Spots Global Cancer Trial Database for Exemestane in Preventing Cancer in Postmenopausal Women at Increased Risk of Developing Breast Cancer
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Trial Identification
Brief Title: Exemestane in Preventing Cancer in Postmenopausal Women at Increased Risk of Developing Breast Cancer
Official Title: A Phase III Randomized Study of Exemestane Versus Placebo in Postmenopausal Women at Increased Risk of Developing Breast Cancer
Study ID: NCT00083174
Conditions
Interventions
Study Description
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.
Detailed Description: OBJECTIVES: Primary 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. Secondary 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.
Keywords
Eligibility
Minimum Age: 35 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: Yes
Locations
Jefferson Clinic, P.C., Birmingham, Alabama, United States
UAB Comprehensive Cancer Center-LNB 301, Birmingham, Alabama, United States
Providence Alaska Medical Center, Anchorage, Alaska, United States
University of California, San Diego, La Jolla, California, United States
University of California at Davis, Sacramento, California, United States
Los Angeles Biomedical Research Institute, Torrance, California, United States
University of Connecticut Health Center, Farmington, Connecticut, United States
Whittingham Cancer Center at Norwalk Hospital, Norwalk, Connecticut, United States
The George Washington University, Washington, District of Columbia, United States
Mayo Clinic Jacksonville, Jacksonville, Florida, United States
University of Miami School of Medicine, Miami, Florida, United States
Georgia Cancer Specialists, Tucker, Georgia, United States
John H. Stroger, Jr Hospital of Cook County, Chicago, Illinois, United States
Mercy Hospital and Medical Center, Chicago, Illinois, United States
The University of Chicago Medical Center, Chicago, Illinois, United States
Loyola University Medical Centre, Maywood, Illinois, United States
Trinity Medical Center, Moline, Illinois, United States
Mid-Illinois Hematology and Oncology Associates, Ltd., Normal, Illinois, United States
Carle Cancer Centre, Urbana, Illinois, United States
Indiana University Medical Center, Indianapolis, Indiana, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
Maine Center for Cancer Medicine and Blood Disorders, Scarborough, Maine, United States
Suburban Hospital Cancer Program, Bethesda, Maryland, United States
MedStar Health Research Institute, Hyattsville, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Hutzel Women's Health Specialists, Detroit, Michigan, United States
William Beaumont Hospital, Royal Oak, Michigan, United States
Mayo Clinic Rochester, Rochester, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
University of Medicine and Dentistry of New Jersey, Newark, New Jersey, United States
Montefiore Medical Center, Bronx, New York, United States
Kinston Medical Specialists, Kinston, North Carolina, United States
University of Cincinnati, Barrett Cancer Centre, Cincinnati, Ohio, United States
University of Oklahoma, Oklahoma City, Oklahoma, United States
Abramson Cancer Center of the, Philadelphia, Pennsylvania, United States
The Memorial Hospital of Rhode Island, Pawtucket, Rhode Island, United States
Fletcher Allen Health Care, Burlington, Vermont, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Univ. of Wisconsin Center for Women's Health and, Madison, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
BCCA - Cancer Centre for the Southern Interior, Kelowna, British Columbia, Canada
BCCA - Vancouver Cancer Centre, Vancouver, British Columbia, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
Atlantic Health Sciences Corporation, Saint John, New Brunswick, Canada
Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston, Kingston, Ontario, Canada
London Regional Cancer Program, London, Ontario, Canada
Ottawa Health Research Institute - General Division, Ottawa, Ontario, Canada
Meadowlands Family Health Centre, Ottawa, Ontario, Canada
Algoma District Cancer Program, Sault Ste. Marie, Ontario, Canada
Northeast Cancer Center Health Sciences, Sudbury, Ontario, Canada
Toronto East General Hospital, Toronto, Ontario, Canada
Odette Cancer Centre, Toronto, Ontario, Canada
Mount Sinai Hospital, Toronto, Ontario, Canada
Univ. Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada
Women's College Hospital, Toronto, Ontario, Canada
Hopital Maisonneuve-Rosemont, Montreal, Quebec, Canada
CHUM - Hopital Notre-Dame, Montreal, Quebec, Canada
CHUM - Pavillon Saint-Luc, Montreal, Quebec, Canada
CHA-Hopital Du St-Sacrement, Quebec City, Quebec, Canada
CRLCC - Paul Papin, Angers, , France
CHU-Hopital A. Morvan, Brest, , France
Centre Francois Baclesse, Caen, , France
CHU de Limoges - Hopital Mere Enfant, Limoges, , France
CHU - Hopital Arnaud de Villeneuve, Montpellier, , France
Centre Rene Gauducheau, Nantes, , France
Clinique Hartmann, Neuilly-sur-Seine, , France
AP-HP Hopital Tenon, Paris, , France
Institut Jean Godinot, Reims, , France
Centre Henri Becquerel, Rouen, , France
Centre Rene Huguenin, Saint Cloud, , France
Centre Alexis Vautrin, Vandoeuvre les Nancy, , France
Institut Gustave-Roussy, Villejuif, , France
Orocovis Medical Center, Orocovis, , Puerto Rico
Altamira Family Research Center, San Juan, , Puerto Rico
Contact Details
Name: Paul E. Goss, MD, PhD
Affiliation: Massachusetts General Hospital
Role: STUDY_CHAIR
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