Spots Global Cancer Trial Database for A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)
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Trial Identification
Brief Title: 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 ID: NCT01120184
Conditions
Study Description
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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Uni of Arkansas For Medical Sciences; Arkansas Cancer Research Center, Little Rock, Arkansas, United States
Scripps Cancer Center, La Jolla, California, United States
University of California; Moores Cancer Center, La Jolla, California, United States
Clnc L Trials & Rsch Assoc-Inc, Montebello, California, United States
Southern California Kaiser Permanente, San Diego, California, United States
Breastlink Medical Group Inc, Santa Ana, California, United States
Kaiser Permanente; Oncology Clinical Trials, Vallejo, California, United States
Smilow Cancer Hospital at Yale New Haven, New Haven, Connecticut, United States
Innovative Medical Research of South Florida, Aventura, Florida, United States
Northwest Oncology/ Hematology Assoc., Coral Springs, Florida, United States
Florida Cancer Specialists; SCRI, Fort Myers, Florida, United States
Mayo Clinic-Jacksonville, Jacksonville, Florida, United States
Uni of Miami School of Medicine; Sylvester Comprehensive Cancer Center, Miami, Florida, United States
University Cancer & Blood Center, LLC; Research, Athens, Georgia, United States
Cancer Research Center of Hawaii; Clinical Sciences, Honolulu, Hawaii, United States
Mountain States Tumor Inst., Boise, Idaho, United States
Uni of Chicago, Chicago, Illinois, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
Ingalls Memorial Hospital, Harvey, Illinois, United States
Loyola University Med Center, Maywood, Illinois, United States
Illinois Cancer Care, Peoria, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
Horizon Oncology Research, Inc., Lafayette, Indiana, United States
James Graham Brown Cancer Center, University of Louisville, Louisville, Kentucky, United States
New England Cancer Specialists, Scarborough, Maine, United States
Anne Arundel Health System Research Instit-Annapolis Oncology Ctr, Annapolis, Maryland, United States
Boston Medical Center, Boston, Massachusetts, United States
Spectrum Health Grand Rapids, Grand Rapids, Michigan, United States
University of Minnesota., Minneapolis, Minnesota, United States
Mayo Clinic Rochester, Rochester, Minnesota, United States
St. John'S Mercy Medical Center; David C. Pratt Cancer Center, Saint Louis, Missouri, United States
Mercy Clinic Cancer & Hematology, Springfield, Missouri, United States
Dartmouth Hitchcock Med Center, Lebanon, New Hampshire, United States
Hackensack Uni Medical Center; Northern Nj Cancer Center, Hackensack, New Jersey, United States
Cancer Inst. of New Jersey, New Brunswick, New Jersey, United States
San Juan Oncology Associates, Farmington, New Mexico, United States
Queens Medical Associates, Fresh Meadows, New York, United States
Queens Hospital Center, Jamaica, New York, United States
Arena Oncology Associates, Lake Success, New York, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Weill Medical College of Cornell Uni, New York, New York, United States
Carolinas Hem-Oncology Assoc, Charlotte, North Carolina, United States
Carolina Oncology Specialists, PA - Hickory, Hickory, North Carolina, United States
Marion L. Shepard Cancer Center, Washington, North Carolina, United States
Sanford Roger Maris Cancer Center, Fargo, North Dakota, United States
Oncology Hematology Care - SCRI, Cincinnati, Ohio, United States
Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Charleston Oncology, P .A, Charleston, South Carolina, United States
Medical University of SC (MUSC), Charleston, South Carolina, United States
South Carolina Oncology Associates - SCRI, Columbia, South Carolina, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
SCRI Tennessee Oncology Chattanooga, Chattanooga, Tennessee, United States
West Clinic, Germantown, Tennessee, United States
Tennessee Onc., PLLC - SCRI, Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Ctr, Nashville, Tennessee, United States
The Don & Sybil Harrington Cancer Center; Department of Clinical Research, Amarillo, Texas, United States
Uni of Texas Southwestern Medical Center, Dallas, Texas, United States
Uni of Texas - Md Anderson Cancer Center; Dept of Breast Medical Oncology, Houston, Texas, United States
Northern Utah Associates, Ogden, Utah, United States
The Providence Regional Medical Center Everett, Everett, Washington, United States
University of Washington, Seattle, Washington, United States
Northwest Medical Specialties, Tacoma, Washington, United States
Fundación Investigar, Buenos Aires, , Argentina
Centro Medico San Roque, San Miguel de Tucuman, , Argentina
Mater Misericordiae Hospital; Chemotherapy Cottage, Sydney, New South Wales, Australia
Calvary Mater Newcastle; Medical Oncology, Waratah, New South Wales, Australia
Wesley Medical Centre; Clinic For Haematology and Oncology, Auchenflower, Queensland, Australia
Royal Adelaide Hospital; Oncology, Adelaide, South Australia, Australia
Peter Maccallum Cancer Institute; Medical Oncology, Melbourne, Victoria, Australia
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt., Salzburg, , Austria
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie, Wien, , Austria
Oncology Consultants Limited, Nassau, , Bahamas
Cliniques Universitaires St-Luc, Bruxelles, , Belgium
Clinique Ste-Elisabeth, Namur, , Belgium
Sint Augustinus Wilrijk, Wilrijk, , Belgium
University Clinical Centre of the Republic of Srpska, Banja Luka, , Bosnia and Herzegovina
Clinic of Oncology, University Clinical Center Sarajevo, Sarajevo, , Bosnia and Herzegovina
*X*Instituto Nacional do Cancer - INCA, Rio de Janeiro, RJ, Brazil
Liga Norte Riograndense Contra O Câncer, Natal, RN, Brazil
Hospital Nossa Senhora da Conceicao, Porto Alegre, RS, Brazil
Clinica de Oncologia de Porto Alegre - CliniOnco, Porto Alegre, RS, Brazil
Hospital Sao Lucas - PUCRS, Porto Alegre, RS, Brazil
Clinica de Neoplasias Litoral, Itajai, SC, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP, Sao Paulo, SP, Brazil
Hospital Perola Byington, Sao Paulo, SP, Brazil
Cross Cancer Institute; Clinical Trials, Edmonton, Alberta, Canada
North York General Hospital, Toronto, Ontario, Canada
Cuse - Centre Universitaire De Sante; Site Fleurimont, Sherbrooke, Quebec, Canada
CHU de Québec ? Hôpital du Saint-Sacrement / ONCOLOGY, Quebec, , Canada
Clinica del Country, Bogota, , 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, , Czechia
Fakultni nemocnice Olomouc; Onkologicka klinika, Olomouc, , Czechia
Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika, Praha 2, , Czechia
Fakultni Nemocnice Na Bulovce; Ustav Radiacni Onkologie, Praha, , Czechia
Vejle Sygehus; Onkologisk Afdeling, Vejle, , Denmark
HOPITAL JEAN MINJOZ; Oncologie, Besancon, , France
Centre Jean Perrin; Hopital De Jour, Clermont Ferrand, , France
Centre Oscar Lambret; Senologie, Lille, , France
Institut Paoli Calmettes; Oncologie Medicale, Marseille, , France
Institut régional du Cancer Montpellier, Montpellier, , France
Centre D'Oncologie de Gentilly; Oncology, Nancy, , France
Institut Curie; Oncologie Medicale, Paris, , France
Hopital Saint Louis; Service Onco Thoracique, Paris, , France
HOPITAL TENON; Cancerologie Medicale, Paris, , France
Chu La Miletrie; Radiotherapie, Poitiers, , France
Centre Rene Huguenin; ONCOLOGIE GENETIQUE, Saint Cloud, , France
Institut de Cancerologie de La Loire; Radiotherapie, St Priest En Jarez, , France
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum, Essen, , Germany
Universitätsklinikum Halle (Saale); Universitätsklinik Und Poliklinik Für Gynäkologie, Halle, , Germany
Facharztzentrum Eppendorf, Studien GbR, Hamburg, , Germany
MVZ Onko Medical GmbH Hannover, Ralf Lohse (Geschäftsführer), Hannover, , Germany
Nationales Centrum für Tumorerkrankungen (NCT) ; Gyn. Onk. Frauenklinik; Uniklinikum Heidelberg, Heidelberg, , Germany
Universitätsklinikum Magdeburg; Frauenheilkunde & Geburtshilfe, Magdeburg, , Germany
Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde, Mainz, , Germany
Mühlenkreiskliniken; Johannes Wesling Klinikum Minden; Klinik für Frauenheilkunde und Geburtshilfe, Minden, , Germany
Rotkreuzklinikum München; Frauenklinik, Muenchen, , Germany
Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie, Trier, , Germany
Alexandras General Hospital of Athens; Oncology Department, Athens, , Greece
Univ General Hosp Heraklion; Medical Oncology, Heraklion, , Greece
University Hospital of Larissa; Oncology, Larissa, , Greece
Grupo Angeles, Guatemala City, , Guatemala
Centro Oncológico Sixtino / Centro Oncológico SA, Guatemala, , Guatemala
Szent Margit Hospital; Dept. of Oncology, Budapest, , Hungary
Semmelweis Egyetem Onkologiai Központ, Budapest, , Hungary
Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika, Budapest, , Hungary
Pécsi Tudományegyetem; Klinikai Központ Onkoterápiás Intézet, Pécs, , Hungary
Campus Universitario S.Venuta; Centro Oncologico T.Campanella, Catanzaro, Calabria, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica, Meldola, Emilia-Romagna, Italy
A.O. Universitaria Policlinico Di Modena; Ematologia, Modena, Emilia-Romagna, Italy
Arcispedale Santa Maria Nuova; Oncologia, Reggio Emilia, Emilia-Romagna, Italy
Ospedale Degli Infermi; Divisione Di Oncologia, Rimini, Emilia-Romagna, Italy
Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia, Udine, Friuli-Venezia Giulia, Italy
Istituto Europeo Di Oncologia, Milano, Lombardia, Italy
Fondazione Salvatore Maugeri, Pavia, Lombardia, Italy
IRCCS Istituto Clinico Humanitas; Oncologia, Rozzano (MI), Lombardia, Italy
Centro Catanese Di Oncologia; Oncologia Medica, Catania, Sicilia, Italy
Ospedale Papardo- Piemonte;Oncologia Medica, Messina, Sicilia, Italy
Ospedale Misericordia E Dolce; Oncologia Medica, Prato, Toscana, Italy
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica, Perugia, Umbria, Italy
Aichi Cancer Center Hospital, Breast Oncology, Aichi, , Japan
Natl Hosp Org Shikoku; Cancer Ctr, Surgery, Ehime, , Japan
National Hospital Organization Kyushu Cancer Center;Breast Oncology, Fukuoka, , Japan
Gifu University Hospital; Digestive Surgery, Gifu, , Japan
Hiroshima University Hospital; Breast Surgery, Hiroshima, , Japan
National Hospital Organization Hokkaido Cancer Center; Breast Surgery, Hokkaido, , Japan
Hyogo College Of Medicine; Breast And Endocrine Surgery, Hyogo, , Japan
Hyogo Cancer Center; Breast Surgery, Hyogo, , Japan
Kanazawa University Hospital; Breast Oncology, Ishikawa, , Japan
Iwate Med Univ School of Med; Surgery, Iwate, , Japan
Sagara Hospital; Breast Surgery, Kagoshima, , Japan
Tokai University Hospital, Breast Surgery, Kanagawa, , Japan
Kumamoto University Hospital; Breast and Endocrine Surgery, Kumamoto, , Japan
Kumamoto City Hospital, Breast and Endocrine Surgery, Kumamoto, , Japan
Kyoto University Hospital; Breast Surgery, Kyoto, , Japan
Tohoku University Hospital; General Surgery, Miyagi, , Japan
Niigata Cancer Ctr Hospital; Breast Surgery, Niigata, , Japan
Kawasaki Medical School Hospital; Breast and Thyroid Surgery, Okayama, , Japan
National Hospital Organization Osaka National Hospital; Breast Surgery, Osaka, , Japan
Osaka University Hospital; Breast and Endocrine Surgery, Osaka, , Japan
Saitama Medical University International Medical Center; Medical Oncology, Saitama, , Japan
Saitama Cancer Center, Breast Oncology, Saitama, , Japan
Shizuoka Cancer Center; Breast Surgery, Shizuoka, , Japan
Shizuoka General Hospital; Breast Surgery, Shizuoka, , Japan
National Cancer Center Hospital; Medical Oncology, Tokyo, , Japan
Toranomon Hospital; Breast and Endocrine Surgery, Tokyo, , Japan
The Cancer Inst. Hosp. of JFCR; Breast Oncology Center, Tokyo, , Japan
Tokyo Medical Uni. Hospital; Breast Oncology, Tokyo, , Japan
Seoul National University Bundang Hospital; Hematology Medical Oncology, Gyeonggi-do, , Korea, Republic of
Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology, Seoul, , Korea, Republic of
Samsung Medical Centre; Division of Hematology/Oncology, Seoul, , Korea, Republic of
Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology, Seoul, , Korea, Republic of
Korea University Guro Hospital; Oncology, Seoul, , Korea, Republic of
Pantai Hospital Kuala Lumpur; Dept of Oncology & Radiotherapy, Kuala Lumpur, FED. Territory OF Kuala Lumpur, Malaysia
Beacon International Specialist Centre, Petaling Jaya, Selangor, Selangor, Malaysia
Sunway Medical Centre, Selangor, , Malaysia
Centro de Investigacion; Clinica Del Pacifico, Acapulco, Guerrero, Mexico
Centro Universitario Contra El Cancer, Monterrey, Nuevo LEON, Mexico
Oaxaca Site Management Organization, Oaxaca de Juárez, Oaxaca, Mexico
Hospital Privado San Jose; Oncologia, Obregon, Sonora, Mexico
Centenario Hospital Miguel Hidalgo, Aguascalientes, , Mexico
Centro Oncológico Estatal; ISSSEMYM Oncología, Toluca, , Mexico
Auckland city hospital; Auckland Regional Cancer Centre and Blood Service, Auckland, , New Zealand
Waikato Hospital; Regional Cancer Center, Hamilton, , New Zealand
Private Health Organization Acibadem Sistina Hospital, Skopje, , North Macedonia
The Panama Clinic, Panama, , Panama
Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud; Oncology & Haemathology, Arequipa, , Peru
Hospital Nacional Edgardo Rebagliati Martins; Oncologia, Lima, , Peru
Unidad de Investigacion Oncologia Clinica ? Piura; Unidad de Oncología Clínica, Piura, , Peru
Cebu Cancer Institute; Perpetual Succour Hospital, Cebu City, , Philippines
Cardinal Santos Medical Center, San Juan, , Philippines
Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii, Bydgoszcz, , Poland
Medical University of Gdansk, Gdansk, , Poland
Centrum Onkologii, Instytut, Klinika Chemioterapii; Oddzial Chemoterapii, Krakow, , Poland
COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej, Lublin, , Poland
Cent.Onkologii-Instytut im. M. S-Curie, Klinika Now. Piersi i Chirurgii Rekon, Warszawa, , Poland
IPO do Porto; Servico de Oncologia Medica, Porto, , Portugal
Coltea Hospital; Oncology, Bucharest, , Romania
Prof. Dr. I. Chiricuta Institute of Oncology, Cluj Napoca, , Romania
Cluj Clinical County Hospital; Oncology Dept, Cluj-Napoca, , Romania
Moscow city oncology hospital; #62 of Moscow Healthcare Department, Moscow, Moskovskaja Oblast, Russian Federation
Blokhin Cancer Research Center; Combined Treatment, Moskva, Moskovskaja Oblast, Russian Federation
Ryazan State Medical University Named after I.P.Pavlov, Ryazan, Rjazan, Russian Federation
State Budget Institution of Healthcare of Stavropol region Pyatigorsk Oncology Dispensary, Pyatigorsk, Stavropol, Russian Federation
Clinical Oncology Dispensary of Ministry of Health of Tatarstan, Kazan, Tatarstan, Russian Federation
Ivanovo Regional Oncology Dispensary, Ivanovo, , Russian Federation
SBI of Healthcare Samara Regional Clinical Oncology Dispensary, Samara, , Russian Federation
SBI of Healthcare of Stavropol region Stavropol Regional Clinical Oncology Dispensary, Stavropol, , Russian Federation
Tula Regional Oncology Dispensary, Tula, , Russian Federation
GUZ Vladimir Regional Clinical Oncological Dispensary, Vladimir, , Russian Federation
Hospital General Universitario de Elche; Servicio de Oncologia, Elche, Alicante, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia, Sant Andreu de La Barca, Barcelona, Spain
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia, Santiago de Compostela, LA Coruña, Spain
Hospital del Mar; Servicio de Oncologia, Barcelona, , Spain
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia, Jaen, , Spain
Complejo Hospitalario Universitario A Coruña (CHUAC, Materno Infantil), Oncología, La Coruña, , Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario La Paz; Servicio de Oncologia, Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia, Malaga, , Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia, Valencia, , Spain
Skånes Universitetssjukhus; Kliniska Forskningsenheten Onkologimottagning medicinsk behandling, Malmö, , Sweden
Kantonsspital Baden; Medizinische Klinik, Onkologie, Baden, , Switzerland
Universitaetsspital Basel; Onkologie, Basel, , Switzerland
Kantonsspital Graubünden Medizin Onkologie; Onkologie und Hämatologie, Chur, , Switzerland
Changhua Christian Hospital; Hematology-Oncology, Changhua, , Taiwan
Kaohsiung Medical Uni Chung-Ho Hospital; Dept of Surgery, Kaohsiung, , Taiwan
National Taiwan Uni Hospital; Dept of Oncology, Taipei, , Taiwan
Tri-Service General Hospital; Hematology and Oncology, Taipei, , Taiwan
National Cancer Inst., Bangkok, , Thailand
Rajavithi Hospital; Division of Medical Oncology, Bangkok, , Thailand
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc, Bangkok, , Thailand
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology, Bangkok, , Thailand
Maharaj Nakorn Hospital; Internal Medicine, Chiang Mai, , Thailand
Songklanagarind Hospital; Department of Oncology, Songkhla, , Thailand
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology, Adana, , Turkey
Cukurova Uni Faculty of Medicine; Medical Oncology, Adana, , Turkey
Gazi Uni Medical Faculty Hospital; Oncology Dept, Ankara, , Turkey
Ege Uni Medical Faculty Hospital; Oncology Dept, Izmir, , Turkey
Bristol Haematology and Oncology centre, Bristol, , United Kingdom
Cambridge University Hospitals NHS Foundation Trust, Cambridge, , United Kingdom
Royal Cornwall Hospital; Dept of Clinical Oncology, Cornwall, , United Kingdom
The Beatson West of Scotland Cancer Centre; Cancer Clinical Trials Unit, Glasgow, , United Kingdom
Leicester Royal Infirmary; Dept. of Medical Oncology, Leicester, , United Kingdom
Royal Free Hospital; Dept of Oncology, London, , United Kingdom
Guys Hospital; Management Offices, London, , United Kingdom
Royal Marsden Hospital; Dept of Med-Onc, London, , United Kingdom
Christie Hospital; Breast Cancer Research Office, Manchester, , United Kingdom
Nottingham City Hospital; Oncology, Nottingham, , United Kingdom
Peterborough City Hospital; Oncology Ward, Peterborough, , United Kingdom
Queen Alexandra Hospital, Portsmouth, Portsmouth, , United Kingdom
Weston Park Hospital; Cancer Clinical Trials Centre, Sheffield, , United Kingdom
Southampton General Hospital; Somers Cancer Research Building, Southampton, , United Kingdom
Uni Hospital of North Staffordshire; Staffordshire Oncology Centre, Stoke-on-Trent, , United Kingdom
Royal Marsden Hospital; Dept of Medical Oncology, Sutton, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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