Official Title: “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”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: June 2008

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 aromatese 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.

Intervention(s) in this Clinical Trial

• Drug: Exemestane
  • 25 mg orally per day for 16 weeks.
• Drug: Celecoxib
  • 400 mg orally twice per day Weeks 9 - 16.

Primary Measures

• Breast biopsy
  • Time Frame: Pre-study & Week 8
    Safety Issue?: No
• Definitive breast surgery
  • Time Frame: Week 16
    Safety Issue?: No

Secondary Measures

• Physical exam
  • Time Frame: Prestudy, Week 8 & Week 16
    Safety Issue?: Yes
• Breast ultrasound
  • Time Frame: Prestudy, Week 8 & Week 16
    Safety Issue?: Yes
• Mammogram
  • Time Frame: Prestudy, Week 8 & Week 16
    Safety Issue?: Yes

Inclusion Criteria:

• Must be female with histologically confirmed breast cancer
• Stage II-IV disease
• ER and/or PR positive
• ECOG Performance Status 0-1

Exclusion Criteria:

• Inflammatory breast cancer.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Ohio State University Comprehensive Cancer Center

Overall Clinical Trial Officials and Contacts

Stephen Povoski Principal Investigator Ohio State University  

Overall Contact: Ohio State University Cancer Clinical Trial Matching Service 866-627-7616 osu@emergingmed.com

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00201773

Study ID Number: OSU-0245

ClinicalTrials.gov Identifier: NCT00201773

Health Authority: United States: Food and Drug Administration