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

This study is ongoing, but not recruiting participants.
Grupo Espanol de Investigacion del Cancer de Mama
Information provided by (Responsible Party):
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
First received: May 14, 2004
Last updated: October 5, 2015
Last verified: April 2015
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

  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.
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Reporting Groups
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  
[units: participants]
<=18 years     0     0     0  
Between 18 and 65 years     1458     1481     2939  
>=65 years     827     794     1621  
[units: years]
Mean (Standard Deviation)
  63.1  (7.2)     63.1  (7.0)     63.1  (7.1)  
[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 reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

  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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