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Global
A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)
- Cancer
- Breast Cancer
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Completed
This trial runs in
Cities
- A Coruña
- acapulco-de-juarez
- Adana
- Adelaide
- Akashi
- Alvarado
- Amarillo
- Ankara
- Annapolis
- Antwerpen
- Arequipa
- Athens
- Auchenflower
- Auckland
- Baden
- Banja Luka
- Barcelona
- Basel
- Besançon
- Bogotá
- Boise
- Boston
- Bristol
- Brno
- Bruxelles
- Bucaramanga
- București
- Budapest
- Bydgoszcz
- Cali
- Cambridge
- cascina-perseghetto
- Catania
- Catanzaro
- Cebu City
- Chang Wat Chiang Mai
- Changhua County
- Charleston
- Charlotte
- Chattanooga
- Chicago
- Chuo City
- Chur
- Cincinnati
- Ciudad de Guatemala
- Clermont-Ferrand
- Cluj-Napoca
- Columbia
- Dallas
- Decatur
- Edmonton
- Elche
- Essen
- Everett
- Fargo
- Farmington
- Fort Myers
- Fountain Valley
- Fukuoka
- Gdańsk
- Germantown
- Gifu
- Glasgow
- Grand Rapids
- Hackensack
- Halle (Saale)
- Hamburg
- Hamilton
- Hannover
- Harvey
- Heidelberg
- Hershey
- Hickory
- Hidaka
- Hiroshima
- Hlavní město Praha
- Honolulu
- Houston
- Ina
- Indianapolis
- Iraklio
- Isehara
- Ivanovo Oblast
- İzmir
- Jacksonville
- Jaén
- Jesús María
- Kagoshima
- Kaohsiung City
- Kazan
- Kraków
- Krung Thep Maha Nakhon
- Kuala Lumpur
- Kumamoto
- Kurashiki
- Kyoto
- Lafayette
- Larissa
- Lebanon
- Leicester
- Lille
- Little Rock
- Lombardia
- London
- Louisville
- Lublin
- Madrid
- Mainz
- Manchester
- Marseille
- Matsuyama
- Maywood
- Melbourne
- Meldola
- Messina
- Miami
- Minato City
- Minden
- Minneapolis
- Modena
- Monterrey
- Montpellier
- Moscow Oblast
- Málaga
- München
- Nagaizumi
- Nagoya
- Namur
- Nancy
- Nashville
- New Brunswick
- New Haven
- New Hyde Park
- New York
- Niigata
- Nottingham
- oaxaca-de-juarez
- olomouc-9
- Osaka
- Paris
- Pasto
- Pavia
- Peoria
- Perugia
- petaling-jaya
- Peterborough
- Poitiers
- Porto
- Portsmouth
- Prato
- Pyatigorsk
- Pécs
- Québec
- Reggio Emilia
- Rimini
- Rio de Janeiro
- Rio Grande do Norte
- Rio Grande do Sul
- Rochester
- Ryazan'
- Saint-Cloud
- Saint-Priest-en-Jarez
- Salzburg
- Samara
- San Diego
- San Juan
- San Miguel de Tucumán
- sant-andreu-de-la-barca
- Santa Catarina
- Santiago de Compostela
- Sapporo
- Sarajevo
- Scarborough
- Seattle
- Sendai
- Seongnam-si
- Seoul
- Sheffield
- Sherbrooke
- Shinjuku City
- Shizuoka
- shkupi
- Sioux Falls
- south-ogden
- Southampton
- Springfield
- St. Louis
- Stavropol
- Stoke-on-Trent
- Subang Jaya
- Suita
- Sutton
- São Paulo
- Tacoma
- Taipei City
- tambon-kho-hong
- Tokyo
- Toluca de Lerdo
- Toronto
- Trier
- Truro
- tula
- Udine
- Vallejo
- València
- Vejle
- Waratah
- Warsaw
- Wien
- Yahaba
Trial Identifier:
NCT01120184 2009-017905-13 BO22589
Trial 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.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT01120184, BO22589, 2009-017905-13
Trial Identifier
docetaxel, paclitaxel, pertuzumab, pertuzumab-placebo, trastuzumab [Herceptin], trastuzumab emtansine
Treatments
Breast Cancer
Condition
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
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
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
For the latest version of this information please go to www.forpatients.roche.com