Trial record 1 of 6 for:    exemestane high risk
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Exemestane and Celecoxib in Postmenopausal Women at High Risk for Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Georgetown University
ClinicalTrials.gov Identifier:
NCT00073073
First received: November 14, 2003
Last updated: April 11, 2016
Last verified: October 2015
Results First Received: April 11, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Breast Neoplasms
Interventions: Drug: Exemestane
Dietary Supplement: Calcium carbonate
Dietary Supplement: Vitamin D

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Exemestane

exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.

Exemestane: exemestane 25 mg by mouth (PO) every day for two years

Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years

Vitamin D: Vitamin D 400 international units PO every day x 2 years


Participant Flow:   Overall Study
    Exemestane  
STARTED     46  
COMPLETED     42  
NOT COMPLETED     4  



  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.
Patients who were treated

Reporting Groups
  Description
Exemestane

exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.

Exemestane: exemestane 25 mg by mouth (PO) every day for two years

Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years

Vitamin D: Vitamin D 400 international units PO every day x 2 years


Baseline Measures
    Exemestane  
Number of Participants  
[units: participants]
  42  
Age  
[units: years]
Mean (Full Range)
  59.1  
  (45 to 75)  
Gender  
[units: participants]
 
Female     42  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     42  



  Outcome Measures
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1.  Primary:   Percent Change in Mammographic Density at 1 Year on Exemestane   [ Time Frame: 1 year ]

2.  Secondary:   Effect of This Drug on Bone Mineral Density   [ Time Frame: 1 year ]

3.  Secondary:   Change in Breast Density at 2 Years   [ Time Frame: 2 years ]

4.  Secondary:   Effect of This Drug on Serum Hormones, Insulin-like Growth Factor Pathway Components, and Leptin at 3 Months and 1 Year   [ Time Frame: 3 months and 1 year ]

5.  Secondary:   Absolute Change of Lipid Profiles on Exemestane From Baseline   [ Time Frame: 1 year ]

6.  Secondary:   Effect of This Drug on Breast Tissue Trefoil Factor 1 and Proliferating Cell Nuclear Antigen Expression, Prolactin, and Breast Tissue Prolactin Receptor at 1 Year   [ Time Frame: 1 year ]

7.  Secondary:   Effect of Exemestane on Autocrine Prolactin and Breast Tissue Prolactin Receptor at One Year   [ Time Frame: 1 year ]

8.  Secondary:   Number of Serum and Breast Tissue Samples Collected for Exploratory Proteomic Profiles at One Year   [ Time Frame: 1 year ]


  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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Claudine Isaacs
Organization: Georgetown University
phone: (202)444-3677
e-mail: isaacsc@georgetown.edu


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT00073073     History of Changes
Obsolete Identifiers: NCT00085072
Other Study ID Numbers: 040044
04-C-0044 ( Other Identifier: NCI )
Study First Received: November 14, 2003
Results First Received: April 11, 2016
Last Updated: April 11, 2016
Health Authority: United States: Food and Drug Administration