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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
Enrollment 22
Recruitment Details Enrollment of postmenopausal women between January 2003 and July 2007
Pre-assignment Details  
Arm/Group Title Exemestane & Celecoxib
Hide Arm/Group Description

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

Period Title: Overall Study
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
Arm/Group Title Exemestane & Celecoxib
Hide Arm/Group Description

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

Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 22 participants
63
(49 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
22
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Patients
United States Number Analyzed 22 participants
22
ECOG (Eastern Cooperative Oncology Group) Performance Status 0-1   [1] 
Measure Type: Number
Unit of measure:  Patients
Number Analyzed 22 participants
22
[1]
Measure Description:

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.

Menopause Status of Postmenopausal  
Measure Type: Number
Unit of measure:  Patients
Number Analyzed 22 participants
22
Progesterone Receptor status  
Measure Type: Number
Unit of measure:  Patients
Number Analyzed 22 participants
Positive 16
Negative 6
Her-2 FISH   [1] 
Measure Type: Number
Unit of measure:  Patients
Number Analyzed 22 participants
Positive 4
Negative 8
Not available 10
[1]
Measure Description: Fluorescence in situ hybridization
Histology  
Measure Type: Number
Unit of measure:  Patients
Number Analyzed 22 participants
Invasive 15
Lobular 5
Mixed invasive and lobular 2
Clinical Axillary Status  
Measure Type: Number
Unit of measure:  Patients
Number Analyzed 22 participants
Positive 7
Negative 15
Axillary Nodal Evaluation  
Measure Type: Number
Unit of measure:  Patients
Number Analyzed 22 participants
Fine needle aspiration 2
Sentinel 1
Clinical Stage  
Measure Type: Number
Unit of measure:  Patients
Number Analyzed 22 participants
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.Primary Outcome
Title Number of Patients With Decreased Gene Expression of CYP19 in Breast Cancer by Adding COX-2 Inhibitor to Exemestane
Hide Description Collected from postmenopausal women that receive neoadjuvant exemestane.
Time Frame up to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Comparison of immunohistochemistry (IHC) Allred Differences with Neoadjuvant Therapy
Arm/Group Title Exemestane + Celecoxib Exemestane
Hide Arm/Group Description:
Exemestane + celecoxib (16 weeks) vs. Baseline
Exemestane (8 weeks) vs. Baseline
Overall Number of Participants Analyzed 14 9
Measure Type: Number
Unit of Measure: patients
0 0
2.Secondary Outcome
Title Evaluate Response Rate of Neoadjuvant Exemestane and Celecoxib in Postmenopausal Women.
Hide Description Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response, Disappearance of all target lesions; Partial Response, >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease, <30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame up to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Clinical Response was determined by physical exam and breast Ultrasound at baseline and repeated at 8 weeks and 16 weeks, and pathological response by histopathological examination of primary tumor and axillary nodes after definitive breast cancer surgery.
Arm/Group Title Exemestane & Celecoxib
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: patients
Complete Response 0
Partial Response 5
Stable Disease 1
Progressive Disease 1
Non-measurable 15
Time Frame [Not Specified]
Adverse Event Reporting Description Toxicities were graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The same patient could be counted more than once if the same toxicity occured during treatment with exemestane alone and again when exemestane was combined with celecoxib.
 
Arm/Group Title Exemestane Alone Exemestane + Celecoxib
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Exemestane Alone Exemestane + Celecoxib
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Exemestane Alone Exemestane + Celecoxib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      0/22 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Exemestane Alone Exemestane + Celecoxib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/22 (100.00%)      22/22 (100.00%)    
Gastrointestinal disorders     
Heartburn  1  0/22 (0.00%)  0 4/22 (18.18%)  4
Nausea  1  1/22 (4.55%)  1 3/22 (13.64%)  3
Abdominal Pain  1  1/22 (4.55%)  1 5/22 (22.73%)  5
Constipation  1  3/22 (13.64%)  3 2/22 (9.09%)  2
Diarrhea  1  1/22 (4.55%)  1 0/22 (0.00%)  0
Lower Gastrointestional Bleed  1  0/22 (0.00%)  0 2/22 (9.09%)  2
General disorders     
Fatigue  1  10/22 (45.45%)  10 6/22 (27.27%)  6
Musculoskeletal and connective tissue disorders     
Myalgias  1  1/22 (4.55%)  1 0/22 (0.00%)  0
Arthralgia  1  9/22 (40.91%)  9 5/22 (22.73%)  5
Nervous system disorders     
Sensory Neuropathy  1  0/22 (0.00%)  0 1/22 (4.55%)  1
Renal and urinary disorders     
Renal Insufficiency  1  0/22 (0.00%)  0 1/22 (4.55%)  1
Skin and subcutaneous tissue disorders     
Rash  1  0/22 (0.00%)  0 1/22 (4.55%)  1
Vascular disorders     
Hot Flashes  1  9/22 (40.91%)  9 6/22 (27.27%)  6
Edema  1  0/22 (0.00%)  0 2/22 (9.09%)  2
Hypertension  1  0/22 (0.00%)  0 4/22 (18.18%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Steven Provoski, MD
Organization: The Ohio State University Comprehensive Cancer Center
Phone: 614-293-8700
EMail: Stephen.Povoski@osumc.edu
Layout table for additonal information
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