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: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: June 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

Primary Measures

• Time to tumor progression (TTP): defined as time from randomization to the date of confirmation of progressive disease (PD) or breast cancer death.
  • Time Frame: median TTP=15.3 month
    Safety Issue?: Yes

Secondary Measures

• Response rate is defined as the proportion of patients achieving complete remission (CR) or partial remission (PR) in the analysis sets defied according to RECIST criteria.
  • Time Frame: Undecided
    Safety Issue?: Yes

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

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Overall Contact: Pfizer Oncology Clinical Trial Information Service 1-877-369-9753 PfizerCancerTrials@emergingmed.com

Information obtained from ClinicalTrials.gov on November 18, 2008

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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