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

NCT00201773 | Completed Phase 2 Results DMC

• 1 other identifier: OSU-0245
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Post-Menopause; Neoadjuvant Therapy

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Decreased Gene Expression of CYP19 in Breast Cancer by Adding COX-2 Inhibitor to Exemestane

  Collected from postmenopausal women that receive neoadjuvant exemestane.

  up to 16 weeks

Secondary Outcomes (1)

• Evaluate Response Rate of Neoadjuvant Exemestane and Celecoxib in Postmenopausal Women.

  up to 16 weeks

Study Arms (1)

Exemestane & Celecoxib

EXPERIMENTAL

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.

Drug: Exemestane; Drug: Celecoxib; Other: Correlative studies

Interventions

Exemestane DRUG

25 mg orally once per day for 16 weeks.

Also known as: Aromasin

Exemestane & Celecoxib

Celecoxib DRUG

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.

Also known as: Celebrex

Exemestane & Celecoxib

Correlative studies OTHER

Also known as: biopsy, tissue specimens, tissue samples

Exemestane & Celecoxib

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• Pfizer: collaborator

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Links

• Jamesline

MeSH Terms

Conditions

Breast Neoplasms

Interventions

exemestane; Celecoxib; Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Steven Provoski, MD
• Organization: The Ohio State University Comprehensive Cancer Center

Stephen.Povoski@osumc.edu

614-293-8700

Study Officials

• Stephen Povoski

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: July 1, 2003
• Primary Completion: November 1, 2007
• Study Completion: June 1, 2011
• Last Updated: June 30, 2015
• Results First Posted: June 30, 2015

Record last verified: 2015-06

Locations

US (1)