Official Title: “Open-Label, Multicentre, Controlled Study Of Exemestane (Aromasin) With Or Without Celecoxib (Celebrex) In Postmenopausal Women With Advanced Breast Cancer (ABC) Having Progressed On Tamoxifen”

This is an open-label, multicenter, randomized (1:1 randomization ratio) study of either exemestane or exemestane plus celecoxib in postmenopausal women with ABC having progressed on tamoxifen.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2008

Intervention(s) in this Clinical Trial

• Drug: Celecoxib
  • Patient will be instructed to take a 25 mg exemestane tablet, once a day, every day, with food. If randomized to the exemestane + celecoxib treatment arm, she will be instructed to take also two x 200 mg celecoxib capsules twice a day, every day, with food.
• Drug: Exemestane
  • Patient will be instructed to take a 25 mg exemestane tablet, once a day, every day, with food. If randomized to the exemestane + celecoxib treatment arm, she will be instructed to take also two x 200 mg celecoxib capsules twice a day, every day, with food.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 2
• Experimental: 1

Primary Measures

• clinical benefit (defined as the frequency of tumor response and disease stabilization for at least 24 weeks)
  • Time Frame: August 2003
    Safety Issue?: Yes

Secondary Measures

• Other efficacy parameters than clinical benefit; tolerability; PD and PK
  • Time Frame: June 2006
    Safety Issue?: Yes
• Survival
  • Time Frame: December 2012
    Safety Issue?: No

Inclusion Criteria:

• Postmenopausal female patient with histologically or cytologically confirmed breast cancer having progressed on Tamoxifen.
• Advanced disease: patients with advanced breast carcinoma with disease progression who had progressed/relapsed following > 8 weeks of treatment with Tamoxifen for advanced disease; or progressed during adjuvant Tamoxifen for at least 6 or 12 months depending on receptor status; or progressed within 12 months from completion of adjuvant treatment with Tamoxifen.
• at least one measurable lesion

Exclusion Criteria:

• More than one previous chemotherapy and/or more than one hormonotherapy for advanced disease.
• Previous hormonotherapy for advanced disease other than Tamoxifen.
• Myocardial infarction within previous 6 mo

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 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  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00038103

Study ID Number: NQ8-01-02-013

ClinicalTrials.gov Identifier: NCT00038103

Health Authority: United States: Food and Drug Administration

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