Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00075270
First received: January 7, 2004
Last updated: February 13, 2014
Last verified: December 2013
  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
Neoplasms, Breast
Drug: Paclitaxel
Drug: GW572016 (Lapatinib)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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:
  • Time to Progression as Evaluated by the Investigator [ Time Frame: Randomization until the date of disease progression or death (average of 26 weeks) ] [ Designated as safety issue: No ]
    Time to progression (TTP) is defined as the interval between the date of randomization and the earliest date of progression of disease (PD) or death due to breast cancer. The investigator assessed PD based on radiological PD (imaging data) and clinical symptomatic progress (Response Evaluation Criteria in Solid Tumors [RECIST] Criteria: target lesion (TL), at least a 20% increase in the sum of largest diameter (LD) of TLs or the appearance of one or more new lesions; non-TL (NTL), the appearance of one or more new lesions and/or unequivocal progression of existing NTLs). TTP was assessed in participants who died due to breast cancer or progressed, as assessed by the investigator, as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored participants (those without a documented date of disease progression/death due to breast cancer), the date of the last radiographic assessment was used.

  • Time to Progression as Evaluated by the Independent Review Committee (IRC) [ Time Frame: Randomization until the date of disease progression or death (average of 26 weeks) ] [ Designated as safety issue: No ]
    Time to progression is defined as the interval between the date of randomization and the earliest date of progression of disease (PD) or death due to breast cancer. The IRC assessed PD based on radiological PD (imaging data) and clinical symptomatic progress (Response Evaluation Criteria in Solid Tumors [RECIST] Criteria: target lesion (TL), at least a 20% increase in the sum of largest diameter (LD) of TLs or the appearance of one or more new lesions; non-TL (NTL), the appearance of one or more new lesions and/or unequivocal progression of existing NTLs). TTP was assessed in participants who died due to breast cancer or progressed, as assessed by the independent reviewer, as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored participants (those without a documented date of disease progression/death due to breast cancer), the date of the last radiographic assessment was used.


Secondary Outcome Measures:
  • Number of Participants With Tumor Response as Evaluated by the Investigator [ Time Frame: Randomization until the date of disease progression or death (average of 26 weeks) ] [ Designated as safety issue: No ]
    The percentage of participants with tumor response is defined as those participants with measurable disease who achieved either a complete response (CR) or partial response (PR). The Response Evaluation Criteria in Solid Tumors (RECIST) was used to evaluate the measurability of tumor lesions, to determine target lesion (TLs) and non-target lesion (NTLs). CR (TLs and NTLs): the disappearance of all TLs and NTLs; PR (for TLs): at least a 30% decrease in the sum of the largest diameter (LD) of TLs, taking as a reference the Baseline sum LD; PR (for NTLs): persistence of one or more lesions.

  • Number of Participants With Tumor Response as Evaluated by the Independent Review Committee [ Time Frame: Randomization until the date of disease progression or death (average of 26 weeks) ] [ Designated as safety issue: No ]
    The percentage of participants with tumor response is defined as those participants with measurable disease who achieved either a complete response (CR) or partial response (PR). The RECIST criteria was used to evaluate the measurability of tumor lesions, to determine target lesion (TLs) and non-target lesion (NTLs). CR (TLs and NTLs): the disappearance of all TLs and NTLs; PR (for TLs): at least a 30% decrease in the sum of the largest diameter (LD) of TLs, taking as a reference the Baseline sum LD; PR (for NTLs): persistence of one or more lesions.

  • Percentage of Participants With Clinical Benefit (CB) as Assessed by the Investigator [ Time Frame: Randomization until the date of disease progression or death (average of 26 weeks) ] [ Designated as safety issue: No ]
    Percentage of participants. with CB is defined as the percentage of participants with evidence of CR (disappearance of all TLs and NTLs), PR (TLs: a >=30% decrease in the sum of the LD, taking as a reference the Baseline sum LD; NTLs: persistence of >=1 lesion), or stable disease (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD) for >=6 months based on RECIST criteria. PD for TL: a >=20% increase in the sum of the LD of TLs or the appearance of >=1 new lesion. PD for NTLs: the appearance of >=1 new lesion and/or unequivocal progression of existing NTLs.

  • Number of Participants With a Response of CR or PR by the Indicated Study Week [ Time Frame: Weeks 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, and 72 ] [ Designated as safety issue: No ]
    Time to response (TTR) is defined as the time from randomization until the first documented evidence of CR (disappearance of all TLs and NTLs) or PR (for TLs: a >=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD; for NTLs: the persistence of >=1 lesion) (whichever status was recorded first). TTR data are displayed as the number of participants achieving a CR or PR by the indicated week. The investigator evaluated the TTR, and the analysis was based on responses confirmed at a repeat assessment, with the TTR taken as the first time the response was observed.

  • Duration of Response (DOR) [ Time Frame: From the time of the first documented complete or partial response until the first documented evidence of progression or death (average of 26 weeks) ] [ Designated as safety issue: No ]
    The investigator evaluated the DOR for the subset of participants who showed a CR (disappearance of all TLs and NTLs) or PR (TLs: a >=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD; NTLs: persistence of >=1 lesion). DOR is defined as the time from the first documented evidence of PR or CR until the first documented sign of PD (TL: a >=20% increase in the sum of the LD of TLs or the appearance of >=1 new lesion; NTL: the appearance of >=1 new lesion and/or unequivocal progression of existing NTLs) or death due to breast cancer, if sooner.

  • Progression-Free Survival (PFS) [ Time Frame: Randomization until the date of disease progression or death (average of 26 weeks) ] [ Designated as safety issue: No ]
    PFS is defined as the interval between the date of randomization and the earliest date of progression disease (PD) or death due to any cause, if sooner. For TLs, progressive disease is defined as at least a 20% increase in the sum of the LD of TLs or the appearance of 1 or more new lesions. For NTLs, progressive disease is defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. par., participants.

  • Number of Participants Who Progressed or Died at or Prior to 6 Months, as a Measure of Six Months Progression-free Survival (PFS) [ Time Frame: Randomization until the date of disease progression or death (average of 26 weeks) ] [ Designated as safety issue: No ]
    PFS is defined as the interval between the date of randomization and the earliest date of disease progression or death due to any cause, if sooner. Six months PFS is defined as PFS at six months from the time of randomization. Raw data for 6 months PFS are not available; thus, data are presented as the number of participants who progressed or died at or prior to 6 months. For TLs, progressive disease is defined asat least a 20% increase in the sum of the LD of TLs or the appearance of 1 or more new lesions. For NTLs, progressive disease is defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. PFS was assessed in participants who died or progressed, as well as in those who were censored and completed follow-up and those who were censored but are still being followed. For censored participants (those without a documented date of disease progression/death due to breast cancer), the date of the last radiographic assessment was used.

  • Overall Survival [ Time Frame: Randomization until the date of death due to any cause (average of 24 months) ] [ Designated as safety issue: No ]
    Overall survival is defined as the time from randomization until death due to any cause.

  • Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Questionnaire Scores [ Time Frame: Baseline (Day 1); Weeks 9, 21, 33, and 45; Withdrawal ] [ Designated as safety issue: No ]
    The FACT-B questionnaire was designed to measure multidimensional quality of life (QOL) in participants with breast cancer. The physical and functional well-being subscale scores range from 0 to 28, based on 7 questions (each scored from 0 [not at all] to 4 [very much] for all subscales); the emotional and social/family well-being (1 question optional) subscale scores range from 0 to 24 (based on 6 questions), and the additional concerns subscale score ranges from 0 to 40, based on 10 questions. The FACT-B Total Score (0 [better QOL] to 144 [worse QOL]) is the sum of the subscale scores.

  • Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores [ Time Frame: Baseline (Day 1); Weeks 9, 21, 33, and 45; Withdrawal ] [ Designated as safety issue: No ]
    The FACT-G questionnaire was designed to measure multidimensional QOL in participants with cancer and includes subscales for physical, social/family, emotional, and functional well-being. The physical, social/family, and functional well-being subscale scores range from 0 to 28, based on responses to 7 questions (each question scored from 0 [not at all] to 4 [very much]); the emotional well-being subscale score ranges from 0 to 24, based on responses to 6 questions. The FACT-G Total Score (ranging from 0 [better QOL] to 108 [worse QOL]) is the sum of the subscale scores.

  • Change From Baseline in Trial Outcome Index (TOI) Questionnaire Scores [ Time Frame: Baseline (Day 1); Weeks 9, 21, 33, and 45; Withdrawal ] [ Designated as safety issue: No ]
    The TOI questionnaire was designed to measure multidimensional QOL in participants with cancer and includes subscales for physical, functional well-being, and additional cancer concerns. The physical and functional well-being subscale scores range from 0 to 28, based on 7 questions (each question scored from 0 [not at all] to 4 [very much]); the breast cancer unweighted subscale scores range from 0 to 36, based on 9 questions. The total TOI score (ranging from 0 [better QOL] to 92 [worse QOL]) is the sum of the TOI subscale scores.

  • Number of Participants With the Indicated ErbB2 Status at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The Press Laboratory collected tumor tissues of participants for ErbB2 testing. ErbB2 testing is done to detect breast cancer and predict its likely outcome. All samples were analyzed by the Press Laboratory. Participants were categorized as ErbB2 positive (overexpression of the ErbB2 gene), ErbB2 negative, and assay not done (which included participants with no available samples and those with inconclusive results). ErbB2 status is determined by immunohistochemistry (ICH) assay and fluorescence in situ hybridization (FISH) testing. Negative ErbB2 status is defined as 0 or 1+ by IHC, or as 2+ by IHC and FISH.

  • ErbB2 Ratio [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The Press Laboratory collected tumor tissues of participants for biomarker testing. All samples were analyzed by the Press Laboratory. The ratio of ErbB2 gene signals to chromosome 17 signals, which indicates the progression of breast cancer, was calculated. Low levels of amplification (few copies) may have a ratio of 2-5, whereas high levels of amplification may have a ratio >10.

  • Number of Participants With the Indicated Immunohistochemistry (IHC) Results at Screening [ Time Frame: Screening (Day -1) ] [ Designated as safety issue: No ]
    The Press Laboratory tested tumor tissue samples (taken at Screening, prior to randomization to study treatment) to determine intra-tumoral expression levels of ErbB1, ErbB2, and other analytes associated with these pathways by IHC, the process of detecting antigens (e.g., proteins) in cells of a tissue section. The IHC assessment is expressed as: 0, no staining (no cancer cells); 1+, faint staining; 2+, weak to moderate complete staining; 3+, strong complete staining (many cancer cells). A status of "Assay not done" was assigned to participants with no available samples and to those with inconclusive results. If strong staining is observed, breast cancer that has high levels of HER2 expression (overexpression) is indicated. If moderate/weak staining is observed (IHC=2+), breast cancer that has low/moderate expression levels is indicated. When no staining is observed (IHC=0), breast cancer HER2 expression may be below the level of detection of the assay.

  • Number of Participants With the Indicated ErbB2 Fluorescence in Situ Hybridization (FISH) Results [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The Press Laboratory tested participants who were 2+ (weak to moderate complete staining) or 3+ (strong complete staining) for ErbB2 overexpression by IHC for ErbB2 gene amplification using the FISH assay. The results of the FISH assay can be ErbB2 gene "amplification" (increased number of copies of the ErbB2 gene) or "non-amplification" (not many copies of the ErbB2 gene). A status of "Assay not done" was assigned to those participants with no available samples and to those with inconclusive results (e.g., due to hybridization or staining problems).

  • Serum ErbB1 Concentration [ Time Frame: Screening (Day-1) and Withdrawal (up to Study Week 129) ] [ Designated as safety issue: No ]
    The Quest Laboratory collected blood samples for quantitative determination of serum ErbB1. The results of serum monitoring were used to compare tumor response rates following randomized therapy.

  • Serum ErbB2 Concentration [ Time Frame: Screening (Day-1) and Withdrawal (up to Study Week 129) ] [ Designated as safety issue: No ]
    The Quest Laboratory collected blood samples for quantitative determination of serum ErbB2. The results of serum monitoring were used to compare tumor response rates following randomized therapy.

  • Number of Participants With the Indicated Adverse Events (AEs) With a Maximum Toxicity Grade of 3 or 4 [ Time Frame: Baseline (Day 1) until 30 days after the last dose of randomized therapy (average of 26 weeks) ] [ Designated as safety issue: No ]
    The severity of adverse events was graded per the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 3. Grades 1 through 5 have unique clinical descriptions of severity for each AE based on the following general guideline: Grade 1, Mild AE; Grade 2, Moderate AE; Grade 3, Severe AE; Grade 4, Life-threatening or disabling AE; Grade 5, death related to AE.


Enrollment: 580
Study Start Date: January 2004
Study Completion Date: March 2012
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Lapatinib 1500 mg, once daily and Paclitaxel 175 mg/m Intravenously over 3 hours ever 3 weeks
Drug: Paclitaxel
Active Comparator
Drug: GW572016 (Lapatinib)
Oral GW572016 Lapatinib
Other Names:
  • Paclitaxel
  • GW572016 (Lapatinib)
Placebo Comparator: Arm 2
Paclitaxel 175 mg/m Intravenously over 3 hours ever 3 weeks and Placebo
Drug: Paclitaxel
Active Comparator

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Hot Springs, Arkansas, United States, 71913
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
United States, California
GSK Investigational Site
Fountain Valley, California, United States, 92708
GSK Investigational Site
La Jolla, California, United States, 92093-0987
GSK Investigational Site
Rancho Mirage, California, United States, 92270
GSK Investigational Site
Vallejo, California, United States, 94589
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
Orlando, Florida, United States, 32804
GSK Investigational Site
Port St. Lucie, Florida, United States, 34952
GSK Investigational Site
West Palm Beach, Florida, United States, 33401
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30341
GSK Investigational Site
Marietta, Georgia, United States, 30060
GSK Investigational Site
Savannah, Georgia, United States, 31406
GSK Investigational Site
Savannah, Georgia, United States, 31405
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
Baltimore, Maryland, United States, 21201
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
Duluth, Minnesota, United States, 55802
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 Mexico
GSK Investigational Site
Santa Fe, New Mexico, United States, 87505
United States, New York
GSK Investigational Site
Nyack, New York, United States, 10960
GSK Investigational Site
Syracuse, New York, United States, 13210
United States, North Carolina
GSK Investigational Site
Charlotte, North Carolina, United States, 28203
GSK Investigational Site
Greenville, North Carolina, United States, 27834
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
Columbia, South Carolina, United States, 29210
United States, Tennessee
GSK Investigational Site
Knoxville, Tennessee, United States, 37920
GSK Investigational Site
Knoxville, Tennessee, United States, 37916
United States, Texas
GSK Investigational Site
Amarillo, Texas, United States, 79106
GSK Investigational Site
Fort Worth, Texas, United States, 76104
GSK Investigational Site
Houston, Texas, United States, 77054
GSK Investigational Site
San Antonio, Texas, United States, 78229
United States, Vermont
GSK Investigational Site
Burlington, Vermont, United States, 05401
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
Capital Federal, Buenos Aires, Argentina, C1426ANZ
GSK Investigational Site
Capital Federal, Buenos Aires, Argentina, C1405CBA
GSK Investigational Site
Buenos Aires, Argentina, 1425
Australia, Victoria
GSK Investigational Site
Fitzroy, Victoria, Australia, 3065
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
Austria
GSK Investigational Site
Vienna, Austria, A-1090
Belgium
GSK Investigational Site
Brugge, Belgium, 8000
GSK Investigational Site
Brussel, Belgium, 1090
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Brussels, Belgium, 1070
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Kortrijk, Belgium, 8500
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Leuven, Belgium, 3000
GSK Investigational Site
Roeselare, Belgium, 8800
Brazil
GSK Investigational Site
Salvador, Bahía, Brazil, 41825-010
GSK Investigational Site
Rio de Janeiro, Brazil, 20560-120
Canada, Newfoundland and Labrador
GSK Investigational Site
Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
GSK Investigational Site
Sudbury, Ontario, Canada, P3E 5J1
GSK Investigational Site
Thunder Bay, Ontario, Canada, P7B 6V4
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
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7591046
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7500921
Czech Republic
GSK Investigational Site
Brno, Czech Republic, 656 53
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 05
GSK Investigational Site
Olomouc, Czech Republic, 775 20
Germany
GSK Investigational Site
Aalen, Baden-Wuerttemberg, Germany, 73428
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70190
GSK Investigational Site
Ulm, Baden-Wuerttemberg, Germany, 89075
GSK Investigational Site
Augsburg, Bayern, Germany, 86150
GSK Investigational Site
Bayreuth, Bayern, Germany, 95445
GSK Investigational Site
Coburg, Bayern, Germany, 96450
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Muenchen, Bayern, Germany, 80637
GSK Investigational Site
Muenchen, Bayern, Germany, 80335
GSK Investigational Site
Fuerstenwalde, Brandenburg, Germany, 15517
GSK Investigational Site
Stade, Niedersachsen, Germany, 21680
GSK Investigational Site
Herne, Nordrhein-Westfalen, Germany, 44625
GSK Investigational Site
Ibbenbueren, Nordrhein-Westfalen, Germany, 49477
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48149
GSK Investigational Site
Halle, Sachsen-Anhalt, Germany, 06120
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany, 24103
GSK Investigational Site
Jena, Thueringen, Germany, 07743
GSK Investigational Site
Berlin, Germany, 10117
GSK Investigational Site
Berlin, Germany, 13353
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Berlin, Germany, 14195
GSK Investigational Site
Berlin, Germany, 10367
GSK Investigational Site
Hamburg, Germany, 22767
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Hamburg, Germany, 20259
GSK Investigational Site
Hamburg, Germany, 22457
Hungary
GSK Investigational Site
Budapest, Hungary, 1082
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Nyíregyháza, Hungary, 4400
GSK Investigational Site
Szombathely, Hungary, 9700
GSK Investigational Site
Zalaegerszeg-Pózva, Hungary, 8900
Italy
GSK Investigational Site
Benevento, Campania, Italy, 82100
GSK Investigational Site
Napoli, Campania, Italy, 80131
GSK Investigational Site
Forlì, Emilia-Romagna, Italy, 47100
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Parma, Emilia-Romagna, Italy, 43100
GSK Investigational Site
Ravenna, Emilia-Romagna, Italy, 48100
GSK Investigational Site
Rimini, Emilia-Romagna, Italy, 47900
GSK Investigational Site
Roma, Lazio, Italy, 00157
GSK Investigational Site
Roma, Lazio, Italy, 00152
GSK Investigational Site
Pietra Ligure (SV), Liguria, Italy, 17027
GSK Investigational Site
Bergamo, Lombardia, Italy, 24128
GSK Investigational Site
Pavia, Lombardia, Italy, 27100
GSK Investigational Site
Candiolo (TO), Piemonte, Italy, 10060
GSK Investigational Site
Torino, Piemonte, Italy, 10153
GSK Investigational Site
Sassari, Sardegna, Italy, 07100
GSK Investigational Site
Prato (PO), Toscana, Italy, 59100
GSK Investigational Site
Perugia, Umbria, Italy, 06122
Korea, Republic of
GSK Investigational Site
Gyeonggi-do, Korea, Republic of, 411-769
GSK Investigational Site
Seoul, Korea, Republic of, 135-710
Latvia
GSK Investigational Site
Daugavpils, Latvia, LV5420
GSK Investigational Site
Liepaja, Latvia, LV3401
GSK Investigational Site
Riga, Latvia, LV 1079
GSK Investigational Site
Riga, Latvia, LV 1002
Mexico
GSK Investigational Site
Acapulco, Guerrero, Mexico, 39670
GSK Investigational Site
Guadalajara, Jalisco, Mexico, CP44280
GSK Investigational Site
Colima, Mexico, 28010
GSK Investigational Site
Durango, Mexico, 34000
Netherlands
GSK Investigational Site
Amersfoort, Netherlands, 3816 CP
GSK Investigational Site
Leiden, Netherlands, 2333 ZA
GSK Investigational Site
Nieuwegein, Netherlands, 3435 CM
GSK Investigational Site
Utrecht, Netherlands, 3584 CX
GSK Investigational Site
Utrecht, Netherlands, 2584 CX
New Zealand
GSK Investigational Site
Auckland, New Zealand, 1001
GSK Investigational Site
Christchurch, New Zealand, 8001
Pakistan
GSK Investigational Site
Lahore, 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
Krakow, Poland, 31-826
GSK Investigational Site
Olsztyn, Poland, 10-228
GSK Investigational Site
Olsztyn, Poland, 10-226
GSK Investigational Site
Poznan, Poland, 61-866
GSK Investigational Site
Warszawa, Poland, 02-781
GSK Investigational Site
Wroclaw, Poland, 53-413
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 129 128
GSK Investigational Site
Moscow, Russian Federation, 115 478
GSK Investigational Site
Moscow, Russian Federation, 105005
GSK Investigational Site
Moscow, Russian Federation, 117997
GSK Investigational Site
Moscow, Russian Federation, 129301
GSK Investigational Site
Moscow Region, Russian Federation, 143 423
GSK Investigational Site
St. Petersburg, Russian Federation, 197022
GSK Investigational Site
St. Petersburg, Russian Federation, 197758
Slovakia
GSK Investigational Site
Banska Bystrica, Slovakia, 975 17
GSK Investigational Site
Bratislava, Slovakia, 833 10
GSK Investigational Site
Kosice, Slovakia, 041 91
GSK Investigational Site
Poprad, Slovakia, 058 01
South Africa
GSK Investigational Site
Parktown, Gauteng, South Africa, 2193
GSK Investigational Site
Capital Park, South Africa, 0002
GSK Investigational Site
Overport, South Africa, 4001
GSK Investigational Site
Parow, South Africa, 7525
GSK Investigational Site
Port Elizabeth, South Africa, 6001
Spain
GSK Investigational Site
Alcorcón/Madrid, Spain, 28922
GSK Investigational Site
Baracaldo/Vizcaya, Spain, 48903
GSK Investigational Site
Caceres, Spain, 10003
GSK Investigational Site
Cuidad Real, Spain, 13002
GSK Investigational Site
Jaen, Spain, 23007
GSK Investigational Site
La Laguna (Santa Cruz de Tenerife), Spain, 38320
GSK Investigational Site
Las Palmas De Gran Canaria, Spain, 35016
GSK Investigational Site
Madrid, Spain, 28035
GSK Investigational Site
Móstoles/Madrid, Spain, 28935
GSK Investigational Site
Palma de Mallorca, Spain, 07014
GSK Investigational Site
Pontevedra, Spain, 36071
GSK Investigational Site
San Sebastián, Spain, 20014
GSK Investigational Site
Zaragoza, Spain, 50009
GSK Investigational Site
Zaragoza, Spain
Turkey
GSK Investigational Site
Istanbul, Turkey
GSK Investigational Site
Istanbul, Turkey, 34865
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00075270     History of Changes
Obsolete Identifiers: NCT00085046
Other Study ID Numbers: EGF30001
Study First Received: January 7, 2004
Results First Received: March 14, 2013
Last Updated: February 13, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 19, 2014