Status:
COMPLETED
Exemestane With Celecoxib as Neoadjuvant Treatment in Postmenopausal Women With Stage II, III, and IV Breast Cancer
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Collaborating Sponsors:
Pfizer
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
Rationale: In postmenopausal women, the main source of estrogen is through the conversion of androgens, or sex hormones produced by the adrenal glands. An enzyme called aromatase carries out this proc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00201773
Start Date
July 1 2003
End Date
June 1 2011
Last Update
June 30 2015
Active Locations (1)
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1
Ohio State University
Columbus, Ohio, United States, 43210