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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

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

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

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 process. Exemestane, an aromatase inhibitor, blocks production of
estrogens. Research indicates that the gene responsible for aromatase activity is CYPO19.
Therefore, exemestane helps to inhibit aromatase activity through CYP019. Along with CYP019,
another gene associated with breast cancer is an overexpression of COX-2 enzymes. Research
suggests that COX-2 overexpression can cause cancer cell division, increased blood flow to
tumors, and metastases. Celecoxib blocks COX-2 activity and produces fewer side effects
compared with other non-steroidal inflammatory drugs (NSAIDs). This study builds on previous
research to test the combination of exemestane and celecoxib for breast cancer.

Purpose: This study is evaluating the safety and efficacy of exemestane and celecoxib before
surgery for stage II, III, and IV breast cancer in postmenopausal women. Tests will analyze
the CYP019 gene after these treatments.

Treatment: Patients in this study will receive exemestane and celecoxib. Both drugs will be
given to patients as oral pills. Exemestane will be taken daily for sixteen weeks. Starting
in week 9, celecoxib will be taken twice daily for eight weeks. Therefore, during weeks
9-16, patients will be taking both exemestane and celecoxib. Several tests and exams will be
given throughout the study to closely monitor patients, including a biopsy performed after
the first 8 weeks on exemestane. After sixteen weeks on exemestane and celecoxib, patients
will have breast surgery.

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine if the addition of COX-2 inhibitor, celecoxib, will decrease the gene expression of CYP19 in breast cancer.

Outcome Description:

Collected from postmenopausal women that receive neoadjuvant exemestane.

Outcome Time Frame:

up to 16 weeks

Safety Issue:


Principal Investigator

Stephen Povoski

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University


United States: Institutional Review Board

Study ID:




Start Date:

July 2003

Completion Date:

June 2011

Related Keywords:

  • Breast Cancer
  • Post-Menopause
  • Neoadjuvant Therapy
  • Breast Neoplasms



Ohio State University Columbus, Ohio  43210