AzTrials
AzTrials

Neoplasms, BreastNCT00338247

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

A study testing lapatinib + capecitabine in people with Neoplasms, Breast, run by Novartis at 453 sites in 45 countries.

Approved For Marketing

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms, Breast
What is being tested?
lapatinib + capecitabine
How many people
Not given
Where
453 sitesin 45 countries
Study dates
Jul 2006to Mar 2015
Phase
Expanded access
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

453 sites in 45 countries.

453 sites in 45 countries

United States159 sites

  • Novartis Investigative Site

    Anchorage, Alaska, 99508

  • Novartis Investigative Site

    Ann Arbor, Michigan, 48106

  • Novartis Investigative Site

    Arlington, Texas, 76012

  • Novartis Investigative Site

    Asheville, North Carolina, 28816

  • Novartis Investigative Site

    Augusta, Georgia, 30901

  • Novartis Investigative Site

    Aurora, Colorado, 80010

  • Novartis Investigative Site

    Austin, Texas, 78731

  • Novartis Investigative Site

    Austin, Texas, 78759

  • Novartis Investigative Site

    Baltimore, Maryland, 21231-1000

  • Novartis Investigative Site

    Baltimore, Maryland, 21237

  • Novartis Investigative Site

    Baton Rouge, Louisiana, 70809

  • Novartis Investigative Site

    Bellflower, California, 90706

  • Novartis Investigative Site

    Bettendorf, Iowa, 52722

  • Novartis Investigative Site

    Billings, Montana, 59101

  • Novartis Investigative Site

    Bismarck, North Dakota, 58501

  • Novartis Investigative Site

    Boise, Idaho, 83712

  • Novartis Investigative Site

    Boston, Massachusetts, 02111

  • Novartis Investigative Site

    Boston, Massachusetts, 02118

  • Novartis Investigative Site

    Boulder, Colorado, 80304

  • Novartis Investigative Site

    Brunswick, Georgia, 31525

  • Novartis Investigative Site

    Buffalo, New York, 14221

  • Novartis Investigative Site

    Buffalo, New York, 14263

  • Novartis Investigative Site

    Burbank, California, 91505-4866

  • Novartis Investigative Site

    Cedar Rapids, Iowa, 52403

  • Novartis Investigative Site

    Charleston, South Carolina, 29403

  • Novartis Investigative Site

    Charlotte, North Carolina, 28203

  • Novartis Investigative Site

    Charlotte, North Carolina, 28204

  • Novartis Investigative Site

    Chevy Chase, Maryland, 20815

  • Novartis Investigative Site

    Chicago, Illinois, 60637

  • Novartis Investigative Site

    Cincinnati, Ohio, 45219

  • Novartis Investigative Site

    Cincinnati, Ohio, 45242

  • Novartis Investigative Site

    Cleveland, Ohio, 44106

  • Novartis Investigative Site

    Columbia, Missouri, 65201

  • Novartis Investigative Site

    Columbia, South Carolina, 29210

  • Novartis Investigative Site

    Columbus, Ohio, 39705

  • Novartis Investigative Site

    Columbus, Ohio, 43210

  • Novartis Investigative Site

    Council Bluffs, Iowa, 51503

  • Novartis Investigative Site

    Dallas, Texas, 75230

  • Novartis Investigative Site

    Dallas, Texas, 75246

  • Novartis Investigative Site

    Decatur, Illinois, 62526

  • Novartis Investigative Site

    Detroit, Michigan, 48202

  • Novartis Investigative Site

    Drexel Hill, Pennsylvania, 19026

  • Novartis Investigative Site

    Duluth, Minnesota, 55802

  • Novartis Investigative Site

    East Setauket, New York, 11733

  • Novartis Investigative Site

    East Syracuse, New York, 13057

  • Novartis Investigative Site

    El Paso, Texas, 79912

  • Novartis Investigative Site

    Exeter, New Hampshire, 03833

  • Novartis Investigative Site

    Fairfax, Virginia, 22031

  • Novartis Investigative Site

    Fall River, Massachusetts, 02721

  • Novartis Investigative Site

    Fargo, North Dakota, 58122

  • Novartis Investigative Site

    Fayetteville, Arkansas, 72703

  • Novartis Investigative Site

    Fayetteville, North Carolina, 28304

  • Novartis Investigative Site

    Flemington, New Jersey, 08822

  • Novartis Investigative Site

    Florence, South Carolina, 29506

  • Novartis Investigative Site

    Fort Lauderdale, Florida, 33328

  • Novartis Investigative Site

    Fort Myers, Florida, 33916

  • Novartis Investigative Site

    Fort Walton Beach, Florida, 32547

  • Novartis Investigative Site

    Frederick, Maryland, 21701

  • Novartis Investigative Site

    Freehold, New Jersey, 07728

  • Novartis Investigative Site

    Fresh Meadows, New York, 11366

  • Novartis Investigative Site

    Gainesville, Florida, 32605

  • Novartis Investigative Site

    Galesburg, Illinois, 61401

  • Novartis Investigative Site

    Gilroy, California, 95020

  • Novartis Investigative Site

    Glendale, Arizona, 85304

  • Novartis Investigative Site

    Glens Falls, New York, 12801

  • Novartis Investigative Site

    Grand Island, Nebraska, 68803

  • Novartis Investigative Site

    Great Falls, Montana, 59405

  • Novartis Investigative Site

    Green Bay, Wisconsin, 54311

  • Novartis Investigative Site

    Greensboro, North Carolina, 27403

  • Novartis Investigative Site

    Hartford, Connecticut, 06105

  • Novartis Investigative Site

    Highland Park, Illinois, 60035

  • Novartis Investigative Site

    Hollywood, Florida, 33021

  • Novartis Investigative Site

    Honolulu, Hawaii, 96813

  • Novartis Investigative Site

    Houston, Texas, 77030

  • Novartis Investigative Site

    Houston, Texas, 77230-1439

  • Novartis Investigative Site

    Huntsville, Alabama, 35805

  • Novartis Investigative Site

    Indianapolis, Indiana, 46202

  • Novartis Investigative Site

    Jackson, Mississippi, 39202

  • Novartis Investigative Site

    Jacksonville, Florida, 32256

  • Novartis Investigative Site

    Joliet, Illinois, 60435

  • Novartis Investigative Site

    Kalamazoo, Missouri, 49007

  • Novartis Investigative Site

    Kansas City, Missouri, 64118

  • Novartis Investigative Site

    Kennewick, Washington, 99336

  • Novartis Investigative Site

    Klamath Falls, Oregon, 97601

  • Novartis Investigative Site

    Knoxville, Tennessee, 37916

  • Novartis Investigative Site

    La Crosse, Wisconsin, 54601

  • Novartis Investigative Site

    Lafayette, Colorado, 80026

  • Novartis Investigative Site

    Las Vegas, Nevada, 89102

  • Novartis Investigative Site

    Lincoln, Nebraska, 68510

  • Novartis Investigative Site

    Little Rock, Arkansas, 72205

  • Novartis Investigative Site

    Little Silver, New Jersey, 07739

  • Novartis Investigative Site

    Livingston, New Jersey, 07039

  • Novartis Investigative Site

    Long Beach, California, 90806

  • Novartis Investigative Site

    Long Beach, California, 90813

  • Novartis Investigative Site

    Macon, Georgia, 31201

  • Novartis Investigative Site

    Manchester, Connecticut, 06040

  • Novartis Investigative Site

    Marietta, Georgia, 30060

  • Novartis Investigative Site

    Marshfield, Wisconsin, 54449

  • Novartis Investigative Site

    Memphis, Tennessee, 38120

  • Novartis Investigative Site

    Metairie, Louisiana, 70006

  • Novartis Investigative Site

    Miami, Florida, 33133

  • Novartis Investigative Site

    Morgantown, West Virginia, 26506

  • Novartis Investigative Site

    Mount Vernon, Washington, 98273

  • Novartis Investigative Site

    Mountain Lakes, New Jersey, 07046

  • Novartis Investigative Site

    Mt. Pleasant, South Carolina, 29464

  • Novartis Investigative Site

    Nashville, Tennessee, 37203

  • Novartis Investigative Site

    New Havey, Connecticut, 06511

  • Novartis Investigative Site

    New York, New York, 10003

  • Novartis Investigative Site

    New York, New York, 10011

  • Novartis Investigative Site

    New York, New York, 10016

  • Novartis Investigative Site

    New York, New York, 10065

  • Novartis Investigative Site

    Newark, New Jersey, 07112

  • Novartis Investigative Site

    Newport Beach, California, 92663

  • Novartis Investigative Site

    North Platte, Nebraska, 69103

  • Novartis Investigative Site

    Norwich, Connecticut, 06360

  • Novartis Investigative Site

    Oklahoma City, Oklahoma, 73109

  • Novartis Investigative Site

    Omaha, Nebraska, 68114

  • Novartis Investigative Site

    Omaha, Nebraska, 68124-2346

  • Novartis Investigative Site

    Orlando, Florida, 32804

  • Novartis Investigative Site

    Orlando, Florida, 32806

  • Novartis Investigative Site

    Peabody, Massachusetts, 01960

  • Novartis Investigative Site

    Peoria, Illinois, 61615

  • Novartis Investigative Site

    Philadelphia, Pennsylvania, 19104

  • Novartis Investigative Site

    Philadelphia, Pennsylvania, 19106

  • Novartis Investigative Site

    Philadelphia, Pennsylvania, 19111

  • Novartis Investigative Site

    Pittsburgh, Pennsylvania, 15212-4772

  • Novartis Investigative Site

    Pittsburgh, Pennsylvania, 15213

  • Novartis Investigative Site

    Portland, Maine, 04101

  • Novartis Investigative Site

    Portland, Oregon, 97213

  • Novartis Investigative Site

    Pottstown, Pennsylvania, 19464

  • Novartis Investigative Site

    Richmond, Virginia, 23230

  • Novartis Investigative Site

    Richmond, Virginia, 23294

  • Novartis Investigative Site

    Royal Oak, Michigan, 48073

  • Novartis Investigative Site

    Salt Lake City, Utah, 84112-5550

  • Novartis Investigative Site

    San Antonio, Texas, 78207

  • Novartis Investigative Site

    San Diego, California, 92123

  • Novartis Investigative Site

    San Francisco, California, 94115-1710

  • Novartis Investigative Site

    Sandusky, Ohio, 44870

  • Novartis Investigative Site

    Santa Rosa, California, 95403-1757

  • Novartis Investigative Site

    Sayre, Pennsylvania, 18840

  • Novartis Investigative Site

    Scarborough, Maine, 04074

  • Novartis Investigative Site

    Seattle, Washington, 98112

  • Novartis Investigative Site

    Sioux City, Iowa, 51101-1733

  • Novartis Investigative Site

    Springfield, Missouri, 65807

  • Novartis Investigative Site

    St Louis, Missouri, 63110

  • Novartis Investigative Site

    St Louis, Missouri, 63141

  • Novartis Investigative Site

    State College, Pennsylvania, 16803

  • Novartis Investigative Site

    Stockton, California, 95204

  • Novartis Investigative Site

    Tacoma, Washington, 98405

  • Novartis Investigative Site

    Tampa, Florida, 33607

  • Novartis Investigative Site

    Troy, Michigan, 48085

  • Novartis Investigative Site

    Tucker, Georgia, 30084

  • Novartis Investigative Site

    Tulsa, Oklahoma, 74104

  • Novartis Investigative Site

    Tulsa, Oklahoma, 74133

  • Novartis Investigative Site

    Walla Walla, Washington, 99362

  • Novartis Investigative Site

    Washington D.C., District of Columbia, 20007

  • Novartis Investigative Site

    Waterloo, Iowa, 50702

  • Novartis Investigative Site

    Waterville, Maine, 04901

  • Novartis Investigative Site

    Zion, Illinois, 60099

Other trials in United States

United Kingdom27 sites

  • Novartis Investigative Site

    Belfast, BT9 7AB

  • Novartis Investigative Site

    Bournemouth, BH7 7DW

  • Novartis Investigative Site

    Brighton, BN2 5BE

  • Novartis Investigative Site

    Bristol, BS2 8HW

  • Novartis Investigative Site

    Cambridge, Cambridgeshire, CB2 2GG

  • Novartis Investigative Site

    Cardiff, CF14 2TL

  • Novartis Investigative Site

    Chelmsford, Essex, CM1 7ET

  • Novartis Investigative Site

    Cheltenham, GL53 7AN

  • Novartis Investigative Site

    Colchester, CO3 3NB

  • Novartis Investigative Site

    Cumbria, CA2 7HY

  • Novartis Investigative Site

    Denbighshire, LL 18 5UJ

  • Novartis Investigative Site

    Edinburgh, Midlothian, EH4 2XU

  • Novartis Investigative Site

    Hartshill, Stoke-on-Trent, ST4 7LN

  • Novartis Investigative Site

    Lindley, Huddersfield, HD3 3EA

  • Novartis Investigative Site

    London, EC1A 7BE

  • Novartis Investigative Site

    London, NW1 2PG

  • Novartis Investigative Site

    London, NW3 2QG

  • Novartis Investigative Site

    London, SE1 9RT

  • Novartis Investigative Site

    London, SW3 6JJ

  • Novartis Investigative Site

    London, W6 8RF

  • Novartis Investigative Site

    Manchester, M20 4BX

  • Novartis Investigative Site

    Northwood, Middlesex, HA6 2RN

  • Novartis Investigative Site

    Nottingham, NG5 1PB

  • Novartis Investigative Site

    Peterborough, PE3 6DA

  • Novartis Investigative Site

    Poole, Dorset, BH15 2JB

  • Novartis Investigative Site

    Portsmouth, PO3 6AD

  • Novartis Investigative Site

    Shrewsbury, SY3 8XQ

Other trials in United Kingdom

Italy26 sites

  • Novartis Investigative Site

    Ancona, 60020

  • Novartis Investigative Site

    Aviano (PN), Friuli Venezia Giulia, 33081

  • Novartis Investigative Site

    Bari, Apulia, 70126

  • Novartis Investigative Site

    Bergamo, Lombardy, 24128

  • Novartis Investigative Site

    Bolzano, Trentino-Alto Adige, 39100

  • Novartis Investigative Site

    Cagliari, 09127

  • Novartis Investigative Site

    Candiolo (TO), Piedmont, 10060

  • Novartis Investigative Site

    Chieti, 66100

  • Novartis Investigative Site

    Florence, Tuscany, 50134

  • Novartis Investigative Site

    Forlì, Emilia-Romagna, 47100

  • Novartis Investigative Site

    Genoa, Liguria, 16132

  • Novartis Investigative Site

    Milan, Lombardy, 20133

  • Novartis Investigative Site

    Milan, Lombardy, 20141

  • Novartis Investigative Site

    Modena, Emilia-Romagna, 41100

  • Novartis Investigative Site

    Naples, Campania, 80131

  • Novartis Investigative Site

    Padova, 35128

  • Novartis Investigative Site

    Palermo, Sicily, 90127

  • Novartis Investigative Site

    Perugia, Umbria, 06156

  • Novartis Investigative Site

    Pisa, Tuscany, 56126

  • Novartis Investigative Site

    Potenza, Basilicate, 85100

  • Novartis Investigative Site

    Province of Macerata

  • Novartis Investigative Site

    Reggio Calabria, Calabria, 89100

  • Novartis Investigative Site

    Rome, Lazio, 00144

  • Novartis Investigative Site

    San Giovanni Rotondo (FG), Apulia, 71013

  • Novartis Investigative Site

    Trieste, 34100

  • Novartis Investigative Site

    Turin, Piedmont, 10126

Other trials in Italy

Spain26 sites

  • Novartis Investigative Site

    Barcelona, 08003

  • Novartis Investigative Site

    Barcelona, 08035

  • Novartis Investigative Site

    Barcelona, 08907

  • Novartis Investigative Site

    Basurto/Bilbao, 48013

  • Novartis Investigative Site

    Burgos, 09005

  • Novartis Investigative Site

    Cáceres, 10003

  • Novartis Investigative Site

    Elche, 03203

  • Novartis Investigative Site

    Girona, 17007

  • Novartis Investigative Site

    Jaén, 23007

  • Novartis Investigative Site

    Lleida, 25198

  • Novartis Investigative Site

    Madrid, 28007

  • Novartis Investigative Site

    Madrid, 28041

  • Novartis Investigative Site

    Madrid, 28046

  • Novartis Investigative Site

    Málaga, 29020

  • Novartis Investigative Site

    Murcia, 30120

  • Novartis Investigative Site

    Palencia, 34005

  • Novartis Investigative Site

    Palma de Mallorca, 07014

  • Novartis Investigative Site

    Pamplona, 31008

  • Novartis Investigative Site

    Pontevedra, 36071

  • Novartis Investigative Site

    San Sebastián, 20014

  • Novartis Investigative Site

    Santa Cruz de Tenerife, 38320

  • Novartis Investigative Site

    Santiago, 15705

  • Novartis Investigative Site

    Toledo, 45004

  • Novartis Investigative Site

    Valencia, 46009

  • Novartis Investigative Site

    Valencia, 46010

  • Novartis Investigative Site

    Zaragoza, 50009

Other trials in Spain

Germany21 sites

  • Novartis Investigative Site

    Augsburg, Bavaria, 86150

  • Novartis Investigative Site

    Berlin, State of Berlin, 13125

  • Novartis Investigative Site

    Bonn, North Rhine-Westphalia, 53113

  • Novartis Investigative Site

    Braunschweig, Lower Saxony, 38114

  • Novartis Investigative Site

    Cologne, North Rhine-Westphalia, 50931

  • Novartis Investigative Site

    Düsseldorf, North Rhine-Westphalia, 40479

  • Novartis Investigative Site

    Halle, Saxony-Anhalt, 06120

  • Novartis Investigative Site

    Hamburg, Free and Hanseatic City of Hamburg, 20249

  • Novartis Investigative Site

    Hanover, Lower Saxony, 30559

  • Novartis Investigative Site

    Ibbenbueren, North Rhine-Westphalia, 49477

  • Novartis Investigative Site

    Lübeck, Schleswig-Holstein, 23538

  • Novartis Investigative Site

    Magdeburg, Saxony-Anhalt, 39108

  • Novartis Investigative Site

    Mainz, Rhineland-Palatinate, 55131

  • Novartis Investigative Site

    Mannheim, Baden-Wurttemberg, 68161

  • Novartis Investigative Site

    Marburg, Hesse, 35043

  • Novartis Investigative Site

    Mönchengladbach, North Rhine-Westphalia, 41061

  • Novartis Investigative Site

    Saarbrücken, Saarland, 66113

  • Novartis Investigative Site

    Stuttgart, Baden-Wurttemberg, 70176

  • Novartis Investigative Site

    Troisdorf, North Rhine-Westphalia, 53840

  • Novartis Investigative Site

    Tübingen, Baden-Wurttemberg, 72076

  • Novartis Investigative Site

    Wiesbaden, Hesse, 65199

Other trials in Germany

Australia15 sites

  • Novartis Investigative Site

    Bedford Park, South Australia, 5042

  • Novartis Investigative Site

    Box Hill, Victoria, 3128

  • Novartis Investigative Site

    Fitzroy, Victoria, 3065

  • Novartis Investigative Site

    Geelong, Victoria, 3220

  • Novartis Investigative Site

    Herston, Queensland, 4029

  • Novartis Investigative Site

    Hobart, Tasmania, 7000

  • Novartis Investigative Site

    Kogarah, New South Wales, 2217

  • Novartis Investigative Site

    Nedlands, Western Australia, 6009

  • Novartis Investigative Site

    North Sydney, New South Wales, 2060

  • Novartis Investigative Site

    Perth, Western Australia, 6000

  • Novartis Investigative Site

    Port Macquarie, New South Wales, 2444

  • Novartis Investigative Site

    South Brisbane, Queensland, 4101

  • Novartis Investigative Site

    Waratah, New South Wales, 2298

  • Novartis Investigative Site

    Westmead, New South Wales, 2145

  • Novartis Investigative Site

    Wodonga, Victoria, 3690

Other trials in Australia

Belgium11 sites

  • Novartis Investigative Site

    Brussels, 1000

  • Novartis Investigative Site

    Brussels, 1090

  • Novartis Investigative Site

    Brussels, 1200

  • Novartis Investigative Site

    Charleroi, 6000

  • Novartis Investigative Site

    Edegem, 2650

  • Novartis Investigative Site

    Ghent, 9000

  • Novartis Investigative Site

    Haine-Saint-Paul, 7100

  • Novartis Investigative Site

    Leuven, 3000

  • Novartis Investigative Site

    Liège, 4000

  • Novartis Investigative Site

    Wilrijk, 2610

  • Novartis Investigative Site

    Yvoir, 5530

Other trials in Belgium

China10 sites

  • Novartis Investigative Site

    Beijing, 100021

  • Novartis Investigative Site

    Beijing, 100071

  • Novartis Investigative Site

    Dalian, Liaoning, 116011

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510515

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310022

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210009

  • Novartis Investigative Site

    Shanghai, 200032

  • Novartis Investigative Site

    Shanghai, 200080

  • Novartis Investigative Site

    Tianjin, 300060

  • Novartis Investigative Site

    Wuhan, Hubei, 430030

Other trials in China

Taiwan10 sites

  • Novartis Investigative Site

    Kaohsiung City, 807

  • Novartis Investigative Site

    Taichung, 407

  • Novartis Investigative Site

    Tainan, 704

  • Novartis Investigative Site

    Tainan County, 736

  • Novartis Investigative Site

    Taipei, 100

  • Novartis Investigative Site

    Taipei, 104

  • Novartis Investigative Site

    Taipei, 105

  • Novartis Investigative Site

    Taipei, 110

  • Novartis Investigative Site

    Taipei, 112

  • Novartis Investigative Site

    Taipei, 114

Other trials in Taiwan

Netherlands9 sites

  • Novartis Investigative Site

    Amersfoort, 3818 ES

  • Novartis Investigative Site

    Amsterdam, 1066 CX

  • Novartis Investigative Site

    Amsterdam, 1081 HV

  • Novartis Investigative Site

    Dordrecht, 3318 AT

  • Novartis Investigative Site

    Enschede, 7511JX

  • Novartis Investigative Site

    Groningen, 9713 GZ

  • Novartis Investigative Site

    Leeuwarden, 8934 AD

  • Novartis Investigative Site

    Leiden, 2333 ZA

  • Novartis Investigative Site

    Maastricht, 6229 HX

Other trials in Netherlands

Poland9 sites

  • Novartis Investigative Site

    Bialystok, 15-027

  • Novartis Investigative Site

    Bydgoszcz, 85-796

  • Novartis Investigative Site

    Elblag, 82-300

  • Novartis Investigative Site

    Gdansk, 80-210

  • Novartis Investigative Site

    Gliwice, 44-101

  • Novartis Investigative Site

    Olsztyn, 10-226

  • Novartis Investigative Site

    Olsztyn, 10-228

  • Novartis Investigative Site

    Poznan, 61-866

  • Novartis Investigative Site

    Warsaw, 02-781

Other trials in Poland

Brazil8 sites

  • Novartis Investigative Site

    Jaú, São Paulo, 17210-080

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90050-170

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90610 000

  • Novartis Investigative Site

    Rio de Janeiro, Rio de Janeiro, 20260-020

  • Novartis Investigative Site

    Rio de Janeiro, Rio de Janeiro, 21941-913

  • Novartis Investigative Site

    Salvador, Estado de Bahia, 40170-070

  • Novartis Investigative Site

    São Paulo, São Paulo, 05651-901

Other trials in Brazil

Switzerland8 sites

  • Novartis Investigative Site

    Basel, 4031

  • Novartis Investigative Site

    Bern, 3010

  • Novartis Investigative Site

    Chur, 7000

  • Novartis Investigative Site

    Geneva, CH 1211

  • Novartis Investigative Site

    Mendrisio, 6850

  • Novartis Investigative Site

    Neuchâtel, 2002

  • Novartis Investigative Site

    Sankt Gallen, 9007

  • Novartis Investigative Site

    Zurich, 8091

Other trials in Switzerland

Canada7 sites

  • Novartis Investigative Site

    Greater Sudbury, Ontario, P3E 5J1

  • Novartis Investigative Site

    Greenfield Park, Quebec, J4V 2H1

  • Novartis Investigative Site

    Moncton, New Brunswick, E1C 8X3

  • Novartis Investigative Site

    Oshawa, Ontario, L1G 2B9

  • Novartis Investigative Site

    Saskatoon, Saskatchewan, S7N 4H4

  • Novartis Investigative Site

    Vancouver, British Columbia, V5Z 4E6

  • Novartis Investigative Site

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

Israel7 sites

  • Novartis Investigative Site

    Beersheba, 84101

  • Novartis Investigative Site

    Haifa, 31096

  • Novartis Investigative Site

    Jerusalem, 91120

  • Novartis Investigative Site

    Petah Tikva, 49100

  • Novartis Investigative Site

    Ramat Gan, 52621

  • Novartis Investigative Site

    Rehovot, 76100

  • Novartis Investigative Site

    Tel Aviv, 64239

Other trials in Israel

Austria6 sites

  • Novartis Investigative Site

    Graz, A-8036

  • Novartis Investigative Site

    Innsbruck, 6020

  • Novartis Investigative Site

    Linz, A-4020

  • Novartis Investigative Site

    Linz

  • Novartis Investigative Site

    Salzburg, A-5020

  • Novartis Investigative Site

    Vienna, 1180

Other trials in Austria

Ireland6 sites

  • Novartis Investigative Site

    Dublin, 4

  • Novartis Investigative Site

    Dublin, 7

  • Novartis Investigative Site

    Dublin, 8

  • Novartis Investigative Site

    Galway

  • Novartis Investigative Site

    Tallaght, Dublin, 24

  • Novartis Investigative Site

    Wilton, Cork

Other trials in Ireland

South Korea6 sites

  • Novartis Investigative Site

    Kyunggi-do, 410-769

  • Novartis Investigative Site

    Pusan, 602-739

  • Novartis Investigative Site

    Seodaemun-gu, Seoul, 120-752

  • Novartis Investigative Site

    Seoul, 135-710

  • Novartis Investigative Site

    Seoul, 138-736

  • Novartis Investigative Site

    Songpa-gu, Seoul, 138-736

Other trials in South Korea

Denmark5 sites

  • Novartis Investigative Site

    Århus C, 8000

  • Novartis Investigative Site

    Copenhagen, DK- 2100

  • Novartis Investigative Site

    Odense C, 5000

  • Novartis Investigative Site

    Roskilde, DK-4000

  • Novartis Investigative Site

    Vejle, 7100

Other trials in Denmark

Finland5 sites

  • Novartis Investigative Site

    Hämeenlinna

  • Novartis Investigative Site

    Helsinki, 00150

  • Novartis Investigative Site

    Kangasala, 36280

  • Novartis Investigative Site

    Kuopio, 70210

  • Novartis Investigative Site

    OYS, 90029

Other trials in Finland

Mexico5 sites

  • Novartis Investigative Site

    Durango, 34079

  • Novartis Investigative Site

    Mérida, Yucatán, 97500

  • Novartis Investigative Site

    Mexico City, CP 14080

  • Novartis Investigative Site

    Tijuana, Baja California Norte, 22320

  • Novartis Investigative Site

    Toluca, Edo Mex, State of Mexico, 50180

Other trials in Mexico

Portugal5 sites

  • Novartis Investigative Site

    Evora, 7000-811

  • Novartis Investigative Site

    Lisbon, 1099-023

  • Novartis Investigative Site

    Lisbon, 1649-028

  • Novartis Investigative Site

    Porto, 4200-072 Porto

  • Novartis Investigative Site

    Porto, 4200-319

Other trials in Portugal

Singapore5 sites

  • Novartis Investigative Site

    Singapore, 119074

  • Novartis Investigative Site

    Singapore, 169610

  • Novartis Investigative Site

    Singapore, 258499

  • Novartis Investigative Site

    Singapore, 258500

  • Novartis Investigative Site

    Singapore, 308433

Other trials in Singapore

Slovakia5 sites

  • Novartis Investigative Site

    Banská Bystrica, 975 17

  • Novartis Investigative Site

    Bratislava, 812 50

  • Novartis Investigative Site

    Bratislava, 833 10

  • Novartis Investigative Site

    Košice, 041 90

  • Novartis Investigative Site

    Poprad, 058 01

Other trials in Slovakia

Sweden5 sites

  • Novartis Investigative Site

    Jönköping, SE 55185

  • Novartis Investigative Site

    Lund, SE-221 85

  • Novartis Investigative Site

    Stockholm, SE-171 76

  • Novartis Investigative Site

    Umeå, SE-901 85

  • Novartis Investigative Site

    Uppsala, SE-751 85

Other trials in Sweden

Czechia4 sites

  • Novartis Investigative Site

    Brno, 656 53

  • Novartis Investigative Site

    Olomouc, 775 20

  • Novartis Investigative Site

    Prague, 140 59

  • Novartis Investigative Site

    Prague, 150 08

Other trials in Czechia

Philippines4 sites

  • Novartis Investigative Site

    Makati City, 1200

  • Novartis Investigative Site

    Pasay, 1300

  • Novartis Investigative Site

    Quezon City, 1102

  • Novartis Investigative Site

    Sampaloc Manila, 1008

Other trials in Philippines

Romania4 sites

  • Novartis Investigative Site

    Bucharest, 050098

  • Novartis Investigative Site

    Iași, 700106

  • Novartis Investigative Site

    Sibiu, 550245

  • Novartis Investigative Site

    Timișoara, 300239

Other trials in Romania

Thailand4 sites

  • Novartis Investigative Site

    Bangkok, 10110

  • Novartis Investigative Site

    Bangkok, 10330

  • Novartis Investigative Site

    Chiang Mai, 50200

  • Novartis Investigative Site

    Pathum Thani, 12110

Other trials in Thailand

Ukraine4 sites

  • Novartis Investigative Site

    Chernivtsi, 58013

  • Novartis Investigative Site

    Kiev, 03115

  • Novartis Investigative Site

    Odesa, 65055

  • Novartis Investigative Site

    Rivne, 33010

Other trials in Ukraine

Greece3 sites

  • Novartis Investigative Site

    Athens, 115 28

  • Novartis Investigative Site

    Heraklion, Crete, 71201

  • Novartis Investigative Site

    Marousi, 15123

Other trials in Greece

Malaysia3 sites

  • Novartis Investigative Site

    Kuala Lumpur, 50450

  • Novartis Investigative Site

    Kuala Lumpur, 59100

  • Novartis Investigative Site

    Petaling Jaya Selangor, 47000

Other trials in Malaysia

New Zealand3 sites

  • Novartis Investigative Site

    Christchurch, 8001

  • Novartis Investigative Site

    Dunedin, 9001

  • Novartis Investigative Site

    Newtown, Wellington, 6002

Other trials in New Zealand

Russia3 sites

  • Novartis Investigative Site

    Irkutsk, 664035

  • Novartis Investigative Site

    Moscow, 115478

  • Novartis Investigative Site

    Nizhny Novgorod, 603126

Other trials in Russia

Estonia2 sites

  • Novartis Investigative Site

    Tallinn, 13419

  • Novartis Investigative Site

    Tartu, 51003

Other trials in Estonia

Hong Kong2 sites

  • Novartis Investigative Site

    Pokfulam

  • Novartis Investigative Site

    Shatin

Other trials in Hong Kong

Peru2 sites

  • Novartis Investigative Site

    Lima, Lima Province, Lima 13

  • Novartis Investigative Site

    Lima, Lima Province, Lima 34

Other trials in Peru

Slovenia2 sites

  • Novartis Investigative Site

    Ljubljana, 1000

  • Novartis Investigative Site

    Maribor, 2000

Other trials in Slovenia

Bulgaria1 site

  • Novartis Investigative Site

    Sofia, 1156

Other trials in Bulgaria

Chile1 site

  • Novartis Investigative Site

    Santiago, Región Metro de Santiago, 750 1088

Other trials in Chile

Cyprus1 site

  • Novartis Investigative Site

    Stróvolos, 2006

Other trials in Cyprus

Iceland1 site

  • Novartis Investigative Site

    Reykjavik, 101

Other trials in Iceland

Indonesia1 site

  • Novartis Investigative Site

    Jakarta, 10430

Other trials in Indonesia

Luxembourg1 site

  • Novartis Investigative Site

    Luxembourg, 1210

Other trials in Luxembourg

Malta1 site

  • Novartis Investigative Site

    Floriana, VLT 14

Other trials in Malta

About this study

Official title: 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

Being tested
lapatinib + capecitabine
Keywords
advanced, TYKERB, HER2 positive, Stage IIIc, ErbB2 positive, GW572016, metastatic, Stage IIIb, breast cancer
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lapatinib + capecitabineDrug

    Experimental

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2006 (estimated)
  2. Study startJul 2006
  3. Primary completionMar 2015
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Expanded access
IDs, dates and publications
ClinicalTrials.gov ID
NCT00338247
Sponsor's protocol ID
EGF103659
Status last verified
Apr 2016
First submitted
16 Jun 2006
Last updated
6 Apr 2016
Results posted
No

Publications

  • Ro J, Park S, Kim S, Kim TY, Im YH, Rha SY, Chung JS, Moon H, Santillana S. Clinical outcomes of HER2-positive metastatic breast cancer patients with brain metastasis treated with lapatinib and capecitabine: an open-label expanded access study in Korea. BMC Cancer. 2012 Jul 28;12:322. doi: 10.1186/1471-2407-12-322.

    PubMed 22839200

  • Wang L, Zhang Q, Zhang J, Sun S, Guo H, Jia Z, Wang B, Shao Z, Wang Z, Hu X. PI3K pathway activation results in low efficacy of both trastuzumab and lapatinib. BMC Cancer. 2011 Jun 15;11:248. doi: 10.1186/1471-2407-11-248.

    PubMed 21676217

Questions about this trial

What is this clinical trial studying?

A study testing lapatinib + capecitabine in people with Neoplasms, Breast, run by Novartis at 453 sites in 45 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 453 sites in United States, United Kingdom, Italy, Spain, Germany and 40 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00338247, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2016.

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