Open-Label Study Of Exemestane With Or Without Celecoxib In Postmenopausal Women With ABC Having Progressed On Tamoxifen
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00038103
First received: May 29, 2002
Last updated: February 11, 2010
Last verified: February 2010
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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
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 June 17, 2013