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A study to investigate the effectiveness of trastuzumab emtansine compared with trastuzumab in a type of breast cancer (called HER2 positive breast cancer) for patients who still have signs of tumours after receiving previous treatment and undergoing surgery (KATHERINE)
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)
- Breast Cancer HER-2 Positive
- Breast Cancer
Trial Status:
Active, not recruiting
This trial runs in
Cities
- Aarau
- Aguascalientes
- Akron
- Albany
- Alcorcón
- Alvarado
- Anchorage
- Arequipa
- Augsburg
- Augusta
- Avignon
- Baltimore
- Barcelona
- Barretos
- Basel
- Beer Sheva
- Bellavista
- Beograd
- Bergamo
- Berlin
- Besançon
- Bielefeld
- Birmingham
- Bogotá
- Bologna
- Bordeaux
- Bourg-en-Bresse
- Bradford
- Brewer
- Brindisi
- Bristol
- Bruxelles
- Buenos Aires
- Bursa
- Böblingen
- Caen
- Calgary
- Candiolo
- Canton
- Cape Town
- Changchun
- Charleston
- Charlotte
- Chemnitz
- Chicago
- Chihuahua
- Ciudad Autonoma Buenos Aires
- Clermont-Ferrand
- Cleveland
- Columbus
- Concord
- Cork
- Cottingham
- Cremona
- Curitiba
- Cádiz
- Denver
- Detroit
- Devon
- Distrito Federal
- Dortmund
- Dublin
- Dundee
- Düsseldorf
- East Stroudsburg
- Edirne
- Edmonton
- Ephrata
- Erlangen
- Essen
- Esslingen
- Fargo
- Frankfurt
- Frankfurt am Main
- Fredericksburg
- Freiburg
- Fürth
- Gainesville
- Galway
- Gelsenkirchen
- Genova
- Gent
- Glens Falls
- Grand Rapids
- Greenfield Park
- Greifswald
- Guangzhou
- Guatemala
- Gävle
- Halle
- Hamburg
- Hamm
- Hannover
- Harbin
- Hartford
- Heidelberg
- Hilton
- Hong Kong
- Houston
- Hradec Králové
- Huddersfield
- Innsbruck
- Iowa City
- Iraklio
- Issaquah
- Istanbul
- Izmir
- Jacksonville
- Jaú
- Jerusalem
- Jinan
- Johannesburg
- Joplin
- Karlsruhe
- Kassel
- Kiel
- Kirkland
- Knoxville
- Kragujevac
- Köln
- La Rioja
- Lansing
- Las Vegas
- Le Mans
- Lebach
- Leeds
- Leganés
- Lexington
- Lima
- Limburg
- Limerick
- Liège
- London
- Lone Tree
- Long Beach
- Long Branch
- Longview
- Louisville
- Lubbock
- Lund
- Lynchburg
- Lörrach
- Macerata
- Madrid
- Malatya
- Manchester
- Marseille
- Marshfield
- Mayfield Heights
- Medellin-Antioquia
- Mentor
- Miami Beach
- Milano
- Milwaukee
- Minden
- Minneapolis
- Miraflores
- Monroe
- Montería
- Montpellier
- Montréal
- Monza
- Mount Vernon
- Málaga
- München
- Münster
- Nanjing
- Naperville
- Napoli
- Navarra
- New Brunswick
- New Haven
- New York
- Newark
- Nordhausen
- Nottingham
- Oaxaca
- Offenbach
- Olomouc
- Orange
- Orlando
- Ottawa
- Owosso
- Paderborn
- Padova
- Panamá
- Paris
- Parktown, Johannesburg
- Petach Tikva
- Philadelphia
- Pisa
- Pittsburgh
- Plainfield
- Pontedera
- Port Elizabeth
- Portland
- Porto Alegre
- Praha 2
- Pretoria
- Quebec City
- Ramat Gan
- Recklinghausen
- Rehovot
- Reus
- Reutlingen
- Richmond
- Rio de Janeiro
- Roma
- Rosario
- Rostock
- Rouen
- Royal Oak
- Rozzano
- Salamanca
- Salzburg
- San Diego
- San Giovanni Rotondo
- San Sebastián
- Santa Ana
- Sao Jose dos Campos
- Scarborough
- Seattle
- Sevilla
- Shanghai
- Sheffield
- Shelby
- Shijiazhuang
- Sioux Falls
- Sparta
- Spokane
- Springfield
- Sremska Kamenica
- St Cloud
- Stanford
- Stockholm
- Stony Brook
- Stralsund
- Strasbourg
- Stuttgart
- Surrey
- São Paulo
- Taichung
- Taipei City
- Tampa
- Taoyuan
- Terrassa
- Thessaloniki
- Toronto
- Traunstein
- Traverse City
- Troy
- Truro
- Tübingen
- Ulm
- Vallejo
- València
- Vancouver
- Verona
- Vigo
- Villejuif
- Washington
- Wheat Ridge
- Wien
- Wiesbaden
- Wilrijk
- Witten
- Würzburg
- York
- Zürich
Trial Identifier:
NCT01772472 2012-002018-37 BO27938
Trial Summary
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
Sponsor
Phase 3
Phase
NCT01772472 , BO27938 , 2012-002018-37
Trial Identifier
trastuzumab, trastuzumab emtansine
Treatments
Breast Cancer
Condition
Official Title
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
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- 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
Exclusion Criteria
- 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
For the latest version of this information please go to www.forpatients.roche.com