Exemestane With Celecoxib as Neoadjuvant Treatment in Postmenopausal Women With Stage II, III, and IV Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Exemestane; Celecoxib; Correlative studies
Intervention description: 25 mg orally once per day for 16 weeks.; given orally at two 200 mg capsules (400 mg) twice per day. Patients assigned to receive 400 mg twice per day should be instructed to take the drug with food.
Intervention MeSH terms: Celecoxib; Exemestane
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Post-Menopause; Neoadjuvant Therapy

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.
    

Eligibility criteria:

        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.