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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00320411 |
This study (EGF104911) is designed to evaluate the efficacy and safety of lapatinib in patients with advanced or metastatic breast cancer. Eligible subjects must have ErbB2 overexpressing tumors and are refractory to treatment with anthracycline, taxanes and trastuzumab containing regimens. The study data obtained from EGF104911 will be combined with the data from EGF100642 and integrated analysis will be carried out in order to enhance the credibility of the study results.
Condition | Intervention | Phase |
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Metastatic Breast Cancer |
Drug: lapatinib |
Phase II |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Safety/Efficacy Study, Single Group Assignment, Treatment |
Official Title: | Phase II Clinical Study of Lapatinib (GW572016) in Patients With ErbB2 Over - Expressing Advanced or Metastatic Breast Cancer |
Enrollment: | 52 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 20 Years to 74 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A subject will be considered eligible for inclusion in this study only if all of the following criteria apply:
Subjects must meet the following criteria regarding prior therapy:
Anthracyclines, taxanes:
i) If anthracycline- and taxane-containing regimens are administered sequentially;
ii) If anthracycline- and taxane-containing regimen are administered concurrently;
iii) If anthracycline- and taxane-containing regimen are administered separately;
Trastuzumab:
Patients with ErbB2 overexpression:
3+ by IHC, or FISH+ 2+ by IHC and FISH+ are also eligible. However, patients with "2+ by IHC" who have previously been treated with trastuzumab should undergo FISH before study entry, if they have not had this test performed before, and are considered eligible only if their tumours are categorised as FISH+.
A female, ≥20 and ≤74 years (at the time of giving consent), is eligible to enter and participate in this study if she is of:
The subject has a negative serum pregnancy test at screening, and agrees to one of the following from 2 weeks prior to administration of the first dose of lapatinib until 28 days after the final dose of lapatinib*. i) Complete abstinence from intercourse: ii) Consistent and correct use of one of the following acceptable methods of birth control:
Neutrophil count ≥1500 /mm3 Hemoglobin ≥9 g/dL (at least 2 weeks after blood transfusion if needed) Platelet count ≥100,000 /mm3
Albumin ≤2.5 g/dL Total bilirubin ≤1.5xULN AST, ALT: ≤3xULN (without liver metastases), ≤5xULN (if documented liver metastases)
Serum creatinine ≤1.5 mg/dL, or creatinine clearance ≤40 mL/min (calculated by the Cockcroft and Gault Method)
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | EGF104911 |
Study First Received: | May 1, 2006 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00320411 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
ErbB1 ErbB2 Herceptin lapatinib |
metastatic breast cancer Stage IV breast cancer trastuzumab |
Skin Diseases 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 |