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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00479856 |
This study will evaluate the safety and efficacy of lapatinib in combination with chemotherapy in subjects with ErbB2-overexpressing breast cancer who have progressed during or within 12 months after completion of trastuzumab-containing therapy in the neoadjuvant or adjuvant setting.
Condition | Intervention | Phase |
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Relapsed Breast Cancer |
Drug: Lapatinib + chemotherapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label, Multi-Centre Study of Lapatinib in Combination With Chemotherapy in Patients With ErbB2 Overexpressing Breast Cancer After Trastuzumab Failure in the Neoadjuvant or Adjuvant Setting. |
Estimated Enrollment: | 45 |
Study Start Date: | November 2007 |
Estimated Primary Completion Date: | October 2009 (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:
If the disease is restricted to a solitary lesion, the neoplastic nature of the lesion must be confirmed by cytology or histology.
Note: Progression is defined using RECIST criteria, that is, either the appearance of new lesions or a >=20% increase in the sum of longest diameter (LD).
SYSTEM
Hematologic:
Absolute neutrophil count: ≥1.5 X 10^9/L
Hemoglobin: ≥9 g/dL
Platelets: ≥ 75 X 10^9/L
Hepatic:
AST, ALT and Alkaline phosphatase: ≤ 2.5 X ULN
Unless concomitant docetaxel, then ≤ 1.5 x ULN for AST and ALT, with AP ≤ 2.5 x ULN
Unless documented liver metastasis, then ≤ 5 x ULN
Serum bilirubin: ≤ 2.0 X ULN
Albumin: ≥ 2.5 g/dL
Renal:
Serum Creatinine: ≤ 1.5 mg/dL
OR - Calculate Creatinine Clearance: ≥ 40 mL/min
Exclusion Criteria:
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | EGF108916 |
Study First Received: | May 25, 2007 |
Last Updated: | January 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00479856 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Relapsed breast cancer MBC lapatinib GW572016 EGFR |
ErbB1 ErbB2 Her-2/neu dual tyrosine kinase inhibitor FISH amplification |
Skin Diseases Adjuvants, Immunologic Trastuzumab Breast Neoplasms |
Lapatinib Protein Kinase Inhibitors Breast Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Therapeutic Uses |
Breast Neoplasms Enzyme Inhibitors Lapatinib Protein Kinase Inhibitors Pharmacologic Actions Breast Diseases |