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

NCT ID: NCT01120184

Last Updated: 2024-03-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1095 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2016-09-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This randomized, 3-arm, multicenter, phase III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab (Herceptin) plus taxane (docetaxel or paclitaxel) in participants with HER2-positive progressive or recurrent locally advanced or previously untreated metastatic breast cancer. Participants will be randomized to 1 of 3 treatment arms (Arms A, B or C). Arm A will be open-label, whereas Arms B and C will be blinded.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Trastuzumab + Taxane (docetaxel or paclitaxel)

Group Type EXPERIMENTAL

docetaxel

Intervention Type DRUG

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

paclitaxel

Intervention Type DRUG

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

trastuzumab [Herceptin]

Intervention Type DRUG

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.

Trastuzumab emtansine + pertuzumab

Group Type EXPERIMENTAL

pertuzumab

Intervention Type DRUG

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

trastuzumab emtansine

Intervention Type DRUG

3.6 mg/kg intravenously every 3 weeks

Trastuzumab emtansine + pertuzumab placebo

Group Type EXPERIMENTAL

pertuzumab-placebo

Intervention Type DRUG

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

trastuzumab emtansine

Intervention Type DRUG

3.6 mg/kg intravenously every 3 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

docetaxel

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

Intervention Type DRUG

paclitaxel

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

Intervention Type DRUG

pertuzumab

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

Intervention Type DRUG

pertuzumab-placebo

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

Intervention Type 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.

Intervention Type DRUG

trastuzumab emtansine

3.6 mg/kg intravenously every 3 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult participants \>/=18 years of age
* HER2-positive breast cancer
* Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease, and be a candidate for chemotherapy. Participants with locally advanced disease must have recurrent or progressive disease, which must not be amenable to resection with curative intent.
* Participants must have measurable and/or non-measurable disease which must be evaluable per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
* Adequate organ function as determined by laboratory results

Exclusion Criteria

* History of prior (or any) chemotherapy for metastatic breast cancer or recurrent locally advanced disease
* An interval of \<6 months from the last dose of vinca-alkaloid or taxane cytotoxic chemotherapy until the time of metastatic diagnosis
* Hormone therapy \<7 days prior to randomization
* Trastuzumab therapy and/or lapatinib (neo- or adjuvant setting) \<21 days prior to randomization
* Prior trastuzumab emtansine or pertuzumab therapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Uni of Arkansas For Medical Sciences; Arkansas Cancer Research Center

Little Rock, Arkansas, United States

Site Status

Scripps Cancer Center

La Jolla, California, United States

Site Status

University of California; Moores Cancer Center

La Jolla, California, United States

Site Status

Clnc L Trials & Rsch Assoc-Inc

Montebello, California, United States

Site Status

Southern California Kaiser Permanente

San Diego, California, United States

Site Status

Breastlink Medical Group Inc

Santa Ana, California, United States

Site Status

Kaiser Permanente; Oncology Clinical Trials

Vallejo, California, United States

Site Status

Smilow Cancer Hospital at Yale New Haven

New Haven, Connecticut, United States

Site Status

Innovative Medical Research of South Florida

Aventura, Florida, United States

Site Status

Northwest Oncology/ Hematology Assoc.

Coral Springs, Florida, United States

Site Status

Florida Cancer Specialists; SCRI

Fort Myers, Florida, United States

Site Status

Mayo Clinic-Jacksonville

Jacksonville, Florida, United States

Site Status

Uni of Miami School of Medicine; Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Site Status

University Cancer & Blood Center, LLC; Research

Athens, Georgia, United States

Site Status

Cancer Research Center of Hawaii; Clinical Sciences

Honolulu, Hawaii, United States

Site Status

Mountain States Tumor Inst.

Boise, Idaho, United States

Site Status

Uni of Chicago

Chicago, Illinois, United States

Site Status

Decatur Memorial Hospital

Decatur, Illinois, United States

Site Status

Ingalls Memorial Hospital

Harvey, Illinois, United States

Site Status

Loyola University Med Center

Maywood, Illinois, United States

Site Status

Illinois Cancer Care

Peoria, Illinois, United States

Site Status

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Site Status

Horizon Oncology Research, Inc.

Lafayette, Indiana, United States

Site Status

James Graham Brown Cancer Center, University of Louisville

Louisville, Kentucky, United States

Site Status

New England Cancer Specialists

Scarborough, Maine, United States

Site Status

Anne Arundel Health System Research Instit-Annapolis Oncology Ctr

Annapolis, Maryland, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

Spectrum Health Grand Rapids

Grand Rapids, Michigan, United States

Site Status

University of Minnesota.

Minneapolis, Minnesota, United States

Site Status

Mayo Clinic Rochester

Rochester, Minnesota, United States

Site Status

Mercy Clinic Cancer & Hematology

Springfield, Missouri, United States

Site Status

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

St Louis, Missouri, United States

Site Status

Dartmouth Hitchcock Med Center

Lebanon, New Hampshire, United States

Site Status

Hackensack Uni Medical Center; Northern Nj Cancer Center

Hackensack, New Jersey, United States

Site Status

Cancer Inst. of New Jersey

New Brunswick, New Jersey, United States

Site Status

San Juan Oncology Associates

Farmington, New Mexico, United States

Site Status

Queens Medical Associates

Fresh Meadows, New York, United States

Site Status

Queens Hospital Center

Jamaica, New York, United States

Site Status

Arena Oncology Associates

Lake Success, New York, United States

Site Status

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Weill Medical College of Cornell Uni

New York, New York, United States

Site Status

Carolinas Hem-Oncology Assoc

Charlotte, North Carolina, United States

Site Status

Carolina Oncology Specialists, PA - Hickory

Hickory, North Carolina, United States

Site Status

Marion L. Shepard Cancer Center

Washington, North Carolina, United States

Site Status

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Site Status

Oncology Hematology Care - SCRI

Cincinnati, Ohio, United States

Site Status

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Charleston Oncology, P .A

Charleston, South Carolina, United States

Site Status

Medical University of SC (MUSC)

Charleston, South Carolina, United States

Site Status

South Carolina Oncology Associates - SCRI

Columbia, South Carolina, United States

Site Status

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Site Status

SCRI Tennessee Oncology Chattanooga

Chattanooga, Tennessee, United States

Site Status

West Clinic

Germantown, Tennessee, United States

Site Status

Tennessee Onc., PLLC - SCRI

Nashville, Tennessee, United States

Site Status

Vanderbilt-Ingram Cancer Ctr

Nashville, Tennessee, United States

Site Status

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

Amarillo, Texas, United States

Site Status

Uni of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

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

Houston, Texas, United States

Site Status

Northern Utah Associates

Ogden, Utah, United States

Site Status

The Providence Regional Medical Center Everett

Everett, Washington, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Northwest Medical Specialties

Tacoma, Washington, United States

Site Status

Fundación Investigar

Buenos Aires, , Argentina

Site Status

Centro Medico San Roque

San Miguel de Tucumán, , Argentina

Site Status

Mater Misericordiae Hospital; Chemotherapy Cottage

Sydney, New South Wales, Australia

Site Status

Calvary Mater Newcastle; Medical Oncology

Waratah, New South Wales, Australia

Site Status

Wesley Medical Centre; Clinic For Haematology and Oncology

Auchenflower, Queensland, Australia

Site Status

Royal Adelaide Hospital; Oncology

Adelaide, South Australia, Australia

Site Status

Peter Maccallum Cancer Institute; Medical Oncology

Melbourne, Victoria, Australia

Site Status

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

Salzburg, , Austria

Site Status

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

Vienna, , Austria

Site Status

Cliniques Universitaires St-Luc

Brussels, , Belgium

Site Status

Clinique Ste-Elisabeth

Namur, , Belgium

Site Status

Sint Augustinus Wilrijk

Wilrijk, , Belgium

Site Status

University Clinical Centre of the Republic of Srpska

Banja Luka, , Bosnia and Herzegovina

Site Status

Clinic of Oncology, University Clinical Center Sarajevo

Sarajevo, , Bosnia and Herzegovina

Site Status

*X*Instituto Nacional do Cancer - INCA

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Liga Norte Riograndense Contra O Câncer

Natal, Rio Grande do Norte, Brazil

Site Status

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Clinica de Oncologia de Porto Alegre - CliniOnco

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Hospital Sao Lucas - PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Clinica de Neoplasias Litoral

Itajaí, Santa Catarina, Brazil

Site Status

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo, Brazil

Site Status

Hospital Perola Byington

São Paulo, São Paulo, Brazil

Site Status

Cross Cancer Institute; Clinical Trials

Edmonton, Alberta, Canada

Site Status

North York General Hospital

Toronto, Ontario, Canada

Site Status

Cuse - Centre Universitaire De Sante; Site Fleurimont

Sherbrooke, Quebec, Canada

Site Status

CHU de Québec ? Hôpital du Saint-Sacrement / ONCOLOGY

Québec, , Canada

Site Status

Clinica del Country

Bogotá, , Colombia

Site Status

Instituto Colombiano Para El Avance De La Medicina: Icamedic

Bucaramanga, , Colombia

Site Status

Centro Medico Imbanaco

Cali, , Colombia

Site Status

Instituto Cancerologico de Nariño

Pasto, , Colombia

Site Status

Masarykuv onkologicky ustav

Brno, , Czechia

Site Status

Fakultni nemocnice Olomouc; Onkologicka klinika

Olomouc, , Czechia

Site Status

Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika

Prague, , Czechia

Site Status

Fakultni Nemocnice Na Bulovce; Ustav Radiacni Onkologie

Prague, , Czechia

Site Status

Vejle Sygehus; Onkologisk Afdeling

Vejle, , Denmark

Site Status

HOPITAL JEAN MINJOZ; Oncologie

Besançon, , France

Site Status

Centre Jean Perrin; Hopital De Jour

Clermont-Ferrand, , France

Site Status

Centre Oscar Lambret; Senologie

Lille, , France

Site Status

Institut Paoli Calmettes; Oncologie Medicale

Marseille, , France

Site Status

Institut régional du Cancer Montpellier

Montpellier, , France

Site Status

Centre D'Oncologie de Gentilly; Oncology

Nancy, , France

Site Status

Institut Curie; Oncologie Medicale

Paris, , France

Site Status

Hopital Saint Louis; Service Onco Thoracique

Paris, , France

Site Status

HOPITAL TENON; Cancerologie Medicale

Paris, , France

Site Status

Chu La Miletrie; Radiotherapie

Poitiers, , France

Site Status

Centre Rene Huguenin; ONCOLOGIE GENETIQUE

Saint-Cloud, , France

Site Status

Institut de Cancerologie de La Loire; Radiotherapie

Saint-Priest-en-Jarez, , France

Site Status

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

Essen, , Germany

Site Status

Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie

Halle, , Germany

Site Status

Facharztzentrum Eppendorf, Studien GbR

Hamburg, , Germany

Site Status

MVZ Onko Medical GmbH Hannover, Ralf Lohse (Geschäftsführer)

Hanover, , Germany

Site Status

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

Heidelberg, , Germany

Site Status

Universitätsklinikum Magdeburg; Frauenheilkunde & Geburtshilfe

Magdeburg, , Germany

Site Status

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

Mainz, , Germany

Site Status

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

Minden, , Germany

Site Status

Rotkreuzklinikum München; Frauenklinik

München, , Germany

Site Status

Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

Trier, , Germany

Site Status

Alexandras General Hospital of Athens; Oncology Department

Athens, , Greece

Site Status

Univ General Hosp Heraklion; Medical Oncology

Heraklion, , Greece

Site Status

University Hospital of Larissa; Oncology

Larissa, , Greece

Site Status

Centro Oncológico Sixtino / Centro Oncológico SA

Guatemala City, , Guatemala

Site Status

Grupo Angeles

Guatemala City, , Guatemala

Site Status

Szent Margit Hospital; Dept. of Oncology

Budapest, , Hungary

Site Status

Semmelweis Egyetem Onkologiai Központ

Budapest, , Hungary

Site Status

Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika

Budapest, , Hungary

Site Status

Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet

Pécs, , Hungary

Site Status

Campus Universitario S.Venuta; Centro Oncologico T.Campanella

Catanzaro, Calabria, Italy

Site Status

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

Meldola, Emilia-Romagna, Italy

Site Status

A.O. Universitaria Policlinico Di Modena; Ematologia

Modena, Emilia-Romagna, Italy

Site Status

Arcispedale Santa Maria Nuova; Oncologia

Reggio Emilia, Emilia-Romagna, Italy

Site Status

Ospedale Degli Infermi; Divisione Di Oncologia

Rimini, Emilia-Romagna, Italy

Site Status

Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia

Udine, Friuli Venezia Giulia, Italy

Site Status

Istituto Europeo Di Oncologia

Milan, Lombardy, Italy

Site Status

Fondazione Salvatore Maugeri

Pavia, Lombardy, Italy

Site Status

IRCCS Istituto Clinico Humanitas; Oncologia

Rozzano (MI), Lombardy, Italy

Site Status

Centro Catanese Di Oncologia; Oncologia Medica

Catania, Sicily, Italy

Site Status

Ospedale Papardo- Piemonte;Oncologia Medica

Messina, Sicily, Italy

Site Status

Ospedale Misericordia E Dolce; Oncologia Medica

Prato, Tuscany, Italy

Site Status

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

Perugia, Umbria, Italy

Site Status

Aichi Cancer Center Hospital, Breast Oncology

Aichi, , Japan

Site Status

Natl Hosp Org Shikoku; Cancer Ctr, Surgery

Ehime, , Japan

Site Status

National Hospital Organization Kyushu Cancer Center;Breast Oncology

Fukuoka, , Japan

Site Status

Gifu University Hospital; Digestive Surgery

Gifu, , Japan

Site Status

Hiroshima University Hospital; Breast Surgery

Hiroshima, , Japan

Site Status

National Hospital Organization Hokkaido Cancer Center; Breast Surgery

Hokkaido, , Japan

Site Status

Hyogo College Of Medicine; Breast And Endocrine Surgery

Hyōgo, , Japan

Site Status

Hyogo Cancer Center; Breast Surgery

Hyōgo, , Japan

Site Status

Kanazawa University Hospital; Breast Oncology

Ishikawa, , Japan

Site Status

Sagara Hospital; Breast Surgery

Kagoshima, , Japan

Site Status

Tokai University Hospital, Breast Surgery

Kanagawa, , Japan

Site Status

Kumamoto University Hospital; Breast and Endocrine Surgery

Kumamoto, , Japan

Site Status

Kumamoto City Hospital, Breast and Endocrine Surgery

Kumamoto, , Japan

Site Status

Kyoto University Hospital; Breast Surgery

Kyoto, , Japan

Site Status

Tohoku University Hospital; General Surgery

Miyagi, , Japan

Site Status

Niigata Cancer Ctr Hospital; Breast Surgery

Niigata, , Japan

Site Status

Iwate Med Univ School of Med; Surgery

Numakunai, , Japan

Site Status

Kawasaki Medical School Hospital; Breast and Thyroid Surgery

Okayama, , Japan

Site Status

National Hospital Organization Osaka National Hospital; Breast Surgery

Osaka, , Japan

Site Status

Osaka University Hospital; Breast and Endocrine Surgery

Osaka, , Japan

Site Status

Saitama Medical University International Medical Center; Medical Oncology

Saitama, , Japan

Site Status

Saitama Cancer Center, Breast Oncology

Saitama, , Japan

Site Status

Shizuoka Cancer Center; Breast Surgery

Shizuoka, , Japan

Site Status

Shizuoka General Hospital; Breast Surgery

Shizuoka, , Japan

Site Status

National Cancer Center Hospital; Medical Oncology

Tokyo, , Japan

Site Status

Toranomon Hospital; Breast and Endocrine Surgery

Tokyo, , Japan

Site Status

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

Tokyo, , Japan

Site Status

Tokyo Medical Uni. Hospital; Breast Oncology

Tokyo, , Japan

Site Status

Pantai Hospital Kuala Lumpur; Dept of Oncology & Radiotherapy

Kuala Lumpur, FED. Territory of Kuala Lumpur, Malaysia

Site Status

Sunway Medical Centre

Kuala Selangor, Selangor, Malaysia

Site Status

Beacon International Specialist Centre

Petaling Jaya, Selangor, Selangor, Malaysia

Site Status

Centro de Investigacion; Clinica Del Pacifico

Acapulco de Juárez, Guerrero, Mexico

Site Status

Centro Universitario Contra El Cancer

Monterrey, Nuevo León, Mexico

Site Status

Oaxaca Site Management Organization

Oaxaca City, Oaxaca, Mexico

Site Status

Hospital Privado San Jose; Oncologia

Obregón, Sonora, Mexico

Site Status

Centenario Hospital Miguel Hidalgo

Aguascalientes, , Mexico

Site Status

Centro Oncológico Estatal; ISSSEMYM Oncología

Toluca, , Mexico

Site Status

Auckland city hospital; Auckland Regional Cancer Centre and Blood Service

Auckland, , New Zealand

Site Status

Waikato Hospital; Regional Cancer Center

Hamilton, , New Zealand

Site Status

Private Health Organization Acibadem Sistina Hospital

Skopje, , North Macedonia

Site Status

The Panama Clinic

Panama City, , Panama

Site Status

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

Arequipa, , Peru

Site Status

Hospital Nacional Edgardo Rebagliati Martins; Oncologia

Lima, , Peru

Site Status

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

Piura, , Peru

Site Status

Cebu Cancer Institute; Perpetual Succour Hospital

Cebu City, , Philippines

Site Status

Cardinal Santos Medical Center

San Juan City, , Philippines

Site Status

Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii

Bydgoszcz, , Poland

Site Status

Medical University of Gdansk

Gdansk, , Poland

Site Status

Centrum Onkologii, Instytut, Klinika Chemioterapii; Oddzial Chemoterapii

Krakow, , Poland

Site Status

COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej

Lublin, , Poland

Site Status

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

Warsaw, , Poland

Site Status

IPO do Porto; Servico de Oncologia Medica

Porto, , Portugal

Site Status

Coltea Hospital; Oncology

Bucharest, , Romania

Site Status

Cluj Clinical County Hospital; Oncology Dept

Cluj-Napoca, , Romania

Site Status

Prof. Dr. I. Chiricuta Institute of Oncology

Cluj-Napoca, , Romania

Site Status

Moscow city oncology hospital; #62 of Moscow Healthcare Department

Moscow, Moscow Oblast, Russia

Site Status

Blokhin Cancer Research Center; Combined Treatment

Moskva, Moscow Oblast, Russia

Site Status

Ryazan State Medical University Named after I.P.Pavlov

Ryazan, Ryazan Oblast, Russia

Site Status

State Budget Institution of Healthcare of Stavropol region Pyatigorsk Oncology Dispensary

Pyatigorsk, Stavropol Kray, Russia

Site Status

Clinical Oncology Dispensary of Ministry of Health of Tatarstan

Kazan', Tatarstan Republic, Russia

Site Status

Ivanovo Regional Oncology Dispensary

Ivanovo, , Russia

Site Status

SBI of Healthcare Samara Regional Clinical Oncology Dispensary

Samara, , Russia

Site Status

SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary

Stavropol, , Russia

Site Status

Tula Regional Oncology Dispensary

Tula, , Russia

Site Status

GUZ Vladimir Regional Clinical Oncological Dispensary

Vladimir, , Russia

Site Status

Seoul National University Bundang Hospital; Hematology Medical Oncology

Gyeonggi-do, , South Korea

Site Status

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

Seoul, , South Korea

Site Status

Samsung Medical Centre; Division of Hematology/Oncology

Seoul, , South Korea

Site Status

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

Seoul, , South Korea

Site Status

Korea University Guro Hospital; Oncology

Seoul, , South Korea

Site Status

Hospital General Universitario de Elche; Servicio de Oncologia

Elche, Alicante, Spain

Site Status

Hospital Univ Vall d'Hebron; Servicio de Oncologia

Sant Andreu de la Barca, Barcelona, Spain

Site Status

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

Santiago de Compostela, LA Coruña, Spain

Site Status

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

A Coruña, , Spain

Site Status

Hospital del Mar; Servicio de Oncologia

Barcelona, , Spain

Site Status

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

Jaén, , Spain

Site Status

Hospital General Universitario Gregorio Marañon; Servicio de Oncologia

Madrid, , Spain

Site Status

Hospital Universitario 12 de Octubre; Servicio de Oncologia

Madrid, , Spain

Site Status

Hospital Universitario La Paz; Servicio de Oncologia

Madrid, , Spain

Site Status

Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

Málaga, , Spain

Site Status

Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

Valencia, , Spain

Site Status

Skånes Universitetssjukhus; Kliniska Forskningsenheten Onkologimottagning medicinsk behandling

Malmo, , Sweden

Site Status

Kantonsspital Baden; Medizinische Klinik, Onkologie

Baden, , Switzerland

Site Status

Universitaetsspital Basel; Onkologie

Basel, , Switzerland

Site Status

Kantonsspital Graubünden Medizin Onkologie; Onkologie und Hämatologie

Chur, , Switzerland

Site Status

Changhua Christian Hospital; Hematology-Oncology

Changhua, , Taiwan

Site Status

Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery

Kaohsiung City, , Taiwan

Site Status

National Taiwan Uni Hospital; Dept of Oncology

Taipei, , Taiwan

Site Status

Tri-Service General Hospital; Hematology and Oncology

Taipei, , Taiwan

Site Status

National Cancer Inst.

Bangkok, , Thailand

Site Status

Rajavithi Hospital; Division of Medical Oncology

Bangkok, , Thailand

Site Status

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

Bangkok, , Thailand

Site Status

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

Bangkok, , Thailand

Site Status

Maharaj Nakorn Hospital; Internal Medicine

Chiang Mai, , Thailand

Site Status

Songklanagarind Hospital; Department of Oncology

Songkhla, , Thailand

Site Status

Oncology Consultants Limited

Nassau, , The Bahamas

Site Status

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

Adana, , Turkey (Türkiye)

Site Status

Cukurova Uni Faculty of Medicine; Medical Oncology

Adana, , Turkey (Türkiye)

Site Status

Gazi Uni Medical Faculty Hospital; Oncology Dept

Ankara, , Turkey (Türkiye)

Site Status

Ege Uni Medical Faculty Hospital; Oncology Dept

Izmir, , Turkey (Türkiye)

Site Status

Bristol Haematology and Oncology centre

Bristol, , United Kingdom

Site Status

Cambridge University Hospitals NHS Foundation Trust

Cambridge, , United Kingdom

Site Status

Royal Cornwall Hospital; Dept of Clinical Oncology

Cornwall, , United Kingdom

Site Status

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

Glasgow, , United Kingdom

Site Status

Leicester Royal Infirmary; Dept. of Medical Oncology

Leicester, , United Kingdom

Site Status

Royal Free Hospital; Dept of Oncology

London, , United Kingdom

Site Status

Guys Hospital; Management Offices

London, , United Kingdom

Site Status

Royal Marsden Hospital; Dept of Med-Onc

London, , United Kingdom

Site Status

Christie Hospital; Breast Cancer Research Office

Manchester, , United Kingdom

Site Status

Nottingham City Hospital; Oncology

Nottingham, , United Kingdom

Site Status

Peterborough City Hospital; Oncology Ward

Peterborough, , United Kingdom

Site Status

Queen Alexandra Hospital, Portsmouth

Portsmouth, , United Kingdom

Site Status

Weston Park Hospital; Cancer Clinical Trials Centre

Sheffield, , United Kingdom

Site Status

Southampton General Hospital; Somers Cancer Research Building

Southampton, , United Kingdom

Site Status

Uni Hospital of North Staffordshire; Staffordshire Oncology Centre

Stoke-on-Trent, , United Kingdom

Site Status

Royal Marsden Hospital; Dept of Medical Oncology

Sutton, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Australia Austria Belgium Bosnia and Herzegovina Brazil Canada Colombia Czechia Denmark France Germany Greece Guatemala Hungary Italy Japan Malaysia Mexico New Zealand North Macedonia Panama Peru Philippines Poland Portugal Romania Russia South Korea Spain Sweden Switzerland Taiwan Thailand The Bahamas Turkey (Türkiye) United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

Perez EA, de Haas SL, Eiermann W, Barrios CH, Toi M, Im YH, Conte PF, Martin M, Pienkowski T, Pivot XB, Burris HA 3rd, Stanzel S, Patre M, Ellis PA. Relationship between tumor biomarkers and efficacy in MARIANNE, a phase III study of trastuzumab emtansine +/- pertuzumab versus trastuzumab plus taxane in HER2-positive advanced breast cancer. BMC Cancer. 2019 May 30;19(1):517. doi: 10.1186/s12885-019-5687-0.

Reference Type DERIVED
PMID: 31146717 (View on PubMed)

Bighin C, Pronzato P, Del Mastro L. Trastuzumab emtansine in the treatment of HER-2-positive metastatic breast cancer patients. Future Oncol. 2013 Jul;9(7):955-7. doi: 10.2217/fon.13.74.

Reference Type DERIVED
PMID: 23837759 (View on PubMed)

Scott AM, Wolchok JD, Old LJ. Antibody therapy of cancer. Nat Rev Cancer. 2012 Mar 22;12(4):278-87. doi: 10.1038/nrc3236.

Reference Type DERIVED
PMID: 22437872 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2009-017905-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BO22589

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

T-DM1 vs Paclitaxel/Trastuzumab for Breast (ATEMPT Trial)
NCT01853748 ACTIVE_NOT_RECRUITING PHASE2