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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00073528 |
This study will compare the efficacy and tolerability of GW572016 administered in combination with letrozole, versus letrozole and placebo, as treatment for hormone receptor-positive advanced or metastatic breast cancer.
Condition | Intervention | Phase |
---|---|---|
Metastatic Breast Cancer Advanced Breast Cancer |
Drug: Letrozole Drug: Lapatinib (GW572016) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase III Study Comparing GW572016 and Letrozole Versus Letrozole in Subjects With Estrogen/Progesterone Receptor-Positive Advanced or Metastatic Breast Cancer |
Enrollment: | 1280 |
Study Start Date: | December 2003 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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lapatinib plus letrozole: Experimental |
Drug: Letrozole
2.5 mg orally once a day
Drug: Lapatinib (GW572016)
1500 mg orally once a day
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Placebo plus letrozole |
Drug: Letrozole
2.5 mg orally once a day
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | EGF30008 |
Study First Received: | November 24, 2003 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00073528 |
Health Authority: | United States: Food and Drug Administration |
metastatic breast cancer advanced breast cancer |
Progesterone Skin Diseases Breast Neoplasms |
Letrozole Lapatinib Breast Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Enzyme Inhibitors Aromatase Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |