A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

720

Participants

Timeline

Start Date

October 16, 2008

Primary Completion Date

September 30, 2029

Study Completion Date

September 30, 2029

Conditions
Neoplasm Metastasis
Interventions
DRUG

Docetaxel

Docetaxel will be administered as per local prescribing information.

DRUG

Paclitaxel

Paclitaxel will be administered as per local prescribing information.

DRUG

Pertuzumab

Pertuzumab will be administered intravenously at a dose of 420 milligrams (mg) no more frequently than every 3 weeks (Q3W) (or as directed in the parent study protocol if less than Q3W).

DRUG

Trastuzumab

Trastuzumab will be administered as per local prescribing information.

DRUG

Trastuzumab Emtansine

Trastuzumab emtansine will be administered as intravenous (IV) infusion. Participants on weekly dosing schedule of trastuzumab emtansine in parent study, may switch to Q3W schedule as per the clinical judgment of the investigator. The starting dose of Q3W schedule must not exceed 3.6 milligrams per kilograms (mg/kg).

DRUG

Atezolizumab

Atezolizumab will be administered at a dose of 1200 mg by IV infusion every three weeks (Q3W)

Trial Locations (176)

18

Instituto, Lima

100

National Taiwan Uni Hospital, Taipei

736

Chi-Mei Medical Center, Tainan City

1000

Private Health Organization Acibadem Sistina Hospital, Skopje

Institute of Oncology Ljubljana, Ljubljana

1023

Auckland city hospital, Auckland

1031

Szent Margit Hospital, Budapest

1101

Veterans Memorial Medical Ctr, Quezon City

1502

Cardinal Santos Medical Center, San Juan City

1756

SHATO - Sofia, Sofia

2610

ZAS Sint Augustinus Wilrijk, Pharmacy, Wilrijk

3000

Peter MacCallum Cancer Center, Melbourne

3199

Peninsula and South Eastern Haematology and Oncology Group, Frankston

4004

Complex Oncology Center - Plovdiv First Internal Chemotherapy Department, Plovdiv

4032

Debreceni Egyetem, Klinikai Kozpont, Onkologiai Klinika, Debrecen

5000

Odense Universitetshospital, Onkologisk Afdeling R, Odense

6000

Cebu Cancer Institute, Cebu City

7100

Vejle Sygehus, Vejle

8091

Universitätsspital Zürich, Zurich

9000

UZ Gent, Ghent

9700

Markusovszky Hospital, Szombathely

10003

Hospital San Pedro De Alcantara, Cáceres

10016

Laura and ISAAC Perlmutter Cancer Center at NYU Langone., New York

10060

Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo, Candiolo

10110

Bumrungrad International Hosp, Bangkok

10400

Rajavithi Hospital, Bangkok

10408

National Cancer Center, Gyeonggi-do

11042

Clinical Research Alliance, Lake Success

NS-Long Island Jewish Hlth Sys, Lake Success

11407

Hospital de Jerez de la Frontera, Jerez de la Frontera

12163

Frauenarzt-Zentrum Zehlendorf an der Teltower Eiche, Berlin

13125

HELIOS Klinikum Berlin-Buch, Berlin

13273

Institut Paoli Calmettes, Marseille

14076

Centre Francois Baclesse, Caen

14080

Instituto Nacional de Cancer, D.F.

15038

Instituto Nacional de Enfermedades Neoplasicas, Lima

19713

Christina Care Institutional Review Board, Newark

20080

Hospital de Donostia, Donostia / San Sebastian

20133

Irccs Istituto Nazionale Dei Tumori (Int), Milan

20141

Istituto Europeo Di Oncologia, Milan

21079

Centre Georges Francois Leclerc, Dijon

21401

Anne Arundel Medical Center, Annapolis

21565

Gachon University Gil Medical Center, Incheon

25198

Hospital Universitari Arnau de Vilanova de Lleida, Lleida

28007

Hospital General Universitario Gregorio Marañon, Madrid

28034

Hospital Ramon y Cajal, Madrid

28602

Carolina Oncology Specialists, PA - Hickory, Hickory

30060

Northwest Georgia Oncology Centers PC - Marietta, Marietta

33028

Memorial Cancer Institute at Memorial West, Pembroke Pines

33081

RCCS - Centro di Riferimento, Aviano (PN)

33100

Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia, Udine

33607

Florida Cancer Specialists - Tampa (Dr. MLK Blvd), Tampa

33705

Florida Cancer Specialists (St. Petersburg ? St. Anthony?s Professional Building), St. Petersburg

33916

Florida Cancer Specialists, Fort Myers

34298

Institut régional du Cancer Montpellier, Montpellier

37203

Sarah Cannon Research Institute / Tennessee Oncology, Nashville

37404

Sarah Cannon Research Institute / Tennessee Oncology, Chattanooga

39670

Centro de Investigacion, Acapulco de Juárez

43100

Ospedale Regionale Di Parma, Parma

43219

The Mark H. Zangmeister Ctr, Columbus

44805

Ico Rene Gauducheau, Saint-Herblain

46202

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis

47014

IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola, Meldola

48201

Karmanos Cancer Institute, Detroit

50009

Hospital Universitario Miguel Servet, Zaragoza

52403

Oncology Assoc of Cedar Rapids, Cedar Rapids

52722

Hematology-Oncology, Bettendorf

55407

Minnesota Oncology Hematology, Pa, Minneapolis

55455

University of Minnesota., Minneapolis

55905

Mayo Clinic - Rochester, Rochester

60153

Loyola University Med Center, Maywood

61615

Illinois Cancer Care, Peoria

63141

St. John's Mercy Medical Ctr, St Louis

63739

Studienzentrum Aschaffenburg, Aschaffenburg

65804

Mercy Clinic Cancer & Hematology, Springfield

75020

Hopital Tenon, Paris

75231

Texas Oncology - Dallas Presbyterian Hospital, Dallas

Institut Curie, Paris

75702

USO - Tyler Cancer Ctr, Tyler

76022

Texas Oncology, Bedford

78229

Cancer Therapy & Research Center, San Antonio

80045

Univ of Colorado Canc Ctr, Aurora

University of Colorado, Aurora

80131

Istituto Nazionale Tumori Irccs Fondazione g. PASCALE, Napoli

80220

Rocky Mountain Cancer Center - Denver, Denver

80637

Rotkreuzklinikum München, München

81377

Klinikum der Universität München, München

83854

Kootenai Cancer Center, Post Falls

85100

Ospedale San Carlo, Potenza

88100

Campus Universitario S.Venuta, Catanzaro

89148

Comp Cancer Centers of Nevada, Las Vegas

90277

Can Care Assoc Med Group Inc, Redondo Beach

90404

UCLA Oncology Office, Santa Monica

91010

City of Hope National Medical Center, Duarte

91031

Shaare Zedek Medical Center, Jerusalem

92211

Institut Curie - Hopital Rene Huguenin, Saint-Cloud

93454

Central Coast Medical Oncology, San Luis Obispo

94115

Univ of Calif, San Francisco, San Francisco

94596

Kaiser Permanente - Walnut Creek, Walnut Creek

95045

Humanitas Istituto Clinico Catanese S.p.A, Misterbianco (CT)

97227

Northwest Cancer Specialists - Portland (N Broadway), Portland

98109

Univ of WA Medical Center, Seattle

98405

Northwest Medical Specialties, Tacoma

100071

The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA), Beijing

100142

Beijing Cancer Hospital, Beijing

110744

Seoul National University Hospital, Seoul

115478

Blokhin Cancer Research Center, Moskva

130021

the First Hospital of Jilin University, Changchun

143423

City Clinical Oncology Hospital, Moscow

150081

Harbin Medical University Cancer Hospital, Harbin

197758

FSBI?National Medical Research Center of Oncology named after N.N.Petrov? MHRF, Saint Petersburg

200120

Fudan University Shanghai Cancer Center, Shanghai

211100

Jiangsu Cancer Hospital, Nanjing

310014

Zhejiang Provincial People's Hospital, Hangzhou

310022

Zhejiang Cancer Hospital, Hangzhou

355045

SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary, Stavropol

450054

Bashkirian Republican Clinical Oncology Dispensary, Ufa

SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan, Ufa

510060

Sun Yet-sen University Cancer Center, Guangzhou

510120

Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou

6423906

Tel Aviv Sourasky Medical Ctr, Tel Aviv

7500921

Fundacion Arturo Lopez Perez, Santiago

94305-5456

Stanford Cancer Institute, Stanford

21231-1000

Johns Hopkins Univ Med Center, Baltimore

02115

Dana Farber Cancer Institute, Boston

07039

St. Barnabas Health Care Sys, Livingston

75075-7787

USO, Plano

98109-1023

Uni of Washington Medical Center, Seattle

90430-090

Clinica de Oncologia de Porto Alegre - CliniOnco, Porto Alegre

91350-200

Hospital Nossa Senhora da Conceicao, Porto Alegre

88301-220

Clinica de Neoplasias Litoral, Itajaí

09060-650

Faculdade de Medicina do ABC - FMABC, Santo André

01317-000

Hospital Perola Byington, São Paulo

20560-120

Instituto Nacional de Cancer - INCa, Rio de Janeiro

V1Y 5L3

BC Cancer ? Kelowna (Sindi Ahluwalia Hawkins Centre), Kelowna

K1Y 4K7

Ottawa Regional Cancer Centre, Ottawa

SK S7N 4H4

Saskatoon Cancer Centre, Saskatoon

G1S 4L8

CHU de Québec ? Hôpital du Saint-Sacrement / ONCOLOGY, Québec

775 20

Fakultni nemocnice Olomouc, Olomouc

128 08

Fakultni Poliklinika Vseobecne Fakultni Niemocnice, Prague

01015

Grupo Angeles, Guatemala City

Unknown

Queen Mary Hospital, Hong Kong

City Oncology Dispensary, Saint Petersburg

07100

Ospedale Civile, Sassari

734-8551

Hiroshima University Hospital, Hiroshima

673-8558

Hyogo Cancer Center, Hyōgo

03100

Consultorio de Medicina Especializada, Distrito Federal

0310

Oslo Universitetssykehus HF, Oslo

0832

The Panama Clinic, Panama City

80-952

Uniwersyteckie Centrum Kliniczne, Gdansk

25-734

?wi?tokrzyskie Centrum Onkologii, Kielce

05-400

Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii, Otwock

61-866

Wielkopolskie Centrum Onkologii, Poznan

44-200

Wojewódzki Szpital Specjalistyczny Nr 3, Rybnik

02-781

Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie, Warsaw

1500-650

Hospital da Luz, Lisbon

702-210

Kyungpook National University Medical Center, Daegu

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

135-710

Samsung Medical Center, Seoul

03203

Hospital General Universitario de Elche, Elche

08003

Hospital del Mar, Barcelona

08035

Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Barcelona

08907

Hospital Duran i Reynals, Barcelona

DD12 9SY

Ninewells Hospital, Dundee

EH4 2XU

Western General Hospital, Edinburgh

DN33 2BA

Diana Princess of Wales Hosp., Grimsby

LA1 4RP

Royal Lancaster Infirmary, Morecambe Bay Hospitals Nhs Trust, Lancaster

NW3 2QG

Royal Free Hospital, London

M20 4BX

Christie Hospital NHS Trust, Manchester

HA6 2RN

Mount Vernon Hospital, Middlesex

NG5 1PB

Nottingham City Hospital, Nottingham

BH15 2JB

Poole General Hospital, Poole

RM7 0AG

Queen's Hospital, Romford

SA6 6NL

Abertawe and Bro Morgannwg NHS Trust, Swansea

TR1 3LJ

Royal Cornwall Hospital, Truro

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Hoffmann-La Roche

INDUSTRY

lead

Genentech, Inc.

INDUSTRY