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Last Modified: 7/20/2009     First Published: 4/23/2004  
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Phase III Randomized Study of Exemestane in Postmenopausal Women at Increased Risk of Developing Breast Cancer

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Related Publications
Trial Contact Information
Related Information
Registry Information

Alternate Title

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIPreventionActive35 and overOther, Pharmaceutical / IndustryCAN-NCIC-MAP3
PFIZER-EXEAPO-0028-150, ExCel, NCT00083174, MAP3

Objectives

Primary

  1. Compare the incidence of invasive breast cancer in postmenopausal women at increased risk of developing breast cancer when treated with exemestane vs placebo.

Secondary

  1. Compare reduction in total incidence of invasive and non-invasive (ductal carcinoma in situ) breast cancer in patients treated with these regimens.
  2. Compare reduction in total incidence of receptor-negative invasive breast cancer in patients treated with exemestane vs placebo.
  3. Compare the incidence of lobular cancer in situ and atypical ductal hyperplasia in patients treated with these regimens.
  4. Compare the number of clinical breast biopsies in patients treated with these regimens.
  5. Compare the incidence of all clinical fractures, and specifically hip and vertebral fractures, in patients treated with these regimens.
  6. Compare the incidence of clinically relevant cardiac events (i.e., significant coronary heart disease) in patients treated with these regimens.
  7. Compare the impact of these regimens on menopausal symptoms and quality of life of these patients.
  8. Compare adverse effects of these regimens in these patients.
  9. Compare the incidence of other malignancies in patients treated with these regimens.

Entry Criteria

Disease Characteristics:

  • 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 or lobular carcinoma in situ on breast biopsy
    • Prior ductal carcinoma in situ (DCIS) treated with mastectomy
      • No prior DCIS treated with adjuvant tamoxifen

  • No prior invasive breast cancer

  • Hormone receptor status:
    • Not specified

Prior/Concurrent Therapy:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • See Disease Characteristics
  • 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 concurrent endocrine therapy
  • No concurrent estrogens, androgens, or progesterones

Radiotherapy

  • Not specified

Surgery

  • See Disease Characteristics
  • See Menopausal status

Other

  • More than 30 days or 5 half-lives since prior investigational drugs
  • 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

Patient Characteristics:

Age

  • 35 and over

Sex

  • Female

Menopausal status

  • Postmenopausal, defined as one of the following:
    • > 50 years of age with no spontaneous menses for at least 12 months before study entry
    • ≤ 50 years of age 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
    • Bilateral oophorectomy

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • 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
  • Willing to complete quality of life questionnaires in either English or French

Expected Enrollment

4560

A total of 4,560 patients (2,280 per treatment arm) will be accrued for this study within 3 years.

Outcomes

Primary Outcome(s)

Invasive breast cancer-free survival after 38 events (about 4 years after start of study)

Secondary Outcome(s)

Invasive and noninvasive breast cancer-free survival at about 4 years after start of study
Clinical fracture rate at about 4 years after start of study
Cardiac events at about 4 years after start of study
Menopausal symptoms as assessed by MENQOL questionnaire at about 4 years after start of study
Quality of Life assessed by SF36 at about 4 years after start of study

Outline

This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to concurrent low dose (≤ 100 mg/day) aspirin use (yes vs no) and Gail score (≤ 2 vs > 2). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral exemestane once daily for 5 years.

  • Arm II: Patients receive oral placebo once daily for 5 years.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 6 months for 1 year, and then annually for 4 years.

Patients are followed every 6 months for 1 year and then annually thereafter.

Published Results

Goss PE, Richardson H, Chlebowski R, et al.: National Cancer Institute of Canada Clinical Trials Group MAP.3 Trial: evaluation of exemestane to prevent breast cancer in postmenopausal women. Clin Breast Cancer 7 (11): 895-900, 2007.[PUBMED Abstract]

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.

Related Publications

Richardson H, Johnston D, Pater J, et al.: The National Cancer Institute of Canada Clinical Trials Group MAP.3 trial: an international breast cancer prevention trial. Curr Oncol 14 (3): 89-96, 2007.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

NCIC-Clinical Trials Group

Paul Goss, MD, PhD, Protocol chair
Ph: 617-724-3118; 877-726-5130

Trial Sites

U.S.A.
Alabama
  Birmingham
 Jefferson Clinic, PC
 Rowell S. Ashford II
Ph: 205-279-2867
 UAB Comprehensive Cancer Center
 Clinical Trials Office - UAB Comprehensive Cancer Center
Ph: 205-934-0309
Alaska
  Anchorage
 Providence Cancer Center
 Clinical Trials Office - Providence Cancer Center
Ph: 907-261-3109
California
  Sacramento
 University of California Davis Cancer Center
 Clinical Trials Office - University of California Davis Cancer Center
Ph: 916-734-3089
  San Francisco
 UCSF Helen Diller Family Comprehensive Cancer Center
 Clinical Trials Office - UCSF Helen Diller Family Comprehensive Cancer Center
Ph: 877-827-3222
  Torrance
 Los Angeles Biomedical Research Institute
 Rowan Chlebowski
Ph: 310-222-2217
Colorado
  Aurora
 University of Colorado Cancer Center at UC Health Sciences Center
 Clinical Trials Office - University of Colorado Cancer Center
Ph: 720-848-0650
Connecticut
  Farmington
 Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
 Clinical Trials Office - Carole and Ray Neag Comprehensive Cancer Center
Ph: 800-579-7822
  Norwalk
 Norwalk Hospital
 Richard C. Frank
Ph: 203-845-2132
District of Columbia
  Washington
 George Washington University Medical Center
 Clinical Trials Office - George Washington University Medical Center
Ph: 202-741-2981
 MedStar Research Institute
 Clinical Trials Office - MedStar Research Institute
Ph: 202-787-5710
Florida
  Jacksonville
 Mayo Clinic - Jacksonville
 Clinical Trials Office - All Mayo Clinic Locations
Ph: 507-538-7623
  Miami
 University of Miami Sylvester Comprehensive Cancer Center - Miami
 University of Miami Sylvester Comprehensive Cancer Center Clinical Trial Matching Service
Ph: 866-574-5124
 Email: Sylvester@emergingmed.com
Georgia
  Tucker
 Georgia Cancer Specialists - Tucker
 Mansoor Saleh
Ph: 404-256-4777
Illinois
  Chicago
 John H. Stroger, Jr. Hospital of Cook County
 Pamela S. Ganschow
Ph: 312-864-4436
 Mercy Hospital and Medical Center
 Alejandra Perez-Tamayo
Ph: 312-567-5469
 University of Chicago Cancer Research Center
 Clinical Trials Office - University of Chicago Cancer Research Center
Ph: 773-834-7424
  Maywood
 Cardinal Bernardin Cancer Center at Loyola University Medical Center
 Clinical Trials Office - Cardinal Bernardin Cancer Center
Ph: 708-226-4357
  Moline
 Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
 Costas L. Constantinou
Ph: 563-779-5059
  Normal
 Mid-Illinois Hematology-Oncology Associates at Community Cancer Center
 John Migas
Ph: 309-452-9701
  Urbana
 CCOP - Carle Cancer Center
 Clinical Trials Office - CCOP - Carle Cancer Center
Ph: 800-446-5532
Indiana
  Indianapolis
 Indiana University Melvin and Bren Simon Cancer Center
 Clinical Trials Office - Indiana University Cancer Center
Ph: 317-274-2552
Kansas
  Kansas City
 Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
 Clinical Trials Office - Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Ph: 913-588-4709
Maine
  Scarborough
 Maine Center for Cancer Medicine and Blood Disorders - Scarborough
 Tracey F. Weisberg
Ph: 207-885-7600
Maryland
  Bethesda
 Suburban Hospital Cancer Program
 Carolyn Hendricks
Ph: 301-897-1503
Massachusetts
  Boston
 Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
 Judy E. Garber
Ph: 617-632-3800
 Massachusetts General Hospital
 Clinical Trials Office - Massachusetts General Hospital
Ph: 877-726-5130
Michigan
  Detroit
 Hutzel Hospital
 Susan Hendrix
Ph: 313-745-0499
  Royal Oak
 William Beaumont Hospital - Royal Oak Campus
 Clinical Trials Office - William Beaumont Hospital - Royal Oak Campus
Ph: 248-551-7695
Minnesota
  Rochester
 Mayo Clinic Cancer Center
 Clinical Trials Office - All Mayo Clinic Locations
Ph: 507-538-7623
Missouri
  St. Louis
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Antonella Rastelli
Ph: 314-454-8017
New Jersey
  New Brunswick
 Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
 Clinical Trials Office - Cancer Institute of New Jersey
Ph: 732-235-8675
New York
  Bronx
 Albert Einstein Cancer Center at Albert Einstein College of Medicine
 Clinical Trials Office - Albert Einstein Cancer Center at Albert Einstein College of Medicine
Ph: 718-904-2730
 Email: aecc@aecom.yu.edu
  Buffalo
 Roswell Park Cancer Institute
 Clinical Trials Office - Roswell Park Cancer Institute
Ph: 877-275-7724
North Carolina
  Kinston
 Kinston Medical Specialists
 Misbah U. Qadir
Ph: 252-559-2201
Ohio
  Cincinnati
 Charles M. Barrett Cancer Center at University Hospital
 Kathleen A. Havlin
Ph: 514-584-6178
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 William C. Dooley
Ph: 405-271-7867
Pennsylvania
  Philadelphia
 Abramson Cancer Center of the University of Pennsylvania
 Clinical Trials Office - Abramson Cancer Center of the University of Pennsylvania
Ph: 800-474-9892
Rhode Island
  Pawtucket
 Memorial Hospital of Rhode Island
 Michele Cyr
Ph: 401-444-8537
Tennessee
  Memphis
 University of Tennessee College of Medicine
 Clinical Trials Office - University of Tennessee College of Medicine
Ph: 901-516-2212
Vermont
  Burlington
 Fletcher Allen Health Care - University Health Center Campus
 Clinical Trials Office - Fletcher Allen Health Care
Ph: 802-656-8990
Washington
  Seattle
 Fred Hutchinson Cancer Research Center
 Anne McTiernan
Ph: 206-667-6196
Wisconsin
  Madison
 University of Wisconsin Center for Women's Health Research
 Gloria E. Sarto
Ph: 608-267-5572
  Milwaukee
 Medical College of Wisconsin Cancer Center
 Clinical Trials Office - Medical College of Wisconsin Cancer Center
Ph: 414-805-4380
Canada
British Columbia
  Kelowna
 British Columbia Cancer Agency - Centre for the Southern Interior
 Susan Ellard
Ph: 250-712-3922
  Vancouver
 British Columbia Cancer Agency - Vancouver Cancer Centre
 Karen Gelmon
Ph: 604-877-6000
Manitoba
  Winnipeg
 CancerCare Manitoba
 Andrew L. Cooke
Ph: 204-787-1458
New Brunswick
  Saint John
 Saint John Regional Hospital
 Hugh M.C. Scarth
Ph: 506-648-7921
Ontario
  Hamilton
 Margaret and Charles Juravinski Cancer Centre
 James R. Wright
Ph: 905-387-9495
  Kingston
 Cancer Centre of Southeastern Ontario at Kingston General Hospital
 Conrad Falkson
Ph: 613-544-2631
  London
 London Regional Cancer Program at London Health Sciences Centre
 Eric W. Winquist
Ph: 519-685-8640
  Ottawa
 Meadowlands Family Health Center
 Barry Dworkin
Ph: 613-228-2882
 Ottawa Hospital Regional Cancer Centre - General Campus
 Shailendra Verma
Ph: 613-737-7700
  Sault Ste. Marie
 Algoma District Cancer Program at Sault Area Hospital
 Silvana Spadafora
Ph: 705-759-3434
  Sudbury
 Northeastern Ontario Regional Cancer Centre
 Amanda Hey
Ph: 705-522-6237
  Toronto
 Edmond Odette Cancer Centre at Sunnybrook
 Kathleen I. Pritchard
Ph: 416-480-4616
 Mount Sinai Hospital - Toronto
 Angela M. Cheung
Ph: 416-340-4301
 Princess Margaret Hospital
 Angela M. Cheung
Ph: 416-340-4301
 Toronto East General Hospital
 Yasmin H. Rahim
Ph: 416-469-3325
 Women's College Hospital
 Lavina Lickley
Ph: 416-323-6120
Quebec
  Montreal
 CHUM - Hopital Saint-Luc
 Marie-Helen Mayrand
Ph: 514-890-8000
 Hopital Notre-Dame du CHUM
 Edgard Nassif
Ph: 514-890-8000
 Maisonneuve-Rosemont Hospital
 Pierre Dube
Ph: 514-252-3822
  Quebec City
 Hopital du Saint-Sacrement - Quebec
 Louise Provencher
Ph: 418-682-7511
Puerto Rico
  Orocovis
 Orocovis Medical Center
 Jose Sabino Aponte Pagan
Ph: 787-867-0272
  San Juan
 Altamira Family and Prevention Clinic
 Jamie Claudio
Ph: 787-792-9026

Related Information

Web site for additional information

Registry Information
Official Title A Phase III Randomized Study of Exemestane Versus Placebo in Postmenopausal Women at Increased Risk of Developing Breast Cancer
Trial Start Date 2004-02-11
Trial Completion Date 2010-06-01 (estimated)
Registered in ClinicalTrials.gov NCT00083174
Date Submitted to PDQ 2004-03-25
Information Last Verified 2009-07-20

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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