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):
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00083174
First received: May 14, 2004
Last updated: February 7, 2014
Last verified: February 2014
Results First Received: November 7, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   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  
Number of Participants  
[units: participants]
  2285     2275     4560  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     1458     1481     2939  
>=65 years     827     794     1621  
Age  
[units: years]
Mean ± Standard Deviation
  63.1  ± 7.2     63.1  ± 7.0     63.1  ± 7.1  
Gender  
[units: participants]
     
Female     2285     2275     4560  
Male     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
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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) ]

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 posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events
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Time Frame Participants were followed for a median of 35 months
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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

Other Adverse Events
    Exemestane     Placebo  
Total, other (not including serious) adverse events      
# participants affected / at risk     1963/2240     1901/2248  
Cardiac disorders      
hypertension † 1    
# participants affected / at risk     341/2240 (15.22%)     354/2248 (15.75%)  
Endocrine disorders      
hot flashes † 1    
# participants affected / at risk     900/2240 (40.18%)     718/2248 (31.94%)  
fatigue † 1    
# participants affected / at risk     525/2240 (23.44%)     465/2248 (20.69%)  
sweating † 1    
# participants affected / at risk     486/2240 (21.70%)     433/2248 (19.26%)  
insomnia † 1    
# participants affected / at risk     230/2240 (10.27%)     189/2248 (8.41%)  
Gastrointestinal disorders      
Diarrhea † 1    
# participants affected / at risk     118/2240 (5.27%)     75/2248 (3.34%)  
heartburn † 1    
# participants affected / at risk     332/2240 (14.82%)     289/2248 (12.86%)  
Nausea † 1    
# participants affected / at risk     155/2240 (6.92%)     122/2248 (5.43%)  
General disorders      
Pain Back † 1    
# participants affected / at risk     306/2240 (13.66%)     222/2248 (9.88%)  
pain extremity † 1    
# participants affected / at risk     153/2240 (6.83%)     122/2248 (5.43%)  
Pain Joint † 1    
# participants affected / at risk     665/2240 (29.69%)     606/2248 (26.96%)  
pain muscle † 1    
# participants affected / at risk     147/2240 (6.56%)     192/2248 (8.54%)  
Musculoskeletal and connective tissue disorders      
Arthritis † 1    
# participants affected / at risk     247/2240 (11.03%)     196/2248 (8.72%)  
Nervous system disorders      
dizziness † 1    
# participants affected / at risk     189/2240 (8.44%)     209/2248 (9.30%)  
mood alteration or depression † 1    
# participants affected / at risk     236/2240 (10.54%)     235/2248 (10.45%)  
Reproductive system and breast disorders      
vaginal dryness † 1    
# participants affected / at risk     352/2240 (15.71%)     343/2248 (15.26%)  
Respiratory, thoracic and mediastinal disorders      
cough † 1    
# participants affected / at risk     234/2240 (10.45%)     266/2248 (11.83%)  
Events were collected by systematic assessment
1 Term from vocabulary, CTCAE, version 3.0



  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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