Open-Label Study Of Exemestane With Or Without Celecoxib In Postmenopausal Women With ABC Having Progressed On Tamoxifen
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...
Brief Summary
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”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: March 2008
Intervention(s) in this Clinical Trial
- Drug: Exemestane
- Patient will be instructed to take a 25 mg exemestane tablet, once a day, every day, with food.
- 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.
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1.
- Experimental: 2.
Outcome Measures for this Clinical Trial
Primary 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)
Safety Issue?: No
- 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)
Secondary 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
Safety Issue?: No
- 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
- 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
Safety Issue?: No
- 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
- 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
Safety Issue?: No
- 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
- 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
Safety Issue?: No
- 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
- 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
Safety Issue?: No
- 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
- 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
Safety Issue?: No
- 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
- 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
Safety Issue?: No
- 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
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Pfizer Industry
Overall Clinical Trial Officials and Contacts
Pfizer CT.gov Call Center Study Director Pfizer
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00038103
Study ID Number: NQ8-01-02-013
ClinicalTrials.gov Identifier: NCT00038103
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00038103
