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

Sponsor:	Ohio State University Comprehensive Cancer Center
Information provided by:	Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00201773

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: Exemestane Drug: Celecoxib	Phase II

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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Exemestane Celecoxib

U.S. FDA Resources

Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:

Breast biopsy [ Time Frame: Pre-study & Week 8 ] [ Designated as safety issue: No ]
Definitive breast surgery [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Physical exam [ Time Frame: Prestudy, Week 8 & Week 16 ] [ Designated as safety issue: Yes ]
Breast ultrasound [ Time Frame: Prestudy, Week 8 & Week 16 ] [ Designated as safety issue: Yes ]
Mammogram [ Time Frame: Prestudy, Week 8 & Week 16 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	34
Study Start Date:	July 2003
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Intervention Details:

25 mg orally per day for 16 weeks.

400 mg orally twice per day Weeks 9 - 16.

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 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00201773

Contacts

Contact: Ohio State University Cancer Clinical Trial Matching Service

866-627-7616

osu@emergingmed.com

Locations

United States, Ohio
Ohio State University	Recruiting
Columbus, Ohio, United States, 43210

Sponsors and Collaborators

Ohio State University Comprehensive Cancer Center

Investigators

Principal Investigator:

Stephen Povoski

Ohio State University

More Information

No publications provided

Responsible Party:	Ohio State University Comprehensive Cancer Center ( Steven Povoski, M.D. )
Study ID Numbers:	OSU-0245
Study First Received:	September 12, 2005
Last Updated:	December 27, 2007
ClinicalTrials.gov Identifier:	NCT00201773 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Ohio State University Comprehensive Cancer Center:

Post-Menopause
Neoadjuvant Therapy

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Celecoxib
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Breast Neoplasms
Enzyme Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site

Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Exemestane
Antirheumatic Agents
Aromatase Inhibitors
Central Nervous System Agents
Breast Diseases

ClinicalTrials.gov processed this record on February 08, 2010