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
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
Arms and Interventions
Arm | Intervention/Treatment |
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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:
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:
|
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:
Drug: Trastuzumab Emtansine
Trastuzumab emtansine will be administered at a dose of 3.6 mg/kg Q3W for 14 weeks.
Other Names:
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:
|
Outcome Measures
Primary Outcome Measures
- 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
- IDFS Including Second Primary Non-breast Invasive Cancer [From baseline up to 10 years]
- Disease-free Survival (DFS) [From baseline up to 10 years]
- Overall Survival (OS) [From baseline up to 10 years]
- Distant Recurrence-free Interval (DRFI) [From baseline up to 10 years]
- 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)
- 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.
- 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.
- 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]
- 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)]
- 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)]
- 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)]
- 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
- 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)]
- 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)]
- 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
Inclusion Criteria:
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Histologically confirmed invasive breast carcinoma
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Centrally-confirmed human epidermal growth factor receptor 2 (HER2)-positive invasive breast cancer
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Centrally confirmed PD-L1 and hormone receptor status
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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)
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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)
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<=12 weeks between primary surgery and randomization
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Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
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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%
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Life expectancy >= 6 months
-
Adequate hematologic and end organ function
Exclusion Criteria:
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Stage IV breast cancer
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An overall response of disease progression according to the investigator at the conclusion of preoperative systemic therapy
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Prior treatment with T-DM1, or atezolizumab, or other immune checkpoint inhibitors
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History of exposure to various cumulative doses of anthracyclines
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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
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History of idiopathic pulmonary fibrosis, organizing pneumonia, or pneumonitis
-
History of or active autoimmune disease or immune deficiency
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Treatment with immunostimulatory or immunosuppressive agents
-
Cardiopulmonary dysfunction
-
Any known active liver disease
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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.- WO42633
- 2020-003681-40