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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00083174
Recruitment Status : Completed
First Posted : May 17, 2004
Results First Posted : May 20, 2013
Last Update Posted : April 25, 2018
Grupo Espanol de Investigacion del Cancer de Mama
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

  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
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 
[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% 
[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 ]

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

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

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 by Identifier (NCT Number):

Responsible Party: Canadian Cancer Trials Group ( NCIC Clinical Trials Group ) Identifier: NCT00083174     History of Changes
Obsolete Identifiers: NCT00304486
Other Study ID Numbers: MAP3
CAN-NCIC-MAP3 ( Registry Identifier: PDQ )
CDR0000363802 ( Other Identifier: PDQ )
First Submitted: May 14, 2004
First Posted: May 17, 2004
Results First Submitted: November 7, 2012
Results First Posted: May 20, 2013
Last Update Posted: April 25, 2018