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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/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
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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
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Secondary ID [1]
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EGF30001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neoplasms, Breast
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to Progression as Evaluated by the Investigator
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Assessment method [1]
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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.
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Timepoint [1]
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Randomization until the date of disease progression or death (average of 26 weeks)
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Primary outcome [2]
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Time to Progression as Evaluated by the Independent Review Committee (IRC)
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Assessment method [2]
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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.
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Timepoint [2]
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Randomization until the date of disease progression or death (average of 26 weeks)
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Secondary outcome [1]
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Number of Participants With Tumor Response as Evaluated by the Investigator
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Assessment method [1]
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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.
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Timepoint [1]
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Randomization until the date of disease progression or death (average of 26 weeks)
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Secondary outcome [2]
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Number of Participants With Tumor Response as Evaluated by the Independent Review Committee
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Assessment method [2]
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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.
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Timepoint [2]
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Randomization until the date of disease progression or death (average of 26 weeks)
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Secondary outcome [3]
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Percentage of Participants With Clinical Benefit (CB) as Assessed by the Investigator
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Assessment method [3]
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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.
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Timepoint [3]
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Randomization until the date of disease progression or death (average of 26 weeks)
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Secondary outcome [4]
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Number of Participants With a Response of CR or PR by the Indicated Study Week
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Assessment method [4]
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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.
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Timepoint [4]
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Weeks 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, and 72
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Secondary outcome [5]
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Duration of Response (DOR)
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Assessment method [5]
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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.
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Timepoint [5]
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From the time of the first documented complete or partial response until the first documented evidence of progression or death (average of 26 weeks)
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Secondary outcome [6]
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Progression-Free Survival (PFS)
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Assessment method [6]
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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.
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Timepoint [6]
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Randomization until the date of disease progression or death (average of 26 weeks)
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Secondary outcome [7]
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Number of Participants Who Progressed or Died at or Prior to 6 Months, as a Measure of Six Months Progression-free Survival (PFS)
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Assessment method [7]
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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.
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Timepoint [7]
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Randomization until the date of disease progression or death (average of 26 weeks)
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Secondary outcome [8]
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Overall Survival
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Assessment method [8]
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Overall survival is defined as the time from randomization until death due to any cause.
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Timepoint [8]
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Randomization until the date of death due to any cause (average of 24 months)
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Secondary outcome [9]
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Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Questionnaire Scores
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline (Day 1); Weeks 9, 21, 33, and 45; Withdrawal
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Secondary outcome [10]
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Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores
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Assessment method [10]
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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.
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Timepoint [10]
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Baseline (Day 1); Weeks 9, 21, 33, and 45; Withdrawal
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Secondary outcome [11]
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Change From Baseline in Trial Outcome Index (TOI) Questionnaire Scores
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Assessment method [11]
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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.
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Timepoint [11]
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Baseline (Day 1); Weeks 9, 21, 33, and 45; Withdrawal
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Secondary outcome [12]
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Number of Participants With the Indicated ErbB2 Status at Baseline
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Assessment method [12]
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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.
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Timepoint [12]
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Baseline
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Secondary outcome [13]
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ErbB2 Ratio
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Assessment method [13]
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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.
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Timepoint [13]
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Baseline
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Secondary outcome [14]
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Number of Participants With the Indicated Immunohistochemistry (IHC) Results at Screening
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Assessment method [14]
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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.
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Timepoint [14]
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Screening (Day -1)
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Secondary outcome [15]
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Number of Participants With the Indicated ErbB2 Fluorescence in Situ Hybridization (FISH) Results
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Assessment method [15]
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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).
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Timepoint [15]
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Baseline
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Secondary outcome [16]
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Serum ErbB1 Concentration
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Assessment method [16]
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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.
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Timepoint [16]
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Screening (Day-1) and Withdrawal (up to Study Week 129)
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Secondary outcome [17]
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Serum ErbB2 Concentration
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Assessment method [17]
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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.
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Timepoint [17]
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Screening (Day-1) and Withdrawal (up to Study Week 129)
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Secondary outcome [18]
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Number of Participants With the Indicated Adverse Events (AEs) With a Maximum Toxicity Grade of 3 or 4
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Assessment method [18]
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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.
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Timepoint [18]
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Baseline (Day 1) until 30 days after the last dose of randomized therapy (average of 26 weeks)
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2004
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2012
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Sample size
Target
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Accrual to date
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Final
580
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Recruitment in Australia
Recruitment state(s)
VIC,WA
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Recruitment hospital [1]
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GSK Investigational Site - Fitzroy
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Recruitment hospital [2]
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GSK Investigational Site - Malvern
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Recruitment hospital [3]
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GSK Investigational Site - Wodonga
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Recruitment hospital [4]
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GSK Investigational Site - Nedlands
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Recruitment postcode(s) [1]
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3065 - Fitzroy
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Recruitment postcode(s) [2]
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3144 - Malvern
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Recruitment postcode(s) [3]
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3690 - Wodonga
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Recruitment postcode(s) [4]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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Arizona
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Arkansas
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California
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Colorado
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Florida
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Georgia
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Indiana
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Kansas
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Louisiana
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Maryland
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Massachusetts
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Minnesota
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Missouri
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New Jersey
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New Mexico
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New York
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North Carolina
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North Dakota
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Ohio
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Oregon
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South Carolina
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Tennessee
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Texas
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Vermont
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Virginia
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Washington
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Wisconsin
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Argentina
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Buenos Aires
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Austria
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Vienna
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Belgium
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Brugge
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Belgium
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Brussels
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Belgium
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Brussel
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Belgium
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Kortrijk
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Belgium
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Leuven
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Belgium
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Roeselare
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Brazil
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Bahía
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Brazil
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Rio de Janeiro
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Canada
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Newfoundland and Labrador
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Canada
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Ontario
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Canada
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Quebec
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Chile
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Región Metro De Santiago
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Czech Republic
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Brno
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Czech Republic
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Hradec Kralove
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Czech Republic
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Olomouc
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Germany
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Baden-Wuerttemberg
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Germany
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Bayern
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Germany
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Brandenburg
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Germany
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Niedersachsen
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Germany
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Nordrhein-Westfalen
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Germany
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Germany
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Italy
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Italy
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Italy
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Italy
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Italy
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Italy
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Lima
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Russian Federation
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Zaragoza
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Turkey
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Istanbul
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Funding & Sponsors
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Commercial sector/Industry
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Name
GlaxoSmithKline
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00075270
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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.
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Public notes
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Contacts
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GSK Clinical Trials
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GlaxoSmithKline
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00075270
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