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 )

Brief Summary:

RATIONALE: The MAP.3 study was designed to test whether hormone therapy using exemestane may prevent breast cancer by blocking the production of estrogen.

PURPOSE: The study protocol was amended in May 2011 and the current purpose of the study is to allow all study participants the opportunity to complete 5 years of exemestane.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: exemestane Phase 3

Detailed Description:



Previously: To determine if exemestane reduces the incidence of invasive breast cancer compared with placebo.

Currently: To determine the frequency of serious adverse events for post-menopausal women at high-risk of developing breast cancer who choose to receive 5 years of exemestane as preventative therapy.


Previously: (same as is currently listed in PDQ) Currently: To address the Trial Committee and Sponsor's commitment to allow women who are randomized to the MAP.3 trial to receive 5 years of exemestane therapy.

OUTLINE: This study was a randomized, double-blind, placebo-controlled, multicentre study. Protocol-specified analyses were performed in April 2011. The results of these analyses are posted in the Results section. Following the amendment of May 2011, the study is now open-label and all eligible patients are receiving exemestane from participating sites for a total of 5 years. After exemestane is stopped, there is no further follow-up.

PROJECTED ACCRUAL:There were 4560 women from the United States, Canada, Spain and France who took part in this study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4560 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase III Randomized Study of Exemestane Versus Placebo in Postmenopausal Women at Increased Risk of Developing Breast Cancer
Actual Study Start Date : February 11, 2004
Actual Primary Completion Date : March 25, 2011
Actual Study Completion Date : January 22, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Exemestane

Arm Intervention/treatment
one 25 mg tablet daily in am
Drug: exemestane
one 25 mg tablet daily in am

Primary Outcome Measures :
  1. Percentage of Women With Serious Adverse Events [ Time Frame: 5 years open-label extension period ]
    Percentage of serious adverse events for women who choose to receive 5 years of exemestane as preventative therapy.

  2. Invasive Breast Cancer Incidence (Breast Cancer-Free Survival) [ Time Frame: Over randomization period of study (median follow-up 35 months) ]
    Invasive breast cancer incidence was estimated from the breast cancer-free survival (BCFS) which was calculated for all women from the day of the randomization to the earliest date of diagnosis for invasive breast cancer. Women who died from other causes were censored at the time of death. If a woman did not develop an invasive breast cancer, or died, BCFS was censored on the date of the last day the woman was known alive (LKA), which was the latest of the date of assessment. Women who had breast cancer before study entry were also censored at the time of randomization.

Secondary Outcome Measures :
  1. Total Incidence of Invasive and Non-invasive (DCIS) Breast Cancer [ Time Frame: Over randomization period of study (median follow-up 35 months) ]
    It was estimated from the Total Breast Cancer-Free Survival (TBCFS), which was calculated for women who developed invasive or non-invasive (DCIS) breast cancer as the time from the date of randomization to the earliest date of diagnosis for invasive or non-invasive (DCIS) breast cancer. Women who died from other causes were censored at the time of death. Women who had breast cancer before entry were censored at the time of randomization. If a woman did not develop an invasive or non-invasive (DCIS) breast cancer, or died, TBCFS will be censored on the date of last known alive.

  2. 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) ]
  3. Number of Clinical Breast Biopsies [ Time Frame: Over randomization period of study (median follow-up 35 months) ]
  4. Incidence of All Clinical Fractures [ Time Frame: During protocol treatment over randomization period of study (up to 5 years) ]
  5. Incidence of Clinically Relevant Cardiac Events [ Time Frame: During protocol treatment in randomization period (up to 5 years) ]
    Events including myocardial infarctions and angina requiring percutaneous transluminal coronary angioplasty or coronary artery bypass graft, fatal and nonfatal strokes and all vascular deaths

  6. Incidences of Other Malignancies [ Time Frame: Over randomization period of study (median follow-up 35 months) ]
    Other malignancies includes any other malignancy which is not in breast.

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
  • At increased risk of developing breast cancer, due to at least one of the following risk factors:

    • Gail score ≥ 1.66
    • Age ≥ 60 years
    • Prior atypical ductal hyperplasia, lobular hyperplasia, or lobular carcinoma in situ on breast biopsy
    • Prior ductal carcinoma in situ (DCIS) treated with total mastectomy with or without tamoxifen (tamoxifen must have been completed ≥ 3 months prior to randomization)
  • No prior DCIS treated with lumpectomy with or without radiation
  • No prior invasive breast cancer
  • Not BRCA1 or BRCA2 carriers



  • 35 and over
  • Female
  • Postmenopausal, defined as one of the following:

    • over 50 years of age with no spontaneous menses for at least 12 months before study entry
    • 50 years of age or under with no menses (spontaneous or secondary to hysterectomy) for at least 12 months before study entry AND with follicle-stimulating hormone level within postmenopausal range
    • Underwent prior bilateral oophorectomy
  • No other malignancies within the past 5 years except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumors with no evidence of disease for ≥ 5 years
  • No uncontrolled hypothyroidism or hyperthyroidism
  • No major medical or psychiatric illness (including substance and alcohol abuse within the past 2 years) that would preclude study participation or compliance
  • Must be accessible for treatment and follow-up
  • Willing to complete quality of life questionnaires in either English or French

Current: MAP.3 participants who were randomized to the exemestane arm, are currently receiving exemestane as part of the MAP.3 study and who have not completed 5 years of exemestane.

OR MAP.3 study participants who were randomized to the placebo arm and who have either completed 5 years of study drug or who are still receiving placebo. Note: this applies only to centres that choose to allow placebo "cross-over".



  • More than 3 months since prior and no concurrent hormone replacement therapies
  • More than 3 months since systemic estrogenic, androgenic, or progestational agents
  • More than 3 months since prior and no concurrent hormonal therapies, including, but not limited to the following:

    • Luteinizing-hormone releasing-hormone analogs (e.g., goserelin or leuprolide)
    • Progestogens (e.g., megestrol)
    • Prolactin inhibitors (e.g., bromocriptine)
    • Antiandrogens (e.g., cyproterone acetate)
    • Selective estrogen-receptor modulators (e.g., tamoxifen, toremifene, or raloxifene)
  • No investigational drug within 30 days or 5 half lives prior to randomization
  • No concurrent endocrine therapy
  • No concurrent estrogens, androgens, or progesterones
  • Concurrent low dose (≤ 100 mg/day) prophylactic aspirin allowed
  • Concurrent bisphosphonates for prevention or treatment of osteoporosis allowed
  • No other concurrent medications that may have an effect on study endpoints

Current: There are no prior concurrent therapy restrictions for the amended MAP.3 study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00083174

  Hide Study Locations
United States, Alabama
Jefferson Clinic, P.C.
Birmingham, Alabama, United States, 35233
UAB Comprehensive Cancer Center-LNB 301
Birmingham, Alabama, United States, 35294-0111
United States, Alaska
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
United States, California
University of California, San Diego
La Jolla, California, United States, 92037
University of California at Davis
Sacramento, California, United States, 95817
Los Angeles Biomedical Research Institute
Torrance, California, United States, 90502
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06032
Whittingham Cancer Center at Norwalk Hospital
Norwalk, Connecticut, United States, 06856
United States, District of Columbia
The George Washington University
Washington, District of Columbia, United States, 20037
United States, Florida
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
University of Miami School of Medicine
Miami, Florida, United States, 33136
United States, Georgia
Georgia Cancer Specialists
Tucker, Georgia, United States, 30084
United States, Illinois
John H. Stroger, Jr Hospital of Cook County
Chicago, Illinois, United States, 60612
Mercy Hospital and Medical Center
Chicago, Illinois, United States, 60616
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637-1470
Loyola University Medical Centre
Maywood, Illinois, United States, 60153
Trinity Medical Center
Moline, Illinois, United States, 61265
Mid-Illinois Hematology and Oncology Associates, Ltd.
Normal, Illinois, United States, 61761
Carle Cancer Centre
Urbana, Illinois, United States, 61801
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7820
United States, Maine
Maine Center for Cancer Medicine and Blood Disorders
Scarborough, Maine, United States, 04074-9308
United States, Maryland
Suburban Hospital Cancer Program
Bethesda, Maryland, United States, 20817
MedStar Health Research Institute
Hyattsville, Maryland, United States, 20782
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
Hutzel Women's Health Specialists
Detroit, Michigan, United States, 48201
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New Jersey
University of Medicine and Dentistry of New Jersey
Newark, New Jersey, United States, 07107
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10461
United States, North Carolina
Kinston Medical Specialists
Kinston, North Carolina, United States, 28501
United States, Ohio
University of Cincinnati, Barrett Cancer Centre
Cincinnati, Ohio, United States, 45219
United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Abramson Cancer Center of the
Philadelphia, Pennsylvania, United States, 19104-4283
United States, Rhode Island
The Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, United States, 02860
United States, Vermont
Fletcher Allen Health Care
Burlington, Vermont, United States, 05401
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
United States, Wisconsin
Univ. of Wisconsin Center for Women's Health and
Madison, Wisconsin, United States, 53715
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Canada, British Columbia
BCCA - Cancer Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, New Brunswick
Atlantic Health Sciences Corporation
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Ontario
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
Cancer Centre of Southeastern Ontario at Kingston
Kingston, Ontario, Canada, K7L 5P9
London Regional Cancer Program
London, Ontario, Canada, N6A 4L6
Ottawa Health Research Institute - General Division
Ottawa, Ontario, Canada, K1H 8L6
Meadowlands Family Health Centre
Ottawa, Ontario, Canada, K2C 3R2
Algoma District Cancer Program
Sault Ste. Marie, Ontario, Canada, P6B 0A8
Northeast Cancer Center Health Sciences
Sudbury, Ontario, Canada, P3E 5J1
Toronto East General Hospital
Toronto, Ontario, Canada, M4C 3E7
Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Univ. Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Women's College Hospital
Toronto, Ontario, Canada, M5S 1B2
Canada, Quebec
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4
CHUM - Hopital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
CHUM - Pavillon Saint-Luc
Montreal, Quebec, Canada, H3X 3J4
CHA-Hopital Du St-Sacrement
Quebec City, Quebec, Canada, G1S 4L8
CRLCC - Paul Papin
Angers, France, 49933
CHU-Hopital A. Morvan
Brest, France, 29608
Centre Francois Baclesse
Caen, France, 14076
CHU de Limoges - Hopital Mere Enfant
Limoges, France, 87042
CHU - Hopital Arnaud de Villeneuve
Montpellier, France, 34295
Centre Rene Gauducheau
Nantes, France, 44805
Clinique Hartmann
Neuilly-sur-Seine, France, 92200
AP-HP Hopital Tenon
Paris, France, 75970
Institut Jean Godinot
Reims, France, 51056
Centre Henri Becquerel
Rouen, France, 76038
Centre Rene Huguenin
Saint Cloud, France, 92210
Centre Alexis Vautrin
Vandoeuvre les Nancy, France, 54500
Institut Gustave-Roussy
Villejuif, France, 94805
Puerto Rico
Orocovis Medical Center
Orocovis, Puerto Rico, 00720
Altamira Family Research Center
San Juan, Puerto Rico, 00920
Sponsors and Collaborators
NCIC Clinical Trials Group
Grupo Espanol de Investigacion del Cancer de Mama
Study Chair: Paul E. Goss, MD, PhD Massachusetts General Hospital

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: 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 Posted: May 17, 2004    Key Record Dates
Results First Posted: May 20, 2013
Last Update Posted: April 25, 2018
Last Verified: March 2018

Keywords provided by Canadian Cancer Trials Group ( NCIC Clinical Trials Group ):
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs