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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00075270




Registration number
NCT00075270
Ethics application status
Date submitted
7/01/2004
Date registered
9/01/2004
Date last updated
6/05/2015

Titles & IDs
Public title
Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer
Scientific 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
Secondary ID [1] 0 0
EGF30001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms, Breast 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Paclitaxel
Treatment: Drugs - GW572016 (Lapatinib)

Experimental: Arm 1 - Lapatinib 1500 mg, once daily and Paclitaxel 175 mg/m Intravenously over 3 hours ever 3 weeks

Placebo Comparator: Arm 2 - Paclitaxel 175 mg/m Intravenously over 3 hours ever 3 weeks and Placebo


Treatment: Drugs: Paclitaxel
Active Comparator

Treatment: Drugs: GW572016 (Lapatinib)
Oral GW572016 Lapatinib

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to Progression as Evaluated by the Investigator - 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.
Timepoint [1] 0 0
Randomization until the date of disease progression or death (average of 26 weeks)
Primary outcome [2] 0 0
Time to Progression as Evaluated by the Independent Review Committee (IRC) - 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.
Timepoint [2] 0 0
Randomization until the date of disease progression or death (average of 26 weeks)
Secondary outcome [1] 0 0
Number of Participants With Tumor Response as Evaluated by the Investigator - 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.
Timepoint [1] 0 0
Randomization until the date of disease progression or death (average of 26 weeks)
Secondary outcome [2] 0 0
Number of Participants With Tumor Response as Evaluated by the Independent Review Committee - 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.
Timepoint [2] 0 0
Randomization until the date of disease progression or death (average of 26 weeks)
Secondary outcome [3] 0 0
Percentage of Participants With Clinical Benefit (CB) as Assessed by the Investigator - 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.
Timepoint [3] 0 0
Randomization until the date of disease progression or death (average of 26 weeks)
Secondary outcome [4] 0 0
Number of Participants With a Response of CR or PR by the Indicated Study Week - 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.
Timepoint [4] 0 0
Weeks 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, and 72
Secondary outcome [5] 0 0
Duration of Response (DOR) - 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.
Timepoint [5] 0 0
From the time of the first documented complete or partial response until the first documented evidence of progression or death (average of 26 weeks)
Secondary outcome [6] 0 0
Progression-Free Survival (PFS) - 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.
Timepoint [6] 0 0
Randomization until the date of disease progression or death (average of 26 weeks)
Secondary outcome [7] 0 0
Number of Participants Who Progressed or Died at or Prior to 6 Months, as a Measure of Six Months Progression-free Survival (PFS) - 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.
Timepoint [7] 0 0
Randomization until the date of disease progression or death (average of 26 weeks)
Secondary outcome [8] 0 0
Overall Survival - Overall survival is defined as the time from randomization until death due to any cause.
Timepoint [8] 0 0
Randomization until the date of death due to any cause (average of 24 months)
Secondary outcome [9] 0 0
Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Questionnaire Scores - 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.
Timepoint [9] 0 0
Baseline (Day 1); Weeks 9, 21, 33, and 45; Withdrawal
Secondary outcome [10] 0 0
Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores - 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.
Timepoint [10] 0 0
Baseline (Day 1); Weeks 9, 21, 33, and 45; Withdrawal
Secondary outcome [11] 0 0
Change From Baseline in Trial Outcome Index (TOI) Questionnaire Scores - 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.
Timepoint [11] 0 0
Baseline (Day 1); Weeks 9, 21, 33, and 45; Withdrawal
Secondary outcome [12] 0 0
Number of Participants With the Indicated ErbB2 Status at Baseline - 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.
Timepoint [12] 0 0
Baseline
Secondary outcome [13] 0 0
ErbB2 Ratio - 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.
Timepoint [13] 0 0
Baseline
Secondary outcome [14] 0 0
Number of Participants With the Indicated Immunohistochemistry (IHC) Results at Screening - 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.
Timepoint [14] 0 0
Screening (Day -1)
Secondary outcome [15] 0 0
Number of Participants With the Indicated ErbB2 Fluorescence in Situ Hybridization (FISH) Results - 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).
Timepoint [15] 0 0
Baseline
Secondary outcome [16] 0 0
Serum ErbB1 Concentration - 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.
Timepoint [16] 0 0
Screening (Day-1) and Withdrawal (up to Study Week 129)
Secondary outcome [17] 0 0
Serum ErbB2 Concentration - 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.
Timepoint [17] 0 0
Screening (Day-1) and Withdrawal (up to Study Week 129)
Secondary outcome [18] 0 0
Number of Participants With the Indicated Adverse Events (AEs) With a Maximum Toxicity Grade of 3 or 4 - 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.
Timepoint [18] 0 0
Baseline (Day 1) until 30 days after the last dose of randomized therapy (average of 26 weeks)

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Fitzroy
Recruitment hospital [2] 0 0
GSK Investigational Site - Malvern
Recruitment hospital [3] 0 0
GSK Investigational Site - Wodonga
Recruitment hospital [4] 0 0
GSK Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
3144 - Malvern
Recruitment postcode(s) [3] 0 0
3690 - Wodonga
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
New Mexico
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
North Dakota
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Oregon
Country [21] 0 0
United States of America
State/province [21] 0 0
South Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
United States of America
State/province [24] 0 0
Vermont
Country [25] 0 0
United States of America
State/province [25] 0 0
Virginia
Country [26] 0 0
United States of America
State/province [26] 0 0
Washington
Country [27] 0 0
United States of America
State/province [27] 0 0
Wisconsin
Country [28] 0 0
Argentina
State/province [28] 0 0
Buenos Aires
Country [29] 0 0
Austria
State/province [29] 0 0
Vienna
Country [30] 0 0
Belgium
State/province [30] 0 0
Brugge
Country [31] 0 0
Belgium
State/province [31] 0 0
Brussels
Country [32] 0 0
Belgium
State/province [32] 0 0
Brussel
Country [33] 0 0
Belgium
State/province [33] 0 0
Kortrijk
Country [34] 0 0
Belgium
State/province [34] 0 0
Leuven
Country [35] 0 0
Belgium
State/province [35] 0 0
Roeselare
Country [36] 0 0
Brazil
State/province [36] 0 0
Bahía
Country [37] 0 0
Brazil
State/province [37] 0 0
Rio de Janeiro
Country [38] 0 0
Canada
State/province [38] 0 0
Newfoundland and Labrador
Country [39] 0 0
Canada
State/province [39] 0 0
Ontario
Country [40] 0 0
Canada
State/province [40] 0 0
Quebec
Country [41] 0 0
Chile
State/province [41] 0 0
Región Metro De Santiago
Country [42] 0 0
Czech Republic
State/province [42] 0 0
Brno
Country [43] 0 0
Czech Republic
State/province [43] 0 0
Hradec Kralove
Country [44] 0 0
Czech Republic
State/province [44] 0 0
Olomouc
Country [45] 0 0
Germany
State/province [45] 0 0
Baden-Wuerttemberg
Country [46] 0 0
Germany
State/province [46] 0 0
Bayern
Country [47] 0 0
Germany
State/province [47] 0 0
Brandenburg
Country [48] 0 0
Germany
State/province [48] 0 0
Niedersachsen
Country [49] 0 0
Germany
State/province [49] 0 0
Nordrhein-Westfalen
Country [50] 0 0
Germany
State/province [50] 0 0
Sachsen-Anhalt
Country [51] 0 0
Germany
State/province [51] 0 0
Schleswig-Holstein
Country [52] 0 0
Germany
State/province [52] 0 0
Thueringen
Country [53] 0 0
Germany
State/province [53] 0 0
Berlin
Country [54] 0 0
Germany
State/province [54] 0 0
Hamburg
Country [55] 0 0
Hungary
State/province [55] 0 0
Budapest
Country [56] 0 0
Hungary
State/province [56] 0 0
Nyíregyháza
Country [57] 0 0
Hungary
State/province [57] 0 0
Szombathely
Country [58] 0 0
Hungary
State/province [58] 0 0
Zalaegerszeg-Pózva
Country [59] 0 0
Italy
State/province [59] 0 0
Campania
Country [60] 0 0
Italy
State/province [60] 0 0
Emilia-Romagna
Country [61] 0 0
Italy
State/province [61] 0 0
Lazio
Country [62] 0 0
Italy
State/province [62] 0 0
Liguria
Country [63] 0 0
Italy
State/province [63] 0 0
Lombardia
Country [64] 0 0
Italy
State/province [64] 0 0
Piemonte
Country [65] 0 0
Italy
State/province [65] 0 0
Sardegna
Country [66] 0 0
Italy
State/province [66] 0 0
Toscana
Country [67] 0 0
Italy
State/province [67] 0 0
Umbria
Country [68] 0 0
Korea, Republic of
State/province [68] 0 0
Gyeonggi-do
Country [69] 0 0
Korea, Republic of
State/province [69] 0 0
Seoul
Country [70] 0 0
Latvia
State/province [70] 0 0
Daugavpils
Country [71] 0 0
Latvia
State/province [71] 0 0
Liepaja
Country [72] 0 0
Latvia
State/province [72] 0 0
Riga
Country [73] 0 0
Mexico
State/province [73] 0 0
Guerrero
Country [74] 0 0
Mexico
State/province [74] 0 0
Jalisco
Country [75] 0 0
Mexico
State/province [75] 0 0
Colima
Country [76] 0 0
Mexico
State/province [76] 0 0
Durango
Country [77] 0 0
Netherlands
State/province [77] 0 0
Amersfoort
Country [78] 0 0
Netherlands
State/province [78] 0 0
Leiden
Country [79] 0 0
Netherlands
State/province [79] 0 0
Nieuwegein
Country [80] 0 0
Netherlands
State/province [80] 0 0
Utrecht
Country [81] 0 0
New Zealand
State/province [81] 0 0
Auckland
Country [82] 0 0
New Zealand
State/province [82] 0 0
Christchurch
Country [83] 0 0
Pakistan
State/province [83] 0 0
Lahore
Country [84] 0 0
Peru
State/province [84] 0 0
Callao
Country [85] 0 0
Peru
State/province [85] 0 0
Lima
Country [86] 0 0
Poland
State/province [86] 0 0
Krakow
Country [87] 0 0
Poland
State/province [87] 0 0
Olsztyn
Country [88] 0 0
Poland
State/province [88] 0 0
Poznan
Country [89] 0 0
Poland
State/province [89] 0 0
Warszawa
Country [90] 0 0
Poland
State/province [90] 0 0
Wroclaw
Country [91] 0 0
Russian Federation
State/province [91] 0 0
Moscow Region
Country [92] 0 0
Russian Federation
State/province [92] 0 0
Moscow
Country [93] 0 0
Russian Federation
State/province [93] 0 0
St. Petersburg
Country [94] 0 0
Slovakia
State/province [94] 0 0
Banska Bystrica
Country [95] 0 0
Slovakia
State/province [95] 0 0
Bratislava
Country [96] 0 0
Slovakia
State/province [96] 0 0
Kosice
Country [97] 0 0
Slovakia
State/province [97] 0 0
Poprad
Country [98] 0 0
South Africa
State/province [98] 0 0
Gauteng
Country [99] 0 0
South Africa
State/province [99] 0 0
Capital Park
Country [100] 0 0
South Africa
State/province [100] 0 0
Overport
Country [101] 0 0
South Africa
State/province [101] 0 0
Parow
Country [102] 0 0
South Africa
State/province [102] 0 0
Port Elizabeth
Country [103] 0 0
Spain
State/province [103] 0 0
Alcorcón/Madrid
Country [104] 0 0
Spain
State/province [104] 0 0
Baracaldo/Vizcaya
Country [105] 0 0
Spain
State/province [105] 0 0
Caceres
Country [106] 0 0
Spain
State/province [106] 0 0
Cuidad Real
Country [107] 0 0
Spain
State/province [107] 0 0
Jaen
Country [108] 0 0
Spain
State/province [108] 0 0
La Laguna (Santa Cruz de Tenerife)
Country [109] 0 0
Spain
State/province [109] 0 0
Las Palmas De Gran Canaria
Country [110] 0 0
Spain
State/province [110] 0 0
Madrid
Country [111] 0 0
Spain
State/province [111] 0 0
Móstoles/Madrid
Country [112] 0 0
Spain
State/province [112] 0 0
Palma de Mallorca
Country [113] 0 0
Spain
State/province [113] 0 0
Pontevedra
Country [114] 0 0
Spain
State/province [114] 0 0
San Sebastián
Country [115] 0 0
Spain
State/province [115] 0 0
Santa Cruz de Tenerife
Country [116] 0 0
Spain
State/province [116] 0 0
Zaragoza
Country [117] 0 0
Turkey
State/province [117] 0 0
Istanbul

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00075270
Trial related presentations / publications
Tenori L, Oakman C, Claudino WM, Bernini P, Cappadona S, Nepi S, Biganzoli L, Arbushites MC, Luchinat C, Bertini I, Di Leo A. Exploration of serum metabolomic profiles and outcomes in women with metastatic breast cancer: a pilot study. Mol Oncol. 2012 Aug;6(4):437-44. doi: 10.1016/j.molonc.2012.05.003. Epub 2012 Jun 1.
Finn RS, Press MF, Dering J, Arbushites M, Koehler M, Oliva C, Williams LS, Di Leo A. Estrogen receptor, progesterone receptor, human epidermal growth factor receptor 2 (HER2), and epidermal growth factor receptor expression and benefit from lapatinib in a randomized trial of paclitaxel with lapatinib or placebo as first-line treatment in HER2-negative or unknown metastatic breast cancer. J Clin Oncol. 2009 Aug 20;27(24):3908-15. doi: 10.1200/JCO.2008.18.1925. Epub 2009 Jul 20.
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications