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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00320385 |
This study will evaluate and compare the safety and efficacy of lapatinib in combination with trastuzumab versus lapatinib monotherapy in subjects with metastatic breast cancer.
Condition | Intervention | Phase |
---|---|---|
Metastatic Breast Cancer |
Drug: lapatinib |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Multicenter, Open-Label, Phase III Study of Lapatinib in Combination With Trastuzumab Versus Lapatinib Monotherapy in Subjects With Metastatic Breast Cancer Whose Disease Has Progressed on Trastuzumab-Containing Regimens |
Estimated Enrollment: | 270 |
Study Start Date: | November 2005 |
Study Completion Date: | June 2007 |
Primary Completion Date: | June 2007 (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:
Metastatic breast cancer, histologically/cytologically confirmed.
·If the disease is restricted to a solitary lesion, its neoplastic nature must be confirmed by cytology or histology.
Subjects must have stage IV breast cancer whereby their disease has progressed in either the adjuvant or metastatic setting. Prior therapies must include, but are not limited to:
Note: The most recent treatment must have contained trastuzumab, either alone or in combination with other therapy in the metastatic setting, and subjects must have progressed while on this regimen. Progression is defined as either new lesions or a ≥20% increase in the sum of longest diameter (LD) on the progression radiologic scan.
Lesion eligibility is as follows:
Table 1 (Definitions for Adequate Hematologic and Hepatic Function) SYSTEM (LABORATORY VALUES)
Hematologic:
ANC (absolute neutrophil count) (≥ 1x10^9/ L) Hemoglobin (≥ 9 g / dL) Platelets (≥75x10^9/ L) Hepatic Albumin (≥ 2.5 g / dL) Serum bilirubin (≤ 2 mg / dL) AST and ALT (≤ 3 x ULN without liver metastases) (≤ 5 xULN if documented liver metastases) Renal Serum Creatinine (≤1.5 mg / dL)
OR - Calculated Creatinine Clearance1 (≥40 mL / min)
1.Calculated by the Cockcroft and Gault Method.
Exclusion Criteria:
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Study ID Numbers: | EGF104900 |
Study First Received: | May 1, 2006 |
Last Updated: | March 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00320385 |
Health Authority: | United States: Food and Drug Administration |
MBC lapatinib GW572016 EGFR ErbB1 |
ErbB2 Her-2/neu dual tyrosine kinase inhibitor FISH amplification |
Skin Diseases Trastuzumab Breast Neoplasms Lapatinib Breast Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |