Phase 2
Completed N=111
Open-Label Study Of Exemestane With Or Without Celecoxib In Postmenopausal Women With ABC Having Progressed On Tamoxifen
Source: ClinicalTrials.gov NCT00038103 ↗Enrolled (actual)
111
Serious AEs
—
Results posted
Feb 2010
Primary outcomePrimary: Number of Subjects With Clinical Benefit — 24; 24 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Clinical Benefit |
24; 24 | — |
| SECONDARY Number of Subjects With Objective Response |
11; 12 | — |
| SECONDARY Duration of Clinical Benefit |
49.1; 96.6 | — |
| SECONDARY Duration of Objective Response (in Subjects With CR or PR) |
32.7; 40.1 | — |
| SECONDARY Duration of Long-Term SD |
52.9; 109.7 | — |
| SECONDARY Time to Tumor Progression |
20; 23.4 | — |
| SECONDARY Time to Treatment Failure |
18.1; 20.4 | — |
| SECONDARY Survival |
74.4; 73.9 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00038103). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.