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

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

Serious Adverse Events
    Exemestane     Placebo  
Total, serious adverse events      
# participants affected / at risk     39/2240 (1.74%)     26/2248 (1.16%)  
Cardiac disorders      
Supraven.arrhyth. Atrial fibrillation † 1    
# participants affected / at risk     1/2240 (0.04%)     0/2248 (0.00%)  
Cardiac ischemia/infarction † 1    
# participants affected / at risk     2/2240 (0.09%)     3/2248 (0.13%)  
Valvular heart disease † 1    
# participants affected / at risk     1/2240 (0.04%)     0/2248 (0.00%)  
Cardiac General - Other † 1    
# participants affected / at risk     2/2240 (0.09%)     1/2248 (0.04%)  
Endocrine disorders      
Endocrine - Other † 1    
# participants affected / at risk     1/2240 (0.04%)     0/2248 (0.00%)  
Eye disorders      
Ocular - Other † 1    
# participants affected / at risk     1/2240 (0.04%)     0/2248 (0.00%)  
Gastrointestinal disorders      
Colitis † 1    
# participants affected / at risk     2/2240 (0.09%)     1/2248 (0.04%)  
Diarrhea † 1    
# participants affected / at risk     1/2240 (0.04%)     1/2248 (0.04%)  
Dysphagia † 1    
# participants affected / at risk     1/2240 (0.04%)     0/2248 (0.00%)  
Gastritis † 1    
# participants affected / at risk     1/2240 (0.04%)     0/2248 (0.00%)  
Incontinence, anal † 1    
# participants affected / at risk     1/2240 (0.04%)     0/2248 (0.00%)  
Nausea † 1    
# participants affected / at risk     1/2240 (0.04%)     0/2248 (0.00%)  
Obstruction, GI Stomach † 1    
# participants affected / at risk     1/2240 (0.04%)     0/2248 (0.00%)  
Vomiting † 1    
# participants affected / at risk     1/2240 (0.04%)     1/2248 (0.04%)  
GI - Other † 1    
# participants affected / at risk     3/2240 (0.13%)     1/2248 (0.04%)  
General disorders      
Sudden death † 1    
# participants affected / at risk     0/2240 (0.00%)     1/2248 (0.04%)  
Pain Abdomen NOS † 1    
# participants affected / at risk     1/2240 (0.04%)     0/2248 (0.00%)  
Pain Back † 1    
# participants affected / at risk     1/2240 (0.04%)     0/2248 (0.00%)  
Pain Joint † 1    
# participants affected / at risk     2/2240 (0.09%)     0/2248 (0.00%)  
Syndromes - Other † 1    
# participants affected / at risk     0/2240 (0.00%)     1/2248 (0.04%)  
Hepatobiliary disorders      
Cholecystitis † 1    
# participants affected / at risk     0/2240 (0.00%)     1/2248 (0.04%)  
Pancreatitis † 1    
# participants affected / at risk     0/2240 (0.00%)     1/2248 (0.04%)  
Immune system disorders      
Allergic reaction † 1    
# participants affected / at risk     1/2240 (0.04%)     0/2248 (0.00%)  
Infections and infestations      
Infec.w.norm.ANC Upper airway NOS † 1    
# participants affected / at risk     1/2240 (0.04%)     0/2248 (0.00%)  
Infection (doc.clin.) Lung † 1    
# participants affected / at risk     0/2240 (0.00%)     1/2248 (0.04%)  
Infection - Other † 1    
# participants affected / at risk     2/2240 (0.09%)     1/2248 (0.04%)  
Metabolism and nutrition disorders      
ALT † 1    
# participants affected / at risk     1/2240 (0.04%)     1/2248 (0.04%)  
AST † 1    
# participants affected / at risk     1/2240 (0.04%)     1/2248 (0.04%)  
Alkaline phosphatase † 1    
# participants affected / at risk     1/2240 (0.04%)     0/2248 (0.00%)  
Creatinine † 1    
# participants affected / at risk     1/2240 (0.04%)     0/2248 (0.00%)  
GGT † 1    
# participants affected / at risk     1/2240 (0.04%)     0/2248 (0.00%)  
Hypercalcemia † 1    
# participants affected / at risk     1/2240 (0.04%)     0/2248 (0.00%)  
Musculoskeletal and connective tissue disorders      
Arthritis † 1    
# participants affected / at risk     2/2240 (0.09%)     3/2248 (0.13%)  
Fracture † 1    
# participants affected / at risk     2/2240 (0.09%)     1/2248 (0.04%)  
Musculoskeletal - Other † 1    
# participants affected / at risk     1/2240 (0.04%)     1/2248 (0.04%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Secondary Malignancy † 1    
# participants affected / at risk     2/2240 (0.09%)     0/2248 (0.00%)  
Nervous system disorders      
CNS ischemia † 1    
# participants affected / at risk     7/2240 (0.31%)     4/2248 (0.18%)  
Memory impairment † 1    
# participants affected / at risk     0/2240 (0.00%)     1/2248 (0.04%)  
Neuropathy-sensory † 1    
# participants affected / at risk     1/2240 (0.04%)     0/2248 (0.00%)  
Neurology - Other † 1    
# participants affected / at risk     0/2240 (0.00%)     1/2248 (0.04%)  
Renal and urinary disorders      
Renal failure † 1    
# participants affected / at risk     1/2240 (0.04%)     1/2248 (0.04%)  
Respiratory, thoracic and mediastinal disorders      
Dyspnea † 1    
# participants affected / at risk     1/2240 (0.04%)     1/2248 (0.04%)  
Pulmonary - Other † 1    
# participants affected / at risk     0/2240 (0.00%)     1/2248 (0.04%)  
Urinary retention † 1    
# participants affected / at risk     0/2240 (0.00%)     1/2248 (0.04%)  
Vascular disorders      
Thrombosis/thrombus/embolism † 1    
# participants affected / at risk     0/2240 (0.00%)     2/2248 (0.09%)  
Events were collected by systematic assessment
1 Term from vocabulary, CTCAE, version 3.0




  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
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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. Paul Goss
Organization: Massachusetts General Hospital
phone: 617-724-3118
e-mail: pgoss@partners.org


Publications of Results:
Moy B, Richardson H, Johnston D, et al.: NCIC CTG MAP.3: enrollment and study drug adherence of ethnic minority women in a breast cancer prevention trial. [Abstract] Breast Cancer Res Treat 106 (1): A-3048, S141-2, 2007.
Richardson H, Johnston D, Goss PE, et al.: Participant characteristics on an international NCIC CTG breast cancer prevention trial. [Abstract] J Clin Oncol 25 (Suppl 18): A-1531, 2007.
Goss PE, Ingle JN, Alés-Martinez J, Cheung A, Chlebowski RT, Wactawski-Wende J, McTiernan A, Robbins J, Johnson K, Martin L, Winquist E, Sarto G, Garber JE, Fabian CJ, Pujol P, Maunsell E, Farmer P, Gelmon KA, Tu D, Richardson H. Exemestane for primary prevention of breast cancer in postmenopausal women: NCIC CTG MAP.3 - A randomized placebo-controlled clinical trial. J Clin Oncol 29[suppl; abstr LBA504], 2011.

Other Publications:
Publications automatically indexed to this study:

Responsible Party: NCIC Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00083174     History of Changes
Obsolete Identifiers: NCT00304486
Other Study ID Numbers: MAP3, CAN-NCIC-MAP3, PFIZER-EXEAPO-0028-150, ExCel, CDR0000363802
Study First Received: May 14, 2004
Results First Received: November 7, 2012
Last Updated: February 7, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Spain: Spanish Agency of Medicine
France: French Medicines Agency