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EAP (Expanded Access Protocol) af Lapatinib kombineret med Capecitabine ved metastatisk brystkræft

4. april 2016 opdateret af: Novartis

En åben-label udvidet adgangsundersøgelse af lapatinib- og capecitabin-terapi hos forsøgspersoner med ErbB2-overudtrykkende lokalt avanceret eller metastatisk brystkræft

Denne undersøgelse vil give lægemiddeladgang til lapatinib, i kombination med capecitabin, til patienter, hvis brystkræft havde udviklet sig med andre behandlinger

Studieoversigt

Status

Godkendt til markedsføring

Betingelser

Neoplasmer, bryst

Intervention / Behandling

Medicin: lapatinib + capecitabin

Undersøgelsestype

Udvidet adgang

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Australien
- New South Wales
  - Kogarah, New South Wales, Australien, 2217
    - Novartis Investigative Site
  - North Sydney, New South Wales, Australien, 2060
    - Novartis Investigative Site
  - Port Macquarie, New South Wales, Australien, 2444
    - Novartis Investigative Site
  - Waratah, New South Wales, Australien, 2298
    - Novartis Investigative Site
  - Westmead, New South Wales, Australien, 2145
    - Novartis Investigative Site
- Queensland
  - Herston, Queensland, Australien, 4029
    - Novartis Investigative Site
  - South Brisbane, Queensland, Australien, 4101
    - Novartis Investigative Site
- South Australia
  - Bedford Park, South Australia, Australien, 5042
    - Novartis Investigative Site
- Tasmania
  - Hobart, Tasmania, Australien, 7000
    - Novartis Investigative Site
- Victoria
  - Box Hill, Victoria, Australien, 3128
    - Novartis Investigative Site
  - Fitzroy, Victoria, Australien, 3065
    - Novartis Investigative Site
  - Geelong, Victoria, Australien, 3220
    - Novartis Investigative Site
  - Wodonga, Victoria, Australien, 3690
    - Novartis Investigative Site
- Western Australia
  - Nedlands, Western Australia, Australien, 6009
    - Novartis Investigative Site
  - Perth, Western Australia, Australien, 6000
    - Novartis Investigative Site
Belgien
- - Brussel, Belgien, 1090
    - Novartis Investigative Site
  - Bruxelles, Belgien, 1200
    - Novartis Investigative Site
  - Bruxelles, Belgien, 1000
    - Novartis Investigative Site
  - Charleroi, Belgien, 6000
    - Novartis Investigative Site
  - Edegem, Belgien, 2650
    - Novartis Investigative Site
  - Gent, Belgien, 9000
    - Novartis Investigative Site
  - Haine Saint Paul, Belgien, 7100
    - Novartis Investigative Site
  - Leuven, Belgien, 3000
    - Novartis Investigative Site
  - Liège, Belgien, 4000
    - Novartis Investigative Site
  - Wilrijk, Belgien, 2610
    - Novartis Investigative Site
  - Yvoir, Belgien, 5530
    - Novartis Investigative Site
Brasilien
- - Rio de Janeiro, Brasilien, 21941-913
    - Novartis Investigative Site
  - Rio de Janeiro, Brasilien, 20260-020
    - Novartis Investigative Site
  - São Paulo, Brasilien, 05651-901
    - Novartis Investigative Site
- Bahía
  - Salvador, Bahía, Brasilien, 40170-070
    - Novartis Investigative Site
- Rio Grande Do Sul
  - Porto Alegre, Rio Grande Do Sul, Brasilien, 90035-903
    - Novartis Investigative Site
  - Porto Alegre, Rio Grande Do Sul, Brasilien, 90050-170
    - Novartis Investigative Site
  - Porto Alegre, Rio Grande Do Sul, Brasilien, 90610 000
    - Novartis Investigative Site
- São Paulo
  - Jau, São Paulo, Brasilien, 17210-080
    - Novartis Investigative Site
Bulgarien
- - Sofia, Bulgarien, 1156
    - Novartis Investigative Site
Canada
- British Columbia
  - Vancouver, British Columbia, Canada, V5Z 4E6
    - Novartis Investigative Site
- Manitoba
  - Winnipeg, Manitoba, Canada, R2H 2A6
    - Novartis Investigative Site
- New Brunswick
  - Moncton, New Brunswick, Canada, E1C 8X3
    - Novartis Investigative Site
- Ontario
  - Oshawa, Ontario, Canada, L1G 2B9
    - Novartis Investigative Site
  - Sudbury, Ontario, Canada, P3E 5J1
    - Novartis Investigative Site
- Quebec
  - Greenfield Park, Quebec, Canada, J4V 2H1
    - Novartis Investigative Site
- Saskatchewan
  - Saskatoon, Saskatchewan, Canada, S7N 4H4
    - Novartis Investigative Site
Chile
- Región Metro De Santiago
  - Santiago, Región Metro De Santiago, Chile, 750 1088
    - Novartis Investigative Site
Cypern
- - Strovolos, Cypern, 2006
    - Novartis Investigative Site
Danmark
- - Copenhagen, Danmark, DK- 2100
    - Novartis Investigative Site
  - Odense C, Danmark, 5000
    - Novartis Investigative Site
  - Roskilde, Danmark, DK-4000
    - Novartis Investigative Site
  - Vejle, Danmark, 7100
    - Novartis Investigative Site
  - Århus C, Danmark, 8000
    - Novartis Investigative Site
Den Russiske Føderation
- - Irkutsk, Den Russiske Føderation, 664035
    - Novartis Investigative Site
  - Moscow, Den Russiske Føderation, 115478
    - Novartis Investigative Site
  - Nizhny Novgorod, Den Russiske Føderation, 603126
    - Novartis Investigative Site
Det Forenede Kongerige
- - Belfast, Det Forenede Kongerige, BT9 7AB
    - Novartis Investigative Site
  - Bournemouth, Det Forenede Kongerige, BH7 7DW
    - Novartis Investigative Site
  - Brighton, Det Forenede Kongerige, BN2 5BE
    - Novartis Investigative Site
  - Bristol, Det Forenede Kongerige, BS2 8HW
    - Novartis Investigative Site
  - Cardiff, Det Forenede Kongerige, CF14 2TL
    - Novartis Investigative Site
  - Cheltenham, Det Forenede Kongerige, GL53 7AN
    - Novartis Investigative Site
  - Colchester, Det Forenede Kongerige, CO3 3NB
    - Novartis Investigative Site
  - Cumbria, Det Forenede Kongerige, CA2 7HY
    - Novartis Investigative Site
  - Denbighshire, Det Forenede Kongerige, LL 18 5UJ
    - Novartis Investigative Site
  - Hartshill, Stoke-on-Trent, Det Forenede Kongerige, ST4 7LN
    - Novartis Investigative Site
  - Lindley, huddersfield, Det Forenede Kongerige, HD3 3EA
    - Novartis Investigative Site
  - London, Det Forenede Kongerige, SE1 9RT
    - Novartis Investigative Site
  - London, Det Forenede Kongerige, SW3 6JJ
    - Novartis Investigative Site
  - London, Det Forenede Kongerige, NW3 2QG
    - Novartis Investigative Site
  - London, Det Forenede Kongerige, EC1A 7BE
    - Novartis Investigative Site
  - London, Det Forenede Kongerige, NW1 2PG
    - Novartis Investigative Site
  - London, Det Forenede Kongerige, W6 8RF
    - Novartis Investigative Site
  - Manchester, Det Forenede Kongerige, M20 4BX
    - Novartis Investigative Site
  - Nottingham, Det Forenede Kongerige, NG5 1PB
    - Novartis Investigative Site
  - Peterborough, Det Forenede Kongerige, PE3 6DA
    - Novartis Investigative Site
  - Poole, Dorset, Det Forenede Kongerige, BH15 2JB
    - Novartis Investigative Site
  - Portsmouth, Det Forenede Kongerige, PO3 6AD
    - Novartis Investigative Site
  - Shrewsbury, Det Forenede Kongerige, SY3 8XQ
    - Novartis Investigative Site
- Cambridgeshire
  - Cambridge, Cambridgeshire, Det Forenede Kongerige, CB2 2GG
    - Novartis Investigative Site
- Essex
  - Chelmsford, Essex, Det Forenede Kongerige, CM1 7ET
    - Novartis Investigative Site
- Middlesex
  - Northwood, Middlesex, Det Forenede Kongerige, HA6 2RN
    - Novartis Investigative Site
- Midlothian
  - Edinburgh, Midlothian, Det Forenede Kongerige, EH4 2XU
    - Novartis Investigative Site
Estland
- - Tallinn, Estland, 13419
    - Novartis Investigative Site
  - Tartu, Estland, 51003
    - Novartis Investigative Site
Filippinerne
- - Makati City, Filippinerne, 1200
    - Novartis Investigative Site
  - Pasay City, Filippinerne, 1300
    - Novartis Investigative Site
  - Quezon City, Filippinerne, 1102
    - Novartis Investigative Site
  - Sampaloc Manila, Filippinerne, 1008
    - Novartis Investigative Site
Finland
- - Helsinki, Finland, 00150
    - Novartis Investigative Site
  - Hämeenlinna, Finland
    - Novartis Investigative Site
  - Kangasala, Finland, 36280
    - Novartis Investigative Site
  - Kuopio, Finland, 70210
    - Novartis Investigative Site
  - OYS, Finland, 90029
    - Novartis Investigative Site
Forenede Stater
- Alabama
  - Huntsville, Alabama, Forenede Stater, 35805
    - Novartis Investigative Site
- Alaska
  - Anchorage, Alaska, Forenede Stater, 99508
    - Novartis Investigative Site
- Arizona
  - Glendale, Arizona, Forenede Stater, 85304
    - Novartis Investigative Site
- Arkansas
  - Fayetteville, Arkansas, Forenede Stater, 72703
    - Novartis Investigative Site
  - Little Rock, Arkansas, Forenede Stater, 72205
    - Novartis Investigative Site
- California
  - Bellflower, California, Forenede Stater, 90706
    - Novartis Investigative Site
  - Burbank, California, Forenede Stater, 91505-4866
    - Novartis Investigative Site
  - Gilroy, California, Forenede Stater, 95020
    - Novartis Investigative Site
  - Long Beach, California, Forenede Stater, 90806
    - Novartis Investigative Site
  - Long Beach, California, Forenede Stater, 90813
    - Novartis Investigative Site
  - Newport Beach, California, Forenede Stater, 92663
    - Novartis Investigative Site
  - San Diego, California, Forenede Stater, 92123
    - Novartis Investigative Site
  - San Francisco, California, Forenede Stater, 94115-1710
    - Novartis Investigative Site
  - Santa Rosa, California, Forenede Stater, 95403-1757
    - Novartis Investigative Site
  - Stockton, California, Forenede Stater, 95204
    - Novartis Investigative Site
- Colorado
  - Aurora, Colorado, Forenede Stater, 80010
    - Novartis Investigative Site
  - Boulder, Colorado, Forenede Stater, 80304
    - Novartis Investigative Site
  - Lafayette, Colorado, Forenede Stater, 80026
    - Novartis Investigative Site
- Connecticut
  - Hartford, Connecticut, Forenede Stater, 06105
    - Novartis Investigative Site
  - Manchester, Connecticut, Forenede Stater, 06040
    - Novartis Investigative Site
  - New Havey, Connecticut, Forenede Stater, 06511
    - Novartis Investigative Site
  - Norwich, Connecticut, Forenede Stater, 06360
    - Novartis Investigative Site
- District of Columbia
  - Washington, District of Columbia, Forenede Stater, 20007
    - Novartis Investigative Site
- Florida
  - Fort Lauderdale, Florida, Forenede Stater, 33328
    - Novartis Investigative Site
  - Fort Myers, Florida, Forenede Stater, 33916
    - Novartis Investigative Site
  - Fort Walton Beach, Florida, Forenede Stater, 32547
    - Novartis Investigative Site
  - Gainesville, Florida, Forenede Stater, 32605
    - Novartis Investigative Site
  - Hollywood, Florida, Forenede Stater, 33021
    - Novartis Investigative Site
  - Jacksonville, Florida, Forenede Stater, 32256
    - Novartis Investigative Site
  - Miami, Florida, Forenede Stater, 33133
    - Novartis Investigative Site
  - Orlando, Florida, Forenede Stater, 32806
    - Novartis Investigative Site
  - Orlando, Florida, Forenede Stater, 32804
    - Novartis Investigative Site
  - Tampa, Florida, Forenede Stater, 33607
    - Novartis Investigative Site
- Georgia
  - Augusta, Georgia, Forenede Stater, 30901
    - Novartis Investigative Site
  - Brunswick, Georgia, Forenede Stater, 31525
    - Novartis Investigative Site
  - Macon, Georgia, Forenede Stater, 31201
    - Novartis Investigative Site
  - Marietta, Georgia, Forenede Stater, 30060
    - Novartis Investigative Site
  - Tucker, Georgia, Forenede Stater, 30084
    - Novartis Investigative Site
- Hawaii
  - Honolulu, Hawaii, Forenede Stater, 96813
    - Novartis Investigative Site
- Idaho
  - Boise, Idaho, Forenede Stater, 83712
    - Novartis Investigative Site
- Illinois
  - Chicago, Illinois, Forenede Stater, 60637
    - Novartis Investigative Site
  - Decatur, Illinois, Forenede Stater, 62526
    - Novartis Investigative Site
  - Galesburg, Illinois, Forenede Stater, 61401
    - Novartis Investigative Site
  - Highland Park, Illinois, Forenede Stater, 60035
    - Novartis Investigative Site
  - Joliet, Illinois, Forenede Stater, 60435
    - Novartis Investigative Site
  - Peoria, Illinois, Forenede Stater, 61615
    - Novartis Investigative Site
  - Zion, Illinois, Forenede Stater, 60099
    - Novartis Investigative Site
- Indiana
  - Indianapolis, Indiana, Forenede Stater, 46202
    - Novartis Investigative Site
- Iowa
  - Bettendorf, Iowa, Forenede Stater, 52722
    - Novartis Investigative Site
  - Cedar Rapids, Iowa, Forenede Stater, 52403
    - Novartis Investigative Site
  - Council Bluffs, Iowa, Forenede Stater, 51503
    - Novartis Investigative Site
  - Sioux City, Iowa, Forenede Stater, 51101-1733
    - Novartis Investigative Site
  - Waterloo, Iowa, Forenede Stater, 50702
    - Novartis Investigative Site
- Louisiana
  - Baton Rouge, Louisiana, Forenede Stater, 70809
    - Novartis Investigative Site
  - Metairie, Louisiana, Forenede Stater, 70006
    - Novartis Investigative Site
- Maine
  - Portland, Maine, Forenede Stater, 04101
    - Novartis Investigative Site
  - Scarborough, Maine, Forenede Stater, 04074
    - Novartis Investigative Site
  - Waterville, Maine, Forenede Stater, 04901
    - Novartis Investigative Site
- Maryland
  - Baltimore, Maryland, Forenede Stater, 21237
    - Novartis Investigative Site
  - Baltimore, Maryland, Forenede Stater, 21231-1000
    - Novartis Investigative Site
  - Chevy Chase, Maryland, Forenede Stater, 20815
    - Novartis Investigative Site
  - Frederick, Maryland, Forenede Stater, 21701
    - Novartis Investigative Site
- Massachusetts
  - Boston, Massachusetts, Forenede Stater, 02111
    - Novartis Investigative Site
  - Boston, Massachusetts, Forenede Stater, 02118
    - Novartis Investigative Site
  - Fall River, Massachusetts, Forenede Stater, 02721
    - Novartis Investigative Site
  - Peabody, Massachusetts, Forenede Stater, 01960
    - Novartis Investigative Site
- Michigan
  - Ann Arbor, Michigan, Forenede Stater, 48106
    - Novartis Investigative Site
  - Detroit, Michigan, Forenede Stater, 48202
    - Novartis Investigative Site
  - Royal Oak, Michigan, Forenede Stater, 48073
    - Novartis Investigative Site
  - Troy, Michigan, Forenede Stater, 48085
    - Novartis Investigative Site
- Minnesota
  - Duluth, Minnesota, Forenede Stater, 55802
    - Novartis Investigative Site
- Mississippi
  - Jackson, Mississippi, Forenede Stater, 39202
    - Novartis Investigative Site
- Missouri
  - Columbia, Missouri, Forenede Stater, 65201
    - Novartis Investigative Site
  - Kalamazoo, Missouri, Forenede Stater, 49007
    - Novartis Investigative Site
  - Kansas City, Missouri, Forenede Stater, 64118
    - Novartis Investigative Site
  - Springfield, Missouri, Forenede Stater, 65807
    - Novartis Investigative Site
  - St. Louis, Missouri, Forenede Stater, 63141
    - Novartis Investigative Site
  - St. Louis, Missouri, Forenede Stater, 63110
    - Novartis Investigative Site
- Montana
  - Billings, Montana, Forenede Stater, 59101
    - Novartis Investigative Site
  - Great Falls, Montana, Forenede Stater, 59405
    - Novartis Investigative Site
- Nebraska
  - Grand Island, Nebraska, Forenede Stater, 68803
    - Novartis Investigative Site
  - Lincoln, Nebraska, Forenede Stater, 68510
    - Novartis Investigative Site
  - North Platte, Nebraska, Forenede Stater, 69103
    - Novartis Investigative Site
  - Omaha, Nebraska, Forenede Stater, 68114
    - Novartis Investigative Site
  - Omaha, Nebraska, Forenede Stater, 68124-2346
    - Novartis Investigative Site
- Nevada
  - Las Vegas, Nevada, Forenede Stater, 89102
    - Novartis Investigative Site
- New Hampshire
  - Exeter, New Hampshire, Forenede Stater, 03833
    - Novartis Investigative Site
- New Jersey
  - Flemington, New Jersey, Forenede Stater, 08822
    - Novartis Investigative Site
  - Freehold, New Jersey, Forenede Stater, 07728
    - Novartis Investigative Site
  - Little Silver, New Jersey, Forenede Stater, 07739
    - Novartis Investigative Site
  - Livingston, New Jersey, Forenede Stater, 07039
    - Novartis Investigative Site
  - Mountain Lakes, New Jersey, Forenede Stater, 07046
    - Novartis Investigative Site
  - Newark, New Jersey, Forenede Stater, 07112
    - Novartis Investigative Site
- New York
  - Buffalo, New York, Forenede Stater, 14263
    - Novartis Investigative Site
  - Buffalo, New York, Forenede Stater, 14221
    - Novartis Investigative Site
  - East Setauket, New York, Forenede Stater, 11733
    - Novartis Investigative Site
  - East Syracuse, New York, Forenede Stater, 13057
    - Novartis Investigative Site
  - Fresh Meadows, New York, Forenede Stater, 11366
    - Novartis Investigative Site
  - Glens Falls, New York, Forenede Stater, 12801
    - Novartis Investigative Site
  - New York, New York, Forenede Stater, 10003
    - Novartis Investigative Site
  - New York, New York, Forenede Stater, 10011
    - Novartis Investigative Site
  - New York, New York, Forenede Stater, 10016
    - Novartis Investigative Site
  - New York, New York, Forenede Stater, 10065
    - Novartis Investigative Site
- North Carolina
  - Asheville, North Carolina, Forenede Stater, 28816
    - Novartis Investigative Site
  - Charlotte, North Carolina, Forenede Stater, 28204
    - Novartis Investigative Site
  - Charlotte, North Carolina, Forenede Stater, 28203
    - Novartis Investigative Site
  - Fayetteville, North Carolina, Forenede Stater, 28304
    - Novartis Investigative Site
  - Greensboro, North Carolina, Forenede Stater, 27403
    - Novartis Investigative Site
- North Dakota
  - Bismarck, North Dakota, Forenede Stater, 58501
    - Novartis Investigative Site
  - Fargo, North Dakota, Forenede Stater, 58122
    - Novartis Investigative Site
- Ohio
  - Cincinnati, Ohio, Forenede Stater, 45242
    - Novartis Investigative Site
  - Cincinnati, Ohio, Forenede Stater, 45219
    - Novartis Investigative Site
  - Cleveland, Ohio, Forenede Stater, 44106
    - Novartis Investigative Site
  - Columbus, Ohio, Forenede Stater, 43210
    - Novartis Investigative Site
  - Columbus, Ohio, Forenede Stater, 39705
    - Novartis Investigative Site
  - Sandusky, Ohio, Forenede Stater, 44870
    - Novartis Investigative Site
- Oklahoma
  - Oklahoma City, Oklahoma, Forenede Stater, 73109
    - Novartis Investigative Site
  - Tulsa, Oklahoma, Forenede Stater, 74133
    - Novartis Investigative Site
  - Tulsa, Oklahoma, Forenede Stater, 74104
    - Novartis Investigative Site
- Oregon
  - Klamath Falls, Oregon, Forenede Stater, 97601
    - Novartis Investigative Site
  - Portland, Oregon, Forenede Stater, 97213
    - Novartis Investigative Site
- Pennsylvania
  - Drexel Hill, Pennsylvania, Forenede Stater, 19026
    - Novartis Investigative Site
  - Philadelphia, Pennsylvania, Forenede Stater, 19111
    - Novartis Investigative Site
  - Philadelphia, Pennsylvania, Forenede Stater, 19104
    - Novartis Investigative Site
  - Philadelphia, Pennsylvania, Forenede Stater, 19106
    - Novartis Investigative Site
  - Pittsburgh, Pennsylvania, Forenede Stater, 15213
    - Novartis Investigative Site
  - Pittsburgh, Pennsylvania, Forenede Stater, 15212-4772
    - Novartis Investigative Site
  - Pottstown, Pennsylvania, Forenede Stater, 19464
    - Novartis Investigative Site
  - Sayre, Pennsylvania, Forenede Stater, 18840
    - Novartis Investigative Site
  - State College, Pennsylvania, Forenede Stater, 16803
    - Novartis Investigative Site
- South Carolina
  - Charleston, South Carolina, Forenede Stater, 29403
    - Novartis Investigative Site
  - Columbia, South Carolina, Forenede Stater, 29210
    - Novartis Investigative Site
  - Florence, South Carolina, Forenede Stater, 29506
    - Novartis Investigative Site
  - Mt. Pleasant, South Carolina, Forenede Stater, 29464
    - Novartis Investigative Site
- Tennessee
  - Knoxville, Tennessee, Forenede Stater, 37916
    - Novartis Investigative Site
  - Memphis, Tennessee, Forenede Stater, 38120
    - Novartis Investigative Site
  - Nashville, Tennessee, Forenede Stater, 37203
    - Novartis Investigative Site
- Texas
  - Arlington, Texas, Forenede Stater, 76012
    - Novartis Investigative Site
  - Austin, Texas, Forenede Stater, 78759
    - Novartis Investigative Site
  - Austin, Texas, Forenede Stater, 78731
    - Novartis Investigative Site
  - Dallas, Texas, Forenede Stater, 75230
    - Novartis Investigative Site
  - Dallas, Texas, Forenede Stater, 75246
    - Novartis Investigative Site
  - El Paso, Texas, Forenede Stater, 79912
    - Novartis Investigative Site
  - Houston, Texas, Forenede Stater, 77030
    - Novartis Investigative Site
  - Houston, Texas, Forenede Stater, 77230-1439
    - Novartis Investigative Site
  - San Antonio, Texas, Forenede Stater, 78207
    - Novartis Investigative Site
- Utah
  - Salt Lake City, Utah, Forenede Stater, 84112-5550
    - Novartis Investigative Site
- Virginia
  - Fairfax, Virginia, Forenede Stater, 22031
    - Novartis Investigative Site
  - Richmond, Virginia, Forenede Stater, 23294
    - Novartis Investigative Site
  - Richmond, Virginia, Forenede Stater, 23230
    - Novartis Investigative Site
- Washington
  - Kennewick, Washington, Forenede Stater, 99336
    - Novartis Investigative Site
  - Mount Vernon, Washington, Forenede Stater, 98273
    - Novartis Investigative Site
  - Seattle, Washington, Forenede Stater, 98112
    - Novartis Investigative Site
  - Tacoma, Washington, Forenede Stater, 98405
    - Novartis Investigative Site
  - Walla Walla, Washington, Forenede Stater, 99362
    - Novartis Investigative Site
- West Virginia
  - Morgantown, West Virginia, Forenede Stater, 26506
    - Novartis Investigative Site
- Wisconsin
  - Green Bay, Wisconsin, Forenede Stater, 54311
    - Novartis Investigative Site
  - La Crosse, Wisconsin, Forenede Stater, 54601
    - Novartis Investigative Site
  - Marshfield, Wisconsin, Forenede Stater, 54449
    - Novartis Investigative Site
Grækenland
- - Athens, Grækenland, 115 28
    - Novartis Investigative Site
  - Heraklion, Crete, Grækenland, 71201
    - Novartis Investigative Site
  - Maroussi, Grækenland, 15123
    - Novartis Investigative Site
Holland
- - Amersfoort, Holland, 3818 ES
    - Novartis Investigative Site
  - Amsterdam, Holland, 1066 CX
    - Novartis Investigative Site
  - Amsterdam, Holland, 1081 HV
    - Novartis Investigative Site
  - Dordrecht, Holland, 3318 AT
    - Novartis Investigative Site
  - Enschede, Holland, 7511JX
    - Novartis Investigative Site
  - Groningen, Holland, 9713 GZ
    - Novartis Investigative Site
  - Leeuwarden, Holland, 8934 AD
    - Novartis Investigative Site
  - Leiden, Holland, 2333 ZA
    - Novartis Investigative Site
  - Maastricht, Holland, 6229 HX
    - Novartis Investigative Site
Hong Kong
- - Pokfulam, Hong Kong
    - Novartis Investigative Site
  - Shatin, Hong Kong
    - Novartis Investigative Site
Indonesien
- - Jakarta, Indonesien, 10430
    - Novartis Investigative Site
Irland
- - Dublin, Irland, 7
    - Novartis Investigative Site
  - Dublin, Irland, 8
    - Novartis Investigative Site
  - Dublin, Irland, 4
    - Novartis Investigative Site
  - Galway, Irland
    - Novartis Investigative Site
  - Tallaght, Dublin, Irland, 24
    - Novartis Investigative Site
  - Wilton, Cork, Irland
    - Novartis Investigative Site
Island
- - Reykjavik, Island, 101
    - Novartis Investigative Site
Israel
- - Beer-Sheva, Israel, 84101
    - Novartis Investigative Site
  - Haifa, Israel, 31096
    - Novartis Investigative Site
  - Jerusalem, Israel, 91120
    - Novartis Investigative Site
  - Petach Tikva, Israel, 49100
    - Novartis Investigative Site
  - Ramat Gan, Israel, 52621
    - Novartis Investigative Site
  - Rehovot, Israel, 76100
    - Novartis Investigative Site
  - Tel Aviv, Israel, 64239
    - Novartis Investigative Site
Italien
- - Ancona, Italien, 60020
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    - Novartis Investigative Site
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    - Novartis Investigative Site
Kina
- - Beijing, Kina, 100021
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  - Beijing, Kina, 100071
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  - Shanghai, Kina, 200080
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  - Shanghai, Kina, 200032
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- Guangdong
  - Guangzhou, Guangdong, Kina, 510515
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- Hubei
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- Jiangsu
  - Nanjing, Jiangsu, Kina, 210009
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- Liaoning
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- Zhejiang
  - Hangzhou, Zhejiang, Kina, 310022
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Korea, Republikken
- - Kyunggi-do, Korea, Republikken, 410-769
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  - Pusan, Korea, Republikken, 602-739
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  - Seoul, Korea, Republikken, 138-736
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  - Seoul, Korea, Republikken, 135-710
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  - seodaemun-gu, Seoul, Korea, Republikken, 120-752
    - Novartis Investigative Site
  - songpa-gu, Seoul, Korea, Republikken, 138-736
    - Novartis Investigative Site
Luxembourg
- - Luxembourg, Luxembourg, 1210
    - Novartis Investigative Site
Malaysia
- - Kuala Lumpur, Malaysia, 59100
    - Novartis Investigative Site
  - Kuala Lumpur, Malaysia, 50450
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  - Petaling Jaya Selangor, Malaysia, 47000
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Malta
- - Floriana, Malta, VLT 14
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Mexico
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  - Mexico City, Mexico, CP 14080
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- Baja California Norte
  - Tijuana, Baja California Norte, Mexico, 22320
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- Estado de México
  - Toluca, Edo Mex, Estado de México, Mexico, 50180
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- Yucatán
  - Merida, Yucatán, Mexico, 97500
    - Novartis Investigative Site
New Zealand
- - Christchurch, New Zealand, 8001
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  - Dunedin, New Zealand, 9001
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  - Newtown, Wellington, New Zealand, 6002
    - Novartis Investigative Site
Peru
- - Lima, Peru, Lima 13
    - Novartis Investigative Site
  - Lima, Peru, Lima 34
    - Novartis Investigative Site
Polen
- - Bialystok, Polen, 15-027
    - Novartis Investigative Site
  - Bydgoszcz, Polen, 85-796
    - Novartis Investigative Site
  - Elblag, Polen, 82-300
    - Novartis Investigative Site
  - Gdansk, Polen, 80-210
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  - Gliwice, Polen, 44-101
    - Novartis Investigative Site
  - Olsztyn, Polen, 10-226
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  - Olsztyn, Polen, 10-228
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  - Poznan, Polen, 61-866
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  - Warszawa, Polen, 02-781
    - Novartis Investigative Site
Portugal
- - Evora, Portugal, 7000-811
    - Novartis Investigative Site
  - Lisboa, Portugal, 1099-023
    - Novartis Investigative Site
  - Lisboa, Portugal, 1649-028
    - Novartis Investigative Site
  - Porto, Portugal, 4200-319
    - Novartis Investigative Site
  - Porto, Portugal, 4200-072 Porto
    - Novartis Investigative Site
Rumænien
- - Bucharest, Rumænien, 050098
    - Novartis Investigative Site
  - Iasi, Rumænien, 700106
    - Novartis Investigative Site
  - Sibiu, Rumænien, 550245
    - Novartis Investigative Site
  - Timisoara, Rumænien, 300239
    - Novartis Investigative Site
Schweiz
- - Basel, Schweiz, 4031
    - Novartis Investigative Site
  - Bern, Schweiz, 3010
    - Novartis Investigative Site
  - Chur, Schweiz, 7000
    - Novartis Investigative Site
  - Geneve, Schweiz, CH 1211
    - Novartis Investigative Site
  - Mendrisio, Schweiz, 6850
    - Novartis Investigative Site
  - Neuchatel, Schweiz, 2002
    - Novartis Investigative Site
  - St Gallen, Schweiz, 9007
    - Novartis Investigative Site
  - Zuerich, Schweiz, 8091
    - Novartis Investigative Site
Singapore
- - Singapore, Singapore, 169610
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  - Singapore, Singapore, 119074
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  - Singapore, Singapore, 308433
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  - Singapore, Singapore, 258500
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  - Singapore, Singapore, 258499
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Slovakiet
- - Banska Bystrica, Slovakiet, 975 17
    - Novartis Investigative Site
  - Bratislava, Slovakiet, 812 50
    - Novartis Investigative Site
  - Bratislava, Slovakiet, 833 10
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  - Kosice, Slovakiet, 041 90
    - Novartis Investigative Site
  - Poprad, Slovakiet, 058 01
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Slovenien
- - Ljubljana, Slovenien, 1000
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  - Maribor, Slovenien, 2000
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Spanien
- - Barcelona, Spanien, 08035
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  - Barcelona, Spanien, 08003
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  - Barcelona, Spanien, 08907
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  - Basurto/Bilbao, Spanien, 48013
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  - Girona, Spanien, 17007
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  - Madrid, Spanien, 28046
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  - Madrid, Spanien, 28007
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Sverige
- - Jonkoping, Sverige, SE 55185
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  - Lund, Sverige, SE-221 85
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  - Stockholm, Sverige, SE-171 76
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Taiwan
- - Kaohsiung, Taiwan, 807
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Thailand
- - Bangkok, Thailand, 10330
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  - Bangkok, Thailand, 10110
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Tjekkiet
- - Brno, Tjekkiet, 656 53
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Tyskland
- - Berlin, Tyskland, 13125
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- Baden-Wuerttemberg
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- Hessen
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- Nordrhein-Westfalen
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  - Vienna, Østrig, 1180
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Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inklusionskriterier:

Kan tidligere have modtaget lapatinib i et andet forsøg. Tidligere capecitabin (som tidligere middel eller ikke-lapatinibholdigt regime) er også tilladt.
Forudgående behandling med hormonbehandling er tilladt.
Skal have fremskreden eller metastatisk brystkræft med progression (som vurderet ved modificeret RECIST) efter forudgående behandling, som skal omfatte alt af følgende: forudgående behandling med en antracyklin, en taxan og trastuzumab alene eller i kombination med anden behandling. Trastuzumab skal have været administreret i adjuvans eller lokalt fremskreden eller metastatisk indstilling.
Skal have tumorer, der overudtrykker ErbB2 defineret som +3 af IHC eller FISH-positive for ErbB2-genamplifikation. Status for ErbB2-ekspression skal dokumenteres før studiestart.
Skal være >/= 18 år
Forventet levetid på > 8 uger
Skal være kommet sig over bivirkninger fra tidligere behandling
Patienter med CNS-mets er kvalificerede, forudsat at behandling med forbudte medicin som anført i protokollen ikke er påkrævet
Hjerteudstødningsfraktion skal være inden for det institutionelle område af normalt målt med ECHO. MUGA-scanninger er tilladt, hvis ECHO'er ikke kan udføres
I stand til at sluge og beholde oral medicin
Skal have tilstrækkelig hæmatologisk, lever- og nyrefunktion

Ekskluderingskriterier:

Drægtige eller ammende hunner
Malabsorptionssyndrom, sygdom, der signifikant påvirker GI-funktionen, eller resektion af mave eller tarm, eller colitis ulcerosa
Samtidig sygdom eller tilstand, der ville gøre patienten uegnet til undersøgelsesdeltagelse
Uafklaret eller ustabil toksicitet fra tidligere administration af et andet forsøgslægemiddel og/eller tidligere cancerbehandling
Ukontrolleret infektion
Aktiv hjertesygdom defineret som historie med ukontrolleret eller symptomatisk angina; historie med arytmier, der kræver medicin, eller klinisk signifikante, med undtagelse af asymptomatisk atrieflimren, der kræver antikoagulering; MI < 6 måneder fra studiestart; ukontrolleret eller symptomatisk CHF; udstødningsfraktion under den institutionelle normalgrænse; enhver anden hjertelidelse, der ville gøre denne protokol urimelig farlig for patienten
Modtagelse af samtidig kemoterapi (bortset fra capecitabin), strålebehandling, immunterapi, biologisk terapi eller hormonbehandling mod kræft. Samtidig behandling med bisfosfonater er tilladt
Anamnese med allergisk reaktion tilskrevet forbindelser med lignende sammensætning som lapatinib eller andre hjælpestoffer
Anamnese med allergiske reaktioner tilskrevet forbindelser med lignende kemisk sammensætning som capecitabin, fluorouracil eller hjælpestoffer
Kendt DPD-mangel

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novartis

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2006

Primær færdiggørelse (Faktiske)

1. marts 2015

Studieafslutning (Faktiske)

1. marts 2015

Datoer for studieregistrering

Først indsendt

16. juni 2006

Først indsendt, der opfyldte QC-kriterier

16. juni 2006

Først opslået (Skøn)

20. juni 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. april 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. april 2016

Sidst verificeret

1. april 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

EGF103659

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .