-Heessen GmbH; Frauenklinik Hamm Germany 59073
    121 Diakovere Henriettenstift, Frauenklinik Hannover Germany 30559
    122 Städtisches Klinikum Karlsruhe gGmbH; Frauenklinik Karlsruhe Germany 76133
    123 UNI-Klinikum Campus Kiel Klinik für Gynäkologie und Geburtshilfe Kiel Germany 24105
    124 Universitätsklinikum Leipzig; Klinik und Poliklinik für Frauenheilkunde Leipzig Germany 04103
    125 Städtische Klinik Lüneburg; Frauenklinik Lüneburg Germany 21339
    126 Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt München Germany 80337
    127 Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe Offenbach Germany 63069
    128 Klinikum Ernst von Bergmann; Frauenklinik Potsdam Germany 14467
    129 Klinikum am Steinenberg Frauenklinik Reutlingen Germany 72764
    130 Leopoldina Krankenhaus der Stadt Schweinfurt GmbH Schweinfurt Germany 97422
    131 Johanniter-Krankenhaus Genthin-Stendal; Klinik Für Frauenheilkunde & Geburtshilfe Stendal Germany 39576
    132 Metropolitan General Hospital Cholargos Greece 155 62
    133 University General Hospital of Heraklion Crete Greece 711 10
    134 University Hospital of Larissa;Department of Medical Oncology Larissa Greece 411 10
    135 Metropolitan Hospital; 2Nd Oncology Clinic Piraeus Greece 185 47
    136 Euromedical General Clinic of Thessaloniki; Oncology Department Thessaloniki Greece 546 45
    137 Queen Mary Hospital; Surgery Hong Kong Hong Kong 852
    138 Pamela Youde Nethersole Eastern Hospital; Clinical Oncology Hong Kong Hong Kong
    139 Tuen Mun Hospital; Clinical Oncology Hong Kong Hong Kong
    140 Honvédelmi Minisztérium Állami Egészségügyi Központ; Onkológiai Osztály; Oncology department Budapest Hungary 1062
    141 Orszagos Onkologiai Intezet; B Belgyogyaszati Osztaly Budapest Hungary 1122
    142 Debreceni Egyetem Klinikai Kozpont ; Department of Oncology Debrecen Hungary 4032
    143 Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly Miskolc Hungary 3501
    144 Rajiv Gandhi Cancer Institute & Research Center New Delhi Delhi India 110085
    145 Max Super Speciality Hospital; Medical Oncology North WEST Delhi Delhi India 110088
    146 Hemato Oncology Clinic Ahmedabad Pvt Ltd Ahmadabad Gujarat India 380054
    147 Manipal Hospital; Department of Oncology Bangalore Karnataka India 560017
    148 Tata Memorial Hospital; Dept of Medical Oncology Mumbai Maharashtra India 400012
    149 HCG Manavata Cancer Centre Nashik Maharashtra India 422002
    150 Sahyadri Super Specialty Hospital Hadapsar Pune Maharashtra India 411028
    151 TATA Medical Centre; Medical Oncology Kolkata WEST Bengal India 700156
    152 Christian Med Clg & Hspt Vellore India 632004
    153 AORN'S.G.Moscati; Oncologia Avellino Campania Italy 83100
    154 U.O.C. Oncologia Medica Senologica Napoli Campania Italy 80131
    155 Università degli Studi Federico II; Clinica di Oncologia Medica Napoli Campania Italy 80131
    156 Policlinico S.Orsola-Malpighi; Istituto Oncologia R. Addarii Bologna Emilia-Romagna Italy 40138
    157 A.O. Universitaria Policlinico Di Modena; Oncologia Modena Emilia-Romagna Italy 41100
    158 Irccs Centro Di Riferimento Oncologico (CRO) Aviano Friuli-Venezia Giulia Italy 33081
    159 ASU FC S. M. DELLA MISERICORDIA; Oncologia Udine Friuli-Venezia Giulia Italy 33100
    160 Policlinico Universitario Agostino Gemelli Roma Lazio Italy 00168
    161 ASST DEGLI SPEDALI CIVILI DI BRESCIA; Oncologia Medica Brescia Lombardia Italy 25123
    162 Ospedale San Raffaele; Medical Oncology Milano Lombardia Italy 20132
    163 Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1 Milano Lombardia Italy 20133
    164 Ospedale Civile - Livorno Livorno Toscana Italy 57124
    165 Azlenda Ospendaliero-Universitaria Pisana; C.O. Oncologia 2 Pisa Toscana Italy 56100
    166 University of Eastern Piedmont - Maggiore della Carità University Hospital Novara Umbria Italy 28100
    167 IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda Padova Veneto Italy 35128
    168 Kyungpook National University Medical Center Daegu Korea, Republic of 41404
    169 National Cancer Center Goyang-si Korea, Republic of 10408
    170 Seoul National University Bundang Hospital Seongnam-si Korea, Republic of 13605
    171 Korea University Anam Hospital Seoul Korea, Republic of 02841
    172 Seoul National University Hospital Seoul Korea, Republic of 03080
    173 Severance Hospital, Yonsei University Health System Seoul Korea, Republic of 03722
    174 Asan Medical Center Seoul Korea, Republic of 05505
    175 Gangnam Severance Hospital Seoul Korea, Republic of 06273
    176 Samsung Medical Center Seoul Korea, Republic of 06351
    177 Seoul St Mary's Hospital Seoul Korea, Republic of 06591
    178 Korea University Guro Hospital Seoul Korea, Republic of 08308
    179 Investigacion Oncofarmaceutica La Paz BAJA California SUR Mexico 23040
    180 Health Pharma Professional Research Cdmx Mexico CITY (federal District) Mexico 03100
    181 Centro Medico Dalinde Cdmx Mexico CITY (federal District) Mexico 06760
    182 Christus Muguerza Clinica Vidriera Monterrey Nuevo LEON Mexico 64570
    183 Centro de Investigacion Clinica de Oaxaca Oaxaca de Juárez Oaxaca Mexico 68020
    184 Instituto Nacional De Cancerologia; Oncology; Tumores Mamarios Distrito Federal Mexico 14000
    185 Auckland City Hospital, Cancer and Blood Research Auckland New Zealand 1023
    186 Tauranga Hospital, Clinical Trials Unit; BOP Clinical School Tauranga New Zealand 3112
    187 Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej Bialystok Poland 15-027
    188 Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii Gdańsk Poland 80-214
    189 Narodowy Instytut Onkologii Odział w Gliwicach; Centrum Diagnostyki i Leczenia Chorób Piersi Gliwice Poland 44-102
    190 Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii Kraków Poland 30-688
    191 Wielkopolskie Centrum Onkologii; Oddzial Chemioterapii Poznan Poland 61-866
    192 Centrum Onkologii Instytut im.M. Sklodowskiej-Curie; Klin. Nowot. Piersii i Chirurgii Rekonstruk Warszawa Poland 02-781
    193 Hospital CUF Tejo; Oncologia Médica e Hematologia Lisboa Portugal 1350-352
    194 Hospital de Santa Maria; Servico de Oncologia Medica Lisboa Portugal 1649-035
    195 Hospital Beatriz Angelo; Departamento de Oncologia Loures Portugal 2674-514
    196 Centro Hospitalar do Porto - Hospital de Santo António; Oncologia Porto Portugal 4099-001
    197 IPO do Porto; Servico de Oncologia Medica Porto Portugal 4200-072
    198 Filantropia Clinical Hospital; Medical oncology Bucuresti Romania 021164
    199 Prof.dr. Alexandru Trestioreanu, The Oncology Institute; Medical oncology I Bucuresti Romania 022328
    200 Amethyst Cluj; Medical Oncology Cluj County Romania 407280
    201 Cluj-Napoca Emergency Clinical County Hospital; Medical Oncology Cluj-Napoca Romania 400006
    202 Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca; Radioterapie I - Oncologie Cluj-Napoca Romania 400015
    203 Sf. Nectarie Oncology Center; Medical oncology Craiova Romania 200347
    204 Oncomed SRL Timisoara Romania 300239
    205 Republican Clinical Oncological Dispensary of the Ministry of Healthcare; Chemotherapy department Kazan Karelija Russian Federation 420029
    206 FSBI"National Medical Research Center of Oncology named after N.N.Petrov" MHRF St Petersburg Leningrad Russian Federation 197758
    207 MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy Moscow Moskovskaja Oblast Russian Federation 143422
    208 SBIH "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of DHM" Moskva Moskovskaja Oblast Russian Federation 111123
    209 Nizhny Novgorod Regional Clinical Oncology Center Nizhny Novgorod Niznij Novgorod Russian Federation 603126
    210 Medical Clinic "AB Medical group" Sankt-peterburg Sankt Petersburg Russian Federation 196006
    211 SBIH Kaluga Region Clinical Oncology Dispensary Kaluga Russian Federation 248007
    212 Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky; Chemotherapy Krasnoyarsk Russian Federation 660133
    213 Oncology Dispensary#1; Out-Patient Oncology Dept Moscow Russian Federation 105005
    214 FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF Moscow Russian Federation 115478
    215 LLC Medical and Sanitary Unit "Clinician" Novosibirsk Russian Federation 630099
    216 S-Pb clinical scientific practical center of specialized kinds of medical care (oncological) Saint-Petersburg Russian Federation 197758
    217 SBI of Healthcare Samara Regional Clinical Oncology Dispensary Samara Russian Federation 443031
    218 SBI of Healthcare Leningrad Regional Oncology Dispensary St Petersburg Russian Federation 191104
    219 Regional Oncology Dispensary Tomsk Russian Federation 634063
    220 Regional Clinical Oncology Hospital Yaroslavl Russian Federation 150040
    221 National Cancer Centre; Medical Oncology Singapore Singapore 169610
    222 Hospital General Universitario de Elche; Servicio de Oncologia Elche Alicante Spain 03203
    223 Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia Badalona Barcelona Spain 08916
    224 Corporacio Sanitaria Parc Tauli; Servicio de Oncologia Sabadell Barcelona Spain 8208
    225 Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia A Coruña LA Coruña Spain 15006
    226 Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia Santiago de Compostela LA Coruña Spain 15706
    227 Hospital Quiron de Madrid; Servicio de Oncologia Pozuelo de Alarcon Madrid Spain 28223
    228 Hospital Alvaro Cunqueiro; Servicio de Oncologia Vigo Pontevedra Spain 36213
    229 Hospital Universitario de Canarias;servicio de Oncologia La Laguna Tenerife Spain 38320
    230 Hospital de Basurto; Servicio de Oncologia Bilbao Vizcaya Spain 48013
    231 Hospital del Mar; Servicio de Oncologia Barcelona Spain 08003
    232 Vall d´Hebron Institute of Oncology (VHIO), Barcelona Barcelona Spain 08035
    233 Hospital Clinic Barcelona; Servicio de oncologia Barcelona Spain 08036
    234 Hospital Universitario Clínico San Cecilio; Servicio de oncologia Granada Spain 18016
    235 Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia Jaen Spain 23007
    236 Hospital General Universitario Gregorio Marañon; Servicio de Oncologia Madrid Spain 28007
    237 Hospital Ramon y Cajal; Servicio de Oncologia Madrid Spain 28034
    238 Hospital Clinico San Carlos; Servicio de Oncologia Madrid Spain 28040
    239 Hospital Universitario La Paz; Servicio de Oncologia Madrid Spain 28046
    240 Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia Malaga Spain 29010
    241 Hospital Clinico Universitario de Salamanca; Servicio de Oncologia Salamanca Spain 37007
    242 Hospital Universitario Virgen Macarena; Servicio de Oncologia Sevilla Spain 41009
    243 Hospital Universitario Virgen del Rocio; Servicio de Oncologia Sevilla Spain 41013
    244 Hospital Clínico Universitario de Valencia; Servicio de Oncología Valencia Spain 46010
    245 Hospital Universitario Dr. Peset; Servicio de Oncologia Valencia Spain 46017
    246 Hospital Universitario Miguel Servet; Servicio Oncologia Zaragoza Spain 50009
    247 China Medical University Hospital; Surgery Taichung Taiwan 404
    248 National Cheng Kung Uni Hospital; Dept of Hematology and Oncology Tainan Taiwan 704
    249 National Taiwan University Hospital ; Dept of Surgery & Hepatitis Research Center Taipei 100 Taiwan 100
    250 Taipei Veterans General Hospital; Department of Clinical Trial Pharmacy Taipei Taiwan 00112
    251 Mackay Memorial Hospital; Dept of Surgery Taipei Taiwan 104
    252 Chulalongkorn Hospital; Medical Oncology Bangkok Thailand 10330
    253 Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc Bangkok Thailand 10400
    254 Srinagarind Hospital; Department of Surgery Khon Kaen Thailand 40002
    255 Songklanagarind Hospital; Department of Surgery Songkla Thailand 90110
    256 Adana Baskent University Hospital; Medical Oncology Adana Turkey 01120
    257 Hacettepe University Medical Faculty Ankara Turkey 06100
    258 Ankara City Hospital Ankara Turkey 06490
    259 Memorial Ankara Hastanesi Ankara Turkey 06520
    260 Antalya Training and Research Hospital ; Oncology Department Antalya Turkey 07100
    261 Ege University Medical Faculty; Medical Oncology Department Bornova, İ̇zmi̇r Turkey 35100
    262 Dicle University Faculty of Medicine Diyarbakir Turkey 21280
    263 Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi Edirne Turkey 22030
    264 Istanbul Faculty of Medicine Istanbul Turkey 34093
    265 Istanbul University Cerrahpasa Faculty of Medicine Istanbul Turkey 34098
    266 Katip Celebi University Ataturk Training and Research Hospital; Oncology Izmir Turkey 35360
    267 Medeniyet University Goztepe Training and Research Hospital. Kadiköy Turkey 34722
    268 Inonu University Medical Faculty of Medicine; Medical Oncology Department Malatya Turkey 44280
    269 Acıbadem Altunizade Hastanesi; Oncology Üsküdar Turkey 34662
    270 Uzhgorod Central City Clinical Hospital Uzhhorod Katerynoslav Governorate Ukraine 88000
    271 Municipal Noncommercial Institution Regional Center of Oncology Kharkiv Kharkiv Governorate Ukraine 61070
    272 Municipal non profit enterprise of Sumy Regional Council Sumy Regional Clinical Oncology Disp Sumy Kholm Governorate Ukraine 40005
    273 MI "Clinical Oncological Dispensary" of Dnipro Reg Council; chemotherapy department Dnipro KIEV Governorate Ukraine 49100
    274 Innovacia Cancer Center Liutizh KIEV Governorate Ukraine 07352
    275 CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC SI Dnipropetrovsk MA of MOHU Ch of Oncology and MR Dnipropetrovsk Ukraine 49102
    276 Municipal Institution Kirovograd Regional Oncology Dispensary Kirovograd Ukraine 25011
    277 Kyiv City Clinical Oncological Center Kyiv Ukraine 03115
    278 Belfast City Hospital Belfast United Kingdom BT9 7AB
    279 Blackpool Victoria Hospital Blackpool United Kingdom FY3 8NR
    280 Bradford Royal Infirmary; Oncology Department Bradford United Kingdom BD9 6RJ
    281 Royal Sussex County Hospital Brighton United Kingdom BN2 5BE
    282 Velindre Cancer Centre; Clinical Trials Unit Cardiff United Kingdom CF14 2TL
    283 Cheltenham General Hospital Cheltenham United Kingdom GL53 7AN
    284 Royal Cornwall Hospital; Dept of Clinical Oncology Cornwall United Kingdom TR1 3LQ
    285 Hairmyres Hospital East Kilbride United Kingdom G75 8RG
    286 Raigmore Hospital Inverness United Kingdom IV2 3UV
    287 Barts & London School of Med; Medical Oncology London United Kingdom EC1A 7BE
    288 University College London Hospital London United Kingdom NW1 - 2PG
    289 Royal Free Hospital London United Kingdom NW3 2QS
    290 Royal Marsden Hospital - London London United Kingdom SW3 6JJ
    291 Christie Hospital NHS Trust Manchester United Kingdom M20 4BX
    292 Nottingham City Hospital Nottingham United Kingdom NG5 1PB
    293 Royal Preston Hospital Preston United Kingdom PR2 9HT
    294 Glan Clywd Hospital Rhyl United Kingdom LL18 5UJ
    295 Royal Marsden Hospital - Surrey Surrey United Kingdom SM2 5PT
    296 Walsall Manor Hospital Walsall United Kingdom WS2 9PS

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT04873362
    Other Study ID Numbers:
    • WO42633
    • 2020-003681-40
    First Posted:
    May 5, 2021
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 18, 2022