A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)
A Randomized, 3 Arm, Multicenter, Phase III Study to Evaluate the Efficacy and the Safety of T-DM1 Combined With Pertuzumab or T-DM1 Combined With Pertuzumab-Placebo (Blinded for Pertuzumab), Versus the Combination of Trastuzumab Plus Taxane, as First Line Treatment in HER2 Positive Progressive or Recurrent Locally Advanced or Metastatic Breast Cancer
2 other identifiers
interventional
1,095
36 countries
249
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 breast-cancer
Started Jul 2010
Typical duration for phase_3 breast-cancer
249 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2010
CompletedFirst Posted
Study publicly available on registry
May 10, 2010
CompletedStudy Start
First participant enrolled
July 31, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 16, 2016
CompletedResults Posted
Study results publicly available
February 23, 2017
CompletedMarch 4, 2024
February 1, 2024
4.2 years
April 28, 2010
May 2, 2016
February 29, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Death or Disease Progression According to Independent Review Facility (IRF) Assessment
Tumor assessments were performed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Disease progression was defined as a greater than or equal to (≥) 20 percent (%) and 5-millimeter (mm) increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). The percentage of participants with death or disease progression was calculated as \[number of participants with event divided by the number analyzed\] multiplied by 100.
Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
Progression-Free Survival (PFS) According to IRF Assessment
Tumor assessments were performed according to RECIST version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. PFS was defined as the time from randomization to first documented disease progression or death from any cause. Disease progression was defined as a ≥20% and 5-mm increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new lesion(s). Median duration of PFS was estimated using Kaplan-Meier analysis, and corresponding confidence intervals (CIs) were computed using the Brookmeyer-Crowley method.
Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
Secondary Outcomes (37)
Percentage of Participants Who Died Prior to Clinical Cutoff
Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)
Overall Survival (OS) at Clinical Cutoff
Up to 70 months from randomization until clinical cutoff of 15-May-2016 (every 3 months until death, loss to follow-up, withdrawal, or study termination)
Percentage of Participants With Death or Disease Progression According to Investigator Assessment
Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
PFS According to Investigator Assessment
Up to 48 months from randomization until clinical cutoff of 16-Sept-2014 (at Screening, every 9 weeks for 81 weeks, then every 12 weeks thereafter and/or up to 42 days after last dose)
Percentage of Participants Experiencing Treatment Failure
Up to 48 months from randomization until clinical cutoff of 16-Sept-2014
- +32 more secondary outcomes
Study Arms (3)
Trastuzumab + Taxane (docetaxel or paclitaxel)
EXPERIMENTALTrastuzumab emtansine + pertuzumab
EXPERIMENTALTrastuzumab emtansine + pertuzumab placebo
EXPERIMENTALInterventions
75 mg/m2 or 100 mg/m2 intravenously every 3 weeks for a minimum of 6 cycles.
80 mg/m2 intravenously weekly for a minimum of 18 weeks
840 mg intravenously on day 1 of cycle 1 followed by 420 mg intravenously every 3 weeks in subsequent cycles
840 mg intravenously on day 1 of cycle 1 followed by 420 mg intravenously every 3 weeks in subsequent cycles
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.
3.6 mg/kg intravenously every 3 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoffmann-La Rochelead
- Genentech, Inc.collaborator
Study Sites (257)
Uni of Arkansas For Medical Sciences; Arkansas Cancer Research Center
Little Rock, Arkansas, 72204, United States
Scripps Cancer Center
La Jolla, California, 92037, United States
University of California; Moores Cancer Center
La Jolla, California, 92093, United States
Clnc L Trials & Rsch Assoc-Inc
Montebello, California, 90640, United States
Southern California Kaiser Permanente
San Diego, California, 92108, United States
Breastlink Medical Group Inc
Santa Ana, California, 92705, United States
Kaiser Permanente; Oncology Clinical Trials
Vallejo, California, 94589, United States
Smilow Cancer Hospital at Yale New Haven
New Haven, Connecticut, 06510, United States
Innovative Medical Research of South Florida
Aventura, Florida, 33180, United States
Northwest Oncology/ Hematology Assoc.
Coral Springs, Florida, 33065-5701, United States
Florida Cancer Specialists; SCRI
Fort Myers, Florida, 33901, United States
Mayo Clinic-Jacksonville
Jacksonville, Florida, 32224, United States
Uni of Miami School of Medicine; Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
University Cancer & Blood Center, LLC; Research
Athens, Georgia, 30607, United States
Cancer Research Center of Hawaii; Clinical Sciences
Honolulu, Hawaii, 96813, United States
Mountain States Tumor Inst.
Boise, Idaho, 83712, United States
Uni of Chicago
Chicago, Illinois, 60637, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Loyola University Med Center
Maywood, Illinois, 60153, United States
Illinois Cancer Care
Peoria, Illinois, 61615, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Horizon Oncology Research, Inc.
Lafayette, Indiana, 47905, United States
James Graham Brown Cancer Center, University of Louisville
Louisville, Kentucky, 40202, United States
New England Cancer Specialists
Scarborough, Maine, 04074, United States
Anne Arundel Health System Research Instit-Annapolis Oncology Ctr
Annapolis, Maryland, 21401, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Spectrum Health Grand Rapids
Grand Rapids, Michigan, 49503, United States
University of Minnesota.
Minneapolis, Minnesota, 55454, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55902, United States
Mercy Clinic Cancer & Hematology
Springfield, Missouri, 65804, United States
St. John'S Mercy Medical Center; David C. Pratt Cancer Center
St Louis, Missouri, 63141, United States
Dartmouth Hitchcock Med Center
Lebanon, New Hampshire, 03756, United States
Hackensack Uni Medical Center; Northern Nj Cancer Center
Hackensack, New Jersey, 07601, United States
Cancer Inst. of New Jersey
New Brunswick, New Jersey, 08901, United States
San Juan Oncology Associates
Farmington, New Mexico, 87401, United States
Queens Medical Associates
Fresh Meadows, New York, 11366, United States
Queens Hospital Center
Jamaica, New York, 11432, United States
Arena Oncology Associates
Lake Success, New York, 11042, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Weill Medical College of Cornell Uni
New York, New York, 10065, United States
Carolinas Hem-Oncology Assoc
Charlotte, North Carolina, 28203, United States
Carolina Oncology Specialists, PA - Hickory
Hickory, North Carolina, 28602, United States
Marion L. Shepard Cancer Center
Washington, North Carolina, 27889, United States
Sanford Roger Maris Cancer Center
Fargo, North Dakota, 58102, United States
Oncology Hematology Care - SCRI
Cincinnati, Ohio, 45242, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Charleston Oncology, P .A
Charleston, South Carolina, 29414, United States
Medical University of SC (MUSC)
Charleston, South Carolina, 29425, United States
South Carolina Oncology Associates - SCRI
Columbia, South Carolina, 29210, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
SCRI Tennessee Oncology Chattanooga
Chattanooga, Tennessee, 37404, United States
West Clinic
Germantown, Tennessee, 38138, United States
Tennessee Onc., PLLC - SCRI
Nashville, Tennessee, 37203, United States
Vanderbilt-Ingram Cancer Ctr
Nashville, Tennessee, 37232, United States
The Don & Sybil Harrington Cancer Center; Department of Clinical Research
Amarillo, Texas, 79106, United States
Uni of Texas Southwestern Medical Center
Dallas, Texas, 75390-9063, United States
Uni of Texas - Md Anderson Cancer Center; Dept of Breast Medical Oncology
Houston, Texas, 77030, United States
Northern Utah Associates
Ogden, Utah, 84403, United States
The Providence Regional Medical Center Everett
Everett, Washington, 98201, United States
University of Washington
Seattle, Washington, 98195, United States
Northwest Medical Specialties
Tacoma, Washington, 98405, United States
Fundación Investigar
Buenos Aires, 1025, Argentina
Centro Medico San Roque
San Miguel de Tucumán, T4000IAK, Argentina
Mater Misericordiae Hospital; Chemotherapy Cottage
Sydney, New South Wales, 2060, Australia
Calvary Mater Newcastle; Medical Oncology
Waratah, New South Wales, 2298, Australia
Wesley Medical Centre; Clinic For Haematology and Oncology
Auchenflower, Queensland, 4066, Australia
Royal Adelaide Hospital; Oncology
Adelaide, South Australia, 5000, Australia
Peter Maccallum Cancer Institute; Medical Oncology
Melbourne, Victoria, 3000, Australia
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
Salzburg, 5020, Austria
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie
Vienna, 1090, Austria
Cliniques Universitaires St-Luc
Brussels, 1200, Belgium
Clinique Ste-Elisabeth
Namur, 5000, Belgium
Sint Augustinus Wilrijk
Wilrijk, 2610, Belgium
University Clinical Centre of the Republic of Srpska
Banja Luka, 78000, Bosnia and Herzegovina
Clinic of Oncology, University Clinical Center Sarajevo
Sarajevo, 71000, Bosnia and Herzegovina
*X*Instituto Nacional do Cancer - INCA
Rio de Janeiro, Rio de Janeiro, 20560-120, Brazil
Liga Norte Riograndense Contra O Câncer
Natal, Rio Grande do Norte, 59040150, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, 90040-373, Brazil
Clinica de Oncologia de Porto Alegre - CliniOnco
Porto Alegre, Rio Grande do Sul, 90430-090, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Clinica de Neoplasias Litoral
Itajaí, Santa Catarina, 88301-220, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, 01246-000, Brazil
Hospital Perola Byington
São Paulo, São Paulo, 01317-000, Brazil
Cross Cancer Institute; Clinical Trials
Edmonton, Alberta, T6G 1Z2, Canada
North York General Hospital
Toronto, Ontario, M2J 1V1, Canada
Cuse - Centre Universitaire De Sante; Site Fleurimont
Sherbrooke, Quebec, J1H 5N4, Canada
CHU de Québec ? Hôpital du Saint-Sacrement / ONCOLOGY
Québec, G1S 4L8, Canada
Clinica del Country
Bogotá, 11001, Colombia
Instituto Colombiano Para El Avance De La Medicina: Icamedic
Bucaramanga, Colombia
Centro Medico Imbanaco
Cali, Colombia
Instituto Cancerologico de Nariño
Pasto, Colombia
Masarykuv onkologicky ustav
Brno, 656 53, Czechia
Fakultni nemocnice Olomouc; Onkologicka klinika
Olomouc, 779 00, Czechia
Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
Prague, 128 08, Czechia
Fakultni Nemocnice Na Bulovce; Ustav Radiacni Onkologie
Prague, 180 00, Czechia
Vejle Sygehus; Onkologisk Afdeling
Vejle, 7100, Denmark
HOPITAL JEAN MINJOZ; Oncologie
Besançon, 25030, France
Centre Jean Perrin; Hopital De Jour
Clermont-Ferrand, 63011, France
Centre Oscar Lambret; Senologie
Lille, 59020, France
Institut Paoli Calmettes; Oncologie Medicale
Marseille, 13273, France
Institut régional du Cancer Montpellier
Montpellier, 34298, France
Centre D'Oncologie de Gentilly; Oncology
Nancy, 54100, France
Institut Curie; Oncologie Medicale
Paris, 75231, France
Hopital Saint Louis; Service Onco Thoracique
Paris, 75475, France
HOPITAL TENON; Cancerologie Medicale
Paris, 75970, France
Chu La Miletrie; Radiotherapie
Poitiers, 86021, France
Centre Rene Huguenin; ONCOLOGIE GENETIQUE
Saint-Cloud, 92210, France
Institut de Cancerologie de La Loire; Radiotherapie
Saint-Priest-en-Jarez, 42271, France
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
Essen, 45136, Germany
Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie
Halle, 06120, Germany
Facharztzentrum Eppendorf, Studien GbR
Hamburg, 20249, Germany
MVZ Onko Medical GmbH Hannover, Ralf Lohse (Geschäftsführer)
Hanover, 30177, Germany
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
Heidelberg, 69120, Germany
Universitätsklinikum Magdeburg; Frauenheilkunde & Geburtshilfe
Magdeburg, 39108, Germany
Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde
Mainz, 55131, Germany
Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Frauenheilkunde und Geburtshilfe
Minden, 32429, Germany
Rotkreuzklinikum München; Frauenklinik
München, 80637, Germany
Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie
Trier, 54290, Germany
Alexandras General Hospital of Athens; Oncology Department
Athens, 115 28, Greece
Univ General Hosp Heraklion; Medical Oncology
Heraklion, 711 10, Greece
University Hospital of Larissa; Oncology
Larissa, Greece
Centro Oncológico Sixtino / Centro Oncológico SA
Guatemala City, 01010, Guatemala
Grupo Angeles
Guatemala City, 01015, Guatemala
Szent Margit Hospital; Dept. of Oncology
Budapest, 1032, Hungary
Semmelweis Egyetem Onkologiai Központ
Budapest, 1083, Hungary
Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika
Budapest, 1125, Hungary
Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet
Pécs, 7623, Hungary
Campus Universitario S.Venuta; Centro Oncologico T.Campanella
Catanzaro, Calabria, 88100, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
Meldola, Emilia-Romagna, 47014, Italy
A.O. Universitaria Policlinico Di Modena; Ematologia
Modena, Emilia-Romagna, 41124, Italy
Arcispedale Santa Maria Nuova; Oncologia
Reggio Emilia, Emilia-Romagna, 42100, Italy
Ospedale Degli Infermi; Divisione Di Oncologia
Rimini, Emilia-Romagna, 47900, Italy
Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia
Udine, Friuli Venezia Giulia, 33100, Italy
Istituto Europeo Di Oncologia
Milan, Lombardy, 20141, Italy
Fondazione Salvatore Maugeri
Pavia, Lombardy, 27100, Italy
IRCCS Istituto Clinico Humanitas; Oncologia
Rozzano (MI), Lombardy, 20089, Italy
Centro Catanese Di Oncologia; Oncologia Medica
Catania, Sicily, 95126, Italy
Ospedale Papardo- Piemonte;Oncologia Medica
Messina, Sicily, 98158, Italy
Ospedale Misericordia E Dolce; Oncologia Medica
Prato, Tuscany, 59100, Italy
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
Perugia, Umbria, 06156, Italy
Aichi Cancer Center Hospital, Breast Oncology
Aichi, 464-8681, Japan
Natl Hosp Org Shikoku; Cancer Ctr, Surgery
Ehime, 791-0280, Japan
National Hospital Organization Kyushu Cancer Center;Breast Oncology
Fukuoka, 811-1395, Japan
Gifu University Hospital; Digestive Surgery
Gifu, 501-1194, Japan
Hiroshima University Hospital; Breast Surgery
Hiroshima, 734-8551, Japan
National Hospital Organization Hokkaido Cancer Center; Breast Surgery
Hokkaido, 003-0804, Japan
Hyogo College Of Medicine; Breast And Endocrine Surgery
Hyōgo, 663-8501, Japan
Hyogo Cancer Center; Breast Surgery
Hyōgo, 673-8558, Japan
Kanazawa University Hospital; Breast Oncology
Ishikawa, 920-8641, Japan
Sagara Hospital; Breast Surgery
Kagoshima, 892-0833, Japan
Tokai University Hospital, Breast Surgery
Kanagawa, 259-1193, Japan
Kumamoto University Hospital; Breast and Endocrine Surgery
Kumamoto, 860-8556, Japan
Kumamoto City Hospital, Breast and Endocrine Surgery
Kumamoto, 862-8505, Japan
Kyoto University Hospital; Breast Surgery
Kyoto, 606-8507, Japan
Tohoku University Hospital; General Surgery
Miyagi, 980-8574, Japan
Niigata Cancer Ctr Hospital; Breast Surgery
Niigata, 951-8566, Japan
Iwate Med Univ School of Med; Surgery
Numakunai, 028-3695, Japan
Kawasaki Medical School Hospital; Breast and Thyroid Surgery
Okayama, 701-0114, Japan
National Hospital Organization Osaka National Hospital; Breast Surgery
Osaka, 540-0006, Japan
Osaka University Hospital; Breast and Endocrine Surgery
Osaka, 565-0871, Japan
Saitama Medical University International Medical Center; Medical Oncology
Saitama, 350-1298, Japan
Saitama Cancer Center, Breast Oncology
Saitama, 362-0806, Japan
Shizuoka Cancer Center; Breast Surgery
Shizuoka, 411-8777, Japan
Shizuoka General Hospital; Breast Surgery
Shizuoka, 420-8527, Japan
National Cancer Center Hospital; Medical Oncology
Tokyo, 104-0045, Japan
Toranomon Hospital; Breast and Endocrine Surgery
Tokyo, 105-8470, Japan
The Cancer Inst. Hosp. of JFCR; Breast Oncology Center
Tokyo, 135-8550, Japan
Tokyo Medical Uni. Hospital; Breast Oncology
Tokyo, 160-0023, Japan
Pantai Hospital Kuala Lumpur; Dept of Oncology & Radiotherapy
Kuala Lumpur, FED. Territory of Kuala Lumpur, 59100, Malaysia
Sunway Medical Centre
Kuala Selangor, Selangor, 46150, Malaysia
Beacon International Specialist Centre
Petaling Jaya, Selangor, Selangor, 46050, Malaysia
Centro de Investigacion; Clinica Del Pacifico
Acapulco de Juárez, Guerrero, 39670, Mexico
Centro Universitario Contra El Cancer
Monterrey, Nuevo León, 64020, Mexico
Oaxaca Site Management Organization
Oaxaca City, Oaxaca, 68000, Mexico
Hospital Privado San Jose; Oncologia
Obregón, Sonora, 85000, Mexico
Centenario Hospital Miguel Hidalgo
Aguascalientes, 20230, Mexico
Centro Oncológico Estatal; ISSSEMYM Oncología
Toluca, 50180, Mexico
Auckland city hospital; Auckland Regional Cancer Centre and Blood Service
Auckland, 1023, New Zealand
Waikato Hospital; Regional Cancer Center
Hamilton, New Zealand
Private Health Organization Acibadem Sistina Hospital
Skopje, 1000, North Macedonia
The Panama Clinic
Panama City, 0832-02723, Panama
Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology
Arequipa, 04001, Peru
Hospital Nacional Edgardo Rebagliati Martins; Oncologia
Lima, 11, Peru
Unidad de Investigacion Oncologia Clinica ? Piura; Unidad de Oncología Clínica
Piura, 20011, Peru
Cebu Cancer Institute; Perpetual Succour Hospital
Cebu City, 6000, Philippines
Cardinal Santos Medical Center
San Juan City, 1502, Philippines
Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii
Bydgoszcz, 85-796, Poland
Medical University of Gdansk
Gdansk, 80-952, Poland
Centrum Onkologii, Instytut, Klinika Chemioterapii; Oddzial Chemoterapii
Krakow, 31-115, Poland
COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej
Lublin, 20-090, Poland
Cent.Onkologii-Instytut im. M. S-Curie, Klinika Now. Piersi i Chirurgii Rekon
Warsaw, 02-781, Poland
IPO do Porto; Servico de Oncologia Medica
Porto, 4200-072, Portugal
Coltea Hospital; Oncology
Bucharest, Romania
Cluj Clinical County Hospital; Oncology Dept
Cluj-Napoca, 400006, Romania
Prof. Dr. I. Chiricuta Institute of Oncology
Cluj-Napoca, 400015, Romania
Moscow city oncology hospital; #62 of Moscow Healthcare Department
Moscow, Moscow Oblast, 143423, Russia
Blokhin Cancer Research Center; Combined Treatment
Moskva, Moscow Oblast, 115478, Russia
Ryazan State Medical University Named after I.P.Pavlov
Ryazan, Ryazan Oblast, 390026, Russia
State Budget Institution of Healthcare of Stavropol region Pyatigorsk Oncology Dispensary
Pyatigorsk, Stavropol Kray, 357502, Russia
Clinical Oncology Dispensary of Ministry of Health of Tatarstan
Kazan', Tatarstan Republic, 420029, Russia
Ivanovo Regional Oncology Dispensary
Ivanovo, 153040, Russia
SBI of Healthcare Samara Regional Clinical Oncology Dispensary
Samara, 443031, Russia
SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary
Stavropol, 355045, Russia
Tula Regional Oncology Dispensary
Tula, 300053, Russia
GUZ Vladimir Regional Clinical Oncological Dispensary
Vladimir, 600009, Russia
Seoul National University Bundang Hospital; Hematology Medical Oncology
Gyeonggi-do, 463-707, South Korea
Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
Seoul, 03080, South Korea
Samsung Medical Centre; Division of Hematology/Oncology
Seoul, 135-710, South Korea
Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology
Seoul, 138-736, South Korea
Korea University Guro Hospital; Oncology
Seoul, 152-703, South Korea
Hospital General Universitario de Elche; Servicio de Oncologia
Elche, Alicante, 03203, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia
Sant Andreu de la Barca, Barcelona, 08740, Spain
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
Santiago de Compostela, LA Coruña, 15706, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
A Coruña, 15006, Spain
Hospital del Mar; Servicio de Oncologia
Barcelona, 08003, Spain
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
Jaén, 23007, Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
Madrid, 28007, Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid, 28041, Spain
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, 28046, Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Málaga, 29010, Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, 46010, Spain
Skånes Universitetssjukhus; Kliniska Forskningsenheten Onkologimottagning medicinsk behandling
Malmo, 200 25, Sweden
Kantonsspital Baden; Medizinische Klinik, Onkologie
Baden, 5404, Switzerland
Universitaetsspital Basel; Onkologie
Basel, 4031, Switzerland
Kantonsspital Graubünden Medizin Onkologie; Onkologie und Hämatologie
Chur, 7000, Switzerland
Changhua Christian Hospital; Hematology-Oncology
Changhua, 500, Taiwan
Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery
Kaohsiung City, 807, Taiwan
National Taiwan Uni Hospital; Dept of Oncology
Taipei, 100, Taiwan
Tri-Service General Hospital; Hematology and Oncology
Taipei, 114, Taiwan
National Cancer Inst.
Bangkok, 10400, Thailand
Rajavithi Hospital; Division of Medical Oncology
Bangkok, 10400, Thailand
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
Bangkok, 10400, Thailand
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
Bangkok, 10700, Thailand
Maharaj Nakorn Hospital; Internal Medicine
Chiang Mai, 50200, Thailand
Songklanagarind Hospital; Department of Oncology
Songkhla, 90110, Thailand
Oncology Consultants Limited
Nassau, 09311, The Bahamas
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
Adana, 01230, Turkey (Türkiye)
Cukurova Uni Faculty of Medicine; Medical Oncology
Adana, 01330, Turkey (Türkiye)
Gazi Uni Medical Faculty Hospital; Oncology Dept
Ankara, 06500, Turkey (Türkiye)
Ege Uni Medical Faculty Hospital; Oncology Dept
Izmir, 35100, Turkey (Türkiye)
Bristol Haematology and Oncology centre
Bristol, BS2 8ED, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ, United Kingdom
Royal Cornwall Hospital; Dept of Clinical Oncology
Cornwall, TR1 3LQ, United Kingdom
The Beatson West of Scotland Cancer Centre; Cancer Clinical Trials Unit
Glasgow, G12 0YN, United Kingdom
Leicester Royal Infirmary; Dept. of Medical Oncology
Leicester, LE1 5WW, United Kingdom
Royal Free Hospital; Dept of Oncology
London, NW3 2QG, United Kingdom
Guys Hospital; Management Offices
London, SE1 9RT, United Kingdom
Royal Marsden Hospital; Dept of Med-Onc
London, SW3 6JJ, United Kingdom
Christie Hospital; Breast Cancer Research Office
Manchester, M20 4QL, United Kingdom
Nottingham City Hospital; Oncology
Nottingham, NG5 1PB, United Kingdom
Peterborough City Hospital; Oncology Ward
Peterborough, PE 3 9GZ, United Kingdom
Queen Alexandra Hospital, Portsmouth
Portsmouth, PO6 3LY, United Kingdom
Weston Park Hospital; Cancer Clinical Trials Centre
Sheffield, S10 2SJ, United Kingdom
Southampton General Hospital; Somers Cancer Research Building
Southampton, SO16 6YD, United Kingdom
Uni Hospital of North Staffordshire; Staffordshire Oncology Centre
Stoke-on-Trent, ST4 6QG, United Kingdom
Royal Marsden Hospital; Dept of Medical Oncology
Sutton, SM2 5PT, United Kingdom
Related Publications (3)
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.
PMID: 31146717DERIVEDBighin 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.
PMID: 23837759DERIVEDScott AM, Wolchok JD, Old LJ. Antibody therapy of cancer. Nat Rev Cancer. 2012 Mar 22;12(4):278-87. doi: 10.1038/nrc3236.
PMID: 22437872DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2010
First Posted
May 10, 2010
Study Start
July 31, 2010
Primary Completion
September 30, 2014
Study Completion
September 16, 2016
Last Updated
March 4, 2024
Results First Posted
February 23, 2017
Record last verified: 2024-02