RATIONALE: The MAP. 3 study was designed to test whether hormone therapy using exemestane may
prevent breast cancer by blocking the production of estrogen. This study was analyzed in
April 2011 and showed a 65% reduction in the incidence of invasive breast cancer in women
receiving exemestane compared to women on placebo.
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.
Minimum age: 35 Years.
Maximum age: N/A.
Gender(s): Female.
- 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
PATIENT CHARACTERISTICS:
Previous:
- 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".
PRIOR CONCURRENT THERAPY:
Previous:
- 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.
CRLCC - Paul Papin, Angers 49933, France
CHU-Hopital A. Morvan, Brest 29608, France
Centre Francois Baclesse, Caen 14076, France
CHU de Limoges - Hopital Mere Enfant, Limoges 87042, France
CHU - Hopital Arnaud de Villeneuve, Montpellier 34295, France
Centre Rene Gauducheau, Nantes 44805, France
Clinique Hartmann, Neuilly Sure Seine 92200, France
AP-HP Hopital Tenon, Paris 75970, France
Institut Jean Godinot, Reims 51056, France
Centre Henri Becquerel, Rouen 76038, France
Centre Rene Huguenin, Saint Cloud 92210, France
Centre Alexis Vautrin, Vandoeuvre les Nancy 54500, France
Institut Gustave-Roussy, Villejuif 94805, France
Orocovis Medical Center, Orocovis 00720, Puerto Rico
Altamira Family Research Center, San Juan 00920, Puerto Rico
Jefferson Clinic, P.C., Birmingham, Alabama 35233, United States
UAB Comprehensive Cancer Center-LNB 301, Birmingham, Alabama 35294-0111, United States
Providence Alaska Medical Center, Anchorage, Alaska 99508, United States
BCCA - Cancer Centre for the Southern Interior, Kelowna, British Columbia V1Y 5L3, Canada
BCCA - Vancouver Cancer Centre, Vancouver, British Columbia V5Z 4E6, Canada
University of California, San Diego, La Jolla, California 92037, United States
University of California at Davis, Sacramento, California 95817, United States
Los Angeles Biomedical Research Institute, Torrance, California 90502, United States
University of Connecticut Health Center, Farmington, Connecticut 06032, United States
Whittingham Cancer Center at Norwalk Hospital, Norwalk, Connecticut 06856, United States
The George Washington University, Washington, District of Columbia 20037, United States
Mayo Clinic Jacksonville, Jacksonville, Florida 32224, United States
University of Miami School of Medicine, Miami, Florida 33136, United States
Georgia Cancer Specialists, Tucker, Georgia 30084, United States
John H. Stroger, Jr Hospital of Cook County, Chicago, Illinois 60612, United States
Mercy Hospital and Medical Center, Chicago, Illinois 60616, United States
The University of Chicago Medical Center, Chicago, Illinois 60637-1470, United States
Loyola University Medical Centre, Maywood, Illinois 60153, United States
Trinity Medical Center, Moline, Illinois 61265, United States
Mid-Illinois Hematology and Oncology Associates, Ltd., Normal, Illinois 61761, United States
Carle Cancer Centre, Urbana, Illinois 61801, United States
Indiana University Medical Center, Indianapolis, Indiana 46202, United States
University of Kansas Medical Center, Kansas City, Kansas 66160-7820, United States
Maine Center for Cancer Medicine and Blood Disorders, Scarborough, Maine 04074-9308, United States
CancerCare Manitoba, Winnipeg, Manitoba R3E 0V9, Canada
Suburban Hospital Cancer Program, Bethesda, Maryland 20817, United States
MedStar Health Research Institute, Hyattsville, Maryland 20782, United States
Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States
Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Hutzel Women's Health Specialists, Detroit, Michigan 48201, United States
William Beaumont Hospital, Royal Oak, Michigan 48073, United States
Mayo Clinic Rochester, Rochester, Minnesota 55905, United States
Washington University School of Medicine, St. Louis, Missouri 63110, United States
Atlantic Health Sciences Corporation, Saint John, New Brunswick E2L 4L2, Canada
University of Medicine and Dentistry of New Jersey, Newark, New Jersey 07107, United States
Montefiore Medical Center, Bronx, New York 10461, United States
Kinston Medical Specialists, Kinston, North Carolina 28501, United States
University of Cincinnati, Barrett Cancer Centre, Cincinnati, Ohio 45219, United States
University of Oklahoma, Oklahoma City, Oklahoma 73104, United States
Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario L8V 5C2, Canada
Cancer Centre of Southeastern Ontario at Kingston, Kingston, Ontario K7L 5P9, Canada
London Regional Cancer Program, London, Ontario N6A 4L6, Canada
Meadowlands Family Health Centre, Ottawa, Ontario K2C 3R2, Canada
Ottawa Health Research Institute - General Division, Ottawa, Ontario K1H 8L6, Canada
Algoma District Cancer Program, Sault Ste. Marie, Ontario P6B 0A8, Canada
Northeast Cancer Center Health Sciences, Sudbury, Ontario P3E 5J1, Canada
Mount Sinai Hospital, Toronto, Ontario M5G 1X5, Canada
Odette Cancer Centre, Toronto, Ontario M4N 3M5, Canada
Toronto East General Hospital, Toronto, Ontario M4C 3E7, Canada
Univ. Health Network-Princess Margaret Hospital, Toronto, Ontario M5G 2M9, Canada
Women's College Hospital, Toronto, Ontario M5S 1B2, Canada
Abramson Cancer Center of the, Philadelphia, Pennsylvania 19104-4283, United States
CHUM - Hopital Notre-Dame, Montreal, Quebec H2L 4M1, Canada
CHUM - Pavillon Saint-Luc, Montreal, Quebec H3X 3J4, Canada
Hopital Maisonneuve-Rosemont, Montreal, Quebec H1T 2M4, Canada
CHA-Hopital Du St-Sacrement, Quebec City, Quebec G1S 4L8, Canada
The Memorial Hospital of Rhode Island, Pawtucket, Rhode Island 02860, United States
Fletcher Allen Health Care, Burlington, Vermont 05401, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington 98109-1024, United States
Univ. of Wisconsin Center for Women's Health and, Madison, Wisconsin 53715, United States
Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States
Richardson H, Johnston D, Pater J, Goss P. The National Cancer Institute of Canada Clinical Trials Group MAP.3 trial: an international breast cancer prevention trial. Curr Oncol. 2007 Jun;14(3):89-96.