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

NCT ID: NCT00338247

Last Updated: 2016-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

APPROVED_FOR_MARKETING

Study Classification

EXPANDED_ACCESS

Study Start Date

2006-07-31

Study Completion Date

2015-03-31

Brief Summary

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

Detailed Description

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Conditions

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Neoplasms, Breast

Interventions

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lapatinib + capecitabine

Experimental

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Huntsville, Alabama, United States

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Anchorage, Alaska, United States

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Glendale, Arizona, United States

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Fayetteville, Arkansas, United States

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Little Rock, Arkansas, United States

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Bellflower, California, United States

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Burbank, California, United States

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Gilroy, California, United States

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Long Beach, California, United States

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Long Beach, California, United States

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Newport Beach, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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Santa Rosa, California, United States

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Stockton, California, United States

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Aurora, Colorado, United States

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Boulder, Colorado, United States

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Lafayette, Colorado, United States

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Hartford, Connecticut, United States

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Manchester, Connecticut, United States

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New Havey, Connecticut, United States

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Norwich, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Fort Lauderdale, Florida, United States

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Fort Myers, Florida, United States

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Fort Walton Beach, Florida, United States

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Gainesville, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Orlando, Florida, United States

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Tampa, Florida, United States

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Augusta, Georgia, United States

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Brunswick, Georgia, United States

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Macon, Georgia, United States

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Marietta, Georgia, United States

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Tucker, Georgia, United States

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Honolulu, Hawaii, United States

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Boise, Idaho, United States

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Chicago, Illinois, United States

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Decatur, Illinois, United States

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Galesburg, Illinois, United States

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Highland Park, Illinois, United States

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Joliet, Illinois, United States

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Peoria, Illinois, United States

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Zion, Illinois, United States

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Indianapolis, Indiana, United States

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Baton Rouge, Louisiana, United States

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Metairie, Louisiana, United States

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Frederick, Maryland, United States

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Fall River, Massachusetts, United States

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Westmead, New South Wales, Australia

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Herston, Queensland, Australia

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South Brisbane, Queensland, Australia

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Bedford Park, South Australia, Australia

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Hobart, Tasmania, Australia

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Box Hill, Victoria, Australia

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Fitzroy, Victoria, Australia

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Geelong, Victoria, Australia

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Wodonga, Victoria, Australia

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Nedlands, Western Australia, Australia

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Perth, Western Australia, Australia

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Graz, , Austria

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Innsbruck, , Austria

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Linz, , Austria

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Linz, , Austria

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Salzburg, , Austria

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Vienna, , Austria

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Brussels, , Belgium

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Brussels, , Belgium

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Brussels, , Belgium

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Charleroi, , Belgium

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Edegem, , Belgium

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Ghent, , Belgium

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Haine-Saint-Paul, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Wilrijk, , Belgium

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Yvoir, , Belgium

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Salvador, Estado de Bahia, Brazil

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Rio de Janeiro, Rio de Janeiro, Brazil

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Rio de Janeiro, Rio de Janeiro, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Jaú, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Sofia, , Bulgaria

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Vancouver, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Moncton, New Brunswick, Canada

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Greater Sudbury, Ontario, Canada

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Oshawa, Ontario, Canada

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Greenfield Park, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Santiago, Región Metro de Santiago, Chile

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Guangzhou, Guangdong, China

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Nanjing, Jiangsu, China

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Dalian, Liaoning, China

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Shanghai, , China

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Shanghai, , China

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Tianjin, , China

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Stróvolos, , Cyprus

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Odense C, , Denmark

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Roskilde, , Denmark

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Vejle, , Denmark

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Tallinn, , Estonia

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Tartu, , Estonia

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Hämeenlinna, , Finland

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Helsinki, , Finland

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Kangasala, , Finland

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Jakarta, , Indonesia

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Dublin, , Ireland

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Lima, Lima Province, Peru

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Lima, Lima Province, Peru

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Makati City, , Philippines

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Pasay, , Philippines

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Quezon City, , Philippines

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Sampaloc Manila, , Philippines

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Bialystok, , Poland

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Bydgoszcz, , Poland

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Elblag, , Poland

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Gdansk, , Poland

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Gliwice, , Poland

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Olsztyn, , Poland

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Olsztyn, , Poland

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Poznan, , Poland

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Warsaw, , Poland

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Evora, , Portugal

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Lisbon, , Portugal

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Lisbon, , Portugal

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Porto, , Portugal

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Porto, , Portugal

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Bucharest, , Romania

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Iași, , Romania

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Sibiu, , Romania

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Timișoara, , Romania

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Irkutsk, , Russia

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Moscow, , Russia

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Nizhny Novgorod, , Russia

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Singapore, , Singapore

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Singapore, , Singapore

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Singapore, , Singapore

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Singapore, , Singapore

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Singapore, , Singapore

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Banská Bystrica, , Slovakia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Košice, , Slovakia

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Poprad, , Slovakia

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Ljubljana, , Slovenia

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Maribor, , Slovenia

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Kyunggi-do, , South Korea

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Pusan, , South Korea

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Seodaemun-gu, Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Songpa-gu, Seoul, , South Korea

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Barcelona, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Basurto/Bilbao, , Spain

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Burgos, , Spain

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Cáceres, , Spain

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Elche, , Spain

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Girona, , Spain

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Jaén, , Spain

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Lleida, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Málaga, , Spain

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Murcia, , Spain

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Palencia, , Spain

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Palma de Mallorca, , Spain

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Pamplona, , Spain

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Pontevedra, , Spain

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San Sebastián, , Spain

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Santa Cruz de Tenerife, , Spain

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Santiago, , Spain

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Toledo, , Spain

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Valencia, , Spain

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Valencia, , Spain

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Zaragoza, , Spain

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Jönköping, , Sweden

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Lund, , Sweden

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Stockholm, , Sweden

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Umeå, , Sweden

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Uppsala, , Sweden

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Basel, , Switzerland

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Bern, , Switzerland

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Chur, , Switzerland

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Geneva, , Switzerland

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Mendrisio, , Switzerland

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Neuchâtel, , Switzerland

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Sankt Gallen, , Switzerland

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Zurich, , Switzerland

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Kaohsiung City, , Taiwan

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Taichung, , Taiwan

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Tainan City, , Taiwan

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Tainan County, , Taiwan

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Taipei, , Taiwan

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Taipei, , Taiwan

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Taipei, , Taiwan

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Taipei, , Taiwan

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Taipei, , Taiwan

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Taipei, , Taiwan

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Bangkok, , Thailand

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Bangkok, , Thailand

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Chiang Mai, , Thailand

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Pathum Thani, , Thailand

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Chernivtsi, , Ukraine

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Kiev, , Ukraine

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Odesa, , Ukraine

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Rivne, , Ukraine

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Cambridge, Cambridgeshire, United Kingdom

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Chelmsford, Essex, United Kingdom

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Northwood, Middlesex, United Kingdom

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Edinburgh, Midlothian, United Kingdom

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Belfast, , United Kingdom

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Bournemouth, , United Kingdom

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Brighton, , United Kingdom

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Bristol, , United Kingdom

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Cardiff, , United Kingdom

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Cheltenham, , United Kingdom

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Colchester, , United Kingdom

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Cumbria, , United Kingdom

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Denbighshire, , United Kingdom

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Hartshill, Stoke-on-Trent, , United Kingdom

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Lindley, Huddersfield, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Nottingham, , United Kingdom

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Peterborough, , United Kingdom

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Poole, Dorset, , United Kingdom

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Portsmouth, , United Kingdom

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Shrewsbury, , United Kingdom

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Countries

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United States Australia Austria Belgium Brazil Bulgaria Canada Chile China Cyprus Czechia Denmark Estonia Finland Germany Greece Hong Kong Iceland Indonesia Ireland Israel Italy Luxembourg Malaysia Malta Mexico Netherlands New Zealand Peru Philippines Poland Portugal Romania Russia Singapore Slovakia Slovenia South Korea Spain Sweden Switzerland Taiwan Thailand Ukraine United Kingdom

References

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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.

Reference Type DERIVED
PMID: 22839200 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21676217 (View on PubMed)

Other Identifiers

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EGF103659

Identifier Type: -

Identifier Source: org_study_id

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