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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00615524 |
This study is being conducted to compare the efficacy and safety of exemestane alone or in combination with pazopanib in postmenopausal women who have hormone receptor positive breast cancer and have failed therapy with tamoxifen, anastrazole or letrozole.
Condition | Intervention | Phase |
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Hormone-Receptor Positive Breast Cancer |
Drug: exemestane and pazopanib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study to Compare the Efficacy and Tolerability of Pazopanib Administered in Combination With Exemestane Versus Exemestane Plus Placebo in Postmenopausal Subjects With Advanced or Metastatic Hormone Receptor Positive Breast Cancer |
Estimated Enrollment: | 150 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | July 2011 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
GSK Clinical Trials Call Center | |
San Francisco, California, United States, 94115 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Study ID Numbers: | VEG108843 |
Study First Received: | February 1, 2008 |
Last Updated: | August 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00615524 |
Health Authority: | United States: Food and Drug Administration |
Breast cancer Advanced Metastatic Pazopanib GW786034 |
Exemestane Efficacy Tolerability Health-Related Quality of Life |
Skin Diseases Quality of Life Breast Neoplasms Exemestane Breast Diseases |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Aromatase Inhibitors Pharmacologic Actions |