Clinical trial · Interventional
Exemestane With Celecoxib as Neoadjuvant Treatment in Postmenopausal Women With Stage II, III, and IV Breast Cancer
A Phase II Trial of Exemestane (Aromasin) in Combination With Celecoxib (Celebrex) as Neoadjuvant Treatment in Postmenopausal Women With Stage II, III, and IV Breast Cancer
NCT00201773CI-TRIAL-00018409completedPhase 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)
To test whether the addition of the COX-2 inhibitor, celecoxib, will decrease the gene expression of CYP19 in breast cancers collected from postmenopausal women that receive neoadjuvant exemestane.
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Celecoxib | Drug | Celecoxib | ALIAS |
| Correlative studies | Other | — | UNRESOLVED |
| Exemestane | Drug | Exemestane | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Exemestane & Celecoxib
- description
- Patients will receive exemestane 25 mg orally per day for 8 weeks. Starting in the 9th week, patients will receive celecoxib 400 mg orally twice per day for 8 weeks in addition to exemestane.
- interventionNames
- Drug: Exemestane
- Drug: Celecoxib
- Other: Correlative studies
Primary outcomes (1)
- measure
- Number of Patients With Decreased Gene Expression of CYP19 in Breast Cancer by Adding COX-2 Inhibitor to Exemestane
- timeFrame
- up to 16 weeks
- description
- Collected from postmenopausal women that receive neoadjuvant exemestane.
Secondary outcomes (1)
- measure
- Evaluate Response Rate of Neoadjuvant Exemestane and Celecoxib in Postmenopausal Women.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must be female with histologically confirmed breast cancer * Stage II-IV disease * ER and/or PR positive * ECOG Performance Status 0-1 * Tumor must be present following core needle biopsy as determined by physical exam or radiographic evaluation. * Postmenopausal * No prior treatment for current breast cancer. No other active malignancy is allowed.Adequately treated basal cell, squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for 5 years is permitted. Biphosphonates and palliative radiation for bone metastasis is permitted while on study. * Hormone replacement therapy must be discontinued. It is not permitted during the time on study. Exclusion Criteria: * Known history of aspirin or NSAID induced asthma, urticaria or allergic reactions; or allergy to sulfonamides severe enough in nature to require emergency room treatment or hospitalization. * History of myocardial infarction or other thrombotic events. * Inflammatory breast cancer (edema or ulceration of the skin of the breast). * Significant renal dysfunction (serum creatinine \> 1.5 x upper limit of normal). * Significant hepatic dysfunction (serum bilirubin \> 1.5 x upper limit of normal or AST, ALT \> 3 x upper limit of normal) * ANC \<1.5, platelets \<100,000 K/uL, and hemoglobin \< 9 g/dL. * Use of other COX-2 inhibitors such as rofecoxib (Vioxx®, aspirin, trisalicylate (Trilisate®), is not permitted during the time on study. No washout period is required. Baby aspirin, 81 mg po daily, is permitted. * Use of NSAID's such as ibuprofen (Advil® or Motrin®), naproxyn (Aleve® Naprosyn®, or Anaprox®), etodolac (Lodine®), oxaprozin (Daypro®), difusanil (Dolobid®), nabumetone (Relafin®), or tolmetin (Tolectin®) is not permitted during the time on study.
References
Publications (0)
Data not yet available
No reference posted for this study.