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

Phase Type Status Age Sponsor Protocol IDs Phase III Prevention Active 35 and over Other, Pharmaceutical / Industry CAN-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

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

Outcomes

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

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.

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.

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

U.S.A.
Alabama
	Birmingham
	Jefferson Clinic, PC
		Rowell S. Ashford II	Ph:  205-279-2867
	Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
		Clinical Trials Office - Lurleen Wallace Comprehensive Cancer	Ph:  205-934-0309
Alaska
	Anchorage
	Providence Cancer Center
		Clinical Trials Office - Providence Cancer Center	Ph:  907-261-3109
California
	Duarte
	City of Hope Comprehensive Cancer Center
		Clinical Trials Office - City of Hope Comprehensive Cancer Center	Ph:  800-826-4673
			Email: becomingapatient@coh.org
	Mission Viego
	Mission Cancer Center at Mission Hospital
		Lisa D. Curcio	Ph:  949-770-0797
	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
		Mishab 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
		Louise Bordeleau	Ph:  416-586-3202
	New Women's College Hospital
		Lavina Lickley	Ph:  416-323-6120
	Princess Margaret Hospital
		Angela M. Cheung	Ph:  416-340-4301
	Toronto East General Hospital
		Yasmin H. Rahim	Ph:  416-469-3325
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		2009-01-11