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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Stephen Povoski, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00201773
First received: September 12, 2005
Last updated: June 25, 2015
Last verified: June 2015
Results First Received: February 17, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Exemestane
Drug: Celecoxib
Other: Correlative studies

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment of postmenopausal women between January 2003 and July 2007

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Exemestane: 25 mg orally once per day for 16 weeks.

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.

Correlative studies


Participant Flow:   Overall Study
    Exemestane & Celecoxib  
STARTED     22  
Completed 8 Weeks of Planned Therapy     16  
Received All Exemestane Therapy     5  
Stopped Exemestane After 4 Weeks     1  
COMPLETED     16  
NOT COMPLETED     6  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Exemestane & Celecoxib

Patients will received 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.

Exemestane: 25 mg orally once per day for 16 weeks.

Celecoxib: given orally at two 200 mg capsules (400 mg) twice per day. Patients assigned to receive 400 mg twice per day and instructed to take the drug with food.

Correlative studies


Baseline Measures
    Exemestane & Celecoxib  
Number of Participants  
[units: participants]
  22  
Age  
[units: years]
Median (Full Range)
  63   (49 to 87)  
Gender  
[units: participants]
 
Female     22  
Male     0  
Region of Enrollment  
[units: patients]
 
United States     22  
ECOG (Eastern Cooperative Oncology Group) Performance Status 0-1 [1]
[units: patients]
  22  
Menopause Status of Postmenopausal  
[units: patients]
  22  
Progesterone Receptor status  
[units: patients]
 
Positive     16  
Negative     6  
Her-2 FISH [2]
[units: patients]
 
Positive     4  
Negative     8  
Not available     10  
Histology  
[units: patients]
 
Invasive     15  
Lobular     5  
Mixed invasive and lobular     2  
Clinical Axillary Status  
[units: patients]
 
Positive     7  
Negative     15  
Axillary Nodal Evaluation  
[units: patients]
 
Fine needle aspiration     2  
Sentinel     1  
Clinical Stage  
[units: patients]
 
I (cancer cells confined to limited area)     1  
IIA (evidence cancer has begun to grow/spread)     14  
IIB (tumor between 2-5 cm or larger)     3  
IIIA (cancer considered advanced)     3  
Occult primary (axillary metastases)     1  
[1]

ECOG Performance Status 0 is defined as fully active, able to carry on all pre-disease performance without restriction.

ECOG Performance Status1 is defined as restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.

[2] Fluorescence in situ hybridization



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Patients With Decreased Gene Expression of CYP19 in Breast Cancer by Adding COX-2 Inhibitor to Exemestane   [ Time Frame: up to 16 weeks ]

2.  Secondary:   Evaluate Response Rate of Neoadjuvant Exemestane and Celecoxib in Postmenopausal Women.   [ Time Frame: up to 16 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Steven Provoski, MD
Organization: The Ohio State University Comprehensive Cancer Center
phone: 614-293-8700
e-mail: Stephen.Povoski@osumc.edu


No publications provided


Responsible Party: Stephen Povoski, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00201773     History of Changes
Other Study ID Numbers: OSU-0245
Study First Received: September 12, 2005
Results First Received: February 17, 2015
Last Updated: June 25, 2015
Health Authority: United States: Institutional Review Board