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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00338247 |
This study will provide pre-approval drug access to lapatinib, in combination with capecitabine, to patients whose breast cancer had progressed on other therapies
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: lapatinib + capecitabine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | An Open-Label Expanded Access Study of Lapatinib and Capecitabine Therapy in Subjects With ErbB2 Overexpressing Locally Advanced or Metastatic Breast Cancer |
Estimated Enrollment: | 3400 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Study Director: | GSK Clincial Trials, MD | GlaxoSmithKline |
Study ID Numbers: | EGF103659 |
Study First Received: | June 16, 2006 |
Last Updated: | September 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00338247 |
Health Authority: | United States: Food and Drug Administration; Australia: Department of Health and Ageing Therapeutic Goods Administration |
breast cancer ErbB2 positive HER2 positive GW572016 TYKERB |
Stage IIIb Stage IIIc advanced metastatic |
Capecitabine Skin Diseases Breast Neoplasms Lapatinib Breast Diseases |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |