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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00038103

Purpose

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.

Condition	Intervention	Phase
Breast Neoplasms	Drug: Celecoxib Drug: Exemestane	Phase II

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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Tamoxifen Exemestane Celecoxib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

clinical benefit (defined as the frequency of tumor response and disease stabilization for at least 24 weeks) [ Time Frame: August 2003 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Other efficacy parameters than clinical benefit; tolerability; PD and PK [ Time Frame: June 2006 ] [ Designated as safety issue: Yes ]
Survival [ Time Frame: December 2012 ] [ Designated as safety issue: No ]

Enrollment:	110
Study Start Date:	January 2002
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Active Comparator	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.
1: Experimental	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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00038103

Locations

United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75204
Belgium
Pfizer Investigational Site
Leuven, Belgium, 3000
Pfizer Investigational Site
WILRIJK, Belgium, 2610
Pfizer Investigational Site
Antwerpen, Belgium, 2020
Pfizer Investigational Site
Bruxelles, Belgium, 1000
Pfizer Investigational Site
Namur, Belgium, 5000
Brazil, RS
Pfizer Investigational Site
Porto Alegre, RS, Brazil, 90610-000
Brazil, SP
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 01509-900
Canada, Nova Scotia
Pfizer Investigational Site
Sydney, Nova Scotia, Canada, B1P 1P3
Colombia
Pfizer Investigational Site
Cali, Colombia
Colombia, Bogota . DC
Pfizer Investigational Site
Bogota, Bogota . DC, Colombia
India, Andhra Pradesh
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, India, 500 082
India, Karnataka
Pfizer Investigational Site
Bangalore, Karnataka, India, 560 029
India, Maharashtra
Pfizer Investigational Site
Mumbai, Maharashtra, India, 400 012
Pfizer Investigational Site
Pune, Maharashtra, India, 41101
Mexico, Distrito Federal
Pfizer Investigational Site
Mexico, Distrito Federal, Mexico, 07760
Mexico, Jalisco
Pfizer Investigational Site
Guadalajara, Jalisco, Mexico, 44280
Peru
Pfizer Investigational Site
Lima, Peru, 11
Pfizer Investigational Site
Lima, Peru, 34
Philippines
Pfizer Investigational Site
Manila, Philippines, 1000

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	NQ8-01-02-013
Study First Received:	May 29, 2002
Last Updated:	September 25, 2008
ClinicalTrials.gov Identifier:	NCT00038103 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anti-Inflammatory Agents
Celecoxib
Skin Diseases
Cyclooxygenase Inhibitors
Breast Neoplasms
Tamoxifen
Analgesics, Non-Narcotic

Anti-Inflammatory Agents, Non-Steroidal
Exemestane
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Aromatase Inhibitors
Breast Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Celecoxib
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Breast Neoplasms
Enzyme Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site

Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Exemestane
Antirheumatic Agents
Aromatase Inhibitors
Central Nervous System Agents
Breast Diseases

ClinicalTrials.gov processed this record on September 11, 2009