Exemestane in Preventing Cancer in Postmenopausal Women at Increased Risk of Developing Breast Cancer
- Registration Number
- NCT00083174
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 4560
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Exemestane exemestane one 25 mg tablet daily in am
- Primary Outcome Measures
Name Time Method Percentage of Women With Serious Adverse Events 5 years open-label extension period Percentage of serious adverse events for women who choose to receive 5 years of exemestane as preventative therapy.
Invasive Breast Cancer Incidence (Breast Cancer-Free Survival) 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
Name Time Method Total Incidence of Invasive and Non-invasive (DCIS) Breast Cancer 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.
Incidence of Lobular Carcinoma in Situ, Atypical Ductal Hyperplasia and Atypical Lobular Hyperplasia Events Over randomization period of study (median follow-up 35 months) Number of Clinical Breast Biopsies Over randomization period of study (median follow-up 35 months) Incidence of All Clinical Fractures During protocol treatment over randomization period of study (up to 5 years) Incidence of Clinically Relevant Cardiac Events 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
Incidences of Other Malignancies Over randomization period of study (median follow-up 35 months) Other malignancies includes any other malignancy which is not in breast.
Trial Locations
- Locations (76)
Trinity Medical Center
🇺🇸Moline, Illinois, United States
University of California, San Diego
🇺🇸La Jolla, California, United States
Providence Alaska Medical Center
🇺🇸Anchorage, Alaska, United States
MedStar Health Research Institute
🇺🇸Hyattsville, Maryland, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
Meadowlands Family Health Centre
🇨🇦Ottawa, Ontario, Canada
Mid-Illinois Hematology and Oncology Associates, Ltd.
🇺🇸Normal, Illinois, United States
Ottawa Health Research Institute - General Division
🇨🇦Ottawa, Ontario, Canada
CHA-Hopital Du St-Sacrement
🇨🇦Quebec City, Quebec, Canada
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
CHUM - Pavillon Saint-Luc
🇨🇦Montreal, Quebec, Canada
The Memorial Hospital of Rhode Island
🇺🇸Pawtucket, Rhode Island, United States
Northeast Cancer Center Health Sciences
🇨🇦Sudbury, Ontario, Canada
CHU de Limoges - Hopital Mere Enfant
🇫🇷Limoges, France
Centre Francois Baclesse
🇫🇷Caen, France
Juravinski Cancer Centre at Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Women's College Hospital
🇨🇦Toronto, Ontario, Canada
University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
Whittingham Cancer Center at Norwalk Hospital
🇺🇸Norwalk, Connecticut, United States
The University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Carle Cancer Centre
🇺🇸Urbana, Illinois, United States
Georgia Cancer Specialists
🇺🇸Tucker, Georgia, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Fletcher Allen Health Care
🇺🇸Burlington, Vermont, United States
Mercy Hospital and Medical Center
🇺🇸Chicago, Illinois, United States
Loyola University Medical Centre
🇺🇸Maywood, Illinois, United States
Maine Center for Cancer Medicine and Blood Disorders
🇺🇸Scarborough, Maine, United States
University of Medicine and Dentistry of New Jersey
🇺🇸Newark, New Jersey, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Kinston Medical Specialists
🇺🇸Kinston, North Carolina, United States
Abramson Cancer Center of the
🇺🇸Philadelphia, Pennsylvania, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Toronto East General Hospital
🇨🇦Toronto, Ontario, Canada
Odette Cancer Centre
🇨🇦Toronto, Ontario, Canada
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston
🇨🇦Kingston, Ontario, Canada
Univ. Health Network-Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
University of Miami School of Medicine
🇺🇸Miami, Florida, United States
Indiana University Medical Center
🇺🇸Indianapolis, Indiana, United States
University of Cincinnati, Barrett Cancer Centre
🇺🇸Cincinnati, Ohio, United States
Centre Rene Huguenin
🇫🇷Saint Cloud, France
Centre Alexis Vautrin
🇫🇷Vandoeuvre les Nancy, France
CHU - Hopital Arnaud de Villeneuve
🇫🇷Montpellier, France
Los Angeles Biomedical Research Institute
🇺🇸Torrance, California, United States
John H. Stroger, Jr Hospital of Cook County
🇺🇸Chicago, Illinois, United States
Mayo Clinic Jacksonville
🇺🇸Jacksonville, Florida, United States
CHUM - Hopital Notre-Dame
🇨🇦Montreal, Quebec, Canada
Algoma District Cancer Program
🇨🇦Sault Ste. Marie, Ontario, Canada
London Regional Cancer Program
🇨🇦London, Ontario, Canada
Hopital Maisonneuve-Rosemont
🇨🇦Montreal, Quebec, Canada
CHU-Hopital A. Morvan
🇫🇷Brest, France
CRLCC - Paul Papin
🇫🇷Angers, France
Clinique Hartmann
🇫🇷Neuilly-sur-Seine, France
Centre Rene Gauducheau
🇫🇷Nantes, France
AP-HP Hopital Tenon
🇫🇷Paris, France
Institut Jean Godinot
🇫🇷Reims, France
Institut Gustave-Roussy
🇫🇷Villejuif, France
Centre Henri Becquerel
🇫🇷Rouen, France
Altamira Family Research Center
🇵🇷San Juan, Puerto Rico
UAB Comprehensive Cancer Center-LNB 301
🇺🇸Birmingham, Alabama, United States
University of California at Davis
🇺🇸Sacramento, California, United States
Suburban Hospital Cancer Program
🇺🇸Bethesda, Maryland, United States
University of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Hutzel Women's Health Specialists
🇺🇸Detroit, Michigan, United States
Jefferson Clinic, P.C.
🇺🇸Birmingham, Alabama, United States
Orocovis Medical Center
🇵🇷Orocovis, Puerto Rico
BCCA - Vancouver Cancer Centre
🇨🇦Vancouver, British Columbia, Canada
BCCA - Cancer Centre for the Southern Interior
🇨🇦Kelowna, British Columbia, Canada
Atlantic Health Sciences Corporation
🇨🇦Saint John, New Brunswick, Canada
Univ. of Wisconsin Center for Women's Health and
🇺🇸Madison, Wisconsin, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
The George Washington University
🇺🇸Washington, District of Columbia, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States