Aromasin Vs Arimidex Study As Initial Hormonal Therapy In Postmenopausal Women With Advanced/Recurrent Breast Cancer
To verify the non-inferiority of exemestane compared to anastrozole in time to tumor progression (TTP), the primary efficacy endpoint, in postmenopausal women with advanced/recurrent breast cancer...
Brief Summary
Official Title: “A Randomized, Double-Blind, Controlled Study Of Exemestane (Aromasin) Vs Anastrozole (Arimidex) As Initial Hormonal Therapy In Postmenopausal Women With Advanced/Recurrent Breast Cancer”
To verify the non-inferiority of exemestane compared to anastrozole in time to tumor progression (TTP), the primary efficacy endpoint, in postmenopausal women with advanced/recurrent breast cancer.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
- Study Primary Completion Date: December 2010
Intervention(s) in this Clinical Trial
- Drug: exemestane
- take orally one tablet per day of exemestane 25 mg and one tablet per day of anastrozole placebo daily after meal
- Drug: anastrozole
- take orally one tablet of anastrozole 1 mg and one tablet of exemestane placebo daily after meal
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Experimental: 2
Outcome Measures for this Clinical Trial
Primary Measures
- Time to Progression (TTP) - Expert Evaluation Committee Assessment
- Time Frame: Up to 2008 days of the treatment
Safety Issue?: No
- Time Frame: Up to 2008 days of the treatment
Secondary Measures
- Time to Progression (TTP) - Investigators Assessment
- Time Frame: Up to 2008 days of the treatment
Safety Issue?: No
- Time Frame: Up to 2008 days of the treatment
- Number of Participants With Objective Response - Investigators Assessment
- Time Frame: Up to 2008 days of the treatment
Safety Issue?: No
- Time Frame: Up to 2008 days of the treatment
- Number of Participants With Clinical Benefit - Investigator Assessment
- Time Frame: Up to 2008 days of the treatment
Safety Issue?: No
- Time Frame: Up to 2008 days of the treatment
- Overall Survival (OS)
- Time Frame: Up to 2008 days of the treatment
Safety Issue?: Yes
- Time Frame: Up to 2008 days of the treatment
- Time to Treatment Failure (TTF)
- Time Frame: Up to 2008 days of the treatment
Safety Issue?: Yes
- Time Frame: Up to 2008 days of the treatment
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Have histologically or cytologically confirmed breast cancer at original diagnosis.
- At study entry, the patient must have metastatic progressive or locally recurrent inoperable breast cancer.
Exclusion Criteria:
- Having received any hormonal therapy (e.g., Tamoxifen, LHRH-agonists) ovariectomy or any chemotherapy for advanced/recurrent breast cancer
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 20 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Pfizer Industry
Overall Clinical Trial Officials and Contacts
Pfizer CT.gov Call Center Study Director Pfizer
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00143390
Study ID Number: A5991048
ClinicalTrials.gov Identifier: NCT00143390
Health Authority: Japan: Ministry of Health, Labor and Welfare
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00143390
