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Estudio de trastuzumab emtansina frente a trastuzumab como tratamiento adyuvante en personas con cáncer de mama positivo para HER2 que tienen tumor residual en la mama o en los ganglios linfáticos axilares después del tratamiento preoperatorio
A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE)
- Cáncer
- Cáncer de mama
- Cáncer de mama Her-2 positivo
- Cancer de mama HER2-positivo
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:
Completo
Este estudio clínico se lleva a cabo en
Ciudades
- Aarau
- ABD
- Aguascalientes
- Anchorage
- Antwerpen
- Arequipa
- Augsburg
- Avignon
- Baltimore
- Barcelona
- barnstaple
- Beerseba
- Bellavista
- Beograd
- Berlín
- Besançon
- Bielefeld
- Birmingham
- Bogotá
- Bologna
- Bordeaux
- Bourg-en-Bresse
- Bradford
- Brewer
- Brindisi
- Bristol
- Bruxelles
- Bursa
- Caen
- Calgary
- Candiolo
- Canton
- Cape Town
- chang-chun-shi
- Charleston
- Charlotte
- Chicago
- Ciudad de Guatemala
- Ciudad de México
- Clermont-Ferrand
- Cleveland
- Columbus
- Cork
- Cottingham
- Cremona
- cuauhtemoc
- Denver
- Detroit
- Donostia
- dooradoyle
- Dortmund
- Dublin
- Dublin 4
- Dublin 7
- Dundee
- Düsseldorf
- Edirne
- Edmonton
- Erlangen
- Esmirna
- Essen
- Esslingen am Neckar
- Fargo
- Fountain Valley
- Frankfurt am Main
- Fredericksburg
- Freiburg im Breisgau
- Gainesville
- Galway
- Gauteng
- Gelsenkirchen
- Genova
- Gent
- gqeberha
- Grand Rapids
- Greifswald
- guang-zhou-shi
- Guangzhou Shi
- Guatemala
- Gävle
- Halle (Saale)
- Hamburgo
- Hamm
- Hannover
- Harbin
- Heidelberg
- Hong Kong Island
- Houston
- Huddersfield
- Innsbruck
- Iowa City
- Iraklio
- Issaquah
- İstanbul
- Jerusalem
- Jinan
- Johannesburgo
- Kassel
- Kiel
- Knoxville
- Královéhradecký kraj
- Köln
- La Rioja
- La Victoria
- Lacio
- Lansing
- Le Mans
- Lebach
- Leeds
- Lexington
- Lombardia
- London
- Long Beach
- Longueuil
- Louisville
- Lubbock
- luik
- Lynchburg
- Madrid
- Manchester
- Marseille
- Marshfield
- Medellin-Antioquia
- Medellín
- Miami Beach
- Milano
- Minneapolis
- monastir-governorate
- Montería
- Montpellier
- Montréal
- Monza
- Málaga
- München
- Naperville
- Napoli
- New Brunswick
- New Haven
- New Territories
- New York
- Nordhausen
- Nottingham
- oaxaca-de-juarez
- Offenbach am Main
- olomouc-9
- Orange
- Orlando
- Ottawa
- Paderborn
- Padova
- Pamplona
- Panamá
- Paraná
- Paris
- Petah Tikva
- Philadelphia
- pietermaritzburg
- Pisa
- Pittsburgh
- Plainfield
- Pontedera
- Portland
- Praga
- Provincia de Malatya
- Québec
- Ramat Gan
- Recklinghausen
- Rejovot
- Reus
- Reutlingen
- Richmond
- Rio de Janeiro
- Rio Grande do Sul
- Rosario
- Rosedale
- Rostock
- Rouen
- Royal Oak
- Saint-Cloud
- Salamanca
- Salzburg
- San Borja
- San Diego
- Scarborough
- Sevilla
- shang-hai-shi
- Sheffield
- Sindelfingen
- Sioux Falls
- Solna
- Sparta
- Spokane
- Stanford
- Stralsund
- Strasbourg
- Stuttgart
- Surrey
- São Paulo
- Taichung City
- Taipei City
- Tampa
- Thessaloniki
- Toronto
- Towson
- Traunstein
- Troy
- Truro
- Tübingen
- Ulm
- Vallejo
- València
- Vancouver
- Verona
- Vigo
- Villejuif
- Washington
- Wien
- Wiesbaden
- Witten
- Würzburg
- York
- Zürich
Identificador del Ensayo:
NCT01772472 2012-002018-37 BO27938 RENIS IS000258
Resumen del estudio
This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6 mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or hormone therapy will be given in addition if indicated.
Hoffmann-La Roche
Patrocinador
Fase 3
Fase
NCT01772472, BO27938, 2012-002018-37
Identificador del Ensayo
trastuzumab, trastuzumab emtansine
Tratamientos
Breast Cancer
Afección
Título Oficial
A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy for Patients With HER2-Positive Primary Breast Cancer Who Have Residual Tumor Present Pathologically in the Breast or Axillary Lymph Nodes Following Preoperative Therapy
Criterios de selección
Todos
Género
≥18 Años
Edad
No
Voluntarios sanos
Criterios de Inclusión
- Adult patient, >/= 18 years of age
- HER2-positive breast cancer
- Histologically confirmed invasive breast carcinoma
- Clinical stage T1-4/N0-3/M0 at presentation (patients with T1a/bN0 tumors will not be eligible)
- Completion of preoperative systemic chemotherapy and HER2-directed treatment consisting of at least 6 cycles of chemotherapy with a total duration of at least 16 weeks, including at least 9 weeks of trastuzumab and at least 9 weeks of taxane-based therapy
- Adequate excision: surgical removal of all clinically evident disease in the breast and lymph nodes as specified in protocol
- Pathological evidence of residual invasive carcinoma in the breast or axillary lymph nodes following completion of preoperative therapy
- An interval of no more than 12 weeks between the date of surgery and the date of randomization
- Known hormone-receptor status
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate hematologic, renal and liver function
- Screening Left ventricular ejection fraction (LVEF) >/= 50% on echocardiogram (ECHO) or multiple-gated acquisition (MUGA) after receiving neoadjuvant chemotherapy and no decrease in LVEF by more than 15% absolute points from the pre-chemotherapy LVEF. Or, if pre-chemotherapy LVEF was not assessed, the screening LVEF must be >/= 55% after completion of neoadjuvant chemotherapy.
- For women who are not postmenopausal or surgically sterile: agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 7 months after the last dose of study drug
- Documentation of hepatitis B virus and hepatitis C virus serology is required
Criterios de Exclusión
- Stage IV (metastatic) breast cancer
- History of any prior (ipsi- or contralateral breast cancer except lobular carcinoma in situ
- Evidence of clinically evident gross residual or recurrent disease following preoperative therapy and surgery
- Progressive disease during preoperative systemic therapy
- Treatment with any anti-cancer investigational drug within 28 days prior to commencing study treatment
- History of other malignancy within the last 5 years except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other non-breast malignancies with a similar outcome to those mentioned above
- Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons
- Current NCI CTCAE (Version 4.0) Grade >/= 2 peripheral neuropathy
- History of exposure to the following cumulative doses of anthracyclines: Doxorubicin > 240 mg/m2; Epirubicin or Liposomal Doxorubicin-Hydrochloride (Myocet®) > 480 mg/m2; For other anthracyclines, exposure equivalent to doxorubicin > 240 mg/m2
- Cardiopulmonary dysfunction as defined by protocol
- Prior treatment with trastuzumab emtansine
- Current severe, uncontrolled systemic disease
- Pregnant or lactating women
- Any known active liver disease, e.g. due to HBV, HCV, autoimmune hepatic disorders, or sclerosing cholangitis
- Concurrent serious uncontrolled infections requiring treatment or known infection with HIV
- History of intolerance, including Grade 3 to 4 infusion reaction or hypersensitivity to trastuzumab or murine proteins or any components of the product