帕妥珠单抗HER2阳性晚期乳腺癌安全性研究

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试验详情
入选标准
排除标准
研究中心

试验详情

一、临床试验项目名称
帕妥珠单抗HER2阳性晚期乳腺癌安全性研究

二、适应症
HER2阳性晚期乳腺癌

三、试验介绍

评价帕妥珠单抗联合曲妥珠单抗和一种紫杉烷类的安全性和耐受性

主要排除标准

1	既往接受过针对转移性或局部复发疾病的全身性非激素抗癌疗法。注意:在进入研究之前，允许采用至多两线内分泌疗法治疗转移性或局部复发疾病，其中一种可与Everolimus联用。
2	从辅助或新辅助全身性非激素治疗到复发之间的无疾病间期在6个月之内。
3	既往以任何形式接受过已获批准或正在研究的抗HER2制剂作为乳腺癌的治疗，但作为辅助或新辅助治疗的曲妥珠单抗和/或拉帕替尼除外。
4	在接受曲妥珠单抗和/或拉帕替尼作为辅助或新辅助治疗过程中，出现了疾病进展。
5	既往辅助或新辅助治疗导致持续性2级或以上（NCI-CTC，第4.0版）血液毒性的病史。
6	根据计算机断层扫描（CT）或核磁共振成像（MRI）评定，具有中枢神经系统（CNS）转移的放射学证据但未获得良好控制的患者 (症状性或需要持续皮质类固醇治疗(例如，地塞米松)加以控制 )。注意：发生CNS 转移的患者在接受局部治疗 (放射，手术等) 不加抗HER2治疗之后，如果其在筛选前3个月内病情稳定的话（根据研究者评估），则允许其参与研究。
7	目前有3级或以上的外周神经病变（NCI-CTC，第4.0版）。
8	第一次应用研究药物（给药）之前算起的过去5年内有其它恶性疾病史，但宫颈原位癌或者基底细胞癌除外。
9	同时伴有可能导致本研究中研究药物禁忌使用的严重且不可控制或者使病人处于发生治疗相关并发症高风险的合并疾病。
10	器官功能不良，以下列实验室结果为证据：？绝对中性粒细胞计数<1,500细胞/mm3。？血小板计数<100,000细胞/mm3。？血红蛋白<9 g/dL。？总胆红素大于正常上限（ULN；除非患者有记录在案的Gilbert综合征）。？ AST (SGOT) 或 ALT (SGPT) >2.5 × ULN（有肝转移的患者> 5 × ULN）。Pertuzumab—F. Hoffmann-La Roche Ltd 32/ MO28047中文方案版本 6.0，版本日期 2019年 01月 07日；基于英文方案版本 6.0，版本日期 2018年 11月 21日？碱性磷酸酶水平> 2.5 ×ULN（有肝转移的患者> 5 × ULN，或者有骨转移的患者>10 × ULN）。？血清肌酐>2.0 mg/dL或177 μmol/L。？国际标准化比率（INR）和激活部分凝血激酶时间（aPTT）或部分凝血激酶时间（或PTT）>1.5 × ULN（除非正在使用治疗性抗凝疗法）。
11	不受控制的高血压（收缩压>150 mmHg和/或舒张压>100 mmHg）或者具有临床意义（即活动性）的心血管疾病：第一次给药研究药物之前的6个月内有脑血管意外/中风或心肌梗死、不稳定心绞痛、纽约心脏协会（NYHA）II级或以上的充血性心力衰竭（CHF）、或需要药物治疗的严重心律失常。
12	目前有已知的HIV、乙型肝炎病毒或丙型肝炎病毒感染。
13	因晚期恶性疾病的并发症而在静息状态下有呼吸困难，或者其它需要持续氧气疗法的疾病。
14	第一次使用研究药物（给药）之前的14天内有重大的外科手术或严重外伤，或者预期在研究治疗的过程中需要重大手术。注意：如果研究过程中需要手术治疗，应允许受试者最少恢复14天，之后方可开始后续帕妥珠单抗和曲妥珠单抗治疗入选之前的7天内因感染而接受过静脉抗生素。
15	目前长期使用(持续>3个月)每日的皮质激素治疗（剂量相当于或大于10 mg/天甲基强的松龙），但吸入性激素除外。
16	已知对任何一种研究药物治疗或者对重组人源或人源化抗体的赋形剂过敏。
17	第一次使用研究药物（给药）之前28天内有接受过任何研究性治疗史。
18	根据研究者评估，不能够或不愿意遵守方案的要求。
19	同时参加任何干预型的临床试验。

*以上临床试验信息摘自国家药品监督管理局药品审评中心临床试验登记与信息公示平台，具体入排以研究中心医生评估为准

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
复旦大学附属肿瘤医院	胡夕春

序号	机构名称	主要研究者	国家	省（州）	城市
1	复旦大学附属肿瘤医院	胡夕春	中国	上海市	上海市
2	北京肿瘤医院	李惠萍	中国	北京市	北京市
3	江苏省肿瘤医院	冯继锋	中国	江苏省	南京市
4	中山大学附属肿瘤医院	王树森	中国	广东省	广州市
5	西安交通大学医学院第一附属医院	李恩孝	中国	陕西省	西安市
6	天津市肿瘤医院	佟仲生	中国	天津市	天津市
7	第三军医大学附属西南医院	姜军	中国	重庆市	重庆市
8	第四军医大学西京医院	李南林	中国	陕西省	西安市
9	哈尔滨医科大学附属肿瘤医院	张清媛	中国	黑龙江省	哈尔滨市
10	CPMC; Service d'Oncologie Médicale	KAMEL BOUZID	ALGERIA	ALGIERS	Algiers
11	Centro Oncologico Riojano Integral (CORI)	Luis Kaen	ARGENTINA	LA RIOJA	La Rioja
12	Instituto de Oncología de Rosario	Luis Fein	ARGENTINA	ROSARIO	Rosario
13	AUSTIN AND REPATRIATION MEDICAL CENTRE; CANCER SERVICES	Jacqui Thomson	AUSTRALIA	Victoria	MELBOURNE
14	CANBERRA HOSPITAL; MEDICAL ONCOLOGY	ROBIN STUART-HARRIS	AUSTRALIA	Australian Capital Territory	CANBERRA
15	HOCA Chermside	Nicole McCarthy	AUSTRALIA	Queensland	Chermside
16	ROYAL MELBOURNE HOSPITAL; HEMATOLOGY AND MEDICAL ONCOLOGY	RICHARD DE BOER	AUSTRALIA	Victoria	PARKVILLE
17	Royal Prince Alfred Hospital; Medical Oncology	JANE BEITH	AUSTRALIA	New South Wales	Camperdown
18	LKH SALZBURG - UNIV. KLINIKUM SALZBURG; III. MEDIZINISCHE ABT.	RICHARD GREIL	AUSTRIA	Salzburg	Salzburg
19	LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie	HELLMUT SAMONIGG	AUSTRIA	Steiermark	GRAZ
20	UNIVERSIT？TSKLINIK FüR FRAUENHEILKUNDE; KLINIK FüR GYN？KOLOGIE IV	CHRISTIAN SINGER	AUSTRIA	WIEN	WIEN
21	KH Der Barmherzigen Schwestern; Abteilung für Innere Medizin 1	ANDREAS PETZER	AUSTRIA	Upper Austria	LINZ
22	UNIVERSITAIR ZIEKENHUIS BRUSSEL; ONCOLOGY	JACQUES DE GREVE	BELGIUM	BRUXELLES	BRUXELLES
23	UNIVERSITAIR ZIEKENHUIS; ONCOLOGIE - CANCEROLOGIE	Veronique Cocquyt	BELGIUM	GENT	GENT
24	U.Z. GASTHUISBERG; ONCOLOGY	Hans Wildiers	BELGIUM	LEUVEN	LEUVEN
25	CHU Sart Tilman	GUY JERUSALEM	BELGIUM	LIEGE	Liège
26	Hospital Amaral Carvalho	Augusto BeatoCarlos	BRAZIL	SP	Jau
27	Hospital das Clinicas - FMUSP Ribeirao Preto	Jurandyr Moreira de Andrade	BRAZIL	SP	Ribeirao Preto
28	Hospital Perola Byington	Roberto Hegg	BRAZIL	SP	Sao Paulo
29	Hospital Sao Jose	Marceio Curz	BRAZIL	SP	Sao Paulo
30	Hospital Sao Lucas - PUCRS	Carlos Henrique Barrios	BRAZIL	RS	Porto Alegre
31	HOSPITAL SIRIO LIBANES; CENTRO DE ONCOLOGIA	Max Mano	BRAZIL	SP	Sao Paulo
32	ONCOLOGISTAS ASSOCIADOS	Gilberto Luiz Amorim	BRAZIL	RJ	Rio de Janeiro
33	BCCA - VANCOUVER ISLAND CANCER CENTRE; ONCOLOGY	Nicole Macpherson	CANADA	British Columbia	VICTORIA
34	Capital Health; QEII HSC; Oncology	DANIEL RAYSON	CANADA	Nova Scotia	Halifax
35	CHUM - HOTEL DIEU DE MONTREAL	Andre Robidoux	CANADA	Quebec	MONTREAL
36	CROSS CANCER INSTITUTE ; DEPT OF MEDICAL ONCOLOGY	ANIL ABRAHAM JOY	CANADA	Alberta	EDMONTON
37	CSSS champlain - Charles-Le Moyne	Susan Fox	CANADA	Quebec	Greenfield Park
38	GRAND RIVER REGIONAL CANCER CENTRE	Nadia Califaretti	CANADA	Ontario	Kitchener
39	McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology	LAWRENCE PANASCI	CANADA	Quebec	MONTREAL
40	SUNNYBROOK ODETTE CANCER CENTRE	SUNIL VERMA	CANADA	Ontario	Toronto
41	William Osler Health System Brampton Civic Hospital	SANDEEP SEHDEV	CANADA	Ontario	Brampton
42	HOSPITAL SOLCA PORTOVIEJO; ONCOLOGIA	Miguel Cedeao	ECUADOR	QUITO	PORTOVIEJO
43	HOSPITAL SOLCA QUITO; ONCOLOGIA	Tannia Soria	ECUADOR	QUITO	QUITO
44	Manial Specialized Hospital; Oncology	AZEEM HAMDY ABDEL	EGYPT	CAIRO	Cairo
45	NCI; ONCOLOGY DEPT	Rabab Gaafar	EGYPT	CAIRO	Cairo
46	North Estonia Medical Centre Foundation; Oncology Center	Riina Kutner	ESTONIA	TALINN	Tallinn
47	Tartu University Hospital; Clinic of Hematology and Oncology	PEETER PADRIK	ESTONIA	TARTU	Tartu
48	HELSINKI UNIVERSITY CENTRAL HOSPITAL; ONCOLOGY CLINICS	Johanna Mattson	FINLAND	HELSINKI	HELSINKI
49	SATAKUNTA CENTRAL HOSPITAL; ONCOLOGY	OUTI SAARNI	FINLAND	PORI	PORI
50	TAMPERE UNIVERSITY HOSPITAL; DEPT OF ONCOLOGY	MINNA TANNER	FINLAND	TAMPERE	Tampere
51	TURKU UNI CENTRAL HOSPITAL; ONCOLOGY CLINICS	Johanna Ruohola	FINLAND	TURKU	Turku
52	Centre Azureen De Cancerologie; Cons externes	REMY LARGILLIER	FRANCE	MOUGINS	MOUGINS
53	CENTRE CATALAN D' ONCOLOGIE	Stephanie Catala	FRANCE	PERPIGNAN	PERPIGNAN
54	CENTRE EUGENE MARQUIS; UNITE HUGUENIN	Christophe Perrin	FRANCE	RENNES	Rennes
55	Centre Georges Francois Leclerc; Oncologie 3	Bruno Coudert	FRANCE	DIJON	Dijon
56	CENTRE HOSPITALIER FLEYRIAT; ONCOLOGIE/HEMATOLOGIE	HUBERT ORFEUVRE	FRANCE	BOURG EN BRESSE	BOURG EN BRESSE
57	Centre Leonard De Vinci;Chimiotherapie	Virginie Pottier	FRANCE	DECHY	Dechy
58	Centre Leon Berard; Departement Oncologie Medicale	THOMAS BACHELOT	FRANCE	LYON	Lyon
59	Centre Rene Huguenin; ONCOLOGIE GENETIQUE	ETIENNE BRAIN	FRANCE	SAINT CLOUD	Saint Cloud
60	Chp Saint Gregoire; Cancerologie Radiotherapie	Xavier Artignan	FRANCE	SAINT GREGOIRE	SAINT GREGOIRE
61	CLINIQUE CHENIEUX; ONCOLOGY	Dominique Genet	FRANCE	LIMOGES	Limoges
62	Institut D Oncologie Medical	Mihaela Achille	FRANCE	STRASBOURG	STRASBOURG
63	Clinique De L Europe; Radiotherapie Chimiotherapie	MICHEL GOZY	FRANCE	AMIENS	Amiens
64	Clinique Du Docteur Calabet; Cromg	Olivier Bernard	FRANCE	AGEN	Agen
65	Clinique Radio Des Dentellieres; Chimiotherapie Radiotherapie	Jessica Grosjean	FRANCE	VALENCIENNES	Valenciennes
66	CLINIQUE SAINTE MARGUERITE; ONCOLOGIE MEDICALE	JEAN-FRANCOIS BERDAH	FRANCE	HYERES	HYERES
67	Clinique Victor Hugo	Hugues Bourgeois	FRANCE	LEMANS	LeMans
68	Crlcc Paul Papin; Oncologie Medicale	Paule Augereau	FRANCE	ANGERS	Angers
69	Hopital Cochin; Unite Fonctionnelle D Oncologie	JEROME ALEXANDRE	FRANCE	PARIS	Paris
70	Ico Rene Gauducheau; Oncologie	MARIO CAMPONE	FRANCE	SAINT HERBLAIN	Saint Herblain
71	Institut Claudius Regaud; Departement Oncologie Medicale	FLORENCE DALENC	FRANCE	TOULOUSE	Toulouse
72	Institut Curie; Oncologie Medicale	VERONIQUE DIERAS	FRANCE	PARIS	Paris
73	INSTITUT PAOLI CALMETTES; ONCOLOGIE MEDICALE	Anthony Goncalves	FRANCE	MARSEILLE	Marseille
74	POLYCLINIQUE BORDEAUX NORD AQUITAINE; CHIMIOTHERAPIE RADIOTHERAPIE	NADINE DOHOLLOU	FRANCE	BORDEAUX	BORDEAUX
75	POLYCLINIQUE DE BLOIS; CHIMIOTHERAPIE AMBULATOIRE	Philippe Laplaige	FRANCE	LA CHAUSSEE ST VICTOR	La Chaussee St Victor
76	Polyclinique De Courlancy; Centre Radiotherapie Oncologie	THOMAS FACCHINI	FRANCE	REIMS	REIMS
77	Polyclinique Du Languedoc; Chimiotherapie	Andre Mathieu	FRANCE	NARBONNE	Narbonne
78	Hopital Prive Drome Ardeche; Hopital De Jour	Hugues Barletta	FRANCE	GUIHERAND GRANGES	Guilherand Granges
79	HOPITAL SAINT LOUIS; SERVICE ONCO THORACIQUE	Luis Teixeira	FRANCE	PARIS	PARIS
80	Agaplesion Diakonieklinikum Rotenburg	Tobias Hesse	GERMANY	Hesse-Darmstadt	ROTENBURG-WUEMME
81	EV. KRANKENHAUS BETHESDA; M？NCHENGLADBACH GGMBH	Raquel von Schumann	GERMANY	Nordrhein-Westfalen	M？nchengladbach
82	Gynaekologisch-Onkologische Schwerpunktpraxis Prof. Dr. med. Lueck, Dr. Schrader und Dr. Noeding	Hans- Joachim Lueck	GERMANY	Saxony	Hannover
83	Gyn？kologicum Bremen Prof.Dr. Willibald Schr？der	Willibald Schrader	GERMANY	Transdisciplinary programs	Bremen
84	Klinikum am Bruderwald; Frauenklinik	Roland Repp	GERMANY	Freistaat Bayern	Bamberg
85	Klinikum Esslingen Klinik f. Frauenheilkunde und Geburtshilfe	Thorsten Kuehn	GERMANY	Baden-Württemberg	Esslingen
86	Klinikum rechts der Isar - Technische Uni München; Frauenklinik & Poliklinik	Johannes Ettl	GERMANY	Freistaat Bayern	München
87	Kreiskrankenhaus Torgau Abt.Gyn？kologie und Geburtshilfe	Eike Simon	GERMANY	Saxony	Torgau
88	Nationales Centrum für Tumorerkrankungen (NCT)	Andreas Schneeweiss	GERMANY	Baden-Württemberg	Heidelberg
89	Praxis Dr. Wagner	Steffen Wagner	GERMANY	saarland	Saarbruecken
90	Ruppiner Kliniken, Klinik fuer Gynaekologie und Geburtshilfe	Bernd Christensen	GERMANY	Brandenburg	Neuruppin
91	SRH Wald-Klinikum Gera Klinik f.Frauenheilkunde und Geburtshilfe	DIRK-MICHAEL ZAHM	GERMANY	Freistaat Thüringen	Gera
92	St.-Vincenz-Krankenhaus Frauenklinik	Angelika Ober	GERMANY	LIMBURG	Limburg
93	Uniklinik Tübingen; Frauenklinik	Eva-Maria Grischke	GERMANY	Baden-Württemberg	Tübingen
94	Universitaetsklinikum des Saarlandes; Klinik f. Frauenheilkunden und Geburtshilfe	Ingolf Juhasz-Bass	GERMANY	Hesse-Darmstadt	Homburg/Saar
95	Universitatsklinikum Erlangen; Frauenklinik	Michael Lux	GERMANY	Freistaat Bayern	Erlangen
96	Universitatsklinikum Essen; Zentrum Für Frauenheilkunde	Bahriye Aktas	GERMANY	Nordrhein-Westfalen	Essen
97	Universitatsklinikum Hamburg-Eppendorf; Frauenklinik	Volkmarv Mueller	GERMANY	HAMBURG	Hamburg
98	Universitatsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe	Achim Rody	GERMANY	Holstein	Lübeck
99	AGAPLESION Markus-Krankenhaus)	Fariba Khandan	GERMANY	Hesse-Darmstadt	Frankfurt am Main
100	Papageorgiou General Hospital; Medical Oncology	GEORGE FOUNTZILAS	GREECE	THESSALONIKI	Thessaloniki
101	University General Hospital of Heraklion	Dimitris Mavroudis	GREECE	GRETE	Crete
102	UNIVERSITY HOSPITAL OF LARISSA; ONCOLOGY	CHRISTOS PAPANDREOU	GREECE	LARISSA	LARISSA
103	UNIVERSITY HOSPITAL OF PATRAS; MEDICAL ONCOLOGY	HARALABOS KALOFONOS	GREECE	PATRAS	PATRAS
104	QUEEN ELIZABETH HOSPITAL; CLINICAL ONCOLOGY	ROGER NGAN	HONG KONG	HONG KONG	HONG KONG
105	BORSOD-ABAUJ-ZEMPLEN MEGYEI KORHAZ ES EGYETEMI OKTATO KORHAZ; ONKOLOGIAI OSZTALY	Janos Revesz	HUNGARY	MISKOLC	Miskolc
106	DEBRECENI EGYETEM ORVOS ES EGESZSEGTUDOMANYI CENTRUM; ONKOLOGIAI TANSZEK	Zsolt Horvath	HUNGARY	DEBRECEN	DEBRECEN
107	FOVAROSI SZENT LASZLO KORHAZ-RENDELOINTEZET; ONKOLOGIAI OSZTALY	GYORGY BODOKY	HUNGARY	BUDAPEST	BUDAPEST
108	ORSZAGOS ONKOLOGIAL INTEZET; ONKOLOGIAI OSZTALY	ISTVAN LANG	HUNGARY	BUDAPEST	BUDAPEST
109	SZEGEDI TUDOMANYEGYETEM SZENT GYORGYI ALBERT ORVOS ES GYOGYSZERES; ONKOTERAPIAS KLINIKA	Zsuzsanna Kahan	HUNGARY	SZEGED	Szeged
110	Fov.Onk.Szt Janos Korh. E-Budai Egyesitett Korhazai	KATALIN BOER	HUNGARY	BUDAPEST	BUDAPEST
111	Assuta Medical Centre; Oncology	Irina Jiveliouk	ISRAEL	TEL AVIV	Tel Aviv
112	CHAIM SHEBA MEDICAL CENTER; ONCOLOGY DEPT	Shani Paluch-Shimon	ISRAEL	RAMAT-GAN	Ramat-Gan
113	HADASSAH EIN KAREM HOSPITAL; ONCOLOGY DEPT	Tamar PERETZ	ISRAEL	JERUSALEM	JERUSALEM
114	KAPLAN MEDICAL CENTER; ONCOLOGY INST.	NOA BEN BARUCH	ISRAEL	REHOVOT	Rehovot
115	NAHARIYA HOSPITAL; ONCOLOGY	Hadassah Goldberg	ISRAEL	NAHARIYA	NAHARIYA
116	Rabin Medical Center; Oncology Dept	SALOMON STEMMER	ISRAEL	PETACH TIKVA	PETACH TIKVA
117	RAMBAM MEDICAL CENTER; ONCOLOGY	GEORGETA FRIED	ISRAEL	HAIFA	HAIFA
118	SOROKA MEDICAL CENTER; ONCOLOGY DEPT	DAVID GEFFEN	ISRAEL	BEER SHEVA	BEER SHEVA
119	SOURASKY / ICHILOV HOSPITAL; DEPT. OF ONCOLOGY	MOSHE INBAR	ISRAEL	TEL AVIV	TEL AVIV
120	ASSAF HAROFEH; ONCOLOGY	ELLA EVRON	ISRAEL	ZERIFIN	Zerifin
121	ARCISPEDALE S.ANNA; ONCOLOGIA MEDICA	ANTONIO FRASSOLDATI	ITALY	Veneto	Cona (FE)
122	Azienda Ospedaliera Papa Giovanni XXIII;Oncologia Medica	CARLO TONDINI	ITALY	Lombardia	BERGAMO
123	Azienda Ospedaliera San Giuseppe Moscati	CESARE GRIDELLI	ITALY	Campania	Avellino
124	AZIENDA OSPEDALIERO-UNIVERSITARIA CAREGGI;S.C. ONCOLOGIA MEDICA 1	FRANCESCO DI COSTANZO	ITALY	Toscana	FIRENZE
125	AZIENDA OSPEDALIERO-UNIVERSITARIA DIPARTIMENTO INTERAZIENDALE DI ONCOLOGIA	FABIO PUGLISI	ITALY	Friuli-Venezia Giulia	UDINE
126	Azienda USL di Ravenna; Unità Operativa di Oncologia Medica	Amelia Tienghi	ITALY	Emilia-Romagna	RAVENNA
127	AZ. OSP. OSPEDALE CIVILE; U.O. DI ONCOLOGIA MEDICA ED EMATOLOGIA	LUIGI CAVANNA	ITALY	Emilia-Romagna	PIACENZA
128	Ente Ospedaliero Ospedali Galliera; S.C. Oncologia Medica	Alessandra Gennari	ITALY	Liguria	Genova
129	Fondazione Del Piemonte; Medical Oncology	Filippo Montemurro	ITALY	Piemonte	Candiolo
130	Irccs Istituto Europeo Di Oncologia (IEO)	Giuseppe Curigliano	ITALY	Lombardia	MILANO
131	Irccs Ospedale San Raffaele;Oncologia Medica	LUCA GIANNI	ITALY	Lombardia	MILANO
132	IRCCS POLICLINICO S. MATTEO - UNI PAVIA; CLINICA MEDICA I DIV. MED. INT. ONC. MEDICA E GASTROENT.	Donatella Grasso	ITALY	Lombardia	Pavia
133	OSPEDALE BELCOLLE DI VITERBO; ONCOLOGIA	LUCA MOSCETTI	ITALY	Lazio	VITERBO
134	OSPEDALE DEGLI INFERMI DI BIELLA; REPARTO ONCOLOGIA MEDICA	Alice Giacobino	ITALY	Piemonte	BIELLA
135	Ospedale Di Macerata; Oncologia	LUCIANO LATINI	ITALY	Marche	Macerata
136	OSPEDALE MAGGIORE DELLA CARITA; ONCOLOGIA MEDICA	OSCAR ALABISO	ITALY	Piemonte	NOVARA
137	OSPEDALE MATER SALUTIS; DEPT OF ONCOLOGY	ANDREA BONETTI	ITALY	Lombardia	LEGNAGO
138	OSPEDALE S. VINCENZO; ONCOLOGIA MEDICA	FRANCESCO FERRAU	ITALY	Sicilia	Taormina
139	OSPEDALI RIUNITI DI ANCONA; ONCOLOGY	STEFANO CASCINU	ITALY	Marche	ANCONA
140	American University of Beirut - Medical Center	Nagi El-Saghir	LEBANON	BEIRUT	Beirut
141	HOTEL DIEU DE FRANCE; ONCOLOGY	MARWAN GHOSN	LEBANON	BEIRUT	Beirut
142	Lithuanian University of Health. Sciences Kauno klinikos	ELONA JUOZAITYTE	LITHUANIA	KAUNAS	KAUNAS
143	UNI ONCOLOGY INST. ; CHEMO - RADIATION DEPT	EDUARDAS ALEKNAVICIUS	LITHUANIA	VILNIUS	VILNIUS
144	Cancerologia de Queretaro; Oncologia	ADRIANA DOMINGUEZ	MEXICO	Querétaro Arteaga	MEXICO
145	CENTRO MEDICO NACIONAL SIGLO XXI - IMSS; HOSPITAL DE ONCOLOGIA	Mario Aquilino Pérez Martínez	MEXICO	MEXICO CITY	MEXICO CITY
146	HOSPITAL GENERAL DE MéXICO; UNIDAD DE ONCOLOGIA	Jesus Miguel Lazaro Leon	MEXICO	MEXICO CITY	MEXICO CITY
147	HOSPITAL HMG COYOACAN	Alejandro Juarez Ramiro	MEXICO	DF	DF
148	IEM-FUCAM	FLAVIA MORALES-VASQUES	MEXICO	DF	DF
149	INSTITUTO NACIONAL DE CANCEROLOGIA; ONCOLOGY	Juan Matus Santos	MEXICO	MEXICO CITY	MEXICO CITY
150	INSTITUTO NACIONAL DE CIENCIAS MéDICAS Y DE LA NUTRICION ZUBIRáN	Yanin Chavarri Guerra	MEXICO	MEXICO CITY	MEXICO CITY
151	Medica Sur Centro Oncologico Integral	Jeronimo Rafael Rodriguez Cid	MEXICO	D.F.	D.F.
152	Institut National D'oncologie Sidi Mohammed Ben Abdellah; Anatomopathologie	HASSAN ERRIHANI	MOROCCO	RABAT	Rabat
153	ALBERT SCHWEITZER ZIEKENHUIS; INWENDIGE GENEESKUNDE	J. VAN DEN BOSCH	NETHERLANDS	DORDRECHT	DORDRECHT
154	Catharina ZKHS; Inwendige Geneeskunde Afd.	L.J.C. van Warmerdam	NETHERLANDS	Eindhoven	Eindhoven
155	IKAZIA ZIEKENHUIS; INTERNE ONCOLOGIE	F.E. de Jongh	NETHERLANDS	ROTTERDAM	ROTTERDAM
156	MARTINI ZIEKENHUIS; DEPT OF INTERNAL MEDICINE	Annette van der Velden	NETHERLANDS	GRONINGEN	GRONINGEN
157	MC HAAGLANDEN, LOCATIE ANTONIUSHOVE; INTERNE GENEESKUNDE	H.M. OOSTERKAMP	NETHERLANDS	DEN HAAG	DEN HAAG
158	MEDISCH CENTRUM ALKMAAR	Susan Vrijaldenhoven	NETHERLANDS	ALKMAAR	ALKMAAR
159	TWEE STEDEN ZIEKENHUIS - LOCATIE TILBURG; INTERNE GENEESEKUNDE	H.T.J. ROERDINK	NETHERLANDS	TIBURG	Tilburg
160	Vie Curie	A.J. van de Wouw	NETHERLANDS	WENLO	Venlo
161	Hameed Latif Hospital; Department of Oncology	Aziz Zeba	PAKISTAN	LAHORE	Lahore
162	Shaukat Khanum Memorial Cancer Hospital; Department of Oncology	Siddiqi Neelum	PAKISTAN	LAHORE	Lahore
163	Shifa International Hospital; Department of Oncology	Kamran Rashid	PAKISTAN	ISLAMABAD	Islamabad
164	Hospital Nacional LNS dela Policia Nacional del Perú. Unidad Onco; Deapartamento de Oncología	Milagros Cavero	PERU	LIMA	Lima
165	Instituto;Oncologico Miraflores	FERNANDO SALAS	PERU	LIMA	Lima
166	Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej	MAREK WOJTUKIEWICZ	POLAND	BIALYSTOK	BIALYSTOK
167	Cent.Onkologii-Instytut im. M. S-Curie, Klinika Now. Piesi i Chirurgii Rekon.	Zbigniew Nowecki	POLAND	WARSZAWA	WARSZAWA
168	Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii	TADEUSZ PIENKOWSKI	POLAND	OTWOCK	Otwock
169	Szpital Uniwersytecki w Krakowie, Oddzia？ Kliniczny Kliniki Onkologii	Krzysztof Krzemieniecki	POLAND	KRAKOW	Krakow
170	Wojewodzki Szpital Specjalistyczny im. M. Kopernika;Oddzial Chemioterapii	Ewa Kalinka-Warzocha	POLAND	LODZ	Lodz
171	？wi？tokrzyskie Centrum Onkologii;	Jolanta Smok-Kalwat	POLAND	KIEICE	Kielce
172	Hospital da Luz; Departamento de Oncologia Medica	JOSE LUIS PASSOS COELHO	PORTUGAL	LISBOA	Lisboa
173	Hospital de Santa Maria; Servico de Oncologia Medica	Luis Costa	PORTUGAL	LISBOA	LISBOA
174	Hospital de Sao Joao; Servico de Oncologia	MARGARIDA DAMASCENO	PORTUGAL	PORTO	PORTO
175	Inst Portugues Oncologia Coim; Oncologia Medica	Gabriela Sousa	PORTUGAL	COIMBRA	Coimbra
176	IPO do Porto; Servico de Oncologia Medica	Ana Alexandra Ferreira	PORTUGAL	PORTO	PORTO
177	King Abdul Aziz Medical City, King Fahd National Guard; Oncology	OMALKHAIR ABULKHAIR	SAUDI ARABIA	RIYADH	RIYADH
178	KING FAISAL SPECIALIST HOSPITAL & RESEARCH CENTRE; ONCOLOGY	TAHER AL-TWEGIERI	SAUDI ARABIA	RIYADH	RIYADH
179	Institute for Oncology of Vojvodina	JASNA TRIFUNOVIC	SERBIA	SREMSKA KAMENICA	SREMSKA KAMENICA
180	Institute for Onc/Rad Serbia	Snezana Susnjar	SERBIA	BELGRADE	BELGRADE
181	INSTITUTE OF ONCOLOGY LJUBLJANA	Erika Matos	SLOVENIA	LJUBLJANA	LJUBLJANA
182	Centro Oncologico MD Anderson Internacional; Servicio de Oncologia	Antonio Gonzalez Martin	SPAIN	MADRID	MADRID
183	Clinica Universitaria de Navarra; Servicio de Oncologia	Marta Santisteban Eslava	SPAIN	NAVARRA	PAMPLONA
184	Complejo Asistencial Universitario De Burgos; Servicio de Oncologia	Maria Garcia Gonzalez	SPAIN	BURGOS	BURGOS
185	Complejo Asistencial Universitario de Leon; Servicio de Oncologia	Andres Garcia-Palomo Perez	SPAIN	LEON	LEON
186	Complejo Hospitalario de Orense; Servicio de Oncologia	Jesus Garcia Mata	SPAIN	ORENSE	ORENSE
187	Complejo Hospitalario Nuestra Se？ora de la Candelaria; Servicio de Oncologia	Pilar Lopez Alvarez	SPAIN	TENERIFE	SANTA CRUZ DE TENERIFE
188	Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia	Rafael Lopez Lopez	SPAIN	LA CORU？A	SANTIAGO DE COMPOSTELA
189	Fundacion Hospital de Alcorcon; Servicio de Oncologia	Clara Olier Garate	SPAIN	MADRID	Alcorcon
190	Fundacion Jimenez Diaz; Servicio de Oncologia	Yann Izarzugaza Peron	SPAIN	MADRID	MADRID
191	Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia	Antonio Llombart Cussac	SPAIN	VALENCIA	Valencia
192	Hospital Clínic i Provincial; Servicio de Hematología y Oncología	Ana Arance Fernandez	SPAIN	BARCELONA	Barcelona
193	Hospital Clinico Universitario de Salamanca; Servicio de Oncologia	Cesar Rodriguez Sanchez	SPAIN	SALAMANCA	SALAMANCA
194	Hospital Clinico Universitario de Valladolid; Servicio de Oncologia	Diego Soto de Prado	SPAIN	VALLADOLID	VALLADOLID
195	Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia	Nuria Ribelles Entrena	SPAIN	MALAGA	Málaga
196	Hospital de Barbastro; Servicio de Oncologia	Jesus Florian Gerico	SPAIN	HUESCA	BARBASTRO
197	Hospital de Basurto; Servicio de Oncologia	Purificacion Martinez Del Prado	SPAIN	VIZCAYA	BILBAO
198	Hospital de Cabue？es; Servicio de Oncologia	Ignacio Pelaez Fernandez	SPAIN	ASTURIAS	Gijon
199	Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia	Salvador Saura Grau	SPAIN	LAS PALMAS	LAS PALMAS DE GRAN CANARIA
200	Hospital de Jerez de la Frontera; Servicio de Oncologia	M. Del Mar Gordon Santiago	SPAIN	CADIZ	JEREZ DE LA FRONTERA
201	Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia	Agusti Barnadas Molins	SPAIN	BARCELONA	Barcelona
202	HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia	Laura Garcia Estevez	SPAIN	MADRID	Laura Garcia Estevez
203	Hospital de Navarra; Servicio de Oncologia	José Juan Illarramendi Ma？as	SPAIN	NAVARRA	José Juan Illarramendi Ma？as
204	Hospital de Rio Hortega; Servicio de Oncologia	Juan Carlos Torrego Garcia	SPAIN	VALLADOLID	Juan Carlos Torrego Garcia
205	Hospital de Sagunto; Servicio de Oncologia	Antonio Galan Brotons	SPAIN	VALENCIA	Antonio Galan Brotons
206	Hospital General de Elda; Servicio de Oncologia	Cristina Llorca Ferrandiz	SPAIN	ALICANTE	Cristina Llorca Ferrandiz
207	Hospital General Universitario de Guadalajara; Servicio de Oncologia	Alberto Arcediano Del Amo	SPAIN	GUADALAJARA	Alberto Arcediano Del Amo
208	Hospital General Universitario J.M Morales Meseguer; Servicio de Oncologia	Elisa Garcia Garre	SPAIN	MURCIA	Elisa Garcia Garre
209	Hospital Provincial de Castellon; Servicio de Oncologia	Eduardo Martinez De Due？as	SPAIN	CASTELLON	Eduardo Martinez De Due？as
210	Hospital Quiron Barcelona; Servicio de Oncologia	M. Jesus Vidal Losada	SPAIN	BARCELONA	M. Jesus Vidal Losada
211	Hospital Ramon y Cajal; Servicio de Oncologia	Noelia Martinez Ja？ez	SPAIN	MADRID	Noelia Martinez Ja？ez
212	Hospital San Pedro De Alcantara; Servicio de Oncologia	M. Helena Lopez De Ceballos	SPAIN	CACERES	M. Helena Lopez De Ceballos
213	Hospital Severo Ochoa; Servicio de Oncologia	M.Jose Echarri Gonzalez	SPAIN	MADRID	M.Jose Echarri Gonzalez
214	Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia	Gemma Vi？as Vilaro	SPAIN	GIRONA	Gemma Viaas Vilaro
215	Hospital Universitario 12 de Octubre; Servicio de Oncologia	Eva Ciruelos Gil	SPAIN	MADRID	Eva Ciruelos Gil
216	Hospital Universitario Clínico San Carlos; Servicio de Oncologia	Jose Angel Garcia Saenz	SPAIN	MADRID	Jose Angel Garcia Saenz
217	Hospital Universitario Dr. Peset	Rosa M. Llorente Domenech	SPAIN	VALENCIA	Rosa M. Llorente Domenech
218	Hospital Universitario La Paz; Servicio de Oncologia	Andres Redondo Sanchez	SPAIN	MADRID	Andres Redondo Sanchez
219	HOSPITAL UNIVERSITARIO SON ESPASES	Jesus Alarcon Company	SPAIN	ISLAS BALEARES	Jesus Alarcon Company
220	Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia	Jose Luis Alonso Romero	SPAIN	MURCIA	Jose Luis Alonso Romero
221	Hospital Universitario Virgen de las Nieves; Servicio de Oncologia	Salomon Menjon Beltran	SPAIN	GRANADA	Salomon Menjon Beltran
222	Hospital Universitario Virgen Macarena; Servicio de Oncologia	Luis De La Cruz Merino	SPAIN	SEVILLA	SEVILLA
223	Hospital Universitari Sant Joan de Reus; Servicio de Oncologia	Mireia Mele Olive	SPAIN	TARRAGONA	Reus
224	Centrallasarettet V？xj？, Onkologkliniken	Ulrik Narbe	SWEDEN	VAXJO	VAXJO
225	Centralsjukhuset Karlstad, Onkologkliniken	Kilian Bachmeier	SWEDEN	KARLSTAD	KARLSTAD
226	Gavle Sjukhus; Onkologiska Kliniken	Olga Del Val Munoz	SWEDEN	GAVLE	gavle
227	Sahlgrenska Universitetssjukhuset; Jubileumskliniken	Leif Klint	SWEDEN	GaTEBORG	GaTEBORG
228	Skanes University Hospital, Sk？nes Department of Onclology	NIKLAS LOMAN	SWEDEN	LUND	Lund
229	Vastmanlands sjukhus V？ster？s, Onkologkliniken	Helena Granstam Bjarneklett	SWEDEN	VaSTERaS	VaSTERaS
230	Akdeniz University Medical Faculty; Medical Oncology Department	Coskun Hasan Senol	TURKEY	ANTALYA	Antalya
231	Baskent Uni. Practice and Research Hospital; Medical Oncology	Ozgur Ozyilkan	TURKEY	ADANA	Adana
232	Ege University Medical Faculty; Medical Oncology Department	RUCHAN USLU	TURKEY	IZMIR	IZMIR
233	HACETTEPE UNI MEDICAL FACULTY HOSPITAL; ONCOLOGY DEPT	KADRI ALTUNDAG	TURKEY	ANKARA	ANKARA
234	Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department	Irfan Cicin	TURKEY	EDIRNE	EDIRNE
235	Kyiv City Clinical Oncological Center; Chemotherapy Department	Nataliia Voitko	UKRAINE	KIEV	Kiev
236	Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU; Chair of Oncology and Medical Radiology	IGOR BONDARENKO	UKRAINE	Dnipropetrovsk Oblast	Dnipropetrovsk
237	State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department	Yaroslav Shparyk	UKRAINE	Lviv	Lviv
238	ZAPOROZHYE REGIONAL ONCOLOGY HOSPITAL; DEPT OF ONCOLOGY	ALEXEY KOVALEV	UKRAINE	Zaporozhye	ZAPOROZHYE
239	Tawam Hospital	Hassan Jaafar	UNITED ARAB EMIRATES	Al Ain	Al Ain
240	Addenbrookes Hospital; Dept of Oncology	Richard Baird	UNITED KINGDOM	England	Cambridge
241	Barts and the London NHS Trust.	CHRIS GALLAGHER	UNITED KINGDOM	England	LONDON
242	BEATSON WEST OF SCOTLAND CANCER CENTRE	Sophie Barrett	UNITED KINGDOM	Scottish	GLASGOW
243	Christie Hospital; Breast Cancer Research Office	ANDREW WARDLEY	UNITED KINGDOM	England	Manchester
244	Churchill Hospital	Nicola Levitt	UNITED KINGDOM	England	OXFORD
245	City Hospital NHS Trust	DAN REA	UNITED KINGDOM	England	BIRMINGHAM
246	DERRIFORD HOSPITAL; PLYMOUTH ONCOLOGY CENTRE	Stephen Kelly	UNITED KINGDOM	England	PLYMOUTH
247	Diana Princess of Wales Hosp.	Mohammed Butt	UNITED KINGDOM	England	Grimsby
248	Eastbourne District Hospital; Department of Pharmacy	Sarah Westwell	UNITED KINGDOM	England	EASTBOURNE
249	FREEMAN HOSPITAL; NORTHERN CENTRE FOR CANCER CARE	MARK VERRILL	UNITED KINGDOM	England	New Castle upon Tyne
250	HAIRMYRES HOSPITAL; ONCOLOGY DEPT	Grainne Dunn	UNITED KINGDOM	England	EAST KILBRIDE
251	HUDDERSFIELD ROYAL INFIRMARY	JOHNATHAN JOFFE	UNITED KINGDOM	England	HUDDERSFIELD
252	JAMES COOK UNI HOSPITAL	Alison Humphreys	UNITED KINGDOM	England	MIDDLESBOROUGH
253	Leeds Teaching Hosp NHS Trust;St James's Institute of Onc	TIMOTHY PERREN	UNITED KINGDOM	England	LEEDS
254	Macclesfield District General Hospital	Lisa Barraclough	UNITED KINGDOM	England	Macclesfield
255	Mount Vernon Cancer Centre	DAVID MILES	UNITED KINGDOM	England	Northwood, Essex
256	Musgrove Park Hospital	Mohini Varughese	UNITED KINGDOM	England	Somerset
257	Peterborough City Hospital	KAREN MCADAM	UNITED KINGDOM	England	Peterborough
258	Royal Cornwall Hospital	DUNCAN WHEATLEY	UNITED KINGDOM	England	Truro
259	ROYAL DERBY HOSPITAL	Prabir Chakraborti	UNITED KINGDOM	England	Derby
260	ROYAL FREE HOSPITAL; DEPT OF ONCOLOGY	ALISON JONES	UNITED KINGDOM	England	LONDON
261	Royal Marsden Hospital	Nicholas Turner	UNITED KINGDOM	England	London
262	Royal Surrey County Hospital	ROBERT LAING	UNITED KINGDOM	England	GUILDFORD
263	Royal United Hospital; Oncology Department	Mark Beresford	UNITED KINGDOM	England	Bath
264	Wishaw General Hospital	Jonathan Hicks	UNITED KINGDOM	England	Glasgow
265	The Royal Marsden Hospital	Nicholas Turner	UNITED KINGDOM	England	SUTTON
266	University Hospital of North Durham	Wendy Taylor	UNITED KINGDOM	England	Durham
267	Velindre Hospital	Peter J. BARRETT-LEE	UNITED KINGDOM	England	Cardiff
268	WALSGRAVE HOSPITAL	CHRIS POOLE	UNITED KINGDOM	England	COVENTRY
269	Grupo Oncológico Cooperativo Uruguayo; Hospital de Clínicas - Dpto. de Oncología	Cecilia Castillo	URUGUAY	MONTEVIDEO	Montevideo
270	Hospital Central De Las FF.AA.; Servicio De Oncologia	Robinson Rodriguez	URUGUAY	MONTEVIDEO	Montevideo
271	Hospital Pereira Rossell; Oncology Department	Isabel Alonso	URUGUAY	MONTEVIDEO	Montevideo
272	Centro Integral de Oncología	Gassan Yordi	VENEZUELA	CARACAS	CARACAS
273	Centro Médico Docente La Trinidad; Servicio de Gastroenterología	RAúLVERA	VENEZUELA	CARACAS	CARACAS
274	Instituto Oncológico Luis Razetti	Juan JoseRodriguez	VENEZUELA	CARACAS	CARACAS
275	ANTICANCER HOSPITAL AG. SAVAS ; 2ND DEPT. OF ONCOLOGY - INTERNAL MEDICINE	Georgios Koumakis	GREECE	ATHENS	ATHENS
276	Euromedical General Clinic of Thessaloniki; Oncology Department	Konstantinos Papazisis	GREECE	THESSALONIKI	Thessaloniki
277	HIPPOKRATIO HOSPITAL; 2ND INTERNAL MEDICINE	DIMITRIOS PECTASIDES	GREECE	ATHENS	Athens

1	签署了经过相关的机构评审委员会（IRB）或独立伦理委员会（IEC）审批的书面知情同意。
2	男性或女性患者，年龄18岁或以上。
3	组织学或细胞学确诊并记录在案的乳腺腺癌，伴不可能根治性切除的转移性疾病或局部复发病灶。
4	根据当地实验室对原发肿瘤和/或者如果原发肿瘤不能获得时对转移部位的评估结果，呈HER2阳性（定义为免疫组化[IHC] 3+或原位杂交[ISH]阳性）（ISH阳性的定义为HER2基因拷贝数与CEP17信号的数量之比率为2.0或以上，或者对于单探针检测，HER2基因计数大于4）。
5	至少有一个可测量的病灶，而且/或者可根据实体肿瘤疗效评价标准（RECIST）第1.1 版进行评估的不可测量疾病（附录5）。
6	东部肿瘤合作组（ECOG）体能状态为0分、1分或2分。
7	左心室射血分数（LVEF）至少50%。
8	有怀孕可能性的女性（WOCBP；绝经前或者绝经后闭经不足12个月，以及尚未接受过手术绝育的女性），血清妊娠测试阴性。
9	对于WOCBP以及伴侣为CBP而且性生活活跃的男性患者，同意在研究期间和研究治疗后至少7个月使用高度有效的非激素型避孕措施（例如手术绝育）或两种有效的非激素避孕措施（例如屏障避孕法结合杀精凝胶）（详细内容请参考第4.5.2.1节）。
10	预期寿命至少有12周。

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