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
Collaborator:	Pfizer
Information provided by (Responsible Party):	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:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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 ]

Enrollment:	22
Study Start Date:	July 2003
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Intervention Details:

25 mg orally per day for 16 weeks.

Other Name: Aromasin

400 mg orally twice per day Weeks 9 - 16.

Other Name: Celebrex

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.

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

Locations

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

Sponsors and Collaborators

Ohio State University Comprehensive Cancer Center

Pfizer

Investigators

Principal Investigator:

Stephen Povoski

Ohio State University

More Information

Additional Information:

Jamesline

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00201773 History of Changes
Other Study ID Numbers:	OSU-0245, 2003C0014
Study First Received:	September 12, 2005
Last Updated:	November 9, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:

Post-Menopause
Neoadjuvant Therapy

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Exemestane
Celecoxib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors

Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 09, 2012