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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00078572 |
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.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: capecitabine Drug: lapatinib (GW572016) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Randomized, Open-Label, Multicenter Study Comparing GW572016 and Capecitabine (XELODA) Versus Capecitabine in Women With Refractory Advanced or Metastatic Breast Cancer |
Enrollment: | 528 |
Study Start Date: | March 2004 |
Estimated Study Completion Date: | June 2008 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects must have refractory breast cancer defined as progression in the locally advanced or metastatic setting or relapse within 6 months of completing adjuvant therapy. Prior therapies must include, but are not limited to:
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 ULN
Exclusion Criteria:
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 100151 |
Study First Received: | March 1, 2004 |
Last Updated: | March 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00078572 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Advanced Breast Cancer Metastatic HERCEPTIN XELODA |
Antimetabolites Capecitabine Skin Diseases Trastuzumab |
Breast Neoplasms Lapatinib Protein Kinase Inhibitors Breast Diseases |
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Breast Neoplasms Enzyme Inhibitors |
Lapatinib Protein Kinase Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Breast Diseases |