Exemestane With Celecoxib as Neoadjuvant Treatment in Postmenopausal Women With Stage II, III, and IV Breast Cancer

NCT00201773

Last updated date
Study Location
Ohio State University
Columbus, Ohio, 43210, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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ALL GENDERS
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Advanced Information
Descriptive Information
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
  • Drug: Exemestane
    25 mg orally once per day for 16 weeks.
    Other Name: Aromasin
  • Drug: Celecoxib
    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.
    Other Name: Celebrex
  • Other: Correlative studies
    Other Names:
    • biopsy
    • tissue specimens
    • tissue samples
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:
  • Drug: Exemestane
  • Drug: Celecoxib
  • Other: Correlative studies
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
 (submitted: August 1, 2011)
22
Original Enrollment  ICMJE
 (submitted: September 12, 2005)
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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
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
Principal Investigator:Stephen PovoskiOhio State University
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