Open-Label Study Of Exemestane With Or Without Celecoxib In Postmenopausal Women With ABC Having Progressed On Tamoxifen

Completed · Phase 2

Conditions studied: Breast Neoplasms

In brief

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.

Key facts

Study ID

NCT00038103

Run by

Pfizer

People needed

111

Starts

2002-01-01

Expected to finish

2008-03-01

Last updated by the study team

2010-02-25

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pfizer Investigational Site — Dallas, Texas, United States
• Pfizer Investigational Site — Antwerp, Belgium
• Pfizer Investigational Site — Brussels, Belgium
• Pfizer Investigational Site — Leuven, Belgium
• Pfizer Investigational Site — Namur, Belgium
• Pfizer Investigational Site — Wilrijk, Belgium
• Pfizer Investigational Site — Porto Alegre, Rio Grande do Sul, Brazil
• Pfizer Investigational Site — São Paulo, São Paulo, Brazil
• Pfizer Investigational Site — Sydney, Nova Scotia, Canada
• Pfizer Investigational Site — Bogotá, Bogota . DC, Colombia
• Pfizer Investigational Site — Cali, Colombia
• Pfizer Investigational Site — Hyderabad, Andhra Pradesh, India
• Pfizer Investigational Site — Bangalore, Karnataka, India
• Pfizer Investigational Site — Mumbai, Maharashtra, India
• Pfizer Investigational Site — Pune, Maharashtra, India
• Pfizer Investigational Site — Guadalajara, Jalisco, Mexico
• Pfizer Investigational Site — Mexico City, Mexico City, Mexico
• Pfizer Investigational Site — Lima, Lima Province, Peru
• Pfizer Investigational Site — Lima, Lima Province, Peru
• Pfizer Investigational Site — Manila, Philippines

Full record on ClinicalTrials.gov

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