Capecitabine (XELODA) With Or Without Lapatinib (GW572016) For Women With Refractory Advanced or Metastatic Breast Cancer
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00078572 |
Recruitment Status :
Completed
First Posted : March 3, 2004
Last Update Posted : December 13, 2010
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Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
Tracking Information | |||
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First Submitted Date ICMJE | March 1, 2004 | ||
First Posted Date ICMJE | March 3, 2004 | ||
Last Update Posted Date | December 13, 2010 | ||
Study Start Date ICMJE | March 2004 | ||
Actual Primary Completion Date | April 2006 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Time to progression [ Time Frame: randomization to time of progression or death due to breast cancer ] | ||
Original Primary Outcome Measures ICMJE | Not Provided | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Capecitabine (XELODA) With Or Without Lapatinib (GW572016) For Women With Refractory Advanced or Metastatic Breast Cancer | ||
Official Title ICMJE | A Phase III, Randomized, Open-label, Multicenter Study Comparing GW572016 and Capecitabine (XELODA) Versus Capecitabine in Women With Refractory Advanced or Metastatic Breast Cancer | ||
Brief Summary | This study was designed to compare the efficacy and safety of an oral dual tyrosine kinase inhibitor in combination with capecitabine versus capecitabine alone in women with locally advanced or metastatic breast cancer that has not responded to previous therapy. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 3 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Breast Cancer | ||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
408 | ||
Original Enrollment ICMJE | Not Provided | ||
Actual Study Completion Date ICMJE | February 2010 | ||
Actual Primary Completion Date | April 2006 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Table 1 (Body System and Adequate Function Definitions) SYSTEM (LABORATORY VALUES) Hematologic: ANC (absolute neutrophil count) ≥1.5 x 10^9/L Hemoglobin ≥9 g/dL Platelets ≥100 x 10^9/L Hepatic: Albumin ≥2.5 g/dL Serum bilirubin ≤1.5 x upper limit of normal (ULN)
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Not Provided | ||
Removed Location Countries | Argentina, Australia, Belgium, Brazil, Canada, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Poland, Portugal, Russian Federation, Slovakia, South Africa, Spain, Switzerland, United Kingdom, United States | ||
Administrative Information | |||
NCT Number ICMJE | NCT00078572 | ||
Other Study ID Numbers ICMJE | 100151 | ||
Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Current Responsible Party | E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure | ||
Original Responsible Party | Not Provided | ||
Current Study Sponsor ICMJE | GlaxoSmithKline | ||
Original Study Sponsor ICMJE | Same as current | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | GlaxoSmithKline | ||
Verification Date | December 2010 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |