Clinical trial NCT01120184: A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Genentech, Inc.
First posted: 2010-05-10
Enrollment: 1095
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Death or Disease Progression According to Independent Review Facility (IRF) Assessment
timeFrame: 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)
measure: Progression-Free Survival (PFS) According to IRF Assessment
timeFrame: 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:
measure: Percentage of Participants Who Died Prior to Clinical Cutoff
timeFrame: 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)
measure: Overall Survival (OS) at Clinical Cutoff
timeFrame: 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)
measure: Percentage of Participants With Death or Disease Progression According to Investigator Assessment
timeFrame: 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)
measure: PFS According to Investigator Assessment
timeFrame: 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)
measure: Percentage of Participants Experiencing Treatment Failure
timeFrame: Up to 48 months from randomization until clinical cutoff of 16-Sept-2014
measure: Time to Treatment Failure (TTF)
timeFrame: Up to 48 months from randomization until clinical cutoff of 16-Sept-2014
measure: One-Year Survival Rate
timeFrame: From randomization until 1 year
measure: Percentage of Participants With Grade ≥3 Adverse Events
timeFrame: Up to 50 months from randomization until clinical cutoff of 16-Sept-2014 (continuously until 28 days after last dose
measure: Percentage of Participants Who Died at 2 Years
timeFrame: From randomization until 2 years
measure: Overall Survival Truncated at 2 Years
timeFrame: From randomization until 2 years
measure: Percentage of Participants With Grade 5 Adverse Events
timeFrame: Up to 50 months from randomization until clinical cutoff of 16-Sept-2014 (continuously until 28 days after last dose)
measure: Percentage of Participants With Grade 3-4 Laboratory Parameters
timeFrame: Day 1, 8, and 15 of Cycle 1-3 and on Day 1 of each subsequent cycle up to 50 months from randomization until clinical cutoff of 16-Sept-2014
measure: Percentage of Participants With Decline of ≥2 Points From Baseline in Eastern Cooperative Oncology Group (ECOG) Performance Status
timeFrame: Baseline, Day 1 of every Cycle up to Clinical Data Cut (up to 48 months)
measure: Hospitalization Days
timeFrame: Up to 48 months from randomization until clinical cutoff of 16-Sept-2014
measure: Percentage of Participants With Hospitalization
timeFrame: Up to 48 months from randomization until clinical cutoff of 16-Sept-2014
measure: Percentage of Participants With Objective Response According to IRF Assessment
timeFrame: Up to 46 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)
measure: Percentage of Participants With Objective Response According to Investigator Assessment
timeFrame: Up to 46 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)
measure: Duration of Response According to IRF Assessment
timeFrame: Up to 46 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)
measure: Percentage of Participants With a Best Overall Response of CR, PR, or Stable Disease (SD) According to IRF Assessment
timeFrame: Up to 46 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)
measure: Percentage of Participants Experiencing a Clinically Significant Increase in Taxane-Related Treatment Symptoms as Measured by Taxane Subscale of the Functional Assessment of Cancer Therapy (FACT) Taxane (FACT-TaxS) Score
timeFrame: Up to 39 months from randomization until clinical cutoff of 16-Sept-2014 (at Baseline, on Day 1 of Cycles 2 to 8 and every even-numbered cycle thereafter and/or up to 42 days after last dose)
measure: Percentage of Participants Reporting Nausea According to the Relevant Single Items of The FACT Colorectal Cancel (FACT-C) Module
timeFrame: At Baseline, Day 8 of Cycle 1, and Days 1 and 8 of Cycle 2
measure: Percentage of Participants Reporting Diarrhea According to the Relevant Single Items of The FACT-C Module
timeFrame: At Baseline, Day 8 of Cycle 1, and Days 1 and 8 of Cycle 2
measure: Percentage of Participants With a Clinically Significant Deterioration in Health Related Quality of Life (HRQoL) as Measured by FACT Breast (FACT-B) Trial Outcome Index-Physical Function Breast (TOI-PFB) Score
timeFrame: Up to 39 months from randomization until clinical cutoff of 16-Sept-2014 (at Baseline, on Day 1 of Cycles 2 to 8 and every even-numbered cycle thereafter and/or up to 42 days after last dose)
measure: Time to Deterioration in HRQoL as Assessed by FACT-B TOI-PFB Score
timeFrame: Baseline up to 39 months from randomization until clinical cutoff of 16-Sept-2014
measure: Change From Baseline in Rotterdam Symptom Checklist (RSCL) Activity Level Scale Score
timeFrame: Baseline, Cycle 7 (Week 18)
measure: Change From Baseline in Work Productivity According to Work Productivity and Activity Impairment (WPAI) Questionnaire Score
timeFrame: Baseline, Cycle 7 (Week 18)
measure: Change From Baseline in Activity Impairment According to Work Productivity and Activity Impairment (WPAI) Questionnaire Score
timeFrame: Baseline, Cycle 7 (Week 18)
measure: Percentage of Participants With a Best Overall Response of CR or PR According to IRF Assessment Among Those With High Human Epidermal Growth Factor Receptor 2 (HER2) Messenger Ribonucleic Acid (mRNA) Levels
timeFrame: Up to 46 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)
measure: Percentage of Participants With a Best Overall Response of CR or PR According to IRF Assessment Among Those With Low HER2 mRNA Levels
timeFrame: Up to 46 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)
measure: Percentage of Participants With Death or Disease Progression According to IRF Assessment Among Those With High HER2 mRNA Levels
timeFrame: 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)
measure: PFS According to IRF Assessment Among Those With High HER2 mRNA Levels
timeFrame: 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)
measure: Percentage of Participants With Death or Disease Progression According to IRF Assessment Among Those With Low HER2 mRNA Levels
timeFrame: 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)
measure: PFS According to IRF Assessment Among Those With Low HER2 mRNA Levels
timeFrame: 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)
measure: Percentage of Participants Who Died Prior to Clinical Cutoff Among Those With High HER2 mRNA Levels
timeFrame: 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)
measure: OS at Clinical Cutoff Among Those With High HER2 mRNA Levels
timeFrame: 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)
measure: Percentage of Participants Who Died Prior to Clinical Cutoff Among Those With Low HER2 mRNA Levels
timeFrame: 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)
measure: OS at Clinical Cutoff Among Those With Low HER2 mRNA Levels
timeFrame: 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)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Uni of Arkansas For Medical Sciences; Arkansas Cancer Research Center
state: Arkansas
city: La Jolla
country: United States
facility: Scripps Cancer Center
state: California
city: La Jolla
country: United States
facility: University of California; Moores Cancer Center
state: California
city: Montebello
country: United States
facility: Clnc L Trials & Rsch Assoc-Inc
state: California
city: San Diego
country: United States
facility: Southern California Kaiser Permanente
state: California
city: Santa Ana
country: United States
facility: Breastlink Medical Group Inc
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente; Oncology Clinical Trials
state: California
city: New Haven
country: United States
facility: Smilow Cancer Hospital at Yale New Haven
state: Connecticut
city: Aventura
country: United States
facility: Innovative Medical Research of South Florida
state: Florida
city: Coral Springs
country: United States
facility: Northwest Oncology/ Hematology Assoc.
state: Florida
city: Fort Myers
country: United States
facility: Florida Cancer Specialists; SCRI
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic-Jacksonville
state: Florida
city: Miami
country: United States
facility: Uni of Miami School of Medicine; Sylvester Comprehensive Cancer Center
state: Florida
city: Athens
country: United States
facility: University Cancer & Blood Center, LLC; Research
state: Georgia
city: Honolulu
country: United States
facility: Cancer Research Center of Hawaii; Clinical Sciences
state: Hawaii
city: Boise
country: United States
facility: Mountain States Tumor Inst.
state: Idaho
city: Chicago
country: United States
facility: Uni of Chicago
state: Illinois
city: Decatur
country: United States
facility: Decatur Memorial Hospital
state: Illinois
city: Harvey
country: United States
facility: Ingalls Memorial Hospital
state: Illinois
city: Maywood
country: United States
facility: Loyola University Med Center
state: Illinois
city: Peoria
country: United States
facility: Illinois Cancer Care
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Cancer Center
state: Indiana
city: Lafayette
country: United States
facility: Horizon Oncology Research, Inc.
state: Indiana
city: Louisville
country: United States
facility: James Graham Brown Cancer Center, University of Louisville
state: Kentucky
city: Scarborough
country: United States
facility: New England Cancer Specialists
state: Maine
city: Annapolis
country: United States
facility: Anne Arundel Health System Research Instit-Annapolis Oncology Ctr
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Grand Rapids
country: United States
facility: Spectrum Health Grand Rapids
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota.
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Saint Louis
country: United States
facility: St. John'S Mercy Medical Center; David C. Pratt Cancer Center
state: Missouri
city: Springfield
country: United States
facility: Mercy Clinic Cancer & Hematology
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Med Center
state: New Hampshire
city: Hackensack
country: United States
facility: Hackensack Uni Medical Center; Northern Nj Cancer Center
state: New Jersey
city: New Brunswick
country: United States
facility: Cancer Inst. of New Jersey
state: New Jersey
city: Farmington
country: United States
facility: San Juan Oncology Associates
state: New Mexico
city: Fresh Meadows
country: United States
facility: Queens Medical Associates
state: New York
city: Jamaica
country: United States
facility: Queens Hospital Center
state: New York
city: Lake Success
country: United States
facility: Arena Oncology Associates
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Weill Medical College of Cornell Uni
state: New York
city: Charlotte
country: United States
facility: Carolinas Hem-Oncology Assoc
state: North Carolina
city: Hickory
country: United States
facility: Carolina Oncology Specialists, PA - Hickory
state: North Carolina
city: Washington
country: United States
facility: Marion L. Shepard Cancer Center
state: North Carolina
city: Fargo
country: United States
facility: Sanford Roger Maris Cancer Center
state: North Dakota
city: Cincinnati
country: United States
facility: Oncology Hematology Care - SCRI
state: Ohio
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Oncology, P .A
state: South Carolina
city: Charleston
country: United States
facility: Medical University of SC (MUSC)
state: South Carolina
city: Columbia
country: United States
facility: South Carolina Oncology Associates - SCRI
state: South Carolina
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Chattanooga
country: United States
facility: SCRI Tennessee Oncology Chattanooga
state: Tennessee
city: Germantown
country: United States
facility: West Clinic
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Onc., PLLC - SCRI
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Ctr
state: Tennessee
city: Amarillo
country: United States
facility: The Don & Sybil Harrington Cancer Center; Department of Clinical Research
state: Texas
city: Dallas
country: United States
facility: Uni of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Uni of Texas - Md Anderson Cancer Center; Dept of Breast Medical Oncology
state: Texas
city: Ogden
country: United States
facility: Northern Utah Associates
state: Utah
city: Everett
country: United States
facility: The Providence Regional Medical Center Everett
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties
state: Washington
city: Buenos Aires
country: Argentina
facility: Fundación Investigar
city: San Miguel de Tucuman
country: Argentina
facility: Centro Medico San Roque
city: Sydney
country: Australia
facility: Mater Misericordiae Hospital; Chemotherapy Cottage
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle; Medical Oncology
state: New South Wales
city: Auchenflower
country: Australia
facility: Wesley Medical Centre; Clinic For Haematology and Oncology
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital; Oncology
state: South Australia
city: Melbourne
country: Australia
facility: Peter Maccallum Cancer Institute; Medical Oncology
state: Victoria
city: Salzburg
country: Austria
facility: Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
city: Wien
country: Austria
facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie
city: Nassau
country: Bahamas
facility: Oncology Consultants Limited
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Namur
country: Belgium
facility: Clinique Ste-Elisabeth
city: Wilrijk
country: Belgium
facility: Sint Augustinus Wilrijk
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Clinical Centre of the Republic of Srpska
city: Sarajevo
country: Bosnia and Herzegovina
facility: Clinic of Oncology, University Clinical Center Sarajevo
city: Rio de Janeiro
country: Brazil
facility: *X*Instituto Nacional do Cancer - INCA
state: RJ
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra O Câncer
state: RN
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao
state: RS
city: Porto Alegre
country: Brazil
facility: Clinica de Oncologia de Porto Alegre - CliniOnco
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas - PUCRS
state: RS
city: Itajai
country: Brazil
facility: Clinica de Neoplasias Litoral
state: SC
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICESP
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Perola Byington
state: SP
city: Edmonton
country: Canada
facility: Cross Cancer Institute; Clinical Trials
state: Alberta
city: Toronto
country: Canada
facility: North York General Hospital
state: Ontario
city: Sherbrooke
country: Canada
facility: Cuse - Centre Universitaire De Sante; Site Fleurimont
state: Quebec
city: Quebec
country: Canada
facility: CHU de Québec ? Hôpital du Saint-Sacrement / ONCOLOGY
city: Bogota
country: Colombia
facility: Clinica del Country
city: Bucaramanga
country: Colombia
facility: Instituto Colombiano Para El Avance De La Medicina: Icamedic
city: Cali
country: Colombia
facility: Centro Medico Imbanaco
city: Pasto
country: Colombia
facility: Instituto Cancerologico de Nariño
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc; Onkologicka klinika
city: Praha 2
country: Czechia
facility: Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
city: Praha
country: Czechia
facility: Fakultni Nemocnice Na Bulovce; Ustav Radiacni Onkologie
city: Vejle
country: Denmark
facility: Vejle Sygehus; Onkologisk Afdeling
city: Besancon
country: France
facility: HOPITAL JEAN MINJOZ; Oncologie
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin; Hopital De Jour
city: Lille
country: France
facility: Centre Oscar Lambret; Senologie
city: Marseille
country: France
facility: Institut Paoli Calmettes; Oncologie Medicale
city: Montpellier
country: France
facility: Institut régional du Cancer Montpellier
city: Nancy
country: France
facility: Centre D'Oncologie de Gentilly; Oncology
city: Paris
country: France
facility: Institut Curie; Oncologie Medicale
city: Paris
country: France
facility: Hopital Saint Louis; Service Onco Thoracique
city: Paris
country: France
facility: HOPITAL TENON; Cancerologie Medicale
city: Poitiers
country: France
facility: Chu La Miletrie; Radiotherapie
city: Saint Cloud
country: France
facility: Centre Rene Huguenin; ONCOLOGIE GENETIQUE
city: St Priest En Jarez
country: France
facility: Institut de Cancerologie de La Loire; Radiotherapie
city: Essen
country: Germany
facility: Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
city: Halle
country: Germany
facility: Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie
city: Hamburg
country: Germany
facility: Facharztzentrum Eppendorf, Studien GbR
city: Hannover
country: Germany
facility: MVZ Onko Medical GmbH Hannover, Ralf Lohse (Geschäftsführer)
city: Heidelberg
country: Germany
facility: Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg; Frauenheilkunde & Geburtshilfe
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde
city: Minden
country: Germany
facility: Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Frauenheilkunde und Geburtshilfe
city: Muenchen
country: Germany
facility: Rotkreuzklinikum München; Frauenklinik
city: Trier
country: Germany
facility: Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie
city: Athens
country: Greece
facility: Alexandras General Hospital of Athens; Oncology Department
city: Heraklion
country: Greece
facility: Univ General Hosp Heraklion; Medical Oncology
city: Larissa
country: Greece
facility: University Hospital of Larissa; Oncology
city: Guatemala City
country: Guatemala
facility: Grupo Angeles
city: Guatemala
country: Guatemala
facility: Centro Oncológico Sixtino / Centro Oncológico SA
city: Budapest
country: Hungary
facility: Szent Margit Hospital; Dept. of Oncology
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Onkologiai Központ
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika
city: Pécs
country: Hungary
facility: Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet
city: Catanzaro
country: Italy
facility: Campus Universitario S.Venuta; Centro Oncologico T.Campanella
state: Calabria
city: Meldola
country: Italy
facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
state: Emilia-Romagna
city: Modena
country: Italy
facility: A.O. Universitaria Policlinico Di Modena; Ematologia
state: Emilia-Romagna
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova; Oncologia
state: Emilia-Romagna
city: Rimini
country: Italy
facility: Ospedale Degli Infermi; Divisione Di Oncologia
state: Emilia-Romagna
city: Udine
country: Italy
facility: Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia
state: Friuli-Venezia Giulia
city: Milano
country: Italy
facility: Istituto Europeo Di Oncologia
state: Lombardia
city: Pavia
country: Italy
facility: Fondazione Salvatore Maugeri
state: Lombardia
city: Rozzano (MI)
country: Italy
facility: IRCCS Istituto Clinico Humanitas; Oncologia
state: Lombardia
city: Catania
country: Italy
facility: Centro Catanese Di Oncologia; Oncologia Medica
state: Sicilia
city: Messina
country: Italy
facility: Ospedale Papardo- Piemonte;Oncologia Medica
state: Sicilia
city: Prato
country: Italy
facility: Ospedale Misericordia E Dolce; Oncologia Medica
state: Toscana
city: Perugia
country: Italy
facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
state: Umbria
city: Aichi
country: Japan
facility: Aichi Cancer Center Hospital, Breast Oncology
city: Ehime
country: Japan
facility: Natl Hosp Org Shikoku; Cancer Ctr, Surgery
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center;Breast Oncology
city: Gifu
country: Japan
facility: Gifu University Hospital; Digestive Surgery
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital; Breast Surgery
city: Hokkaido
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center; Breast Surgery
city: Hyogo
country: Japan
facility: Hyogo College Of Medicine; Breast And Endocrine Surgery
city: Hyogo
country: Japan
facility: Hyogo Cancer Center; Breast Surgery
city: Ishikawa
country: Japan
facility: Kanazawa University Hospital; Breast Oncology
city: Iwate
country: Japan
facility: Iwate Med Univ School of Med; Surgery
city: Kagoshima
country: Japan
facility: Sagara Hospital; Breast Surgery
city: Kanagawa
country: Japan
facility: Tokai University Hospital, Breast Surgery
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital; Breast and Endocrine Surgery
city: Kumamoto
country: Japan
facility: Kumamoto City Hospital, Breast and Endocrine Surgery
city: Kyoto
country: Japan
facility: Kyoto University Hospital; Breast Surgery
city: Miyagi
country: Japan
facility: Tohoku University Hospital; General Surgery
city: Niigata
country: Japan
facility: Niigata Cancer Ctr Hospital; Breast Surgery
city: Okayama
country: Japan
facility: Kawasaki Medical School Hospital; Breast and Thyroid Surgery
city: Osaka
country: Japan
facility: National Hospital Organization Osaka National Hospital; Breast Surgery
city: Osaka
country: Japan
facility: Osaka University Hospital; Breast and Endocrine Surgery
city: Saitama
country: Japan
facility: Saitama Medical University International Medical Center; Medical Oncology
city: Saitama
country: Japan
facility: Saitama Cancer Center, Breast Oncology
city: Shizuoka
country: Japan
facility: Shizuoka Cancer Center; Breast Surgery
city: Shizuoka
country: Japan
facility: Shizuoka General Hospital; Breast Surgery
city: Tokyo
country: Japan
facility: National Cancer Center Hospital; Medical Oncology
city: Tokyo
country: Japan
facility: Toranomon Hospital; Breast and Endocrine Surgery
city: Tokyo
country: Japan
facility: The Cancer Inst. Hosp. of JFCR; Breast Oncology Center
city: Tokyo
country: Japan
facility: Tokyo Medical Uni. Hospital; Breast Oncology
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital; Hematology Medical Oncology
city: Seoul
country: Korea, Republic of
facility: Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Centre; Division of Hematology/Oncology
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital; Oncology
city: Kuala Lumpur
country: Malaysia
facility: Pantai Hospital Kuala Lumpur; Dept of Oncology & Radiotherapy
state: FED. Territory OF Kuala Lumpur
city: Petaling Jaya, Selangor
country: Malaysia
facility: Beacon International Specialist Centre
state: Selangor
city: Selangor
country: Malaysia
facility: Sunway Medical Centre
city: Acapulco
country: Mexico
facility: Centro de Investigacion; Clinica Del Pacifico
state: Guerrero
city: Monterrey
country: Mexico
facility: Centro Universitario Contra El Cancer
state: Nuevo LEON
city: Oaxaca de Juárez
country: Mexico
facility: Oaxaca Site Management Organization
state: Oaxaca
city: Obregon
country: Mexico
facility: Hospital Privado San Jose; Oncologia
state: Sonora
city: Aguascalientes
country: Mexico
facility: Centenario Hospital Miguel Hidalgo
city: Toluca
country: Mexico
facility: Centro Oncológico Estatal; ISSSEMYM Oncología
city: Auckland
country: New Zealand
facility: Auckland city hospital; Auckland Regional Cancer Centre and Blood Service
city: Hamilton
country: New Zealand
facility: Waikato Hospital; Regional Cancer Center
city: Skopje
country: North Macedonia
facility: Private Health Organization Acibadem Sistina Hospital
city: Panama
country: Panama
facility: The Panama Clinic
city: Arequipa
country: Peru
facility: Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology
city: Lima
country: Peru
facility: Hospital Nacional Edgardo Rebagliati Martins; Oncologia
city: Piura
country: Peru
facility: Unidad de Investigacion Oncologia Clinica ? Piura; Unidad de Oncología Clínica
city: Cebu City
country: Philippines
facility: Cebu Cancer Institute; Perpetual Succour Hospital
city: San Juan
country: Philippines
facility: Cardinal Santos Medical Center
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii
city: Gdansk
country: Poland
facility: Medical University of Gdansk
city: Krakow
country: Poland
facility: Centrum Onkologii, Instytut, Klinika Chemioterapii; Oddzial Chemoterapii
city: Lublin
country: Poland
facility: COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej
city: Warszawa
country: Poland
facility: Cent.Onkologii-Instytut im. M. S-Curie, Klinika Now. Piersi i Chirurgii Rekon
city: Porto
country: Portugal
facility: IPO do Porto; Servico de Oncologia Medica
city: Bucharest
country: Romania
facility: Coltea Hospital; Oncology
city: Cluj Napoca
country: Romania
facility: Prof. Dr. I. Chiricuta Institute of Oncology
city: Cluj-Napoca
country: Romania
facility: Cluj Clinical County Hospital; Oncology Dept
city: Moscow
country: Russian Federation
facility: Moscow city oncology hospital; #62 of Moscow Healthcare Department
state: Moskovskaja Oblast
city: Moskva
country: Russian Federation
facility: Blokhin Cancer Research Center; Combined Treatment
state: Moskovskaja Oblast
city: Ryazan
country: Russian Federation
facility: Ryazan State Medical University Named after I.P.Pavlov
state: Rjazan
city: Pyatigorsk
country: Russian Federation
facility: State Budget Institution of Healthcare of Stavropol region Pyatigorsk Oncology Dispensary
state: Stavropol
city: Kazan
country: Russian Federation
facility: Clinical Oncology Dispensary of Ministry of Health of Tatarstan
state: Tatarstan
city: Ivanovo
country: Russian Federation
facility: Ivanovo Regional Oncology Dispensary
city: Samara
country: Russian Federation
facility: SBI of Healthcare Samara Regional Clinical Oncology Dispensary
city: Stavropol
country: Russian Federation
facility: SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary
city: Tula
country: Russian Federation
facility: Tula Regional Oncology Dispensary
city: Vladimir
country: Russian Federation
facility: GUZ Vladimir Regional Clinical Oncological Dispensary
city: Elche
country: Spain
facility: Hospital General Universitario de Elche; Servicio de Oncologia
state: Alicante
city: Sant Andreu de La Barca
country: Spain
facility: Hospital Univ Vall d'Hebron; Servicio de Oncologia
state: Barcelona
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
state: LA Coruña
city: Barcelona
country: Spain
facility: Hospital del Mar; Servicio de Oncologia
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
city: La Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia
city: Madrid
country: Spain
facility: Hospital Universitario La Paz; Servicio de Oncologia
city: Malaga
country: Spain
facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
city: Malmö
country: Sweden
facility: Skånes Universitetssjukhus; Kliniska Forskningsenheten Onkologimottagning medicinsk behandling
city: Baden
country: Switzerland
facility: Kantonsspital Baden; Medizinische Klinik, Onkologie
city: Basel
country: Switzerland
facility: Universitaetsspital Basel; Onkologie
city: Chur
country: Switzerland
facility: Kantonsspital Graubünden Medizin Onkologie; Onkologie und Hämatologie
city: Changhua
country: Taiwan
facility: Changhua Christian Hospital; Hematology-Oncology
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery
city: Taipei
country: Taiwan
facility: National Taiwan Uni Hospital; Dept of Oncology
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital; Hematology and Oncology
city: Bangkok
country: Thailand
facility: National Cancer Inst.
city: Bangkok
country: Thailand
facility: Rajavithi Hospital; Division of Medical Oncology
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
city: Bangkok
country: Thailand
facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Hospital; Internal Medicine
city: Songkhla
country: Thailand
facility: Songklanagarind Hospital; Department of Oncology
city: Adana
country: Turkey
facility: Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
city: Adana
country: Turkey
facility: Cukurova Uni Faculty of Medicine; Medical Oncology
city: Ankara
country: Turkey
facility: Gazi Uni Medical Faculty Hospital; Oncology Dept
city: Izmir
country: Turkey
facility: Ege Uni Medical Faculty Hospital; Oncology Dept
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology centre
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
city: Cornwall
country: United Kingdom
facility: Royal Cornwall Hospital; Dept of Clinical Oncology
city: Glasgow
country: United Kingdom
facility: The Beatson West of Scotland Cancer Centre; Cancer Clinical Trials Unit
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary; Dept. of Medical Oncology
city: London
country: United Kingdom
facility: Royal Free Hospital; Dept of Oncology
city: London
country: United Kingdom
facility: Guys Hospital; Management Offices
city: London
country: United Kingdom
facility: Royal Marsden Hospital; Dept of Med-Onc
city: Manchester
country: United Kingdom
facility: Christie Hospital; Breast Cancer Research Office
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital; Oncology
city: Peterborough
country: United Kingdom
facility: Peterborough City Hospital; Oncology Ward
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital, Portsmouth
city: Sheffield
country: United Kingdom
facility: Weston Park Hospital; Cancer Clinical Trials Centre
city: Southampton
country: United Kingdom
facility: Southampton General Hospital; Somers Cancer Research Building
city: Stoke-on-Trent
country: United Kingdom
facility: Uni Hospital of North Staffordshire; Staffordshire Oncology Centre
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital; Dept of Medical Oncology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: Scott AM, Wolchok JD, Old LJ. Antibody therapy of cancer. Nat Rev Cancer. 2012 Mar 22;12(4):278-87. doi: 10.1038/nrc3236.