EAP (Expanded Access Protocol) Of Lapatinib Combined With Capecitabine In Metastatic Breast Cancer

April 4, 2016 updated by: Novartis

An Open-Label Expanded Access Study of Lapatinib and Capecitabine Therapy in Subjects With ErbB2 Overexpressing Locally Advanced or Metastatic Breast Cancer

This study will provide pre-approval drug access to lapatinib, in combination with capecitabine, to patients whose breast cancer had progressed on other therapies

Study Overview

Status

Approved for marketing

Conditions

Neoplasms, Breast

Intervention / Treatment

Drug: lapatinib + capecitabine

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- New South Wales
  - Kogarah, New South Wales, Australia, 2217
    - Novartis Investigative Site
  - North Sydney, New South Wales, Australia, 2060
    - Novartis Investigative Site
  - Port Macquarie, New South Wales, Australia, 2444
    - Novartis Investigative Site
  - Waratah, New South Wales, Australia, 2298
    - Novartis Investigative Site
  - Westmead, New South Wales, Australia, 2145
    - Novartis Investigative Site
- Queensland
  - Herston, Queensland, Australia, 4029
    - Novartis Investigative Site
  - South Brisbane, Queensland, Australia, 4101
    - Novartis Investigative Site
- South Australia
  - Bedford Park, South Australia, Australia, 5042
    - Novartis Investigative Site
- Tasmania
  - Hobart, Tasmania, Australia, 7000
    - Novartis Investigative Site
- Victoria
  - Box Hill, Victoria, Australia, 3128
    - Novartis Investigative Site
  - Fitzroy, Victoria, Australia, 3065
    - Novartis Investigative Site
  - Geelong, Victoria, Australia, 3220
    - Novartis Investigative Site
  - Wodonga, Victoria, Australia, 3690
    - Novartis Investigative Site
- Western Australia
  - Nedlands, Western Australia, Australia, 6009
    - Novartis Investigative Site
  - Perth, Western Australia, Australia, 6000
    - Novartis Investigative Site
Austria
- - Graz, Austria, A-8036
    - Novartis Investigative Site
  - Innsbruck, Austria, 6020
    - Novartis Investigative Site
  - Linz, Austria, A-4020
    - Novartis Investigative Site
  - Linz, Austria
    - Novartis Investigative Site
  - Salzburg, Austria, A-5020
    - Novartis Investigative Site
  - Vienna, Austria, 1180
    - Novartis Investigative Site
Belgium
- - Brussel, Belgium, 1090
    - Novartis Investigative Site
  - Bruxelles, Belgium, 1200
    - Novartis Investigative Site
  - Bruxelles, Belgium, 1000
    - Novartis Investigative Site
  - Charleroi, Belgium, 6000
    - Novartis Investigative Site
  - Edegem, Belgium, 2650
    - Novartis Investigative Site
  - Gent, Belgium, 9000
    - Novartis Investigative Site
  - Haine Saint Paul, Belgium, 7100
    - Novartis Investigative Site
  - Leuven, Belgium, 3000
    - Novartis Investigative Site
  - Liège, Belgium, 4000
    - Novartis Investigative Site
  - Wilrijk, Belgium, 2610
    - Novartis Investigative Site
  - Yvoir, Belgium, 5530
    - Novartis Investigative Site
Brazil
- - Rio de Janeiro, Brazil, 21941-913
    - Novartis Investigative Site
  - Rio de Janeiro, Brazil, 20260-020
    - Novartis Investigative Site
  - São Paulo, Brazil, 05651-901
    - Novartis Investigative Site
- Bahía
  - Salvador, Bahía, Brazil, 40170-070
    - Novartis Investigative Site
- Rio Grande Do Sul
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
    - Novartis Investigative Site
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170
    - Novartis Investigative Site
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90610 000
    - Novartis Investigative Site
- São Paulo
  - Jau, São Paulo, Brazil, 17210-080
    - Novartis Investigative Site
Bulgaria
- - Sofia, Bulgaria, 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
China
- - Beijing, China, 100021
    - Novartis Investigative Site
  - Beijing, China, 100071
    - Novartis Investigative Site
  - Shanghai, China, 200080
    - Novartis Investigative Site
  - Shanghai, China, 200032
    - Novartis Investigative Site
  - Tianjin, China, 300060
    - Novartis Investigative Site
- Guangdong
  - Guangzhou, Guangdong, China, 510515
    - Novartis Investigative Site
- Hubei
  - Wuhan, Hubei, China, 430030
    - Novartis Investigative Site
- Jiangsu
  - Nanjing, Jiangsu, China, 210009
    - Novartis Investigative Site
- Liaoning
  - Dalian, Liaoning, China, 116011
    - Novartis Investigative Site
- Zhejiang
  - Hangzhou, Zhejiang, China, 310022
    - Novartis Investigative Site
Cyprus
- - Strovolos, Cyprus, 2006
    - Novartis Investigative Site
Czech Republic
- - Brno, Czech Republic, 656 53
    - Novartis Investigative Site
  - Olomouc, Czech Republic, 775 20
    - Novartis Investigative Site
  - Praha, Czech Republic, 140 59
    - Novartis Investigative Site
  - Praha, Czech Republic, 150 08
    - Novartis Investigative Site
Denmark
- - Copenhagen, Denmark, DK- 2100
    - Novartis Investigative Site
  - Odense C, Denmark, 5000
    - Novartis Investigative Site
  - Roskilde, Denmark, DK-4000
    - Novartis Investigative Site
  - Vejle, Denmark, 7100
    - Novartis Investigative Site
  - Århus C, Denmark, 8000
    - Novartis Investigative Site
Estonia
- - Tallinn, Estonia, 13419
    - Novartis Investigative Site
  - Tartu, Estonia, 51003
    - 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
Germany
- - Berlin, Germany, 13125
    - Novartis Investigative Site
  - Hamburg, Germany, 20249
    - Novartis Investigative Site
- Baden-Wuerttemberg
  - Mannheim, Baden-Wuerttemberg, Germany, 68161
    - Novartis Investigative Site
  - Stuttgart, Baden-Wuerttemberg, Germany, 70176
    - Novartis Investigative Site
  - Tuebingen, Baden-Wuerttemberg, Germany, 72076
    - Novartis Investigative Site
- Bayern
  - Augsburg, Bayern, Germany, 86150
    - Novartis Investigative Site
- Hessen
  - Marburg, Hessen, Germany, 35043
    - Novartis Investigative Site
  - Wiesbaden, Hessen, Germany, 65199
    - Novartis Investigative Site
- Niedersachsen
  - Braunschweig, Niedersachsen, Germany, 38114
    - Novartis Investigative Site
  - Hannover, Niedersachsen, Germany, 30559
    - Novartis Investigative Site
- Nordrhein-Westfalen
  - Bonn, Nordrhein-Westfalen, Germany, 53113
    - Novartis Investigative Site
  - Duesseldorf, Nordrhein-Westfalen, Germany, 40479
    - Novartis Investigative Site
  - Ibbenbueren, Nordrhein-Westfalen, Germany, 49477
    - Novartis Investigative Site
  - Koeln, Nordrhein-Westfalen, Germany, 50931
    - Novartis Investigative Site
  - Moenchengladbach, Nordrhein-Westfalen, Germany, 41061
    - Novartis Investigative Site
  - Troisdorf, Nordrhein-Westfalen, Germany, 53840
    - Novartis Investigative Site
- Rheinland-Pfalz
  - Mainz, Rheinland-Pfalz, Germany, 55131
    - Novartis Investigative Site
- Saarland
  - Saarbruecken, Saarland, Germany, 66113
    - Novartis Investigative Site
- Sachsen-Anhalt
  - Halle, Sachsen-Anhalt, Germany, 06120
    - Novartis Investigative Site
  - Magdeburg, Sachsen-Anhalt, Germany, 39108
    - Novartis Investigative Site
- Schleswig-Holstein
  - Luebeck, Schleswig-Holstein, Germany, 23538
    - Novartis Investigative Site
Greece
- - Athens, Greece, 115 28
    - Novartis Investigative Site
  - Heraklion, Crete, Greece, 71201
    - Novartis Investigative Site
  - Maroussi, Greece, 15123
    - Novartis Investigative Site
Hong Kong
- - Pokfulam, Hong Kong
    - Novartis Investigative Site
  - Shatin, Hong Kong
    - Novartis Investigative Site
Iceland
- - Reykjavik, Iceland, 101
    - Novartis Investigative Site
Indonesia
- - Jakarta, Indonesia, 10430
    - Novartis Investigative Site
Ireland
- - Dublin, Ireland, 7
    - Novartis Investigative Site
  - Dublin, Ireland, 8
    - Novartis Investigative Site
  - Dublin, Ireland, 4
    - Novartis Investigative Site
  - Galway, Ireland
    - Novartis Investigative Site
  - Tallaght, Dublin, Ireland, 24
    - Novartis Investigative Site
  - Wilton, Cork, Ireland
    - 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
Italy
- - Ancona, Italy, 60020
    - Novartis Investigative Site
  - Cagliari, Italy, 09127
    - Novartis Investigative Site
  - Chieti, Italy, 66100
    - Novartis Investigative Site
  - Macerata, Italy
    - Novartis Investigative Site
  - Padova, Italy, 35128
    - Novartis Investigative Site
  - Trieste, Italy, 34100
    - Novartis Investigative Site
- Basilicata
  - Potenza, Basilicata, Italy, 85100
    - Novartis Investigative Site
- Calabria
  - Reggio Calabria, Calabria, Italy, 89100
    - Novartis Investigative Site
- Campania
  - Napoli, Campania, Italy, 80131
    - Novartis Investigative Site
- Emilia-Romagna
  - Forlì, Emilia-Romagna, Italy, 47100
    - Novartis Investigative Site
  - Modena, Emilia-Romagna, Italy, 41100
    - Novartis Investigative Site
- Friuli-Venezia-Giulia
  - Aviano (PN), Friuli-Venezia-Giulia, Italy, 33081
    - Novartis Investigative Site
- Lazio
  - Roma, Lazio, Italy, 00144
    - Novartis Investigative Site
- Liguria
  - Genova, Liguria, Italy, 16132
    - Novartis Investigative Site
- Lombardia
  - Bergamo, Lombardia, Italy, 24128
    - Novartis Investigative Site
  - Milano, Lombardia, Italy, 20133
    - Novartis Investigative Site
  - Milano, Lombardia, Italy, 20141
    - Novartis Investigative Site
- Piemonte
  - Candiolo (TO), Piemonte, Italy, 10060
    - Novartis Investigative Site
  - Torino, Piemonte, Italy, 10126
    - Novartis Investigative Site
- Puglia
  - Bari, Puglia, Italy, 70126
    - Novartis Investigative Site
  - San Giovanni Rotondo (FG), Puglia, Italy, 71013
    - Novartis Investigative Site
- Sicilia
  - Palermo, Sicilia, Italy, 90127
    - Novartis Investigative Site
- Toscana
  - Firenze, Toscana, Italy, 50134
    - Novartis Investigative Site
  - Pisa, Toscana, Italy, 56126
    - Novartis Investigative Site
- Trentino-Alto Adige
  - Bolzano, Trentino-Alto Adige, Italy, 39100
    - Novartis Investigative Site
- Umbria
  - Perugia, Umbria, Italy, 06156
    - Novartis Investigative Site
Korea, Republic of
- - Kyunggi-do, Korea, Republic of, 410-769
    - Novartis Investigative Site
  - Pusan, Korea, Republic of, 602-739
    - Novartis Investigative Site
  - Seoul, Korea, Republic of, 138-736
    - Novartis Investigative Site
  - Seoul, Korea, Republic of, 135-710
    - Novartis Investigative Site
  - seodaemun-gu, Seoul, Korea, Republic of, 120-752
    - Novartis Investigative Site
  - songpa-gu, Seoul, Korea, Republic of, 138-736
    - Novartis Investigative Site
Luxembourg
- - Luxembourg, Luxembourg, 1210
    - Novartis Investigative Site
Malaysia
- - Kuala Lumpur, Malaysia, 59100
    - Novartis Investigative Site
  - Kuala Lumpur, Malaysia, 50450
    - Novartis Investigative Site
  - Petaling Jaya Selangor, Malaysia, 47000
    - Novartis Investigative Site
Malta
- - Floriana, Malta, VLT 14
    - Novartis Investigative Site
Mexico
- - Durango, Mexico, 34079
    - Novartis Investigative Site
  - Mexico City, Mexico, CP 14080
    - Novartis Investigative Site
- Baja California Norte
  - Tijuana, Baja California Norte, Mexico, 22320
    - Novartis Investigative Site
- Estado de México
  - Toluca, Edo Mex, Estado de México, Mexico, 50180
    - Novartis Investigative Site
- Yucatán
  - Merida, Yucatán, Mexico, 97500
    - Novartis Investigative Site
Netherlands
- - Amersfoort, Netherlands, 3818 ES
    - Novartis Investigative Site
  - Amsterdam, Netherlands, 1066 CX
    - Novartis Investigative Site
  - Amsterdam, Netherlands, 1081 HV
    - Novartis Investigative Site
  - Dordrecht, Netherlands, 3318 AT
    - Novartis Investigative Site
  - Enschede, Netherlands, 7511JX
    - Novartis Investigative Site
  - Groningen, Netherlands, 9713 GZ
    - Novartis Investigative Site
  - Leeuwarden, Netherlands, 8934 AD
    - Novartis Investigative Site
  - Leiden, Netherlands, 2333 ZA
    - Novartis Investigative Site
  - Maastricht, Netherlands, 6229 HX
    - Novartis Investigative Site
New Zealand
- - Christchurch, New Zealand, 8001
    - Novartis Investigative Site
  - Dunedin, New Zealand, 9001
    - Novartis Investigative Site
  - Newtown, Wellington, New Zealand, 6002
    - Novartis Investigative Site
Peru
- - Lima, Peru, Lima 13
    - Novartis Investigative Site
  - Lima, Peru, Lima 34
    - Novartis Investigative Site
Philippines
- - Makati City, Philippines, 1200
    - Novartis Investigative Site
  - Pasay City, Philippines, 1300
    - Novartis Investigative Site
  - Quezon City, Philippines, 1102
    - Novartis Investigative Site
  - Sampaloc Manila, Philippines, 1008
    - Novartis Investigative Site
Poland
- - Bialystok, Poland, 15-027
    - Novartis Investigative Site
  - Bydgoszcz, Poland, 85-796
    - Novartis Investigative Site
  - Elblag, Poland, 82-300
    - Novartis Investigative Site
  - Gdansk, Poland, 80-210
    - Novartis Investigative Site
  - Gliwice, Poland, 44-101
    - Novartis Investigative Site
  - Olsztyn, Poland, 10-226
    - Novartis Investigative Site
  - Olsztyn, Poland, 10-228
    - Novartis Investigative Site
  - Poznan, Poland, 61-866
    - Novartis Investigative Site
  - Warszawa, Poland, 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
Romania
- - Bucharest, Romania, 050098
    - Novartis Investigative Site
  - Iasi, Romania, 700106
    - Novartis Investigative Site
  - Sibiu, Romania, 550245
    - Novartis Investigative Site
  - Timisoara, Romania, 300239
    - Novartis Investigative Site
Russian Federation
- - Irkutsk, Russian Federation, 664035
    - Novartis Investigative Site
  - Moscow, Russian Federation, 115478
    - Novartis Investigative Site
  - Nizhny Novgorod, Russian Federation, 603126
    - Novartis Investigative Site
Singapore
- - Singapore, Singapore, 169610
    - Novartis Investigative Site
  - Singapore, Singapore, 119074
    - Novartis Investigative Site
  - Singapore, Singapore, 308433
    - Novartis Investigative Site
  - Singapore, Singapore, 258500
    - Novartis Investigative Site
  - Singapore, Singapore, 258499
    - Novartis Investigative Site
Slovakia
- - Banska Bystrica, Slovakia, 975 17
    - Novartis Investigative Site
  - Bratislava, Slovakia, 812 50
    - Novartis Investigative Site
  - Bratislava, Slovakia, 833 10
    - Novartis Investigative Site
  - Kosice, Slovakia, 041 90
    - Novartis Investigative Site
  - Poprad, Slovakia, 058 01
    - Novartis Investigative Site
Slovenia
- - Ljubljana, Slovenia, 1000
    - Novartis Investigative Site
  - Maribor, Slovenia, 2000
    - Novartis Investigative Site
Spain
- - Barcelona, Spain, 08035
    - Novartis Investigative Site
  - Barcelona, Spain, 08003
    - Novartis Investigative Site
  - Barcelona, Spain, 08907
    - Novartis Investigative Site
  - Basurto/Bilbao, Spain, 48013
    - Novartis Investigative Site
  - Burgos, Spain, 09005
    - Novartis Investigative Site
  - Caceres, Spain, 10003
    - Novartis Investigative Site
  - Elche, Spain, 03203
    - Novartis Investigative Site
  - Girona, Spain, 17007
    - Novartis Investigative Site
  - Jaén, Spain, 23007
    - Novartis Investigative Site
  - Lerida, Spain, 25198
    - Novartis Investigative Site
  - Madrid, Spain, 28041
    - Novartis Investigative Site
  - Madrid, Spain, 28046
    - Novartis Investigative Site
  - Madrid, Spain, 28007
    - Novartis Investigative Site
  - Malaga, Spain, 29020
    - Novartis Investigative Site
  - Murcia, Spain, 30120
    - Novartis Investigative Site
  - Palencia, Spain, 34005
    - Novartis Investigative Site
  - Palma de Mallorca, Spain, 07014
    - Novartis Investigative Site
  - Pamplona, Spain, 31008
    - Novartis Investigative Site
  - Pontevedra, Spain, 36071
    - Novartis Investigative Site
  - San Sebastián, Spain, 20014
    - Novartis Investigative Site
  - Santa Cruz de Tenerife, Spain, 38320
    - Novartis Investigative Site
  - Santiago, Spain, 15705
    - Novartis Investigative Site
  - Toledo, Spain, 45004
    - Novartis Investigative Site
  - Valencia, Spain, 46009
    - Novartis Investigative Site
  - Valencia, Spain, 46010
    - Novartis Investigative Site
  - Zaragoza, Spain, 50009
    - Novartis Investigative Site
Sweden
- - Jonkoping, Sweden, SE 55185
    - Novartis Investigative Site
  - Lund, Sweden, SE-221 85
    - Novartis Investigative Site
  - Stockholm, Sweden, SE-171 76
    - Novartis Investigative Site
  - Umeå, Sweden, SE-901 85
    - Novartis Investigative Site
  - Uppsala, Sweden, SE-751 85
    - Novartis Investigative Site
Switzerland
- - Basel, Switzerland, 4031
    - Novartis Investigative Site
  - Bern, Switzerland, 3010
    - Novartis Investigative Site
  - Chur, Switzerland, 7000
    - Novartis Investigative Site
  - Geneve, Switzerland, CH 1211
    - Novartis Investigative Site
  - Mendrisio, Switzerland, 6850
    - Novartis Investigative Site
  - Neuchatel, Switzerland, 2002
    - Novartis Investigative Site
  - St Gallen, Switzerland, 9007
    - Novartis Investigative Site
  - Zuerich, Switzerland, 8091
    - Novartis Investigative Site
Taiwan
- - Kaohsiung, Taiwan, 807
    - Novartis Investigative Site
  - Taichung, Taiwan, 407
    - Novartis Investigative Site
  - Tainan, Taiwan, 704
    - Novartis Investigative Site
  - Tainan County, Taiwan, 736
    - Novartis Investigative Site
  - Taipei, Taiwan, 100
    - Novartis Investigative Site
  - Taipei, Taiwan, 104
    - Novartis Investigative Site
  - Taipei, Taiwan, 105
    - Novartis Investigative Site
  - Taipei, Taiwan, 112
    - Novartis Investigative Site
  - Taipei, Taiwan, 114
    - Novartis Investigative Site
  - Taipei, Taiwan, 110
    - Novartis Investigative Site
Thailand
- - Bangkok, Thailand, 10330
    - Novartis Investigative Site
  - Bangkok, Thailand, 10110
    - Novartis Investigative Site
  - Chiang Mai, Thailand, 50200
    - Novartis Investigative Site
  - Pathumthani, Thailand, 12110
    - Novartis Investigative Site
Ukraine
- - Chernivtsi, Ukraine, 58013
    - Novartis Investigative Site
  - Kiev, Ukraine, 03115
    - Novartis Investigative Site
  - Odessa, Ukraine, 65055
    - Novartis Investigative Site
  - Rovno, Ukraine, 33010
    - Novartis Investigative Site
United Kingdom
- - Belfast, United Kingdom, BT9 7AB
    - Novartis Investigative Site
  - Bournemouth, United Kingdom, BH7 7DW
    - Novartis Investigative Site
  - Brighton, United Kingdom, BN2 5BE
    - Novartis Investigative Site
  - Bristol, United Kingdom, BS2 8HW
    - Novartis Investigative Site
  - Cardiff, United Kingdom, CF14 2TL
    - Novartis Investigative Site
  - Cheltenham, United Kingdom, GL53 7AN
    - Novartis Investigative Site
  - Colchester, United Kingdom, CO3 3NB
    - Novartis Investigative Site
  - Cumbria, United Kingdom, CA2 7HY
    - Novartis Investigative Site
  - Denbighshire, United Kingdom, LL 18 5UJ
    - Novartis Investigative Site
  - Hartshill, Stoke-on-Trent, United Kingdom, ST4 7LN
    - Novartis Investigative Site
  - Lindley, huddersfield, United Kingdom, HD3 3EA
    - Novartis Investigative Site
  - London, United Kingdom, SE1 9RT
    - Novartis Investigative Site
  - London, United Kingdom, SW3 6JJ
    - Novartis Investigative Site
  - London, United Kingdom, NW3 2QG
    - Novartis Investigative Site
  - London, United Kingdom, EC1A 7BE
    - Novartis Investigative Site
  - London, United Kingdom, NW1 2PG
    - Novartis Investigative Site
  - London, United Kingdom, W6 8RF
    - Novartis Investigative Site
  - Manchester, United Kingdom, M20 4BX
    - Novartis Investigative Site
  - Nottingham, United Kingdom, NG5 1PB
    - Novartis Investigative Site
  - Peterborough, United Kingdom, PE3 6DA
    - Novartis Investigative Site
  - Poole, Dorset, United Kingdom, BH15 2JB
    - Novartis Investigative Site
  - Portsmouth, United Kingdom, PO3 6AD
    - Novartis Investigative Site
  - Shrewsbury, United Kingdom, SY3 8XQ
    - Novartis Investigative Site
- Cambridgeshire
  - Cambridge, Cambridgeshire, United Kingdom, CB2 2GG
    - Novartis Investigative Site
- Essex
  - Chelmsford, Essex, United Kingdom, CM1 7ET
    - Novartis Investigative Site
- Middlesex
  - Northwood, Middlesex, United Kingdom, HA6 2RN
    - Novartis Investigative Site
- Midlothian
  - Edinburgh, Midlothian, United Kingdom, EH4 2XU
    - Novartis Investigative Site
United States
- Alabama
  - Huntsville, Alabama, United States, 35805
    - Novartis Investigative Site
- Alaska
  - Anchorage, Alaska, United States, 99508
    - Novartis Investigative Site
- Arizona
  - Glendale, Arizona, United States, 85304
    - Novartis Investigative Site
- Arkansas
  - Fayetteville, Arkansas, United States, 72703
    - Novartis Investigative Site
  - Little Rock, Arkansas, United States, 72205
    - Novartis Investigative Site
- California
  - Bellflower, California, United States, 90706
    - Novartis Investigative Site
  - Burbank, California, United States, 91505-4866
    - Novartis Investigative Site
  - Gilroy, California, United States, 95020
    - Novartis Investigative Site
  - Long Beach, California, United States, 90806
    - Novartis Investigative Site
  - Long Beach, California, United States, 90813
    - Novartis Investigative Site
  - Newport Beach, California, United States, 92663
    - Novartis Investigative Site
  - San Diego, California, United States, 92123
    - Novartis Investigative Site
  - San Francisco, California, United States, 94115-1710
    - Novartis Investigative Site
  - Santa Rosa, California, United States, 95403-1757
    - Novartis Investigative Site
  - Stockton, California, United States, 95204
    - Novartis Investigative Site
- Colorado
  - Aurora, Colorado, United States, 80010
    - Novartis Investigative Site
  - Boulder, Colorado, United States, 80304
    - Novartis Investigative Site
  - Lafayette, Colorado, United States, 80026
    - Novartis Investigative Site
- Connecticut
  - Hartford, Connecticut, United States, 06105
    - Novartis Investigative Site
  - Manchester, Connecticut, United States, 06040
    - Novartis Investigative Site
  - New Havey, Connecticut, United States, 06511
    - Novartis Investigative Site
  - Norwich, Connecticut, United States, 06360
    - Novartis Investigative Site
- District of Columbia
  - Washington, District of Columbia, United States, 20007
    - Novartis Investigative Site
- Florida
  - Fort Lauderdale, Florida, United States, 33328
    - Novartis Investigative Site
  - Fort Myers, Florida, United States, 33916
    - Novartis Investigative Site
  - Fort Walton Beach, Florida, United States, 32547
    - Novartis Investigative Site
  - Gainesville, Florida, United States, 32605
    - Novartis Investigative Site
  - Hollywood, Florida, United States, 33021
    - Novartis Investigative Site
  - Jacksonville, Florida, United States, 32256
    - Novartis Investigative Site
  - Miami, Florida, United States, 33133
    - Novartis Investigative Site
  - Orlando, Florida, United States, 32806
    - Novartis Investigative Site
  - Orlando, Florida, United States, 32804
    - Novartis Investigative Site
  - Tampa, Florida, United States, 33607
    - Novartis Investigative Site
- Georgia
  - Augusta, Georgia, United States, 30901
    - Novartis Investigative Site
  - Brunswick, Georgia, United States, 31525
    - Novartis Investigative Site
  - Macon, Georgia, United States, 31201
    - Novartis Investigative Site
  - Marietta, Georgia, United States, 30060
    - Novartis Investigative Site
  - Tucker, Georgia, United States, 30084
    - Novartis Investigative Site
- Hawaii
  - Honolulu, Hawaii, United States, 96813
    - Novartis Investigative Site
- Idaho
  - Boise, Idaho, United States, 83712
    - Novartis Investigative Site
- Illinois
  - Chicago, Illinois, United States, 60637
    - Novartis Investigative Site
  - Decatur, Illinois, United States, 62526
    - Novartis Investigative Site
  - Galesburg, Illinois, United States, 61401
    - Novartis Investigative Site
  - Highland Park, Illinois, United States, 60035
    - Novartis Investigative Site
  - Joliet, Illinois, United States, 60435
    - Novartis Investigative Site
  - Peoria, Illinois, United States, 61615
    - Novartis Investigative Site
  - Zion, Illinois, United States, 60099
    - Novartis Investigative Site
- Indiana
  - Indianapolis, Indiana, United States, 46202
    - Novartis Investigative Site
- Iowa
  - Bettendorf, Iowa, United States, 52722
    - Novartis Investigative Site
  - Cedar Rapids, Iowa, United States, 52403
    - Novartis Investigative Site
  - Council Bluffs, Iowa, United States, 51503
    - Novartis Investigative Site
  - Sioux City, Iowa, United States, 51101-1733
    - Novartis Investigative Site
  - Waterloo, Iowa, United States, 50702
    - Novartis Investigative Site
- Louisiana
  - Baton Rouge, Louisiana, United States, 70809
    - Novartis Investigative Site
  - Metairie, Louisiana, United States, 70006
    - Novartis Investigative Site
- Maine
  - Portland, Maine, United States, 04101
    - Novartis Investigative Site
  - Scarborough, Maine, United States, 04074
    - Novartis Investigative Site
  - Waterville, Maine, United States, 04901
    - Novartis Investigative Site
- Maryland
  - Baltimore, Maryland, United States, 21237
    - Novartis Investigative Site
  - Baltimore, Maryland, United States, 21231-1000
    - Novartis Investigative Site
  - Chevy Chase, Maryland, United States, 20815
    - Novartis Investigative Site
  - Frederick, Maryland, United States, 21701
    - Novartis Investigative Site
- Massachusetts
  - Boston, Massachusetts, United States, 02111
    - Novartis Investigative Site
  - Boston, Massachusetts, United States, 02118
    - Novartis Investigative Site
  - Fall River, Massachusetts, United States, 02721
    - Novartis Investigative Site
  - Peabody, Massachusetts, United States, 01960
    - Novartis Investigative Site
- Michigan
  - Ann Arbor, Michigan, United States, 48106
    - Novartis Investigative Site
  - Detroit, Michigan, United States, 48202
    - Novartis Investigative Site
  - Royal Oak, Michigan, United States, 48073
    - Novartis Investigative Site
  - Troy, Michigan, United States, 48085
    - Novartis Investigative Site
- Minnesota
  - Duluth, Minnesota, United States, 55802
    - Novartis Investigative Site
- Mississippi
  - Jackson, Mississippi, United States, 39202
    - Novartis Investigative Site
- Missouri
  - Columbia, Missouri, United States, 65201
    - Novartis Investigative Site
  - Kalamazoo, Missouri, United States, 49007
    - Novartis Investigative Site
  - Kansas City, Missouri, United States, 64118
    - Novartis Investigative Site
  - Springfield, Missouri, United States, 65807
    - Novartis Investigative Site
  - St. Louis, Missouri, United States, 63141
    - Novartis Investigative Site
  - St. Louis, Missouri, United States, 63110
    - Novartis Investigative Site
- Montana
  - Billings, Montana, United States, 59101
    - Novartis Investigative Site
  - Great Falls, Montana, United States, 59405
    - Novartis Investigative Site
- Nebraska
  - Grand Island, Nebraska, United States, 68803
    - Novartis Investigative Site
  - Lincoln, Nebraska, United States, 68510
    - Novartis Investigative Site
  - North Platte, Nebraska, United States, 69103
    - Novartis Investigative Site
  - Omaha, Nebraska, United States, 68114
    - Novartis Investigative Site
  - Omaha, Nebraska, United States, 68124-2346
    - Novartis Investigative Site
- Nevada
  - Las Vegas, Nevada, United States, 89102
    - Novartis Investigative Site
- New Hampshire
  - Exeter, New Hampshire, United States, 03833
    - Novartis Investigative Site
- New Jersey
  - Flemington, New Jersey, United States, 08822
    - Novartis Investigative Site
  - Freehold, New Jersey, United States, 07728
    - Novartis Investigative Site
  - Little Silver, New Jersey, United States, 07739
    - Novartis Investigative Site
  - Livingston, New Jersey, United States, 07039
    - Novartis Investigative Site
  - Mountain Lakes, New Jersey, United States, 07046
    - Novartis Investigative Site
  - Newark, New Jersey, United States, 07112
    - Novartis Investigative Site
- New York
  - Buffalo, New York, United States, 14263
    - Novartis Investigative Site
  - Buffalo, New York, United States, 14221
    - Novartis Investigative Site
  - East Setauket, New York, United States, 11733
    - Novartis Investigative Site
  - East Syracuse, New York, United States, 13057
    - Novartis Investigative Site
  - Fresh Meadows, New York, United States, 11366
    - Novartis Investigative Site
  - Glens Falls, New York, United States, 12801
    - Novartis Investigative Site
  - New York, New York, United States, 10003
    - Novartis Investigative Site
  - New York, New York, United States, 10011
    - Novartis Investigative Site
  - New York, New York, United States, 10016
    - Novartis Investigative Site
  - New York, New York, United States, 10065
    - Novartis Investigative Site
- North Carolina
  - Asheville, North Carolina, United States, 28816
    - Novartis Investigative Site
  - Charlotte, North Carolina, United States, 28204
    - Novartis Investigative Site
  - Charlotte, North Carolina, United States, 28203
    - Novartis Investigative Site
  - Fayetteville, North Carolina, United States, 28304
    - Novartis Investigative Site
  - Greensboro, North Carolina, United States, 27403
    - Novartis Investigative Site
- North Dakota
  - Bismarck, North Dakota, United States, 58501
    - Novartis Investigative Site
  - Fargo, North Dakota, United States, 58122
    - Novartis Investigative Site
- Ohio
  - Cincinnati, Ohio, United States, 45242
    - Novartis Investigative Site
  - Cincinnati, Ohio, United States, 45219
    - Novartis Investigative Site
  - Cleveland, Ohio, United States, 44106
    - Novartis Investigative Site
  - Columbus, Ohio, United States, 43210
    - Novartis Investigative Site
  - Columbus, Ohio, United States, 39705
    - Novartis Investigative Site
  - Sandusky, Ohio, United States, 44870
    - Novartis Investigative Site
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73109
    - Novartis Investigative Site
  - Tulsa, Oklahoma, United States, 74133
    - Novartis Investigative Site
  - Tulsa, Oklahoma, United States, 74104
    - Novartis Investigative Site
- Oregon
  - Klamath Falls, Oregon, United States, 97601
    - Novartis Investigative Site
  - Portland, Oregon, United States, 97213
    - Novartis Investigative Site
- Pennsylvania
  - Drexel Hill, Pennsylvania, United States, 19026
    - Novartis Investigative Site
  - Philadelphia, Pennsylvania, United States, 19111
    - Novartis Investigative Site
  - Philadelphia, Pennsylvania, United States, 19104
    - Novartis Investigative Site
  - Philadelphia, Pennsylvania, United States, 19106
    - Novartis Investigative Site
  - Pittsburgh, Pennsylvania, United States, 15213
    - Novartis Investigative Site
  - Pittsburgh, Pennsylvania, United States, 15212-4772
    - Novartis Investigative Site
  - Pottstown, Pennsylvania, United States, 19464
    - Novartis Investigative Site
  - Sayre, Pennsylvania, United States, 18840
    - Novartis Investigative Site
  - State College, Pennsylvania, United States, 16803
    - Novartis Investigative Site
- South Carolina
  - Charleston, South Carolina, United States, 29403
    - Novartis Investigative Site
  - Columbia, South Carolina, United States, 29210
    - Novartis Investigative Site
  - Florence, South Carolina, United States, 29506
    - Novartis Investigative Site
  - Mt. Pleasant, South Carolina, United States, 29464
    - Novartis Investigative Site
- Tennessee
  - Knoxville, Tennessee, United States, 37916
    - Novartis Investigative Site
  - Memphis, Tennessee, United States, 38120
    - Novartis Investigative Site
  - Nashville, Tennessee, United States, 37203
    - Novartis Investigative Site
- Texas
  - Arlington, Texas, United States, 76012
    - Novartis Investigative Site
  - Austin, Texas, United States, 78759
    - Novartis Investigative Site
  - Austin, Texas, United States, 78731
    - Novartis Investigative Site
  - Dallas, Texas, United States, 75230
    - Novartis Investigative Site
  - Dallas, Texas, United States, 75246
    - Novartis Investigative Site
  - El Paso, Texas, United States, 79912
    - Novartis Investigative Site
  - Houston, Texas, United States, 77030
    - Novartis Investigative Site
  - Houston, Texas, United States, 77230-1439
    - Novartis Investigative Site
  - San Antonio, Texas, United States, 78207
    - Novartis Investigative Site
- Utah
  - Salt Lake City, Utah, United States, 84112-5550
    - Novartis Investigative Site
- Virginia
  - Fairfax, Virginia, United States, 22031
    - Novartis Investigative Site
  - Richmond, Virginia, United States, 23294
    - Novartis Investigative Site
  - Richmond, Virginia, United States, 23230
    - Novartis Investigative Site
- Washington
  - Kennewick, Washington, United States, 99336
    - Novartis Investigative Site
  - Mount Vernon, Washington, United States, 98273
    - Novartis Investigative Site
  - Seattle, Washington, United States, 98112
    - Novartis Investigative Site
  - Tacoma, Washington, United States, 98405
    - Novartis Investigative Site
  - Walla Walla, Washington, United States, 99362
    - Novartis Investigative Site
- West Virginia
  - Morgantown, West Virginia, United States, 26506
    - Novartis Investigative Site
- Wisconsin
  - Green Bay, Wisconsin, United States, 54311
    - Novartis Investigative Site
  - La Crosse, Wisconsin, United States, 54601
    - Novartis Investigative Site
  - Marshfield, Wisconsin, United States, 54449
    - Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion criteria:

May have received prior lapatinib in another trial. Previous capecitabine (as previous agent or non-lapatinib containing regimen) is also permitted.
Prior treatment with hormonal therapy is allowed.
Must have advanced or metastatic breast cancer with progression (as assessed by modified RECIST) after prior therapy, which must include all of the following: prior treatment with an anthracycline, a taxane, and trastuzumab alone or in combination with other therapy. Trastuzumab must have been administered in the adjuvant, or locally advanced or metastatic setting.
Must have tumors that overexpress ErbB2 defined as +3 by IHC or FISH positive for ErbB2 gene amplification. The status of ErbB2 expression must be documented prior to study entry.
Must be >/= 18 years of age
Life expectancy of > 8 weeks
Must have recovered from side effects of previous treatment
Patients with CNS mets are eligible provided treatment with prohibited medications as listed in the protocol are not required
Cardiac ejection fraction must be within the institutional range of normal as measured by ECHO. MUGA scans are allowed if ECHOs cannot be performed
Able to swallow and retain oral medications
Must have adequate hematologic, hepatic and renal function

Exclusion criteria:

Pregnant or lactating females
Malabsorption syndrome, disease significantly affecting GI function, or resection of the stomach or bowel, or ulcerative colitis
Concurrent disease or condition that would make the patient inappropriate for study participation
Unresolved or unstable toxicity from prior administration of another investigational drug and/or prior cancer treatment
Uncontrolled infection
Active cardiac disease defined as history of uncontrolled or symptomatic angina; history of arrhythmias requiring medication, or clinically significant, with the exception of asymptomatic atrial fibrillation requiring anticoagulation; MI < 6 months from study entry; uncontrolled or symptomatic CHF; ejection fraction below the institutional normal limit; any other cardiac condition that would make this protocol unreasonably hazardous for the patient
Receiving concurrent chemotherapy (other than capecitabine), radiation therapy, immunotherapy, biologic therapy or hormonal therapy for cancer. Concurrent therapy with bisphosphonates is allowed
History of allergic reaction attributed to compounds of similar composition to lapatinib or any excipients
History of allergic reactions attributed to compounds of similar chemical composition to capecitabine, fluorouracil or excipients
Known DPD deficiency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

June 16, 2006

First Submitted That Met QC Criteria

June 16, 2006

First Posted (Estimate)

June 20, 2006

Study Record Updates

Last Update Posted (Estimate)

April 6, 2016

Last Update Submitted That Met QC Criteria

April 4, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

EGF103659

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.