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Sponsored by: |
AstraZeneca |
Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00065325 |
The purpose of this study is to compare the efficacy of Faslodex (fulvestrant) to Aromasin (exemestane) in hormone receptor positive postmenopausal women with advanced breast cancer. Patients will be treated until disease progression or until the investigator has determined that treatment is not in the best interest of the patient, whichever occurs first.
Condition | Intervention | Phase |
Locally Advanced Breast Cancer Metastatic Breast Cancer |
Drug: Fulvestrant Drug: Exemestane |
Phase III |
Genetics Home Reference related topics: | breast cancer |
MedlinePlus related topics: | Breast Cancer Cancer |
ChemIDplus related topics: | Ici 182780 Exemestane |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Double Blind, Multicenter Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) vs. Exemestane (AROMASIN™) in Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer With Disease Progression After Prior Non-Steroidal Aromatase Inhibitor (AI) Therapy |
Enrollment: | 694 |
Study Start Date: | May 2003 |
Estimated Study Completion Date: | July 2008 |
Arms | Assigned Interventions |
1: Active Comparator
Exemestane
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Drug: Exemestane
oral capsule
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2: Experimental
Fulvestrant
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Drug: Fulvestrant
intramuscular injection
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Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Show 139 Study Locations |
AstraZeneca |
Study Director: | AstraZeneca Faslodex Medical Science Director, MD | AstraZeneca |
MEDLINEplus related topics: Breast Cancer 
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MEDLINEplus related topics: Cancer (General) 
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MEDLINEplus related topics: Cancer--Living with Cancer 
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Cancer Guide related topics 
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Aromasin related topics: Your Treatment with Aromasin 
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Faslodex Information 
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Study ID Numbers: | 9238IL/0048, EFECT |
First Received: | July 21, 2003 |
Last Updated: | June 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00065325 |
Health Authority: | United States: Food and Drug Administration |
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