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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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)
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
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
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
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
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)
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)
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)
Timepoint [7] 0 0
Randomization until the date of disease progression or death (average of 26 weeks)
Secondary outcome [8] 0 0
Overall Survival
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
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
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
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
Timepoint [12] 0 0
Baseline
Secondary outcome [13] 0 0
ErbB2 Ratio
Timepoint [13] 0 0
Baseline
Secondary outcome [14] 0 0
Number of Participants With the Indicated Immunohistochemistry (IHC) Results at Screening
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
Timepoint [15] 0 0
Baseline
Secondary outcome [16] 0 0
Serum ErbB1 Concentration
Timepoint [16] 0 0
Screening (Day-1) and Withdrawal (up to Study Week 129)
Secondary outcome [17] 0 0
Serum ErbB2 Concentration
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
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
Sex
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
1/01/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2012
Sample size
Target
Accrual to date
Final
580
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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00075270