A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,095

Participants

Timeline

Start Date

July 31, 2010

Primary Completion Date

September 30, 2014

Study Completion Date

September 16, 2016

Conditions
Breast Cancer
Interventions
DRUG

docetaxel

75 mg/m2 or 100 mg/m2 intravenously every 3 weeks for a minimum of 6 cycles.

DRUG

paclitaxel

80 mg/m2 intravenously weekly for a minimum of 18 weeks

DRUG

pertuzumab

840 mg intravenously on day 1 of cycle 1 followed by 420 mg intravenously every 3 weeks in subsequent cycles

DRUG

pertuzumab-placebo

840 mg intravenously on day 1 of cycle 1 followed by 420 mg intravenously every 3 weeks in subsequent cycles

DRUG

trastuzumab [Herceptin]

trastuzumab \[Herceptin\] doses when administered with docetaxel: 8 mg/kg intravenously on cycle 1 followed by 6 mg/kg every 3 weeks in subsequent cycles or trastuzumab (Herceptin) doses when administered with paclitaxel: 4 mg/kg intravenously on day 1 of cycle 1 followed by 2 mg/kg weekly starting on day 8 of cycle 1.

DRUG

trastuzumab emtansine

3.6 mg/kg intravenously every 3 weeks

Trial Locations (257)

11

Hospital Nacional Edgardo Rebagliati Martins; Oncologia, Lima

100

National Taiwan Uni Hospital; Dept of Oncology, Taipei

114

Tri-Service General Hospital; Hematology and Oncology, Taipei

500

Changhua Christian Hospital; Hematology-Oncology, Changhua

807

Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery, Kaohsiung City

1000

Private Health Organization Acibadem Sistina Hospital, Skopje

1023

Auckland city hospital; Auckland Regional Cancer Centre and Blood Service, Auckland

1025

Fundación Investigar, Buenos Aires

1032

Szent Margit Hospital; Dept. of Oncology, Budapest

1083

Semmelweis Egyetem Onkologiai Központ, Budapest

1090

Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie, Vienna

1125

Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika, Budapest

1200

Cliniques Universitaires St-Luc, Brussels

1502

Cardinal Santos Medical Center, San Juan City

2060

Mater Misericordiae Hospital; Chemotherapy Cottage, Sydney

2298

Calvary Mater Newcastle; Medical Oncology, Waratah

2610

Sint Augustinus Wilrijk, Wilrijk

3000

Peter Maccallum Cancer Institute; Medical Oncology, Melbourne

4031

Universitaetsspital Basel; Onkologie, Basel

4066

Wesley Medical Centre; Clinic For Haematology and Oncology, Auchenflower

5000

Royal Adelaide Hospital; Oncology, Adelaide

Clinique Ste-Elisabeth, Namur

5020

Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt., Salzburg

5404

Kantonsspital Baden; Medizinische Klinik, Onkologie, Baden

6000

Cebu Cancer Institute; Perpetual Succour Hospital, Cebu City

7000

Kantonsspital Graubünden Medizin Onkologie; Onkologie und Hämatologie, Chur

7100

Vejle Sygehus; Onkologisk Afdeling, Vejle

7623

Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet, Pécs

10029

Icahn School of Medicine at Mount Sinai, New York

10065

Weill Medical College of Cornell Uni, New York

10400

National Cancer Inst., Bangkok

Rajavithi Hospital; Division of Medical Oncology, Bangkok

Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc, Bangkok

10700

Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology, Bangkok

11001

Clinica del Country, Bogotá

11042

Arena Oncology Associates, Lake Success

11366

Queens Medical Associates, Fresh Meadows

11432

Queens Hospital Center, Jamaica

13273

Institut Paoli Calmettes; Oncologie Medicale, Marseille

15006

Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología, A Coruña

15706

Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia, Santiago de Compostela

17033

Penn State Milton S. Hershey Medical Center, Hershey

20011

Unidad de Investigacion Oncologia Clinica ? Piura; Unidad de Oncología Clínica, Piura

20089

IRCCS Istituto Clinico Humanitas; Oncologia, Rozzano (MI)

20141

Istituto Europeo Di Oncologia, Milan

20230

Centenario Hospital Miguel Hidalgo, Aguascalientes

20249

Facharztzentrum Eppendorf, Studien GbR, Hamburg

21401

Anne Arundel Health System Research Instit-Annapolis Oncology Ctr, Annapolis

23007

Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia, Jaén

25030

HOPITAL JEAN MINJOZ; Oncologie, Besançon

27100

Fondazione Salvatore Maugeri, Pavia

27889

Marion L. Shepard Cancer Center, Washington

28007

Hospital General Universitario Gregorio Marañon; Servicio de Oncologia, Madrid

28041

Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid

28046

Hospital Universitario La Paz; Servicio de Oncologia, Madrid

28203

Carolinas Hem-Oncology Assoc, Charlotte

28602

Carolina Oncology Specialists, PA - Hickory, Hickory

29010

Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia, Málaga

29210

South Carolina Oncology Associates - SCRI, Columbia

29414

Charleston Oncology, P .A, Charleston

29425

Medical University of SC (MUSC), Charleston

30177

MVZ Onko Medical GmbH Hannover, Ralf Lohse (Geschäftsführer), Hanover

30607

University Cancer & Blood Center, LLC; Research, Athens

32224

Mayo Clinic-Jacksonville, Jacksonville

32429

Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Frauenheilkunde und Geburtshilfe, Minden

33100

Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia, Udine

33136

Uni of Miami School of Medicine; Sylvester Comprehensive Cancer Center, Miami

33180

Innovative Medical Research of South Florida, Aventura

33901

Florida Cancer Specialists; SCRI, Fort Myers

34298

Institut régional du Cancer Montpellier, Montpellier

35100

Ege Uni Medical Faculty Hospital; Oncology Dept, Izmir

37203

Tennessee Onc., PLLC - SCRI, Nashville

37232

Vanderbilt-Ingram Cancer Ctr, Nashville

37404

SCRI Tennessee Oncology Chattanooga, Chattanooga

38138

West Clinic, Germantown

39108

Universitätsklinikum Magdeburg; Frauenheilkunde & Geburtshilfe, Magdeburg

39670

Centro de Investigacion; Clinica Del Pacifico, Acapulco de Juárez

40202

James Graham Brown Cancer Center, University of Louisville, Louisville

41124

A.O. Universitaria Policlinico Di Modena; Ematologia, Modena

42100

Arcispedale Santa Maria Nuova; Oncologia, Reggio Emilia

42271

Institut de Cancerologie de La Loire; Radiotherapie, Saint-Priest-en-Jarez

45136

Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum, Essen

45242

Oncology Hematology Care - SCRI, Cincinnati

46010

Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia, Valencia

46050

Beacon International Specialist Centre, Petaling Jaya, Selangor

46150

Sunway Medical Centre, Kuala Selangor

46202

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis

47014

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

47900

Ospedale Degli Infermi; Divisione Di Oncologia, Rimini

47905

Horizon Oncology Research, Inc., Lafayette

49503

Spectrum Health Grand Rapids, Grand Rapids

50180

Centro Oncológico Estatal; ISSSEMYM Oncología, Toluca

50200

Maharaj Nakorn Hospital; Internal Medicine, Chiang Mai

54100

Centre D'Oncologie de Gentilly; Oncology, Nancy

54290

Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie, Trier

55131

Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde, Mainz

55454

University of Minnesota., Minneapolis

55902

Mayo Clinic Rochester, Rochester

57105

Avera Cancer Institute, Sioux Falls

58102

Sanford Roger Maris Cancer Center, Fargo

59020

Centre Oscar Lambret; Senologie, Lille

59100

Ospedale Misericordia E Dolce; Oncologia Medica, Prato

Pantai Hospital Kuala Lumpur; Dept of Oncology & Radiotherapy, Kuala Lumpur

60153

Loyola University Med Center, Maywood

60426

Ingalls Memorial Hospital, Harvey

60637

Uni of Chicago, Chicago

61615

Illinois Cancer Care, Peoria

62526

Decatur Memorial Hospital, Decatur

63011

Centre Jean Perrin; Hopital De Jour, Clermont-Ferrand

63141

St. John'S Mercy Medical Center; David C. Pratt Cancer Center, St Louis

64020

Centro Universitario Contra El Cancer, Monterrey

65804

Mercy Clinic Cancer & Hematology, Springfield

68000

Oaxaca Site Management Organization, Oaxaca City

69120

Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg, Heidelberg

71000

Clinic of Oncology, University Clinical Center Sarajevo, Sarajevo

72204

Uni of Arkansas For Medical Sciences; Arkansas Cancer Research Center, Little Rock

75231

Institut Curie; Oncologie Medicale, Paris

75475

Hopital Saint Louis; Service Onco Thoracique, Paris

75970

HOPITAL TENON; Cancerologie Medicale, Paris

77030

Uni of Texas - Md Anderson Cancer Center; Dept of Breast Medical Oncology, Houston

78000

University Clinical Centre of the Republic of Srpska, Banja Luka

79106

The Don & Sybil Harrington Cancer Center; Department of Clinical Research, Amarillo

80637

Rotkreuzklinikum München; Frauenklinik, München

83712

Mountain States Tumor Inst., Boise

84403

Northern Utah Associates, Ogden

85000

Hospital Privado San Jose; Oncologia, Obregón

86021

Chu La Miletrie; Radiotherapie, Poitiers

87401

San Juan Oncology Associates, Farmington

88100

Campus Universitario S.Venuta; Centro Oncologico T.Campanella, Catanzaro

90110

Songklanagarind Hospital; Department of Oncology, Songkhla

90640

Clnc L Trials & Rsch Assoc-Inc, Montebello

92037

Scripps Cancer Center, La Jolla

92093

University of California; Moores Cancer Center, La Jolla

92108

Southern California Kaiser Permanente, San Diego

92210

Centre Rene Huguenin; ONCOLOGIE GENETIQUE, Saint-Cloud

92705

Breastlink Medical Group Inc, Santa Ana

94589

Kaiser Permanente; Oncology Clinical Trials, Vallejo

95126

Centro Catanese Di Oncologia; Oncologia Medica, Catania

96813

Cancer Research Center of Hawaii; Clinical Sciences, Honolulu

98158

Ospedale Papardo- Piemonte;Oncologia Medica, Messina

98195

University of Washington, Seattle

98201

The Providence Regional Medical Center Everett, Everett

98405

Northwest Medical Specialties, Tacoma

115478

Blokhin Cancer Research Center; Combined Treatment, Moskva

143423

Moscow city oncology hospital; #62 of Moscow Healthcare Department, Moscow

153040

Ivanovo Regional Oncology Dispensary, Ivanovo

300053

Tula Regional Oncology Dispensary, Tula

355045

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

357502

State Budget Institution of Healthcare of Stavropol region Pyatigorsk Oncology Dispensary, Pyatigorsk

390026

Ryazan State Medical University Named after I.P.Pavlov, Ryazan

400006

Cluj Clinical County Hospital; Oncology Dept, Cluj-Napoca

400015

Prof. Dr. I. Chiricuta Institute of Oncology, Cluj-Napoca

420029

Clinical Oncology Dispensary of Ministry of Health of Tatarstan, Kazan'

443031

SBI of Healthcare Samara Regional Clinical Oncology Dispensary, Samara

600009

GUZ Vladimir Regional Clinical Oncological Dispensary, Vladimir

59040150

Liga Norte Riograndense Contra O Câncer, Natal

06510

Smilow Cancer Hospital at Yale New Haven, New Haven

33065-5701

Northwest Oncology/ Hematology Assoc., Coral Springs

04074

New England Cancer Specialists, Scarborough

02118

Boston Medical Center, Boston

03756

Dartmouth Hitchcock Med Center, Lebanon

07601

Hackensack Uni Medical Center; Northern Nj Cancer Center, Hackensack

08901

Cancer Inst. of New Jersey, New Brunswick

75390-9063

Uni of Texas Southwestern Medical Center, Dallas

T4000IAK

Centro Medico San Roque, San Miguel de Tucumán

20560-120

*X*Instituto Nacional do Cancer - INCA, Rio de Janeiro

90040-373

Hospital Nossa Senhora da Conceicao, Porto Alegre

90430-090

Clinica de Oncologia de Porto Alegre - CliniOnco, Porto Alegre

90610-000

Hospital Sao Lucas - PUCRS, Porto Alegre

88301-220

Clinica de Neoplasias Litoral, Itajaí

01246-000

Instituto do Cancer do Estado de Sao Paulo - ICESP, São Paulo

01317-000

Hospital Perola Byington, São Paulo

T6G 1Z2

Cross Cancer Institute; Clinical Trials, Edmonton

M2J 1V1

North York General Hospital, Toronto

J1H 5N4

Cuse - Centre Universitaire De Sante; Site Fleurimont, Sherbrooke

G1S 4L8

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

Unknown

Instituto Colombiano Para El Avance De La Medicina: Icamedic, Bucaramanga

Instituto Cancerologico de Nariño, Pasto

Centro Medico Imbanaco, Santiago de Cali

University Hospital of Larissa; Oncology, Larissa

Waikato Hospital; Regional Cancer Center, Hamilton

Coltea Hospital; Oncology, Bucharest

656 53

Masarykuv onkologicky ustav, Brno

779 00

Fakultni nemocnice Olomouc; Onkologicka klinika, Olomouc

128 08

Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika, Prague

180 00

Fakultni Nemocnice Na Bulovce; Ustav Radiacni Onkologie, Prague

06120

Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie, Halle

115 28

Alexandras General Hospital of Athens; Oncology Department, Athens

711 10

Univ General Hosp Heraklion; Medical Oncology, Heraklion

01010

Centro Oncológico Sixtino / Centro Oncológico SA, Guatemala City

01015

Grupo Angeles, Guatemala City

06156

Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica, Perugia

464-8681

Aichi Cancer Center Hospital, Breast Oncology, Aichi

791-0280

Natl Hosp Org Shikoku; Cancer Ctr, Surgery, Ehime

811-1395

National Hospital Organization Kyushu Cancer Center;Breast Oncology, Fukuoka

501-1194

Gifu University Hospital; Digestive Surgery, Gifu

734-8551

Hiroshima University Hospital; Breast Surgery, Hiroshima

003-0804

National Hospital Organization Hokkaido Cancer Center; Breast Surgery, Hokkaido

663-8501

Hyogo College Of Medicine; Breast And Endocrine Surgery, Hyōgo

673-8558

Hyogo Cancer Center; Breast Surgery, Hyōgo

920-8641

Kanazawa University Hospital; Breast Oncology, Ishikawa

892-0833

Sagara Hospital; Breast Surgery, Kagoshima

259-1193

Tokai University Hospital, Breast Surgery, Kanagawa

860-8556

Kumamoto University Hospital; Breast and Endocrine Surgery, Kumamoto

862-8505

Kumamoto City Hospital, Breast and Endocrine Surgery, Kumamoto

606-8507

Kyoto University Hospital; Breast Surgery, Kyoto

980-8574

Tohoku University Hospital; General Surgery, Miyagi

951-8566

Niigata Cancer Ctr Hospital; Breast Surgery, Niigata

028-3695

Iwate Med Univ School of Med; Surgery, Numakunai

701-0114

Kawasaki Medical School Hospital; Breast and Thyroid Surgery, Okayama

540-0006

National Hospital Organization Osaka National Hospital; Breast Surgery, Osaka

565-0871

Osaka University Hospital; Breast and Endocrine Surgery, Osaka

350-1298

Saitama Medical University International Medical Center; Medical Oncology, Saitama

362-0806

Saitama Cancer Center, Breast Oncology, Saitama

411-8777

Shizuoka Cancer Center; Breast Surgery, Shizuoka

420-8527

Shizuoka General Hospital; Breast Surgery, Shizuoka

104-0045

National Cancer Center Hospital; Medical Oncology, Tokyo

105-8470

Toranomon Hospital; Breast and Endocrine Surgery, Tokyo

135-8550

The Cancer Inst. Hosp. of JFCR; Breast Oncology Center, Tokyo

160-0023

Tokyo Medical Uni. Hospital; Breast Oncology, Tokyo

0832-02723

The Panama Clinic, Panama City

04001

Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology, Arequipa

85-796

Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii, Bydgoszcz

80-952

Medical University of Gdansk, Gdansk

31-115

Centrum Onkologii, Instytut, Klinika Chemioterapii; Oddzial Chemoterapii, Krakow

20-090

COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej, Lublin

02-781

Cent.Onkologii-Instytut im. M. S-Curie, Klinika Now. Piersi i Chirurgii Rekon, Warsaw

4200-072

IPO do Porto; Servico de Oncologia Medica, Porto

463-707

Seoul National University Bundang Hospital; Hematology Medical Oncology, Gyeonggi-do

03080

Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology, Seoul

135-710

Samsung Medical Centre; Division of Hematology/Oncology, Seoul

138-736

Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology, Seoul

152-703

Korea University Guro Hospital; Oncology, Seoul

03203

Hospital General Universitario de Elche; Servicio de Oncologia, Elche

08740

Hospital Univ Vall d'Hebron; Servicio de Oncologia, Sant Andreu de la Barca

08003

Hospital del Mar; Servicio de Oncologia, Barcelona

200 25

Skånes Universitetssjukhus; Kliniska Forskningsenheten Onkologimottagning medicinsk behandling, Malmo

09311

Oncology Consultants Limited, Nassau

01230

Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology, Adana

01330

Cukurova Uni Faculty of Medicine; Medical Oncology, Adana

06500

Gazi Uni Medical Faculty Hospital; Oncology Dept, Ankara

BS2 8ED

Bristol Haematology and Oncology centre, Bristol

CB2 0QQ

Cambridge University Hospitals NHS Foundation Trust, Cambridge

TR1 3LQ

Royal Cornwall Hospital; Dept of Clinical Oncology, Cornwall

G12 0YN

The Beatson West of Scotland Cancer Centre; Cancer Clinical Trials Unit, Glasgow

LE1 5WW

Leicester Royal Infirmary; Dept. of Medical Oncology, Leicester

NW3 2QG

Royal Free Hospital; Dept of Oncology, London

SE1 9RT

Guys Hospital; Management Offices, London

SW3 6JJ

Royal Marsden Hospital; Dept of Med-Onc, London

M20 4QL

Christie Hospital; Breast Cancer Research Office, Manchester

NG5 1PB

Nottingham City Hospital; Oncology, Nottingham

PE 3 9GZ

Peterborough City Hospital; Oncology Ward, Peterborough

PO6 3LY

Queen Alexandra Hospital, Portsmouth, Portsmouth

S10 2SJ

Weston Park Hospital; Cancer Clinical Trials Centre, Sheffield

SO16 6YD

Southampton General Hospital; Somers Cancer Research Building, Southampton

ST4 6QG

Uni Hospital of North Staffordshire; Staffordshire Oncology Centre, Stoke-on-Trent

SM2 5PT

Royal Marsden Hospital; Dept of Medical Oncology, Sutton

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

Hoffmann-La Roche

INDUSTRY