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Un estudio que investiga el uso de pertuzumab en combinación con trastuzumab y quimioterapia como terapia adyuvante en participantes con cáncer de mama temprano y receptor del factor de crecimiento epidérmico humano 2 (HER2) positivo
- Cáncer
- Cáncer de mama
- Cáncer de mama Her-2 negativo
Tenga en cuenta que el estado de reclutamiento del estudio clínico en su centro puede diferir del estado general del estudio debido a que algunos centros del estudio pueden llevar a cabo el reclutamiento antes que otros.
Estado del estudio:
Activo, no reclutando
Este estudio clínico se lleva a cabo en
Ciudades
- A Coruña
- Aalborg
- Adelaide
- Aguascalientes
- Albany
- Amberg
- Amiens
- Angers
- Antioquia
- Antwerpen
- Arras
- Auchenflower
- Avellino
- Avignon
- Bad Nauheim
- Badalona
- Baltimore
- Barcelona
- Basel
- bei-jing-shi
- Belcolle
- Bergisch Gladbach
- Berlín
- Bethesda
- Białystok
- Bielefeld
- Bloemfontein
- Bogotá
- Bologna
- Bonn
- Bordeaux
- Boston
- Braunschweig
- Breda
- Bremen
- Brescia
- Brest
- Brewer
- Brindisi
- Bristol
- Brno
- Bruxelles
- București
- Budapest
- Buffalo
- Bunkyo City
- Bydgoszcz
- c-r-o--ospedale
- Caen
- Calgary
- California
- Candiolo
- Cardiff
- Carpi
- cascina-perseghetto
- Castelló de la Plana
- Catanzaro
- chamblee
- Chang Wat Phitsanulok
- chang-chun-shi
- chang-sha-shi
- Changhua County
- Chapel Hill
- Charleroi
- Charleston
- Chattanooga
- Cheltenham
- Chemnitz
- Cheng Du Shi
- Cherkasy
- Chiba
- Chicago
- Chihuahua
- Chuo City
- Cincinnati
- Ciudad de Guatemala
- Clayton
- Clermont-Ferrand
- Cluj-Napoca
- Colchester
- Columbus
- Cork
- Coventry
- cuauhtemoc
- Córdoba
- Dallas
- Dayton
- Debrecen
- Dechy
- Deggendorf
- Dijon
- Dnipropetrovsk
- Donostia
- dooradoyle
- Dortmund
- Dresden
- Dublin
- Dublin 4
- Dublin 7
- Dublin 9
- Durango
- Düsseldorf
- Edegem
- Edimburgo
- Edina
- Edmonton
- El Paso
- Elche
- Erfurt
- Erlangen
- esbjerg
- Esslingen am Neckar
- Exeter
- Feldkirch
- Fort Myers
- Fort Worth
- Frankfurt am Main
- Freiburg im Breisgau
- fu-zhou-shi
- Fukuoka
- Fuzhou
- Fürth
- Galway
- Gdańsk
- Geelong
- Genova
- Genève
- Gothenburg
- Grand Rapids
- Graz
- greater-sudbury
- Greenville
- Greifswald
- Grenoble
- Guadalajara
- guang-zhou-shi
- Guatemala
- Gyula
- Győr
- Génova
- Haifa
- Halifax
- Halle (Saale)
- Hamburgo
- Hamilton
- hang-zhou-shi
- Hannover
- Harbin
- Harvey
- Hasselt
- Hayward
- Headington
- Heidelberg
- Henderson
- Herlev
- Hickory
- Hidaka
- Hildesheim
- Hillerød
- Hiroshima
- Hobart
- Hollywood
- Hong Kong Island
- Houston
- Huelva
- Ina
- Innsbruck
- Iowa City
- Ipswich
- Irving
- Isehara
- Ivano-Frankivsk
- Jacksonville
- Jaén
- jilin-city
- Johannesburgo
- Kagoshima
- Kalamazoo
- Kansas City
- Kaohsiung City
- Karlsruhe
- Kashiwa
- Kassel
- Kawasaki
- Kazán
- Kecskemét
- Kelowna
- Kiel
- Kortrijk
- Královéhradecký kraj
- Kumamoto
- Kyiv
- Kyoto
- Köln
- København
- L'Hospitalet de Llobregat
- La Laguna
- La Roche-sur-Yon
- la-calera
- Lafayette
- Landshut
- larkspur
- Le Havre
- Lebanon
- Lecco
- Leeds
- Legnago
- Leipzig
- leon-de-los-aldama
- Leuven
- Leópolis
- Lille
- Lima
- Limoges
- Lincoln
- Linköping
- Linz
- Lismore
- Littleton
- Ljubljana
- Lleida
- Lombardia
- London
- Los Angeles
- luik
- Lutsk
- Luzern
- Lyon
- Lübeck
- Maastricht
- Madrid
- Maebashi
- Mainz
- Manchester
- Manila
- Marietta
- Marseille
- Marshfield
- Matsuyama
- Maywood
- Melbourne
- Minneapolis
- Mississauga
- Monterrey
- Montería
- Montpellier
- Montréal
- Monza
- Morgantown
- Murcia
- Málaga
- Mönchengladbach
- München
- Münster
- Nagaizumi
- Nagoya
- Namur
- Nanchang
- Naperville
- Napoli
- Nashville
- Nedlands
- New York
- Newmarket
- Nice
- Niigata
- North Sydney
- Northwood
- Norwich
- Nottingham
- Næstved
- Nîmes
- oaxaca-de-juarez
- Odense
- Offenbach am Main
- Ogden
- Oldenburg
- olomouc-9
- Omaha
- Opole
- Osaka
- Ottawa
- Palma
- Palmerston North
- Panamá
- Pardubický kraj
- Paris
- Pasig
- Pavia
- Peoria
- Perugia
- Petah Tikva
- Peterborough
- Philadelphia
- piedmont
- Pittsburgh
- Pittsfield
- Plainfield
- Plano
- Plérin
- Poitiers
- Port St. Lucie
- Portland
- Portsmouth
- Post Falls
- Prato
- Preston
- Pretoria
- Providencia
- Périgueux
- Quezon City
- Quincy
- Québec
- Ramat Gan
- Ravensburg
- Recklinghausen
- Reggio Emilia
- Regina
- Reims
- Rejovot
- Rennes
- Richmond
- Rosenheim
- Roseville
- Roskilde
- Rostock
- Rouen
- saarlouis
- Sabadell
- Sacramento
- Saint-Cloud
- Saint-Herblain
- Salamanca
- Salzburg
- Samara
- San Diego
- San Francisco
- San Isidro
- San Jose
- San Miguel de Tucumán
- sankt-veit-an-der-glan
- sant-andreu-de-la-barca
- Santa Clara
- Santander
- Santiago de Compostela
- Santiago de Querétaro
- Scarborough
- Scottsdale
- Seongnam-si
- Seoul
- Sevilla
- shang-hai-shi
- Shanghai
- Sheffield
- shi-jia-zhuang-shi
- Shimotsuke
- Shinjuku City
- Sindelfingen
- Sioux Falls
- Sofia
- South Brisbane
- South San Francisco
- Split
- St Priest En Jarez
- st--catharines
- St. Gallen
- St. Louis
- Stade
- Stoke-on-Trent
- Strasbourg
- Stávropol
- Surquillo
- Surrey
- Sutton
- Syracuse
- Szeged
- Taichung City
- Tainan City
- Taipei City
- tambon-kho-hong
- Terni
- Ternópil
- Tokio
- Toledo
- Toronto
- Toulouse
- trentino-alto-adige
- Trier
- Trujillo
- Truro
- Tübingen
- Udine
- Ulm
- Uppsala län
- Urbana
- Vallejo
- València
- Vancouver
- Vandœuvre-lès-Nancy
- vara_din
- Varna
- Vejle
- Velbert
- Veszprém
- Victoria
- Vienna
- Villejuif
- Walla Walla
- Walnut Creek
- Waratah
- Warszawa
- Washington
- Wels
- West Orange
- West Palm Beach
- Westmead
- Wheat Ridge
- Wichita
- Wieliszew
- Wien
- Winnipeg
- Wirral
- Witten
- Wolverhampton
- wu-han-shi
- Wuhan
- Würzburg
- Yahaba
- Zagreb
- Zaragoza
- Zwolle
- Zürich
- Óblast de Moscú
Identificador del Ensayo:
NCT01358877 TOC4939G 2010-022902-41 BIG 4-11 RENIS IS000136 BO25126
Resumen del estudio
This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus trastuzumab as adjuvant therapy in participants with operable HER2-positive primary breast cancer. This study will be carried out in collaboration with the Breast International Group (BIG).
Hoffmann-La Roche
Patrocinador
Phase 3
Fase
NCT01358877, BO25126, TOC4939G,2010-022902-41,BIG 4-11, RENIS IS000136
Identificador del Ensayo
5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin, Paclitaxel, Pertuzumab, Placebo, Trastuzumab
Tratamientos
Breast Cancer
Afección
Título Oficial
A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer
Criterios de selección
Todos
Género
≥18 Años
Edad
No
Voluntarios sanos
Criterios de Inclusión
- Non-metastatic operable primary invasive HER2-positive carcinoma of the breast that is histologically confirmed, and adequately excised
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (</=) 1
- Known hormone receptor status (estrogen receptor and progesterone receptor)
- The interval between definitive surgery for breast cancer and the first dose of chemotherapy must be no more than 8 weeks (56 days). The first cycle of chemotherapy must be administered within 7 days of randomization or on Day 56, whichever occurs first
- Baseline left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 55 percent (%) measured by echocardiogram (ECHO) or Multiple-Gated Acquisition (MUGA) Scan
- Confirmed HER2 positive status
- Completion of all necessary baseline laboratory and radiologic investigations prior to randomization
- Women of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception (as defined by the protocol) by the participant and/or partner for the duration of the study treatment and for at least 7 months after the last dose of study drug
Criterios de Exclusión
- History of any prior (ipsi- and/or contralateral) invasive breast cancer
- History of non-breast malignancies within the 5 years prior to study entry, except for carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin
- Any "clinical" T4 tumor as defined by primary tumor/regional lymph nodes/distant metastasis (TNM), including inflammatory breast cancer
- Any node-negative tumor
- Any previous systemic chemotherapy for cancer or radiotherapy for cancer
- Prior use of anti-HER2 therapy for any reason or other prior biologic or immunotherapy for cancer
- Concurrent anti-cancer treatment in another investigational trial
- Serious cardiac or cardiovascular disease or condition
- Other concurrent serious diseases that may interfere with planned treatment including severe pulmonary conditions/illness
- Abnormal laboratory tests immediately prior to randomization
- Pregnant or lactating women
- Sensitivity to any of the study medications or any of the ingredients or excipients of these medications