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Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer
This study has been completed.
First Received: January 7, 2004   Last Updated: December 23, 2008   History of Changes
Sponsor: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00075270
  Purpose

The purpose of this study is to determine the efficacy and safety of an oral dual tyrosine kinase inhibitor (GW572016) in combination with paclitaxel compared to paclitaxel alone in first line advanced or metastatic breast cancer.


Condition Intervention Phase
Metastatic Breast Cancer
Drug: Paclitaxel
Drug: GW572016 (Lapatinib)
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Phase III Study of Oral GW572016 in Combination With Paclitaxel in Subjects Previously Untreated or Advanced or Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • To evaluate and compare the 2 treatment groups with respect to time to progression (TTP) in subjects with metastatic breast cancer.

Secondary Outcome Measures:
  • Compare the following data between the 2 treatment groups: Tumor Response Clinical Benefit Time to Response Duration of Response Survival Rate Toxicity Biomarker Signals

Enrollment: 570
Study Start Date: January 2004
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Signed Informed Consent
  • Able to swallow an oral medication
  • Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram
  • Adequate kidney and liver function
  • Adequate bone marrow function
  • Tumor tissue available for testing
  • Prior adjuvant or neoadjuvant therapy is permitted with an anthracycline or anthracenedione-containing regimen however, subjects must have had cumulative doses of less than 360 mg/m2 of doxorubicin, 720 mg/m2 of epirubicin, or 72 mg/m2 of mitoxantrone
  • No Her2/neu overexpression in tumor tissue tested or status unknown if tissue has never been tested

Exclusion criteria:

  • Prior treatment regimens for advanced or metastatic breast cancer.
  • Pregnant or lactating
  • Conditions that would effect the absorption of an oral drug
  • Active infection
  • Brain metastases
  • Treatment with EGFR (Endothelial Growth Factor Receptor) inhibitor.
  • Known hypersensitivity to Taxol or excipients of Taxol
  • Peripheral neuropathy of Grade 2 or greater is not permitted
  • Severe Cardiovascular disease or cardiac disease requiring a device.
  • Serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075270

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Locations
United States, Arizona
GSK Investigational Site
Tucson, Arizona, United States, 85712
United States, Arkansas
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
United States, California
GSK Investigational Site
Fountain Valley, California, United States, 92708
GSK Investigational Site
Vallejo, California, United States, 94589
GSK Investigational Site
La Jolla, California, United States, 92093-0987
United States, Colorado
GSK Investigational Site
Denver, Colorado, United States, 80218
United States, Florida
GSK Investigational Site
Boca Raton, Florida, United States, 33486
GSK Investigational Site
Altamonte Springs, Florida, United States, 32701
GSK Investigational Site
Port St. Lucie, Florida, United States, 34952
United States, Georgia
GSK Investigational Site
Marietta, Georgia, United States, 30060
GSK Investigational Site
Atlanta, Georgia, United States, 30341
GSK Investigational Site
Savannah, Georgia, United States, 31405
GSK Investigational Site
Savannah, Georgia, United States, 31406
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46260
United States, Kansas
GSK Investigational Site
Kansas City, Kansas, United States, 66160
United States, Louisiana
GSK Investigational Site
Metairie, Louisiana, United States, 70006
United States, Maryland
GSK Investigational Site
Glen Burnie, Maryland, United States, 21225
United States, Massachusetts
GSK Investigational Site
Springfield, Massachusetts, United States, 01199
United States, Minnesota
GSK Investigational Site
Robbinsdale, Minnesota, United States, 55422
United States, Missouri
GSK Investigational Site
St. Louis, Missouri, United States, 63141
United States, New Jersey
GSK Investigational Site
Voorhees, New Jersey, United States, 08043
United States, New York
GSK Investigational Site
Nyack, New York, United States, 10960
United States, North Dakota
GSK Investigational Site
Fargo, North Dakota, United States, 58103
United States, Ohio
GSK Investigational Site
Canton, Ohio, United States, 44718
United States, Oregon
GSK Investigational Site
Portland, Oregon, United States, 97227
United States, South Carolina
GSK Investigational Site
West Columbia, South Carolina, United States, 29169
United States, Tennessee
GSK Investigational Site
Knoxville, Tennessee, United States, 37916
GSK Investigational Site
Knoxville, Tennessee, United States, 37920
United States, Texas
GSK Investigational Site
Fort Worth, Texas, United States, 76104
GSK Investigational Site
San Antonio, Texas, United States, 78229
GSK Investigational Site
Amarillo, Texas, United States, 79106
United States, Virginia
GSK Investigational Site
Norfolk, Virginia, United States, 23502
United States, Washington
GSK Investigational Site
Tacoma, Washington, United States, 98405
United States, Wisconsin
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53226
Argentina
GSK Investigational Site
Buenos Aires, Argentina, 1425
Argentina, Buenos Aires
GSK Investigational Site
Capital Federal, Buenos Aires, Argentina, C1426ANZ
GSK Investigational Site
Capital Federal, Buenos Aires, Argentina, C1405CBA
Australia, Victoria
GSK Investigational Site
Malvern, Victoria, Australia, 3144
GSK Investigational Site
Wodonga, Victoria, Australia, 3690
Australia, Western Australia
GSK Investigational Site
Nedlands, Western Australia, Australia, 6009
Belgium
GSK Investigational Site
Kortrijk, Belgium, 8500
GSK Investigational Site
Roeselare, Belgium, 8800
GSK Investigational Site
Leuven, Belgium, 3000
GSK Investigational Site
Brussels, Belgium, 1070
GSK Investigational Site
Brussel, Belgium, 1090
Brazil
GSK Investigational Site
Rio de Janeiro, Brazil, 20560-120
Brazil, Bahía
GSK Investigational Site
Salvador, Bahía, Brazil, 41825-010
Canada, Newfoundland and Labrador
GSK Investigational Site
Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Quebec
GSK Investigational Site
Montreal, Quebec, Canada, H4J 1C5
GSK Investigational Site
Montreal, Quebec, Canada, H3T 1E2
GSK Investigational Site
Sherbrooke, Quebec, Canada, J1H 5N4
Chile, Región Metro De Santiago
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7500921
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7591046
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile
Czech Republic
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 05
GSK Investigational Site
Olomouc, Czech Republic, 775 20
GSK Investigational Site
Brno, Czech Republic, 656 53
Germany
GSK Investigational Site
Berlin, Germany, 10117
GSK Investigational Site
Berlin, Germany, 10367
GSK Investigational Site
Hamburg, Germany, 22457
GSK Investigational Site
Hamburg, Germany, 20259
GSK Investigational Site
Hamburg, Germany, 22765
Germany, Baden-Wuerttemberg
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70190
GSK Investigational Site
Ulm, Baden-Wuerttemberg, Germany, 89075
GSK Investigational Site
Aalen, Baden-Wuerttemberg, Germany, 73428
Germany, Bayern
GSK Investigational Site
Muenchen, Bayern, Germany, 80637
GSK Investigational Site
Coburg, Bayern, Germany, 96450
Germany, Brandenburg
GSK Investigational Site
Fuerstenwalde, Brandenburg, Germany, 15517
Germany, Nordrhein-Westfalen
GSK Investigational Site
Ibbenbueren, Nordrhein-Westfalen, Germany, 49477
Germany, Schleswig-Holstein
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany, 24103
Germany, Thueringen
GSK Investigational Site
Jena, Thueringen, Germany, 07743
Hungary
GSK Investigational Site
Budapest, Hungary, 1082
GSK Investigational Site
Szombathely, Hungary, 9700
GSK Investigational Site
Zalaegerszeg-Pózva, Hungary, 8900
GSK Investigational Site
Nyíregyháza, Hungary, 4400
Italy, Campania
GSK Investigational Site
Benevento, Campania, Italy, 82100
GSK Investigational Site
Napoli, Campania, Italy, 80131
Italy, Emilia-Romagna
GSK Investigational Site
Parma, Emilia-Romagna, Italy, 43100
GSK Investigational Site
Forlì, Emilia-Romagna, Italy, 47100
GSK Investigational Site
Rimini, Emilia-Romagna, Italy, 47900
GSK Investigational Site
Ravenna, Emilia-Romagna, Italy, 48100
Italy, Lazio
GSK Investigational Site
Roma, Lazio, Italy, 00157
GSK Investigational Site
Roma, Lazio, Italy, 00152
Italy, Liguria
GSK Investigational Site
Pietra Ligure (SV), Liguria, Italy, 17027
Italy, Lombardia
GSK Investigational Site
Pavia, Lombardia, Italy, 27100
GSK Investigational Site
Bergamo, Lombardia, Italy, 24128
Italy, Piemonte
GSK Investigational Site
Torino, Piemonte, Italy, 10153
GSK Investigational Site
Candiolo (TO), Piemonte, Italy, 10060
Italy, Sardegna
GSK Investigational Site
Sassari, Sardegna, Italy, 07100
Italy, Toscana
GSK Investigational Site
Prato (PO), Toscana, Italy, 59100
Italy, Umbria
GSK Investigational Site
Perugia, Umbria, Italy, 06156
Korea, Republic of
GSK Investigational Site
Seoul, Korea, Republic of, 135-710
GSK Investigational Site
Gyeonggi-do, Korea, Republic of, 411-769
Latvia
GSK Investigational Site
Liepaja, Latvia, LV3401
GSK Investigational Site
Daugavpils, Latvia, LV5420
GSK Investigational Site
Riga, Latvia, LV 1002
GSK Investigational Site
Riga, Latvia, LV 1079
Mexico
GSK Investigational Site
Colima, Mexico, 28010
GSK Investigational Site
Durango, Mexico, 34000
Mexico, Guerrero
GSK Investigational Site
Acapulco, Guerrero, Mexico, 39670
Mexico, Jalisco
GSK Investigational Site
Guadalajara, Jalisco, Mexico, CP44280
Netherlands
GSK Investigational Site
UTRECHT, Netherlands, 3584 CX
GSK Investigational Site
NIEUWEGEIN, Netherlands, 3435 CM
GSK Investigational Site
AMERSFOORT, Netherlands, 3816 CP
GSK Investigational Site
UTRECHT, Netherlands, 2584 CX
New Zealand
GSK Investigational Site
Christchurch, New Zealand, 8001
GSK Investigational Site
Auckland, New Zealand, 1001
Pakistan
GSK Investigational Site
Lahore, Pakistan, 54000
Peru
GSK Investigational Site
Callao, Peru, Callao 2
GSK Investigational Site
Lima, Peru, Lima 34
Poland
GSK Investigational Site
Poznan, Poland, 61-866
GSK Investigational Site
Warszawa, Poland, 02-781
GSK Investigational Site
Wroclaw, Poland, 53-413
GSK Investigational Site
Krakow, Poland, 31-826
GSK Investigational Site
Olsztyn, Poland, 10-228
GSK Investigational Site
Olsztyn, Poland, 10-226
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 129301
GSK Investigational Site
Moscow, Russian Federation, 129 128
GSK Investigational Site
Moscow Region, Russian Federation, 143 423
GSK Investigational Site
Moscow, Russian Federation, 115 478
GSK Investigational Site
Moscow, Russian Federation, 107005
GSK Investigational Site
St. Petersburg, Russian Federation, 197758
GSK Investigational Site
St. Petersburg, Russian Federation, 197022
GSK Investigational Site
Moscow, Russian Federation, 117997
Slovakia
GSK Investigational Site
Bratislava, Slovakia, 833 10
GSK Investigational Site
Banska Bystrica, Slovakia, 975 17
GSK Investigational Site
Kosice, Slovakia, 041 91
South Africa
GSK Investigational Site
Pretoria, South Africa, 0084
GSK Investigational Site
Port Elizabeth, South Africa, 6001
GSK Investigational Site
OVERPORT, South Africa, 4000
Spain
GSK Investigational Site
Madrid, Spain, 28035
GSK Investigational Site
Caceres, Spain, 10003
GSK Investigational Site
Las Palmas De Gran Canaria, Spain, 35016
GSK Investigational Site
La Laguna (Santa Cruz de Tenerife), Spain, 38320
GSK Investigational Site
Palma de Mallorca, Spain, 07014
GSK Investigational Site
Jaen, Spain, 23007
GSK Investigational Site
Alcorcon, Spain, 28922
GSK Investigational Site
Zaragoza, Spain, 50009
GSK Investigational Site
Baracaldo/Vizcaya, Spain, 48903
GSK Investigational Site
Cuidad Real, Spain, 13002
GSK Investigational Site
Zaragoza, Spain
GSK Investigational Site
Móstoles/Madrid, Spain, 28935
GSK Investigational Site
San Sebastián, Spain, 20014
GSK Investigational Site
Pontevedra, Spain, 36071
Turkey
GSK Investigational Site
Istanbul, Turkey, 34865
GSK Investigational Site
Istanbul, Turkey
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: EGF30001
Study First Received: January 7, 2004
Last Updated: December 23, 2008
ClinicalTrials.gov Identifier: NCT00075270     History of Changes
Health Authority: United States: Food and Drug Administration;   Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:
lapatinib
metastatic breast cancer
EGFR
Her2-neu
ErbB1
ErbB2
kinase inhibitor

Additional relevant MeSH terms:
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Breast Neoplasms
Enzyme Inhibitors
Lapatinib
Antimitotic Agents
Protein Kinase Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Breast Diseases

ClinicalTrials.gov processed this record on November 25, 2009