Last updated: 11/04/2018 06:35:08
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.
Paclitaxel With / Without GW572016 (Lapatinib) As First Line Therapy For Women With Advanced Or Metastatic Breast Cancer
EudraCT ID
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Time to progression as evaluated by the investigator
Timeframe: Randomization until the date of disease progression or death (average of 26 weeks)
Time to progression as evaluated by the Independent Review Committee (IRC)
Timeframe: Randomization until the date of disease progression or death (average of 26 weeks)
Secondary outcomes:
Number of participants with tumor response as evaluated by the investigator
Timeframe: Randomization until the date of disease progression or death (average of 26 weeks)
Number of participants with tumor response as evaluated by the Independent Review Committee
Timeframe: Randomization until the date of disease progression or death (average of 26 weeks)
Percentage of participants with clinical benefit (CB) as assessed by the investigator
Timeframe: Randomization until the date of disease progression or death (average of 26 weeks)
Number of participants with a response of CR or PR by the indicated study week
Timeframe: Weeks 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, and 72
Duration of Response (DOR)
Timeframe: From the time of the first documented complete or partial response until the first documented evidence of progression or death (average of 26 weeks)
Progression-Free Survival (PFS)
Timeframe: Randomization until the date of disease progression or death (average of 26 weeks)
Number of participants who progressed or died at or prior to 6 months, as a measure of six months progression-free survival (PFS)
Timeframe: Randomization until the date of disease progression or death (average of 26 weeks)
Overall Survival
Timeframe: Randomization until the date of death due to any cause (average of 24 months)
Change from Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Questionnaire Scores
Timeframe: Baseline (Day 1); Weeks 9, 21, 33, and 45; Withdrawal
Change from Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores
Timeframe: Baseline (Day 1); Weeks 9, 21, 33, and 45; Withdrawal
Change from Baseline in Trial Outcome Index (TOI) Questionnaire Scores
Timeframe: Baseline (Day 1); Weeks 9, 21, 33, and 45; Withdrawal
Number of participants with the indicated ErbB2 status at Baseline
Timeframe: Baseline
ErbB2 ratio
Timeframe: Baseline
Number of participants with the indicated immunohistochemistry (IHC) results at Screening
Timeframe: Screening (Day -1)
Number of participants with the indicated ErbB2 fluorescence in situ hybridization (FISH) results
Timeframe: Baseline
Serum ErbB1 concentration
Timeframe: Screening (Day-1) and Withdrawal (up to Study Week 129)
Serum ErbB2 concentration
Timeframe: Screening (Day-1) and Withdrawal (up to Study Week 129)
Number of participants with the indicated adverse events (AEs) with a maximum toxicity grade of 3 or 4
Timeframe: Baseline (Day 1) until 30 days after the last dose of randomized therapy (average of 26 weeks)
Interventions:
Drug: Paclitaxel
Drug: GW572016 (Lapatinib)
Enrollment:
580
Observational study model:
Not applicable
Primary completion date:
2006-02-10
Time perspective:
Not applicable
Clinical publications:
Leonardo Tenori, Catherine Oakman, Wederson M. Claudino, Patrizia Bernini, Silvia Cappadona , Stefano Nepi, Laura Biganzoli , Claudio Luchinat, Ivano Bertini, Angelo Di Leo . Correlation of ‘on-treatment’ serum metabolomic profiles with outcomes in patients with HER2-positive metastatic breast cancer. Molecular Oncologyhas. 2012;6(4):437-44. .
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 Randomized Trial of Paclitaxel With Lapatinib or Placebo As First-Line Treatment in HER2-Negative or Unknown Metastatic Breast Cancer.J Clin Oncol - Published Ahead of Print on July 20, 2009 as 10.1200/JCO.2008.18.1925.2009;27(24):3908-3915
Medical condition
Neoplasms, Breast
Product
lapatinib
Collaborators
Not applicable
Study date(s)
January 2004 to March 2012
Type
Interventional
Phase
3
Participation criteria
Sex
Female
Age
18+ years
Accepts healthy volunteers
No
- Signed Informed Consent
- Able to swallow an oral medication
- Prior treatment regimens for advanced or metastatic breast cancer.
- Pregnant or lactating
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7591046
Status
Study Complete
Location
GSK Investigational Site
Halle, Sachsen-Anhalt, Germany, 06120
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Nyack, New York, United States, 10960
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ulm, Baden-Wuerttemberg, Germany, 89075
Status
Study Complete
Location
GSK Investigational Site
Capital Federal, Buenos Aires, Argentina, C1405CBA
Status
Study Complete
Location
GSK Investigational Site
La Laguna (Santa Cruz de Tenerife), Spain, 38320
Status
Study Complete
Location
GSK Investigational Site
Fort Worth, Texas, United States, 76104
Status
Study Complete
Location
GSK Investigational Site
Benevento, Campania, Italy, 82100
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Glen Burnie, Maryland, United States, 21225
Status
Study Complete
Location
GSK Investigational Site
Muenchen, Bayern, Germany, 80335
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46260
Status
Study Complete
Location
GSK Investigational Site
Las Palmas De Gran Canaria, Spain, 35016
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Fuerstenwalde, Brandenburg, Germany, 15517
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28203
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pietra Ligure (SV), Liguria, Italy, 17027
Status
Study Complete
Location
GSK Investigational Site
Banska Bystrica, Slovakia, 975 17
Status
Terminated/Withdrawn
Location
GSK Investigational Site
West Palm Beach, Florida, United States, 33401
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Sudbury, Ontario, Canada, P3E 5J1
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 05
Status
Study Complete
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, 1425
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97227
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hot Springs, Arkansas, United States, 71913
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ibbenbueren, Nordrhein-Westfalen, Germany, 49477
Status
Study Complete
Location
GSK Investigational Site
Santa Fe, New Mexico, United States, 87505
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21201
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Herne, Nordrhein-Westfalen, Germany, 44625
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Houston, Texas, United States, 77054
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Stade, Niedersachsen, Germany, 21680
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Savannah, Georgia, United States, 31405
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Knoxville, Tennessee, United States, 37920
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Voorhees, New Jersey, United States, 08043
Status
Study Complete
Location
GSK Investigational Site
Fountain Valley, California, United States, 92708
Status
Study Complete
Location
GSK Investigational Site
NIEUWEGEIN, Netherlands, 3435 CM
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Robbinsdale, Minnesota, United States, 55422
Status
Study Complete
Location
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48149
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Knoxville, Tennessee, United States, 37916
Status
Study Complete
Location
GSK Investigational Site
Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Norfolk, Virginia, United States, 23502
Status
Study Complete
Location
GSK Investigational Site
Metairie, Louisiana, United States, 70006
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30341
Status
Study Complete
Location
GSK Investigational Site
Burlington, Vermont, United States, 05401
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Vallejo, California, United States, 94589
Status
Study Complete
Location
GSK Investigational Site
Aalen, Baden-Wuerttemberg, Germany, 73428
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
Ravenna, Emilia-Romagna, Italy, 48100
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rimini, Emilia-Romagna, Italy, 47900
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Fargo, North Dakota, United States, 58103
Status
Study Complete
Location
GSK Investigational Site
Greenville, North Carolina, United States, 27834
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Savannah, Georgia, United States, 31406
Status
Study Complete
Location
GSK Investigational Site
Rancho Mirage, California, United States, 92270
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Denver, Colorado, United States, 80218
Status
Study Complete
Location
GSK Investigational Site
Bayreuth, Bayern, Germany, 95445
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Augsburg, Bayern, Germany, 86150
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rio de Janeiro, Rio De Janeiro, Brazil, 20560-120
Status
Study Complete
Location
GSK Investigational Site
Kiel, Schleswig-Holstein, Germany, 24103
Status
Study Complete
Location
GSK Investigational Site
La Jolla, California, United States, 92093-0987
Status
Study Complete
Location
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70190
Status
Study Complete
Location
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53226
Status
Study Complete
Location
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
Status
Study Complete
Location
GSK Investigational Site
Tacoma, Washington, United States, 98405
Status
Study Complete
Location
GSK Investigational Site
Port St. Lucie, Florida, United States, 34952
Status
Study Complete
Location
GSK Investigational Site
Springfield, Massachusetts, United States, 01199
Status
Study Complete
Location
GSK Investigational Site
Syracuse, New York, United States, 13210
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Orlando, Florida, United States, 32804
Status
Study Complete
Location
GSK Investigational Site
Columbia, South Carolina, United States, 29210
Status
Study Complete
Location
GSK Investigational Site
Nedlands, Western Australia, Australia, 6009
Status
Study Complete
Location
GSK Investigational Site
Boca Raton, Florida, United States, 33486
Status
Study Complete
Location
GSK Investigational Site
Thunder Bay, Ontario, Canada, P7B 6V4
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Marietta, Georgia, United States, 30060
Status
Study Complete
Location
GSK Investigational Site
Duluth, Minnesota, United States, 55802
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Kansas City, Kansas, United States, 66160
Status
Terminated/Withdrawn
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
No longer a GSK study
Actual primary completion date
2006-02-10
Actual study completion date
2012-26-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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Access to clinical trial data by researchers
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