Exemestane With Celecoxib as Neoadjuvant Treatment in Postmenopausal Women With Stage II, III, and IV Breast Cancer
NCT00201773
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- 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.
- 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.
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Descriptive Information | ||||
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Brief Title ICMJE | Exemestane With Celecoxib as Neoadjuvant Treatment in Postmenopausal Women With Stage II, III, and IV Breast Cancer | |||
Official Title ICMJE | 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 | |||
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 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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Breast Cancer | |||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Exemestane & Celecoxib
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. Interventions:
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 22 | |||
Original Enrollment ICMJE | 34 | |||
Actual Study Completion Date ICMJE | June 2011 | |||
Actual Primary Completion Date | November 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00201773 | |||
Other Study ID Numbers ICMJE | OSU-0245 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Stephen Povoski, Ohio State University Comprehensive Cancer Center | |||
Study Sponsor ICMJE | Ohio State University Comprehensive Cancer Center | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | Ohio State University Comprehensive Cancer Center | |||
Verification Date | June 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |