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

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ClinicalTrials.gov Identifier: NCT00083174
Recruitment Status : Completed
First Posted : May 17, 2004
Results First Posted : May 20, 2013
Last Update Posted : April 25, 2018
Sponsor:
Collaborators:
Grupo Espanol de Investigacion del Cancer de Mama
UNICANCER
Information provided by (Responsible Party):
Canadian Cancer Trials Group ( NCIC Clinical Trials Group )

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Breast Cancer
Intervention: Drug: exemestane

  Participant Flow

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
Randomization Period: Exemestane one 25 mg tablet daily in am
Randomization Period: Placebo one tablet daily in am
Open-label Extension: Exemestane one 25 mg tablet daily in am

Participant Flow for 2 periods

Period 1:   Randomization Period
    Randomization Period: Exemestane   Randomization Period: Placebo   Open-label Extension: Exemestane
STARTED   2285   2275   0 
COMPLETED   2285 [1]   2275 [1]   0 
NOT COMPLETED   0   0   0 
[1] All women randomized were included in the analysis based on intent-to-treat principle.

Period 2:   Open-label Extension
    Randomization Period: Exemestane   Randomization Period: Placebo   Open-label Extension: Exemestane
STARTED   0   0   2831 
COMPLETED   0   0   2831 
NOT COMPLETED   0   0   0 



  Baseline Characteristics

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
Randomization Period: Exemestane one 25 mg tablet daily in am
Randomization Period: Placebo one tablet daily in am
Total Total of all reporting groups

Baseline Measures
   Randomization Period: Exemestane   Randomization Period: 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) 
Sex: Female, Male 
[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

1.  Primary:   Percentage of Women With Serious Adverse Events   [ Time Frame: 5 years open-label extension period ]
  Hide Outcome Measure 1

Measure Type Primary
Measure Title Percentage of Women With Serious Adverse Events
Measure Description Percentage of serious adverse events for women who choose to receive 5 years of exemestane as preventative therapy.
Time Frame 5 years open-label extension period  

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.
Postmenopausal women who were randomized to exemestane in original MAP.3 study and chose to continue to receive exemestane for up to 5 years and those randomized to placebo and decided to start 5 years of exemestane.

Reporting Groups
  Description
Open-label Extension: Exemestane

one 25 mg tablet daily in am

exemestane: one 25 mg tablet daily in am


Measured Values
   Open-label Extension: Exemestane 
Participants Analyzed 
[Units: Participants]
 2831 
Percentage of Women With Serious Adverse Events 
[Units: Percentage of women]
Number (95% Confidence Interval)
 0.0 
 (0.0 to 0.5) 

No statistical analysis provided for Percentage of Women With Serious Adverse Events



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

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

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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