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
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms
Female
Breast Neoplasms
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Subjects With Clinical Benefit
Outcome 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
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
NQ8-01-02-013
NCT ID:
NCT00038103
Start Date:
January 2002
Completion Date:
March 2008
Related Keywords:
- Breast Neoplasms
- Breast Neoplasms
- Neoplasms
Name | Location |
|---|---|
| Pfizer Investigational Site | Houston, Texas 77030 |
