HER-2过表达乳腺癌BIBW2992联合治疗的Ⅲ期研究

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试验详情

一、临床试验项目名称
HER-2过表达乳腺癌BIBW2992联合治疗的Ⅲ期研究

二、适应症
乳腺癌

三、试验介绍

试验的主要目的是显示BIBW 2992+长春瑞滨联用（组A）与曲妥珠单抗（疾病进展后继续使用）+长春瑞滨联用（组B）联用相比，作为转移性乳腺癌一线和二线治疗，具有优效性

研究中心所在省份及城市（具体启动情况以后期咨询为准）

研究中心	主要研究者
中国医学科学院肿瘤医院	徐兵河 PhD， MD

序号	机构名称	主要研究者	国家	省（州）	城市
1	中国医学科学院肿瘤医院	徐兵河	中国	北京	北京
2	中国人民解放军总医院	杨俊兰	中国	北京	北京
3	北京大学人民医院	杨德起	中国	北京	北京
4	中国人民解放军307医院	江泽飞	中国	北京	北京
5	北京协和医院	孙强	中国	北京	北京
6	天津肿瘤医院	佟仲生	中国	天津	天津
7	吉林大学第一医院	李薇	中国	吉林	长春
8	上海瑞金医院	沈坤伟	中国	上海	上海
9	复旦大学肿瘤医院	邵志敏	中国	上海	上海
10	南京解放军八一医院	秦叔逵	中国	江苏	南京
11	浙江大学医学院附属第一医院	沈朋	中国	浙江	杭州
12	浙江省肿瘤医院	王晓稼	中国	浙江	杭州
13	山东大学齐鲁医院	王秀问	中国	山东	济南
14	广州中山肿瘤医院	林桐榆	中国	广东	广州
15	广州南方医院	罗荣城	中国	广东	广州
16	广东省人民医院	廖宁	中国	广东	广州
17	福建省肿瘤医院	刘健	中国	福建	福州
18	武汉协和医院	武钢	中国	湖北	武汉
19	四川大学华西医院	郑鸿	中国	四川	成都
20	哈尔滨医科大学附属肿瘤医院	张清媛	中国	黑龙江	哈尔滨
21	St Vincent's Hospital	Raymond Snyder	Australia	VIC	Fitzroy
22	Port Macquarie Base Hospital (PMBH)	Stephen Begbie	Australia	NSW	Port Macquarie
23	Maroondah Breast Clinic	Susan Chua	Australia	VIC	Ringwood East
24	Mount Medical Centre	Chan Arlene	Australia	WA	Perth
25	Peninsula Oncology Centre	Vinod Ganju	Australia	VIC	Frankston
26	Institut Bordet	Ahmad Awada	Belgium	N/A	Bruxelles
27	CHC - Les Cliniques Saint-Joseph	Marie-Pascale Graas	Belgium	N/A	Liège
28	Universitair Ziekenhuis Antwerpen	Manon Huizing	Belgium	N/A	Edegem
29	University of California at Los Angeles	Sara Hurvitz	United States of America	CA	Los Angeles
30	Overlake Cancer Center	Kathryn Crossland	United States of America	WA	Bellevue
31	Robert A. Moss MD, FACP, Inc	Robert Moss	United States of America	CA	Fountain Valley
32	Achieve Clinical Research, LLC	Allen Yeilding	United States of America	AL	Birmingham
33	Cedar Valley Cancer Center	Joginder Singh	United States of America	IA	Waterloo
34	North Shore Cancer Research Associates	Edward Kaplan	United States of America	IL	Skokie
35	Northeast Arkansas Baptist Clinic	Carroll Scroggin, Jr	United States of America	AR	Jonesboro
36	Utah Cancer Specialists	S. Kendall	United States of America	UT	Salt lake City
37	Pro Health Care Associates	Marc Citron	United States of America	NY	Lake Success
38	The Thomas Jefferson University	Tiffany Avery	United States of America	PA	Philadelphia
39	Ironwood Cancer and Research Centers	Sujith Kalmadi	United States of America	AZ	Chandler
40	Central Coast Medical Oncology Corporation	Robert Dichmann	United States of America	CA	Santa Maria
41	Santa Barbara Hematology Oncology Medical Group, Inc	Frederick Kass	United States of America	CA	Santa Barbara
42	Cancer Care Associates Medical Group, Inc	David Chan	United States of America	CA	Redondo Beach
43	Hope Women's Cancer Center	David Hetzel	United States of America	NC	Asheville
44	St. Jude Heritage Healthcare	William Lawler	United States of America	CA	Fullerton
45	Central Hematology Oncology Medical Group, Inc	Eddie Hu	United States of America	CA	Alhambra
46	Hopital Notre-Dame du CHUM	Louise Yelle	Canada	QC	Montreal
47	Dr. Leon Richard Oncology Centre	Skander Ghedira	Canada	NB	Moncton
48	Princess Margaret Hospital	Srikala Sridhar	Canada	ON	Toronto
49	Grand River Regional Cancer Centre	Nadia Califaretti	Canada	ON	Kitchener
50	BC Cancer Agency	Diego Villa	Canada	BC	Vancouver
51	Ottawa Hospital Cancer Centre	Susan Dent	Canada	ON	Ottawa
52	Centre Hospitalier Affilie Universitaire de Quebec	Eric Poirier	Canada	QC	Quebec
53	Uniklinik Koeln	Lisa Richters	Germany	N/A	Koeln
54	Klinikum des Landkreises Deggendorf	Doris Augustin	Germany	N/A	Deggendorf
55	Staedtisches Klinikum Brandenburg GmbH	Cornelia Mueller	Germany	N/A	Brandenburg an der Havel
56	Klinikum der RWTH Aachen	Nicolai Maass	Germany	N/A	Aachen
57	St. Elisabeth-Krankenhaus	Claudia Schumacher	Germany	N/A	Koeln
58	Klinikum Rechts der Isar	Stefan Paepke	Germany	D	Muenchen
59	Gynaekologisch-onkologische Gemeinschaftspraxis	Christoph Uleer	Germany	N/A	Hildesheim
60	Universitaetsklinikum Erlangen Frauenklinik	Matthias Beckmann	Germany	N/A	Erlangen
61	Onkologische Praxis Oldenburg	Burkhard Otremba	Germany	N/A	Oldenburg
62	Klinikum Suedstadt	Bernd Gerber	Germany	N/A	Rostock
63	Medizinisches Zentrum Bonn	Christian Martin Kurbacher	Germany	N/A	Bonn
64	Universitaetsklinikum Magdeburg A.oe.R.	Joachim Bischoff	Germany	N/A	Magdeburg
65	Universitaetsklinikum	Wolfgang Janni	Germany	N/A	Ulm
66	Kliniken Essen-Mitte	Jana Barinoff	Germany	N/A	Essen
67	Facharzt fuer Innere Medizin	Werner Fett	Germany	N/A	Wuppertal
68	LMU Innenstadt	Nadia Harbeck	Germany	N/A	Muenchen
69	Onkologische Gemeinschaftspraxis	Carla Verena Hannig	Germany	N/A	Bottrop
70	Hospital del Mar (IMAS)	Ignasi Tusquets Trias de Bes	Spain	CATALUNYA	Barcelona
71	Servicio de Oncología	Maria Gonzalez Cao	Spain	SPAIN	Barcelona
72	Servicio de Oncología	Adolfo Murias	Spain	N/A	Las Palmas de gran Canaria
73	Servicio de Oncología Médica	Jose Ignacio Chacon Lopez-Mu？iz	Spain	N/A	Toledo
74	Servicio de Oncología Médica	José Angel García Sáenz	Spain	N/A	Madrid
75	Servicio de Oncología	Vicente Cara？ana	Spain	N/A	Valencia
76	Complejo Hospitalario Universitario de Santiago de Compostela	Rafael Lopez Lopez	Spain	N/A	Santiago de Compostela
77	Hospital Vall d′Hebron	Javier Cortés	Spain	N/A	Barcelona
78	Institut Jean Godinot	Hervé Curé	France	N/A	Reims
79	Centre Oscar Lambret	Audrey Mailliez	France	N/A	Lille Cedex
80	Centre Jean Perrin	Jean-Marc Nabholtz	France	N/A	Clermont-Ferrand Cedex
81	Hospital Jean Minjoz	Xavier Pivot	France	N/A	Besanoson Cedex
82	Centre Paul Strauss	Thierry Petit	France	N/A	Strasbourg Cedex
83	Polyclinique Bordeaux Nord	Nadine Dohollou	France	N/A	Bordeaux
84	Centre Paul Papin	Rémy Delva	France	N/A	Angers Cedex 9
85	Hospital Saint-Louis	Marc Espie	France	N/A	Paris
86	Centre Catherine de Sienne	Alain Lortholary	France	N/A	Nantes
87	Centre Eugène Marquis	Pierre Kerbrat	France	N/A	Rennes Cedex
88	CHU d'Amiens Sud - Salouel	Bruno Chauffert	France	N/A	Amiens Cedex 1
89	Centre René Huguenin	Etienne Brain	France	N/A	St Cloud
90	Kidwai Memorial Institute of Oncology, Bangalore	Linu Abraham Jacob	India	N/A	Bangalore
91	KEM Hospital	Minish Mahendra Jain	India	N/A	Pune
92	King George Hospital, Visakhapatnam	Pedapenki Ravi Mohan	India	N/A	Visakhapatnam
93	Curie Manavata Cancer Center	Rajnish V. Nagarkar	India	N/A	Nashik
94	Orchid Nursing Home	Gouri Shankar Bhattacharyya	India	N/A	Kolkata
95	Sujan Surgical Cancer Hospital	Rajender Singh Arora	India	N/A	Amravati
96	Bibi General Hospital and Cancer Centre	V.Satya Suresh Attili	India	N/A	Hyderabad
97	Central India Cancer Research Institute	Ajay Omprakash Mehta	India	N/A	Nagpur
98	Dr. Rai Memorial Cancer Centre	Srinivisan Krishnan	India	N/A	Chennai
99	Jehangir Hospital	Shona Nag	India	N/A	Pune, Maharahtra
100	National Cancer Institute	N.A Mahendra Perera	India	SRI LANKA	Maharagama
101	Divisione Oncologia Medica	Aron GOLDHIRSCH	Italy	N/A	Milan
102	U.O. di Oncologia ed Oncoematologia	Lorenzo GIANNI	Italy	I	Rimini
103	S.C. Oncologia Medica	Maria Teresa IONTA	Italy	I	Monserrato (CA)
104	U.O. Oncologia Clinica	Monica Indelli	Italy	I	Ferrara
105	National Cancer Center Hospital,	Chikako Shimizu	Japan	N/A	Chuo-ku, Tokyo
106	Tokai University Hospital,	Yutaka Tokuda	Japan	N/A	Isehara-shi, Kanagawa
107	Osaka Medical Center for Cancer and Cardiovascular Diseases,	Takahiro Nakayama	Japan	N/A	Higashinari-ku, Osaka
108	Orbis Medisch Centrum	F.L.G. Erdkamp	Netherlands	N/A	SITTARD-GELEEN
109	Albert Schweitzer Ziekenhuis Locatie Dordwijk	J. Bosch van den	Netherlands	N/A	DORDRECHT
110	Maxima Medisch Centrum	M.W. Dercksen	Netherlands	N/A	EINDHOVEN
111	Academisch Ziekenhuis Maastricht	V.C.G. Tjan-Heijnen	Netherlands	N/A	MAASTRICHT
112	Atrium Medisch Centrum	F. Berkmortel van den	Netherlands	N/A	HEERLEN
113	Isala	A. Honkoop	Netherlands	N/A	ZWOLLE
114	Akershus Universitetssykehus	Hilde Presterud ？deg？rd	Norway	N/A	L？RENSKOG
115	Instituto Português de Oncologia Lisboa Francisco Gentil	Fatima Vaz	Portugal	N/A	Lisboa
116	Centro Hospitalar de Coimbra	Joana Belo	Portugal	N/A	Coimbra
117	Centro Hospitalar S？o Jo？o, EPE	Margarida Damasceno	Portugal	N/A	Porto
118	Instituto Português de Oncologia de Coimbra Francisco Gentil	Ana Filipa Pais	Portugal	N/A	Coimbra
119	Instituto Português de Oncologia do Porto Francisco Gentil	Susana Sousa	Portugal	N/A	Porto
120	Hospital Británico	Ernesto Korbenfeld	Argentina	BS AS	Capital Federal
121	CER Instituto Médico	Mirta Varela	Argentina	BS AS	CER Instituto Médico
122	Sanatorio Parque	Graciela Uranga	Argentina	STA FE	Rosario
123	Instituto Medico de Asistencia e Investigaciones S. A.	Silvia Carraro	Argentina	N/A	Buenos Aires
124	Centro Medico Austral OMI	Juan Pablo Re	Argentina	N/A	Ciudad Autónoma de Buenos Aires
125	Centro de Investigaciones Pergamino	Susana Kahl	Argentina	N/A	Pergamino - Buenos Aires
126	IONC - Instituto Oncologico de Cordoba	Eduardo Richardet	Argentina	CORDOBA	Cordoba
127	Sanatorio de la Providencia	Guillermo Lerzo	Argentina	CABA	Ciudad Autonoma de Buenos Aires
128	Irmandade da Santa Casa de Misericórdia de Porto Alegre	Manuela Zereu	Brazil	RS	Porto Alegre
129	Centro de Pesquisas Clínicas em Oncologia	Sabina Aleixo	Brazil	ES	Cachoeiro de Itapemirim
130	Instituto Nacional do Cancer - INCA	José Bines	Brazil	RJ	Rio de Janeiro
131	Associa？？o Hospitalar Moinhos de Vento	Maira Caleffi	Brazil	RS	Porto Alegre
132	Centro de Novos Tratamentos CliniOnco	Jeferson Jose da Fonseca Vinholes	Brazil	RS	Porto Alegre
133	Hospital Santa Cruz	Rodrigo Rigo	Brazil	PR	Curitiba
134	FACULDADE DE MEDICINA DO ABC	Patricia Xavier Santi	Brazil	SP	Santo André
135	Associacao Hospital de Caridade de Ijui	Fabio Andre Franke	Brazil	RS	Ijui
136	Centro de Referencia da Saude da Mulher-Hosp Perola Byington	Roberto Hegg	Brazil	SP	Sao Paulo
137	Unidade de Pesquisas Clinicas em Oncologia	Marcio Valerio Costa	Brazil	RS	Pelotas
138	Instituto do Cancer Arnaldo Vieira de Carvalho	Cassia Maria Costa	Brazil	SP	Sao Paulo
139	Clinica Las Americas	Alejo Jimenez	Colombia	N/A	Medelin
140	Hospital de Jesus	Gabriela Alvarado Luna	Mexico	DF	Colonia Centro
141	Centro Regional de Efermidades Oncologicas	Jaime Arturo Guel Panola	Mexico	N/A	San Luis Potosi
142	Clinica Anglo Americana	Claudia Lozada Zingoni	Peru	LIMA	San Isidro
143	Instituto Oncologico Miraflores S. A.	Jorge Fernando Salas Sánchez	Peru	LIMA	Miraflores
144	Hospital Nacional Adolfo Guevara Velasco	Osbert Luis Mejia Palomino	Peru	PE	Cusco
145	Clinica San Judas Tadeo	Wilbert Rodriguez	Peru	N/A	Lima
146	Clinica Peruano Americana de Trujillo	Jose David Zorrilla Silvera	Peru	N/A	Trujillo
147	Centro Especializado en Enfermedades Neoplasicas (CENN)	Heman David Moron	Peru	N/A	Arequipa
148	Instituto Clínico Oncológico del Sur - ICOS	Eduardo Ya？ez Ruiz	Chile	CHILE	Temuco
149	National Taiwan University Hospital	Chiun-Sheng Huang	中国	N/A	Taipei
150	Taichung Veterans General Hospital	Dah-Cherng Yeh	中国	N/A	Taichung
151	Taipei Veterans General Hospital	Ling-Min Tseng	中国	N/A	Taipei
152	Kaohsiung Medical University Chung-Ho Memorial Hospital	Ming-Feng Hou	中国	N/A	Kaohsiung
153	Chang Gung Memorial Hospital,Linkou	Shin-Cheh Chen	中国	N/A	Taoyuan County
154	Mackay Memorial Hospital	Ruey-Kuen Hsieh	中国	N/A	Taipei
155	Chang-Hua Christian Hospital	Shou-Tung Chen	中国	N/A	Changhua
156	Kaohsiung Veterans General Hospital	Hong-Tai Chang	中国	N/A	Kaohsiung
157	National Cheng Kung University Hospital	Tsai-Wang Chang	中国	N/A	Tainan
158	Koo Foundation Sun Yet-Sen Cancer Center	Mei-Ching Liu	中国	N/A	Taipei
159	National Cancer Center	In Hye Park	Korea, Republic of	NA	Goyang
160	Asan Medical Center	Kyung Hae Jung	Korea, Republic of	NA	Seoul
161	Seoul National University Hospital	Seock-Ah Im	Korea, Republic of	NA	Seoul
162	Samsung Medical Center	Young-Hyuck Im	Korea, Republic of	NA	Seoul
163	Severance Hospital	Joo Hyuk Sohn	Korea, Republic of	NA	Seoul
164	Korea University Anam Hospital	Yoonji Choi	Korea, Republic of	NA	Seoul
165	Kaiser Franz Josef Spital mit Preyer'schem Kinderspital	Christian Dittrich	Austria	N/A	Wien
166	Krankenhaus der Elisabethinen Linz	Reinhard Ziebermayr	Austria	N/A	Linz
167	N. N. Alexandrov national cancer center of Belarus	Nikolai Ermakov	Belarus	N/A	Minsk region
168	Public Health Inst. Minsk City Clinical Oncologic Dispensary	Yauheni Baranau	Belarus	N/A	Minsk
169	Vitebsk Regional Clinical Oncology Dispensary	Yauheniya Karchmit	Belarus	N/A	Vitebsk
170	Grodno Regional Clinical Hospital	Dzmitry Noryk	Belarus	N/A	Grodno
171	MEDICON a.s.	Renata Kozevnikovova	Czech Republic	N/A	Praha 4
172	Faculty Hospital Olomouc	Bohuslav Melichar	Czech Republic	N/A	Olomouc
173	Hospital Ceske Budejovice	Petr Vitek	Czech Republic	N/A	Ceske Budejovice
174	The Chaim Sheba Medical Center	Bella Kaufman	Israel	N/A	Tel Hashomer
175	Rambam Medical Center	Georgeta Fried	Israel	N/A	Haifa
176	Shaare Zedek Medical Center	Rut Isacson	Israel	N/A	Jerusalem
177	Sourasky Medical Centre	Moshe Inbar	Israel	N/A	Tel-Aviv
178	Meir Medical Centre	Bella Nisenbaum	Israel	N/A	Kfar Saba
179	Hospital of Lithuanian Univ.of HealthSciences Kauno Klinikos	Elona Juozaityte	Lithuania	N/A	Kaunas
180	Vilnius University Hospital	Ruta Grigiene	Lithuania	N/A	Vilnius
181	Paul Stradins Clinical University Hospital	Gunta Purkalne	Latvia	N/A	Riga
182	Riga East University Hospital	Iveta Kudaba	Latvia	N/A	Riga
183	Oncology Centre of Olsztyn	Pawel Rozanowski	Poland	N/A	Olsztyn
184	Bialystock's Oncology Center	Marek Wojtukiewicz	Poland	N/A	Bialystok
185	University Clinical Center	Jacek Jassem	Poland	N/A	Gdansk
186	Kopernik's Specialised Hospital	Maria Blasinska-Morawiec	Poland	N/A	Lodz
187	District Specialized Hospital No. 4	Zofia Rusinowska	Poland	N/A	Bytom
188	Ziemia Lubelska Oncological Center	Elzbieta Staroslawska	Poland	N/A	Lublin
189	Military Medical Institute	Cezary Szczylik	Poland	N/A	Warsaw
190	Wielkopolskie Oncology Centre n.a. Maria Sklodowska-Courie	Piotr Wysocki	Poland	N/A	Poznan
191	Regional Clinical Oncology Dispensary	Dmitriy Krasnozhon	Russia	N/A	Saint Petersburg
192	GUZ Kazansky Oncology Dispensary, Kazan	Guzel Mukhametshina	Russia	RF	Kazan
193	N.A. Semashko Central Clinical Hospital No. 2	Irina Selezneva	Russia	N/A	Moscow
194	GUZ	Marina Shomova	Russia	N/A	Ryazan
195	National Institute of Oncology	Jozef Sufliarsky	Bratislava	N/A	Bratislava
196	St. Jacobs Hospital	Jozef Chovanec	Slovakia	N/A	Bardejov
197	POKO Poprad	Juraj Beniak	Slovakia	N/A	Poprad
198	Institute of Oncology	Cvetka Grasic Kuhar	Slovenia	N/A	Ljubljana
199	John Hopkins Singapoer International Medical Centre	Lavina Bharwani	Singapore	N/A	Singapore
200	National University Hospital	Soo Chin Lee	Singapore	SINGAPORE	Singapore
201	National Cancer Centre	Yoon Sim Yap	Singapore	N/A	Singapore
202	Oncology Centre - Mansoura University	Sameh Shamaa	Egypt	N/A	Mansoura
203	El Manial Specialized Hospital	Hamdy Abdel Azim	Egypt	N/A	Cairo
204	Hammoud Hospital University Medical Centre (HHUMC)	Fadi Farhat	Lebanon	N/A	Lebanon
205	Ege Universitesi Tip Fakültesi Ic Hastaliklari Anabilim Dali	Erhan Gokmen	Turkey	N/A	Izmir
206	Hacettepe Universitesi Tip Fakultesi, Ic Hastaliklari ABD	Kadri Altundag	Turkey	N/A	Ankara
207	Guy's and St Thomas' NHS Foundation Trust	Hartmut Kristeleit	Great Britain	N/A	London
208	NHS Tayside	Douglas Adamson	Great Britain	SCOT	Dundee
209	NHS Lothian	Angela Bowman	Great Britain	SCOT	Edinburgh

1	组织学检查明确诊断为HER2过表达的乳腺癌
2	Ⅳ期转移性疾病
3	既往接受过一种曲妥珠单抗治疗且疾病进展
4	仅接受过一种基于曲妥珠单抗的治疗方案（作为辅助用药或一线治疗）且治疗无效
5	接受过基于蒽环类抗生素和/或紫杉烷化疗作为乳腺癌的辅助治疗或作为转移性乳腺癌的一线治疗
6	必须有（存档的）肿瘤组织样本可供进行HER2状态的再次中心化评估，且证实为HER2阳性
7	至少有一个按照RECIST 1.1标准可评估的病灶
8	美国东部肿瘤协作组织(ECOG) 评分0 或 1

1	既往接受过除了曲妥珠单抗之外的EGFR/HER2靶向小分子或抗体治疗
2	既往采用过长春瑞滨治疗
3	既往有已知的肺间质疾病
4	脑转移病灶活跃期
5	以前或现在存在临床相关的心血管异常，如未得到控制的高血压、NYHA 3类充血性心力衰竭、不稳定型心绞痛或控制不佳的心律不齐。随机之前6个月内曾发心肌梗塞
6	心脏左心室的静息射血分数低于50%
7	不愿遵从研究方案的患者
8	有任何对长春瑞滨或曲妥珠单抗的禁忌症
9	己知对BIBW 2992或试验药物的任何成份过敏
10	随机前4周内使用过任何试验药物
11	肝肾功能不足，血液疾病等器官功能障碍

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