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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00038103
First received: May 29, 2002
Last updated: February 11, 2010
Last verified: February 2010
  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: Exemestane
Drug: Celecoxib + Exemestane
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Subjects With Clinical Benefit [ Time Frame: Baseline, Week 8, 16, 24, and every 12 weeks beyond 24 up to Week 108 and every 24 weeks thereafter until 9 months following last subject last visit (LSLV) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Subjects With Objective Response [ Time Frame: Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV ] [ Designated as safety issue: No ]
  • Duration of Clinical Benefit [ Time Frame: Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV ] [ Designated as safety issue: No ]
  • Duration of Objective Response (in Subjects With CR or PR) [ Time Frame: Baseline, Weeks 8, 16, 24, every 12 weeks beyond 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV ] [ Designated as safety issue: No ]
  • Duration of Long-Term SD [ Time Frame: Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months LSLV ] [ Designated as safety issue: No ]
  • Time to Tumor Progression [ Time Frame: Baseline, Weeks 8, 16, 24, every 12 weeks beyond Week 24 up to Week 108 and every 24 weeks thereafter until 9 months following LSLV ] [ Designated as safety issue: No ]
  • Time to Treatment Failure [ Time Frame: Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: Baseline, Weeks 8, 16, 24, every 12 weeks from Week 24 up to Week 108, and every 24 weeks thereafter until 9 months following LSLV or death ] [ Designated as safety issue: No ]

Enrollment: 111
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
Active Comparator: 1. Drug: Exemestane
Patient will be instructed to take a 25 mg exemestane tablet, once a day, every day, with food.
Other Name: Aromasin
Experimental: 2. Drug: Celecoxib + Exemestane
Exemestane + celecoxib treatment arm, she will be instructed to take also two x 200 mg celecoxib capsules twice a day, every day, with food.
Other Name: Celebrex, Aromasin

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Antwerpen, Belgium, 2020
Pfizer Investigational Site
Bruxelles, Belgium, 1000
Pfizer Investigational Site
Leuven, Belgium, 3000
Pfizer Investigational Site
Namur, Belgium, 5000
Pfizer Investigational Site
Wilrijk, Belgium, 2610
Brazil
Pfizer Investigational Site
Porto Alegre, RS, Brazil, 90610-000
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
Bogota, Bogota . DC, Colombia
Pfizer Investigational Site
Cali, Colombia
India
Pfizer Investigational Site
Hyderabad, Andhra Pradesh, India, 500 082
Pfizer Investigational Site
Bangalore, Karnataka, India, 560 029
Pfizer Investigational Site
Mumbai, Maharashtra, India, 400 012
Pfizer Investigational Site
Pune, Maharashtra, India, 41101
Mexico
Pfizer Investigational Site
Mexico, Distrito Federal, Mexico, 07760
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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00038103     History of Changes
Other Study ID Numbers: NQ8-01-02-013, A3191139
Study First Received: May 29, 2002
Results First Received: March 27, 2009
Last Updated: February 11, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Tamoxifen
Exemestane
Celecoxib
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 20, 2014