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Exemestane in Preventing Cancer in Postmenopausal Women at Increased Risk of Developing Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Grupo Espanol de Investigacion del Cancer de Mama
UNICANCER
Information provided by (Responsible Party):
Canadian Cancer Trials Group ( NCIC Clinical Trials Group )
ClinicalTrials.gov Identifier:
NCT00083174
First received: May 14, 2004
Last updated: January 13, 2017
Last verified: October 2016
Results First Received: November 7, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Breast Cancer
Intervention: Drug: exemestane

  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
Between February 11, 2004, and March 23, 2010, 4560 women were recruited in medical clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligibility of women was first checked before the randomization to the trial.

Reporting Groups
  Description
Exemestane one 25 mg tablet daily in am
Placebo one tablet daily in am

Participant Flow:   Overall Study
    Exemestane   Placebo
STARTED   2285   2275 
COMPLETED   2285 [1]   2275 [1] 
NOT COMPLETED   0   0 
[1] All women randomized were included in the analysis based on intent-to-treat principle.



  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 one 25 mg tablet daily in am
Placebo one tablet daily in am
Total Total of all reporting groups

Baseline Measures
   Exemestane   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 2285   2275   4560 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      1458  63.8%      1481  65.1%      2939  64.5% 
>=65 years      827  36.2%      794  34.9%      1621  35.5% 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.1  (7.2)   63.1  (7.0)   63.1  (7.1) 
Gender 
[Units: Participants]
Count of Participants
     
Female      2285 100.0%      2275 100.0%      4560 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   1416   1408   2824 
France   9   10   19 
Canada   643   642   1285 
Spain   217   215   432 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Invasive Breast Cancer Incidence (Breast Cancer-Free Survival)   [ Time Frame: Over study (median follow-up 35 months) ]

2.  Secondary:   Total Incidence of Invasive and Non-invasive (DCIS) Breast Cancer   [ Time Frame: Over study (median follow-up 35 months) ]

3.  Secondary:   Incidence of Lobular Carcinoma in Situ, Atypical Ductal Hyperplasia and Atypical Lobular Hyperplasia Events   [ Time Frame: Over study (median follow-up 35 months) ]
  Hide Outcome Measure 3

Measure Type Secondary
Measure Title Incidence of Lobular Carcinoma in Situ, Atypical Ductal Hyperplasia and Atypical Lobular Hyperplasia Events
Measure Description No text entered.
Time Frame Over study (median follow-up 35 months)  

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.
Intent-to-treat (ITT)

Reporting Groups
  Description
Exemestane one 25 mg tablet daily in am
Placebo one tablet daily in am

Measured Values
   Exemestane   Placebo 
Participants Analyzed 
[Units: Participants]
 2285   2275 
Incidence of Lobular Carcinoma in Situ, Atypical Ductal Hyperplasia and Atypical Lobular Hyperplasia Events 
[Units: Percentage of cases/follow-up person-yr]
Number (95% Confidence Interval)
 0.07 
 (0.00 to 0.15) 
 0.20 
 (0.08 to 0.32) 


Statistical Analysis 1 for Incidence of Lobular Carcinoma in Situ, Atypical Ductal Hyperplasia and Atypical Lobular Hyperplasia Events
Groups [1] All groups
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Log Rank
P Value [4] 0.07
Hazard Ratio (HR) [5] 0.36
95% Confidence Interval 0.11 to 1.12
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[5] Other relevant estimation information:
  No text entered.



4.  Secondary:   Number of Clinical Breast Biopsies   [ Time Frame: Over study (median follow-up 35 months) ]

5.  Secondary:   Incidence of All Clinical Fractures   [ Time Frame: During protocol treatment (up to 5 years) ]

6.  Secondary:   Incidence of Clinically Relevant Cardiac Events   [ Time Frame: During protocol treatment (up to 5 years) ]

7.  Secondary:   Incidences of Other Malignancies   [ Time Frame: Over study (median follow-up 35 months) ]

8.  Primary:   Frequency of Serious Adverse Events   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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