Clinical trial NCT00338247: EAP (Expanded Access Protocol) Of Lapatinib Combined With Capecitabine In Metastatic Breast Cancer
Official title: An Open-Label Expanded Access Study of Lapatinib and Capecitabine Therapy in Subjects With ErbB2 Overexpressing Locally Advanced or Metastatic Breast Cancer
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Neoplasms, Breast
Keywords: advanced
TYKERB
HER2 positive
Stage IIIc
ErbB2 positive
GW572016
metastatic
Stage IIIb
breast cancer
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-06-20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief 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


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Novartis Investigative Site
state: Alabama
city: Anchorage
country: United States
facility: Novartis Investigative Site
state: Alaska
city: Glendale
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Fayetteville
country: United States
facility: Novartis Investigative Site
state: Arkansas
city: Little Rock
country: United States
facility: Novartis Investigative Site
state: Arkansas
city: Bellflower
country: United States
facility: Novartis Investigative Site
state: California
city: Burbank
country: United States
facility: Novartis Investigative Site
state: California
city: Gilroy
country: United States
facility: Novartis Investigative Site
state: California
city: Long Beach
country: United States
facility: Novartis Investigative Site
state: California
city: Long Beach
country: United States
facility: Novartis Investigative Site
state: California
city: Newport Beach
country: United States
facility: Novartis Investigative Site
state: California
city: San Diego
country: United States
facility: Novartis Investigative Site
state: California
city: San Francisco
country: United States
facility: Novartis Investigative Site
state: California
city: Santa Rosa
country: United States
facility: Novartis Investigative Site
state: California
city: Stockton
country: United States
facility: Novartis Investigative Site
state: California
city: Aurora
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Boulder
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Lafayette
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Hartford
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: Manchester
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: New Havey
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: Norwich
country: United States
facility: Novartis Investigative Site
state: Connecticut
city: Washington
country: United States
facility: Novartis Investigative Site
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Novartis Investigative Site
state: Florida
city: Fort Myers
country: United States
facility: Novartis Investigative Site
state: Florida
city: Fort Walton Beach
country: United States
facility: Novartis Investigative Site
state: Florida
city: Gainesville
country: United States
facility: Novartis Investigative Site
state: Florida
city: Hollywood
country: United States
facility: Novartis Investigative Site
state: Florida
city: Jacksonville
country: United States
facility: Novartis Investigative Site
state: Florida
city: Miami
country: United States
facility: Novartis Investigative Site
state: Florida
city: Orlando
country: United States
facility: Novartis Investigative Site
state: Florida
city: Orlando
country: United States
facility: Novartis Investigative Site
state: Florida
city: Tampa
country: United States
facility: Novartis Investigative Site
state: Florida
city: Augusta
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Brunswick
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Macon
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Marietta
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Tucker
country: United States
facility: Novartis Investigative Site
state: Georgia
city: Honolulu
country: United States
facility: Novartis Investigative Site
state: Hawaii
city: Boise
country: United States
facility: Novartis Investigative Site
state: Idaho
city: Chicago
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Decatur
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Galesburg
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Highland Park
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Joliet
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Peoria
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Zion
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Indianapolis
country: United States
facility: Novartis Investigative Site
state: Indiana
city: Bettendorf
country: United States
facility: Novartis Investigative Site
state: Iowa
city: Cedar Rapids
country: United States
facility: Novartis Investigative Site
state: Iowa
city: Council Bluffs
country: United States
facility: Novartis Investigative Site
state: Iowa
city: Sioux City
country: United States
facility: Novartis Investigative Site
state: Iowa
city: Waterloo
country: United States
facility: Novartis Investigative Site
state: Iowa
city: Baton Rouge
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Metairie
country: United States
facility: Novartis Investigative Site
state: Louisiana
city: Portland
country: United States
facility: Novartis Investigative Site
state: Maine
city: Scarborough
country: United States
facility: Novartis Investigative Site
state: Maine
city: Waterville
country: United States
facility: Novartis Investigative Site
state: Maine
city: Baltimore
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Baltimore
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Chevy Chase
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Frederick
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Boston
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Boston
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Fall River
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Peabody
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Detroit
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Royal Oak
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Troy
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Duluth
country: United States
facility: Novartis Investigative Site
state: Minnesota
city: Jackson
country: United States
facility: Novartis Investigative Site
state: Mississippi
city: Columbia
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Kalamazoo
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Kansas City
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Springfield
country: United States
facility: Novartis Investigative Site
state: Missouri
city: St. Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: St. Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Billings
country: United States
facility: Novartis Investigative Site
state: Montana
city: Great Falls
country: United States
facility: Novartis Investigative Site
state: Montana
city: Grand Island
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Lincoln
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: North Platte
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Omaha
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Omaha
country: United States
facility: Novartis Investigative Site
state: Nebraska
city: Las Vegas
country: United States
facility: Novartis Investigative Site
state: Nevada
city: Exeter
country: United States
facility: Novartis Investigative Site
state: New Hampshire
city: Flemington
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Freehold
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Little Silver
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Livingston
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Mountain Lakes
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Newark
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Buffalo
country: United States
facility: Novartis Investigative Site
state: New York
city: Buffalo
country: United States
facility: Novartis Investigative Site
state: New York
city: East Setauket
country: United States
facility: Novartis Investigative Site
state: New York
city: East Syracuse
country: United States
facility: Novartis Investigative Site
state: New York
city: Fresh Meadows
country: United States
facility: Novartis Investigative Site
state: New York
city: Glens Falls
country: United States
facility: Novartis Investigative Site
state: New York
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: Asheville
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Charlotte
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Charlotte
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Fayetteville
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Greensboro
country: United States
facility: Novartis Investigative Site
state: North Carolina
city: Bismarck
country: United States
facility: Novartis Investigative Site
state: North Dakota
city: Fargo
country: United States
facility: Novartis Investigative Site
state: North Dakota
city: Cincinnati
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Cincinnati
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Cleveland
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Columbus
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Columbus
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Sandusky
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Oklahoma City
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Tulsa
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Tulsa
country: United States
facility: Novartis Investigative Site
state: Oklahoma
city: Klamath Falls
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Portland
country: United States
facility: Novartis Investigative Site
state: Oregon
city: Drexel Hill
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Pottstown
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Sayre
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: State College
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: Charleston
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Columbia
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Florence
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Mt. Pleasant
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Knoxville
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Memphis
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Nashville
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Arlington
country: United States
facility: Novartis Investigative Site
state: Texas
city: Austin
country: United States
facility: Novartis Investigative Site
state: Texas
city: Austin
country: United States
facility: Novartis Investigative Site
state: Texas
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: El Paso
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: San Antonio
country: United States
facility: Novartis Investigative Site
state: Texas
city: Salt Lake City
country: United States
facility: Novartis Investigative Site
state: Utah
city: Fairfax
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Richmond
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Richmond
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Kennewick
country: United States
facility: Novartis Investigative Site
state: Washington
city: Mount Vernon
country: United States
facility: Novartis Investigative Site
state: Washington
city: Seattle
country: United States
facility: Novartis Investigative Site
state: Washington
city: Tacoma
country: United States
facility: Novartis Investigative Site
state: Washington
city: Walla Walla
country: United States
facility: Novartis Investigative Site
state: Washington
city: Morgantown
country: United States
facility: Novartis Investigative Site
state: West Virginia
city: Green Bay
country: United States
facility: Novartis Investigative Site
state: Wisconsin
city: La Crosse
country: United States
facility: Novartis Investigative Site
state: Wisconsin
city: Marshfield
country: United States
facility: Novartis Investigative Site
state: Wisconsin
city: Kogarah
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: North Sydney
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Port Macquarie
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Waratah
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Westmead
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Herston
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: South Brisbane
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Bedford Park
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: Hobart
country: Australia
facility: Novartis Investigative Site
state: Tasmania
city: Box Hill
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Fitzroy
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Geelong
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Wodonga
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Nedlands
country: Australia
facility: Novartis Investigative Site
state: Western Australia
city: Perth
country: Australia
facility: Novartis Investigative Site
state: Western Australia
city: Graz
country: Austria
facility: Novartis Investigative Site
city: Innsbruck
country: Austria
facility: Novartis Investigative Site
city: Linz
country: Austria
facility: Novartis Investigative Site
city: Linz
country: Austria
facility: Novartis Investigative Site
city: Salzburg
country: Austria
facility: Novartis Investigative Site
city: Vienna
country: Austria
facility: Novartis Investigative Site
city: Brussel
country: Belgium
facility: Novartis Investigative Site
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Charleroi
country: Belgium
facility: Novartis Investigative Site
city: Edegem
country: Belgium
facility: Novartis Investigative Site
city: Gent
country: Belgium
facility: Novartis Investigative Site
city: Haine Saint Paul
country: Belgium
facility: Novartis Investigative Site
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Liège
country: Belgium
facility: Novartis Investigative Site
city: Wilrijk
country: Belgium
facility: Novartis Investigative Site
city: Yvoir
country: Belgium
facility: Novartis Investigative Site
city: Salvador
country: Brazil
facility: Novartis Investigative Site
state: Bahía
city: Porto Alegre
country: Brazil
facility: Novartis Investigative Site
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Novartis Investigative Site
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Novartis Investigative Site
state: Rio Grande Do Sul
city: Jau
country: Brazil
facility: Novartis Investigative Site
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Novartis Investigative Site
city: Rio de Janeiro
country: Brazil
facility: Novartis Investigative Site
city: São Paulo
country: Brazil
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Vancouver
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Novartis Investigative Site
state: Manitoba
city: Moncton
country: Canada
facility: Novartis Investigative Site
state: New Brunswick
city: Oshawa
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Sudbury
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Greenfield Park
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Saskatoon
country: Canada
facility: Novartis Investigative Site
state: Saskatchewan
city: Santiago
country: Chile
facility: Novartis Investigative Site
state: Región Metro De Santiago
city: Guangzhou
country: China
facility: Novartis Investigative Site
state: Guangdong
city: Wuhan
country: China
facility: Novartis Investigative Site
state: Hubei
city: Nanjing
country: China
facility: Novartis Investigative Site
state: Jiangsu
city: Dalian
country: China
facility: Novartis Investigative Site
state: Liaoning
city: Hangzhou
country: China
facility: Novartis Investigative Site
state: Zhejiang
city: Beijing
country: China
facility: Novartis Investigative Site
city: Beijing
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Tianjin
country: China
facility: Novartis Investigative Site
city: Strovolos
country: Cyprus
facility: Novartis Investigative Site
city: Brno
country: Czech Republic
facility: Novartis Investigative Site
city: Olomouc
country: Czech Republic
facility: Novartis Investigative Site
city: Praha
country: Czech Republic
facility: Novartis Investigative Site
city: Praha
country: Czech Republic
facility: Novartis Investigative Site
city: Copenhagen
country: Denmark
facility: Novartis Investigative Site
city: Odense C
country: Denmark
facility: Novartis Investigative Site
city: Roskilde
country: Denmark
facility: Novartis Investigative Site
city: Vejle
country: Denmark
facility: Novartis Investigative Site
city: Århus C
country: Denmark
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tartu
country: Estonia
facility: Novartis Investigative Site
city: Helsinki
country: Finland
facility: Novartis Investigative Site
city: Hämeenlinna
country: Finland
facility: Novartis Investigative Site
city: Kangasala
country: Finland
facility: Novartis Investigative Site
city: Kuopio
country: Finland
facility: Novartis Investigative Site
city: OYS
country: Finland
facility: Novartis Investigative Site
city: Mannheim
country: Germany
facility: Novartis Investigative Site
state: Baden-Wuerttemberg
city: Stuttgart
country: Germany
facility: Novartis Investigative Site
state: Baden-Wuerttemberg
city: Tuebingen
country: Germany
facility: Novartis Investigative Site
state: Baden-Wuerttemberg
city: Augsburg
country: Germany
facility: Novartis Investigative Site
state: Bayern
city: Marburg
country: Germany
facility: Novartis Investigative Site
state: Hessen
city: Wiesbaden
country: Germany
facility: Novartis Investigative Site
state: Hessen
city: Braunschweig
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Hannover
country: Germany
facility: Novartis Investigative Site
state: Niedersachsen
city: Bonn
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Duesseldorf
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Ibbenbueren
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Koeln
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Moenchengladbach
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Troisdorf
country: Germany
facility: Novartis Investigative Site
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Novartis Investigative Site
state: Rheinland-Pfalz
city: Saarbruecken
country: Germany
facility: Novartis Investigative Site
state: Saarland
city: Halle
country: Germany
facility: Novartis Investigative Site
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
state: Sachsen-Anhalt
city: Luebeck
country: Germany
facility: Novartis Investigative Site
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Athens
country: Greece
facility: Novartis Investigative Site
city: Heraklion, Crete
country: Greece
facility: Novartis Investigative Site
city: Maroussi
country: Greece
facility: Novartis Investigative Site
city: Pokfulam
country: Hong Kong
facility: Novartis Investigative Site
city: Shatin
country: Hong Kong
facility: Novartis Investigative Site
city: Reykjavik
country: Iceland
facility: Novartis Investigative Site
city: Jakarta
country: Indonesia
facility: Novartis Investigative Site
city: Dublin
country: Ireland
facility: Novartis Investigative Site
city: Dublin
country: Ireland
facility: Novartis Investigative Site
city: Dublin
country: Ireland
facility: Novartis Investigative Site
city: Galway
country: Ireland
facility: Novartis Investigative Site
city: Tallaght, Dublin
country: Ireland
facility: Novartis Investigative Site
city: Wilton, Cork
country: Ireland
facility: Novartis Investigative Site
city: Beer-Sheva
country: Israel
facility: Novartis Investigative Site
city: Haifa
country: Israel
facility: Novartis Investigative Site
city: Jerusalem
country: Israel
facility: Novartis Investigative Site
city: Petach Tikva
country: Israel
facility: Novartis Investigative Site
city: Ramat Gan
country: Israel
facility: Novartis Investigative Site
city: Rehovot
country: Israel
facility: Novartis Investigative Site
city: Tel Aviv
country: Israel
facility: Novartis Investigative Site
city: Potenza
country: Italy
facility: Novartis Investigative Site
state: Basilicata
city: Reggio Calabria
country: Italy
facility: Novartis Investigative Site
state: Calabria
city: Napoli
country: Italy
facility: Novartis Investigative Site
state: Campania
city: Forlì
country: Italy
facility: Novartis Investigative Site
state: Emilia-Romagna
city: Modena
country: Italy
facility: Novartis Investigative Site
state: Emilia-Romagna
city: Aviano (PN)
country: Italy
facility: Novartis Investigative Site
state: Friuli-Venezia-Giulia
city: Roma
country: Italy
facility: Novartis Investigative Site
state: Lazio
city: Genova
country: Italy
facility: Novartis Investigative Site
state: Liguria
city: Bergamo
country: Italy
facility: Novartis Investigative Site
state: Lombardia
city: Milano
country: Italy
facility: Novartis Investigative Site
state: Lombardia
city: Milano
country: Italy
facility: Novartis Investigative Site
state: Lombardia
city: Candiolo (TO)
country: Italy
facility: Novartis Investigative Site
state: Piemonte
city: Torino
country: Italy
facility: Novartis Investigative Site
state: Piemonte
city: Bari
country: Italy
facility: Novartis Investigative Site
state: Puglia
city: San Giovanni Rotondo (FG)
country: Italy
facility: Novartis Investigative Site
state: Puglia
city: Palermo
country: Italy
facility: Novartis Investigative Site
state: Sicilia
city: Firenze
country: Italy
facility: Novartis Investigative Site
state: Toscana
city: Pisa
country: Italy
facility: Novartis Investigative Site
state: Toscana
city: Bolzano
country: Italy
facility: Novartis Investigative Site
state: Trentino-Alto Adige
city: Perugia
country: Italy
facility: Novartis Investigative Site
state: Umbria
city: Ancona
country: Italy
facility: Novartis Investigative Site
city: Cagliari
country: Italy
facility: Novartis Investigative Site
city: Chieti
country: Italy
facility: Novartis Investigative Site
city: Macerata
country: Italy
facility: Novartis Investigative Site
city: Padova
country: Italy
facility: Novartis Investigative Site
city: Trieste
country: Italy
facility: Novartis Investigative Site
city: Kyunggi-do
country: Korea, Republic of
facility: Novartis Investigative Site
city: Pusan
country: Korea, Republic of
facility: Novartis Investigative Site
city: seodaemun-gu, Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: songpa-gu, Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Luxembourg
country: Luxembourg
facility: Novartis Investigative Site
city: Kuala Lumpur
country: Malaysia
facility: Novartis Investigative Site
city: Kuala Lumpur
country: Malaysia
facility: Novartis Investigative Site
city: Petaling Jaya Selangor
country: Malaysia
facility: Novartis Investigative Site
city: Floriana
country: Malta
facility: Novartis Investigative Site
city: Tijuana
country: Mexico
facility: Novartis Investigative Site
state: Baja California Norte
city: Toluca, Edo Mex
country: Mexico
facility: Novartis Investigative Site
state: Estado de México
city: Merida
country: Mexico
facility: Novartis Investigative Site
state: Yucatán
city: Durango
country: Mexico
facility: Novartis Investigative Site
city: Mexico City
country: Mexico
facility: Novartis Investigative Site
city: Amersfoort
country: Netherlands
facility: Novartis Investigative Site
city: Amsterdam
country: Netherlands
facility: Novartis Investigative Site
city: Amsterdam
country: Netherlands
facility: Novartis Investigative Site
city: Dordrecht
country: Netherlands
facility: Novartis Investigative Site
city: Enschede
country: Netherlands
facility: Novartis Investigative Site
city: Groningen
country: Netherlands
facility: Novartis Investigative Site
city: Leeuwarden
country: Netherlands
facility: Novartis Investigative Site
city: Leiden
country: Netherlands
facility: Novartis Investigative Site
city: Maastricht
country: Netherlands
facility: Novartis Investigative Site
city: Christchurch
country: New Zealand
facility: Novartis Investigative Site
city: Dunedin
country: New Zealand
facility: Novartis Investigative Site
city: Newtown, Wellington
country: New Zealand
facility: Novartis Investigative Site
city: Lima
country: Peru
facility: Novartis Investigative Site
city: Lima
country: Peru
facility: Novartis Investigative Site
city: Makati City
country: Philippines
facility: Novartis Investigative Site
city: Pasay City
country: Philippines
facility: Novartis Investigative Site
city: Quezon City
country: Philippines
facility: Novartis Investigative Site
city: Sampaloc Manila
country: Philippines
facility: Novartis Investigative Site
city: Bialystok
country: Poland
facility: Novartis Investigative Site
city: Bydgoszcz
country: Poland
facility: Novartis Investigative Site
city: Elblag
country: Poland
facility: Novartis Investigative Site
city: Gdansk
country: Poland
facility: Novartis Investigative Site
city: Gliwice
country: Poland
facility: Novartis Investigative Site
city: Olsztyn
country: Poland
facility: Novartis Investigative Site
city: Olsztyn
country: Poland
facility: Novartis Investigative Site
city: Poznan
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Evora
country: Portugal
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Lisboa
country: Portugal
facility: Novartis Investigative Site
city: Porto
country: Portugal
facility: Novartis Investigative Site
city: Porto
country: Portugal
facility: Novartis Investigative Site
city: Bucharest
country: Romania
facility: Novartis Investigative Site
city: Iasi
country: Romania
facility: Novartis Investigative Site
city: Sibiu
country: Romania
facility: Novartis Investigative Site
city: Timisoara
country: Romania
facility: Novartis Investigative Site
city: Irkutsk
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Nizhny Novgorod
country: Russian Federation
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Singapore
country: Singapore
facility: Novartis Investigative Site
city: Banska Bystrica
country: Slovakia
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
city: Poprad
country: Slovakia
facility: Novartis Investigative Site
city: Ljubljana
country: Slovenia
facility: Novartis Investigative Site
city: Maribor
country: Slovenia
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Basurto/Bilbao
country: Spain
facility: Novartis Investigative Site
city: Burgos
country: Spain
facility: Novartis Investigative Site
city: Caceres
country: Spain
facility: Novartis Investigative Site
city: Elche
country: Spain
facility: Novartis Investigative Site
city: Girona
country: Spain
facility: Novartis Investigative Site
city: Jaén
country: Spain
facility: Novartis Investigative Site
city: Lerida
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Malaga
country: Spain
facility: Novartis Investigative Site
city: Murcia
country: Spain
facility: Novartis Investigative Site
city: Palencia
country: Spain
facility: Novartis Investigative Site
city: Palma de Mallorca
country: Spain
facility: Novartis Investigative Site
city: Pamplona
country: Spain
facility: Novartis Investigative Site
city: Pontevedra
country: Spain
facility: Novartis Investigative Site
city: San Sebastián
country: Spain
facility: Novartis Investigative Site
city: Santa Cruz de Tenerife
country: Spain
facility: Novartis Investigative Site
city: Santiago
country: Spain
facility: Novartis Investigative Site
city: Toledo
country: Spain
facility: Novartis Investigative Site
city: Valencia
country: Spain
facility: Novartis Investigative Site
city: Valencia
country: Spain
facility: Novartis Investigative Site
city: Zaragoza
country: Spain
facility: Novartis Investigative Site
city: Jonkoping
country: Sweden
facility: Novartis Investigative Site
city: Lund
country: Sweden
facility: Novartis Investigative Site
city: Stockholm
country: Sweden
facility: Novartis Investigative Site
city: Umeå
country: Sweden
facility: Novartis Investigative Site
city: Uppsala
country: Sweden
facility: Novartis Investigative Site
city: Basel
country: Switzerland
facility: Novartis Investigative Site
city: Bern
country: Switzerland
facility: Novartis Investigative Site
city: Chur
country: Switzerland
facility: Novartis Investigative Site
city: Geneve
country: Switzerland
facility: Novartis Investigative Site
city: Mendrisio
country: Switzerland
facility: Novartis Investigative Site
city: Neuchatel
country: Switzerland
facility: Novartis Investigative Site
city: St Gallen
country: Switzerland
facility: Novartis Investigative Site
city: Zuerich
country: Switzerland
facility: Novartis Investigative Site
city: Kaohsiung
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Tainan County
country: Taiwan
facility: Novartis Investigative Site
city: Tainan
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Chiang Mai
country: Thailand
facility: Novartis Investigative Site
city: Pathumthani
country: Thailand
facility: Novartis Investigative Site
city: Chernivtsi
country: Ukraine
facility: Novartis Investigative Site
city: Kiev
country: Ukraine
facility: Novartis Investigative Site
city: Odessa
country: Ukraine
facility: Novartis Investigative Site
city: Rovno
country: Ukraine
facility: Novartis Investigative Site
city: Cambridge
country: United Kingdom
facility: Novartis Investigative Site
state: Cambridgeshire
city: Chelmsford
country: United Kingdom
facility: Novartis Investigative Site
state: Essex
city: Northwood
country: United Kingdom
facility: Novartis Investigative Site
state: Middlesex
city: Edinburgh
country: United Kingdom
facility: Novartis Investigative Site
state: Midlothian
city: Belfast
country: United Kingdom
facility: Novartis Investigative Site
city: Bournemouth
country: United Kingdom
facility: Novartis Investigative Site
city: Brighton
country: United Kingdom
facility: Novartis Investigative Site
city: Bristol
country: United Kingdom
facility: Novartis Investigative Site
city: Cardiff
country: United Kingdom
facility: Novartis Investigative Site
city: Cheltenham
country: United Kingdom
facility: Novartis Investigative Site
city: Colchester
country: United Kingdom
facility: Novartis Investigative Site
city: Cumbria
country: United Kingdom
facility: Novartis Investigative Site
city: Denbighshire
country: United Kingdom
facility: Novartis Investigative Site
city: Hartshill, Stoke-on-Trent
country: United Kingdom
facility: Novartis Investigative Site
city: Lindley, huddersfield
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Manchester
country: United Kingdom
facility: Novartis Investigative Site
city: Nottingham
country: United Kingdom
facility: Novartis Investigative Site
city: Peterborough
country: United Kingdom
facility: Novartis Investigative Site
city: Poole, Dorset
country: United Kingdom
facility: Novartis Investigative Site
city: Portsmouth
country: United Kingdom
facility: Novartis Investigative Site
city: Shrewsbury
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.