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

Condition(s) targeted: Breast Neoplasms

Intervention: Celecoxib (Drug); Exemestane (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

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

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

Primary outcome: clinical benefit (defined as the frequency of tumor response and disease stabilization for at least 24 weeks)

Secondary outcome:

Other efficacy parameters than clinical benefit; tolerability; PD and PK

Survival

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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

Pfizer Investigational Site, Leuven 3000, Belgium

Pfizer Investigational Site, WILRIJK 2610, Belgium

Pfizer Investigational Site, Antwerpen 2020, Belgium

Pfizer Investigational Site, Bruxelles 1000, Belgium

Pfizer Investigational Site, Namur 5000, Belgium

Pfizer Investigational Site, Cali, Colombia

Pfizer Investigational Site, Lima 11, Peru

Pfizer Investigational Site, Lima 34, Peru

Pfizer Investigational Site, Manila 1000, Philippines

Pfizer Investigational Site, Hyderabad, Andhra Pradesh 500 082, India

Pfizer Investigational Site, Bogota, Bogota . DC, Colombia

Pfizer Investigational Site, Mexico, Distrito Federal 07760, Mexico

Pfizer Investigational Site, Guadalajara, Jalisco 44280, Mexico

Pfizer Investigational Site, Bangalore, Karnataka 560 029, India

Pfizer Investigational Site, Mumbai, Maharashtra 400 012, India

Pfizer Investigational Site, Pune, Maharashtra 41101, India

Pfizer Investigational Site, Sydney, Nova Scotia B1P 1P3, Canada

Pfizer Investigational Site, Porto Alegre, RS 90610-000, Brazil

Pfizer Investigational Site, Sao Paulo, SP 01509-900, Brazil

Pfizer Investigational Site, Dallas, Texas 75204, United States

To obtain contact information for a study center near you, click here.

Starting date: January 2002
Ending date: December 2009
Last updated: June 9, 2008