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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
exemestane
Sponsored by
NCIC Clinical Trials Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring breast cancer

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Jefferson Clinic, P.C.
  • UAB Comprehensive Cancer Center-LNB 301
  • Providence Alaska Medical Center
  • University of California, San Diego
  • University of California at Davis
  • Los Angeles Biomedical Research Institute
  • University of Connecticut Health Center
  • Whittingham Cancer Center at Norwalk Hospital
  • The George Washington University
  • Mayo Clinic Jacksonville
  • University of Miami School of Medicine
  • Georgia Cancer Specialists
  • John H. Stroger, Jr Hospital of Cook County
  • Mercy Hospital and Medical Center
  • The University of Chicago Medical Center
  • Loyola University Medical Centre
  • Trinity Medical Center
  • Mid-Illinois Hematology and Oncology Associates, Ltd.
  • Carle Cancer Centre
  • Indiana University Medical Center
  • University of Kansas Medical Center
  • Maine Center for Cancer Medicine and Blood Disorders
  • Suburban Hospital Cancer Program
  • MedStar Health Research Institute
  • Massachusetts General Hospital
  • Dana-Farber Cancer Institute
  • Hutzel Women's Health Specialists
  • William Beaumont Hospital
  • Mayo Clinic Rochester
  • Washington University School of Medicine
  • University of Medicine and Dentistry of New Jersey
  • Montefiore Medical Center
  • Kinston Medical Specialists
  • University of Cincinnati, Barrett Cancer Centre
  • University of Oklahoma
  • Abramson Cancer Center of the
  • The Memorial Hospital of Rhode Island
  • Fletcher Allen Health Care
  • Fred Hutchinson Cancer Research Center
  • Univ. of Wisconsin Center for Women's Health and
  • Medical College of Wisconsin
  • BCCA - Cancer Centre for the Southern Interior
  • BCCA - Vancouver Cancer Centre
  • CancerCare Manitoba
  • Atlantic Health Sciences Corporation
  • Juravinski Cancer Centre at Hamilton Health Sciences
  • Cancer Centre of Southeastern Ontario at Kingston
  • London Regional Cancer Program
  • Ottawa Health Research Institute - General Division
  • Meadowlands Family Health Centre
  • Algoma District Cancer Program
  • Northeast Cancer Center Health Sciences
  • Toronto East General Hospital
  • Odette Cancer Centre
  • Mount Sinai Hospital
  • Univ. Health Network-Princess Margaret Hospital
  • Women's College Hospital
  • Hopital Maisonneuve-Rosemont
  • CHUM - Hopital Notre-Dame
  • CHUM - Pavillon Saint-Luc
  • CHA-Hopital Du St-Sacrement
  • CRLCC - Paul Papin
  • CHU-Hopital A. Morvan
  • Centre Francois Baclesse
  • CHU de Limoges - Hopital Mere Enfant
  • CHU - Hopital Arnaud de Villeneuve
  • Centre Rene Gauducheau
  • Clinique Hartmann
  • AP-HP Hopital Tenon
  • Institut Jean Godinot
  • Centre Henri Becquerel
  • Centre Rene Huguenin
  • Centre Alexis Vautrin
  • Institut Gustave-Roussy
  • Orocovis Medical Center
  • Altamira Family Research Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Exemestane

Arm Description

one 25 mg tablet daily in am

Outcomes

Primary Outcome Measures

Percentage of Women With Serious Adverse Events
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)
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

Total Incidence of Invasive and Non-invasive (DCIS) Breast Cancer
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
Number of Clinical Breast Biopsies
Incidence of All Clinical Fractures
Incidence of Clinically Relevant Cardiac Events
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
Other malignancies includes any other malignancy which is not in breast.

Full Information

First Posted
May 14, 2004
Last Updated
August 3, 2023
Sponsor
NCIC Clinical Trials Group
Collaborators
Grupo Espanol de Investigacion del Cancer de Mama, UNICANCER
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1. Study Identification

Unique Protocol Identification Number
NCT00083174
Brief Title
Exemestane in Preventing Cancer in Postmenopausal Women at Increased Risk of Developing Breast Cancer
Acronym
ExCel
Official Title
A Phase III Randomized Study of Exemestane Versus Placebo in Postmenopausal Women at Increased Risk of Developing Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
December 3, 2004 (Actual)
Primary Completion Date
March 25, 2011 (Actual)
Study Completion Date
January 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NCIC Clinical Trials Group
Collaborators
Grupo Espanol de Investigacion del Cancer de Mama, UNICANCER

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4560 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exemestane
Arm Type
Other
Arm Description
one 25 mg tablet daily in am
Intervention Type
Drug
Intervention Name(s)
exemestane
Intervention Description
one 25 mg tablet daily in am
Primary Outcome Measure Information:
Title
Percentage of Women With Serious Adverse Events
Description
Percentage of serious adverse events for women who choose to receive 5 years of exemestane as preventative therapy.
Time Frame
5 years open-label extension period
Title
Invasive Breast Cancer Incidence (Breast Cancer-Free Survival)
Description
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.
Time Frame
Over randomization period of study (median follow-up 35 months)
Secondary Outcome Measure Information:
Title
Total Incidence of Invasive and Non-invasive (DCIS) Breast Cancer
Description
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.
Time Frame
Over randomization period of study (median follow-up 35 months)
Title
Incidence of Lobular Carcinoma in Situ, Atypical Ductal Hyperplasia and Atypical Lobular Hyperplasia Events
Time Frame
Over randomization period of study (median follow-up 35 months)
Title
Number of Clinical Breast Biopsies
Time Frame
Over randomization period of study (median follow-up 35 months)
Title
Incidence of All Clinical Fractures
Time Frame
During protocol treatment over randomization period of study (up to 5 years)
Title
Incidence of Clinically Relevant Cardiac Events
Description
Events including myocardial infarctions and angina requiring percutaneous transluminal coronary angioplasty or coronary artery bypass graft, fatal and nonfatal strokes and all vascular deaths
Time Frame
During protocol treatment in randomization period (up to 5 years)
Title
Incidences of Other Malignancies
Description
Other malignancies includes any other malignancy which is not in breast.
Time Frame
Over randomization period of study (median follow-up 35 months)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul E. Goss, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Jefferson Clinic, P.C.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
UAB Comprehensive Cancer Center-LNB 301
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0111
Country
United States
Facility Name
Providence Alaska Medical Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
University of California at Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Los Angeles Biomedical Research Institute
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Facility Name
Whittingham Cancer Center at Norwalk Hospital
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06856
Country
United States
Facility Name
The George Washington University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Mayo Clinic Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
University of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Georgia Cancer Specialists
City
Tucker
State/Province
Georgia
ZIP/Postal Code
30084
Country
United States
Facility Name
John H. Stroger, Jr Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Mercy Hospital and Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
The University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Loyola University Medical Centre
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Trinity Medical Center
City
Moline
State/Province
Illinois
ZIP/Postal Code
61265
Country
United States
Facility Name
Mid-Illinois Hematology and Oncology Associates, Ltd.
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Carle Cancer Centre
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Indiana University Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7820
Country
United States
Facility Name
Maine Center for Cancer Medicine and Blood Disorders
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074-9308
Country
United States
Facility Name
Suburban Hospital Cancer Program
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
MedStar Health Research Institute
City
Hyattsville
State/Province
Maryland
ZIP/Postal Code
20782
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Hutzel Women's Health Specialists
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Medicine and Dentistry of New Jersey
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07107
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Kinston Medical Specialists
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States
Facility Name
University of Cincinnati, Barrett Cancer Centre
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Abramson Cancer Center of the
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
Facility Name
The Memorial Hospital of Rhode Island
City
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States
Facility Name
Fletcher Allen Health Care
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1024
Country
United States
Facility Name
Univ. of Wisconsin Center for Women's Health and
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
BCCA - Cancer Centre for the Southern Interior
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
BCCA - Vancouver Cancer Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Atlantic Health Sciences Corporation
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Juravinski Cancer Centre at Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Cancer Centre of Southeastern Ontario at Kingston
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5P9
Country
Canada
Facility Name
London Regional Cancer Program
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Ottawa Health Research Institute - General Division
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Meadowlands Family Health Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2C 3R2
Country
Canada
Facility Name
Algoma District Cancer Program
City
Sault Ste. Marie
State/Province
Ontario
ZIP/Postal Code
P6B 0A8
Country
Canada
Facility Name
Northeast Cancer Center Health Sciences
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 5J1
Country
Canada
Facility Name
Toronto East General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4C 3E7
Country
Canada
Facility Name
Odette Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Univ. Health Network-Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Women's College Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 1B2
Country
Canada
Facility Name
Hopital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
CHUM - Hopital Notre-Dame
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
CHUM - Pavillon Saint-Luc
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3X 3J4
Country
Canada
Facility Name
CHA-Hopital Du St-Sacrement
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
Facility Name
CRLCC - Paul Papin
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
CHU-Hopital A. Morvan
City
Brest
ZIP/Postal Code
29608
Country
France
Facility Name
Centre Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
CHU de Limoges - Hopital Mere Enfant
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
CHU - Hopital Arnaud de Villeneuve
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Centre Rene Gauducheau
City
Nantes
ZIP/Postal Code
44805
Country
France
Facility Name
Clinique Hartmann
City
Neuilly-sur-Seine
ZIP/Postal Code
92200
Country
France
Facility Name
AP-HP Hopital Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Institut Jean Godinot
City
Reims
ZIP/Postal Code
51056
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Centre Rene Huguenin
City
Saint Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
Centre Alexis Vautrin
City
Vandoeuvre les Nancy
ZIP/Postal Code
54500
Country
France
Facility Name
Institut Gustave-Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Orocovis Medical Center
City
Orocovis
ZIP/Postal Code
00720
Country
Puerto Rico
Facility Name
Altamira Family Research Center
City
San Juan
ZIP/Postal Code
00920
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17593981
Citation
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. doi: 10.3747/co.2007.117.
Results Reference
background
PubMed Identifier
18269782
Citation
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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.
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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.
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Goss PE, Ingle JN, Alés-Martinez J, Cheung A, Chlebowski RT, Wactawski-Wende J, McTiernan A, Robbins J, Johnson K, Martin L, Winquist E, Sarto G, Garber JE, Fabian CJ, Pujol P, Maunsell E, Farmer P, Gelmon KA, Tu D, Richardson H. Exemestane for primary prevention of breast cancer in postmenopausal women: NCIC CTG MAP.3 - A randomized placebo-controlled clinical trial. J Clin Oncol 29[suppl; abstr LBA504], 2011.
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Goss PE, Ingle JN, Ales-Martinez JE, Cheung AM, Chlebowski RT, Wactawski-Wende J, McTiernan A, Robbins J, Johnson KC, Martin LW, Winquist E, Sarto GE, Garber JE, Fabian CJ, Pujol P, Maunsell E, Farmer P, Gelmon KA, Tu D, Richardson H; NCIC CTG MAP.3 Study Investigators. Exemestane for breast-cancer prevention in postmenopausal women. N Engl J Med. 2011 Jun 23;364(25):2381-91. doi: 10.1056/NEJMoa1103507. Epub 2011 Jun 4. Erratum In: N Engl J Med. 2011 Oct 6;365(14):1361.
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Maunsell E, Goss PE, Chlebowski RT, Ingle JN, Ales-Martinez JE, Sarto GE, Fabian CJ, Pujol P, Ruiz A, Cooke AL, Hendrix S, Thayer DW, Rowland KM, Dube P, Spadafora S, Pruthi S, Lickley L, Ellard SL, Cheung AM, Wactawski-Wende J, Gelmon KA, Johnston D, Hiltz A, Brundage M, Pater JL, Tu D, Richardson H. Quality of life in MAP.3 (Mammary Prevention 3): a randomized, placebo-controlled trial evaluating exemestane for prevention of breast cancer. J Clin Oncol. 2014 May 10;32(14):1427-36. doi: 10.1200/JCO.2013.51.2483. Epub 2014 Apr 7.
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Exemestane in Preventing Cancer in Postmenopausal Women at Increased Risk of Developing Breast Cancer

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