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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 |
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Breast Cancer |
Drug: lapatinib + capecitabine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, 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: | July 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:
The status of ErbB2 expression must be documented prior to study entry.
Exclusion criteria:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | EGF103659 |
Study First Received: | June 16, 2006 |
Last Updated: | August 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00338247 History of Changes |
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 |
Antimetabolites Capecitabine Skin Diseases 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 |