Clinical trial · Interventional
Open-Label Study Of Exemestane With Or Without Celecoxib In Postmenopausal Women With ABC Having Progressed On Tamoxifen
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
NCT00038103CI-TRIAL-00003193completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Celecoxib + Exemestane | Drug | — | UNRESOLVED |
| Exemestane | Drug | Exemestane | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1.
- interventionNames
- Drug: Exemestane
- type
- EXPERIMENTAL
- label
- 2.
- interventionNames
- Drug: Celecoxib + Exemestane
Primary outcomes (1)
- measure
- Number of Subjects With Clinical Benefit
- timeFrame
- 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)
- description
- Clinical benefit was based on objective tumor assessments made according to Response Evaluation Criteria (RECIST) system of unidimensional evaluation. Includes subjects with complete response (CR), partial response (PR), and long term disease stabilization (SD) for at least 24 weeks.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.