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

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ClinicalTrials.gov Identifier: NCT00201773
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : June 30, 2015
Last Update Posted : June 30, 2015
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Stephen Povoski, Ohio State University Comprehensive Cancer Center

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Exemestane
Drug: Celecoxib
Other: Correlative studies

  Participant Flow

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

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 
Overall Participants Analyzed 
[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 [1] 
[Units: Patients]
 
Positive   4 
Negative   8 
Not available   10 
[1] Fluorescence in situ hybridization
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 


  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

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

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



Responsible Party: Stephen Povoski, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00201773     History of Changes
Other Study ID Numbers: OSU-0245
First Submitted: September 12, 2005
First Posted: September 20, 2005
Results First Submitted: February 17, 2015
Results First Posted: June 30, 2015
Last Update Posted: June 30, 2015