Exemestane in Preventing Cancer in Postmenopausal Women at Increased Risk of Developing Breast Cancer
A total of 4,560 patients (2,280 per treatment arm) will be accrued for this study within 3 years.
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
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.
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]
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U.S.A. |
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Alabama |
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Birmingham |
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| Jefferson Clinic, PC |
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| Rowell S. Ashford II | |
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| Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham |
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| Clinical Trials Office - Lurleen Wallace Comprehensive Cancer | |
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Alaska |
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Anchorage |
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| Providence Cancer Center |
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| Clinical Trials Office - Providence Cancer Center | |
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California |
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Duarte |
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| City of Hope Comprehensive Cancer Center |
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| Clinical Trials Office - City of Hope Comprehensive Cancer Center | |
| Email:
becomingapatient@coh.org |
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Mission Viego |
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| Mission Cancer Center at Mission Hospital |
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| Lisa D. Curcio | |
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Sacramento |
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| University of California Davis Cancer Center |
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| Clinical Trials Office - University of California Davis Cancer Center | |
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San Francisco |
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| UCSF Helen Diller Family Comprehensive Cancer Center |
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| Clinical Trials Office - UCSF Helen Diller Family Comprehensive Cancer Center | |
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Torrance |
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| Los Angeles Biomedical Research Institute |
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| Rowan Chlebowski | |
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Colorado |
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Aurora |
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| University of Colorado Cancer Center at UC Health Sciences Center |
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| Clinical Trials Office - University of Colorado Cancer Center | |
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Connecticut |
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Farmington |
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| Carole and Ray Neag Comprehensive Cancer Center at the
University of Connecticut Health Center |
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| Clinical Trials Office - Carole and Ray Neag Comprehensive Cancer Center | |
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Norwalk |
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| Norwalk Hospital |
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| Richard C. Frank | |
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District of Columbia |
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Washington |
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| George Washington University Medical Center |
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| Clinical Trials Office - George Washington University Medical Center | |
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| MedStar Research Institute |
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| Clinical Trials Office - MedStar Research Institute | |
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Florida |
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Jacksonville |
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| Mayo Clinic - Jacksonville |
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| Clinical Trials Office - All Mayo Clinic Locations | |
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Miami |
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| University of Miami Sylvester Comprehensive Cancer Center - Miami |
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| University of Miami Sylvester Comprehensive Cancer Center Clinical Trial Matching Service | |
| Email:
Sylvester@emergingmed.com |
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Georgia |
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Tucker |
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| Georgia Cancer Specialists - Tucker |
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| Mansoor Saleh | |
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Illinois |
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Chicago |
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| John H. Stroger, Jr. Hospital of Cook County |
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| Pamela S. Ganschow | |
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| Mercy Hospital and Medical Center |
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| Alejandra Perez-Tamayo | |
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| University of Chicago Cancer Research Center |
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| Clinical Trials Office - University of Chicago Cancer Research Center | |
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Maywood |
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| Cardinal Bernardin Cancer Center at Loyola University Medical Center |
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| Clinical Trials Office - Cardinal Bernardin Cancer Center | |
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Moline |
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| Trinity Cancer Center at Trinity Medical Center - 7th Street Campus |
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| Costas L. Constantinou | |
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Normal |
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| Mid-Illinois Hematology-Oncology Associates at Community Cancer Center |
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| John Migas | |
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Urbana |
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| CCOP - Carle Cancer Center |
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| Clinical Trials Office - CCOP - Carle Cancer Center | |
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Indiana |
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Indianapolis |
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| Indiana University Melvin and Bren Simon Cancer Center |
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| Clinical Trials Office - Indiana University Cancer Center | |
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Kansas |
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Kansas City |
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| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center |
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| Clinical Trials Office - Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | |
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Maine |
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Scarborough |
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| Maine Center for Cancer Medicine and Blood Disorders - Scarborough |
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| Tracey F. Weisberg | |
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Maryland |
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Bethesda |
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| Suburban Hospital Cancer Program |
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| Carolyn Hendricks | |
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Massachusetts |
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Boston |
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| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute |
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| Judy E. Garber | |
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| Massachusetts General Hospital |
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| Clinical Trials Office - Massachusetts General Hospital | |
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Michigan |
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Detroit |
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| Hutzel Hospital |
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| Susan Hendrix | |
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Royal Oak |
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| William Beaumont Hospital - Royal Oak Campus |
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| Clinical Trials Office - William Beaumont Hospital - Royal Oak Campus | |
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Minnesota |
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Rochester |
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| Mayo Clinic Cancer Center |
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| Clinical Trials Office - All Mayo Clinic Locations | |
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Missouri |
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St. Louis |
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| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
|
| Antonella Rastelli | |
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New Jersey |
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New Brunswick |
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| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School |
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| Clinical Trials Office - Cancer Institute of New Jersey | |
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New York |
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Bronx |
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| Albert Einstein Cancer Center at Albert Einstein College of Medicine |
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| Clinical Trials Office - Albert Einstein Cancer Center at Albert Einstein College of Medicine | |
| Email:
aecc@aecom.yu.edu |
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Buffalo |
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| Roswell Park Cancer Institute |
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| Clinical Trials Office - Roswell Park Cancer Institute | |
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North Carolina |
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Kinston |
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| Kinston Medical Specialists |
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| Mishab U. Qadir | |
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Ohio |
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Cincinnati |
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| Charles M. Barrett Cancer Center at University Hospital |
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| Kathleen A. Havlin | |
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Oklahoma |
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Oklahoma City |
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| Oklahoma University Cancer Institute |
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| William C. Dooley | |
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Pennsylvania |
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Philadelphia |
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| Abramson Cancer Center of the University of Pennsylvania |
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| Clinical Trials Office - Abramson Cancer Center of the University of Pennsylvania | |
|
Rhode Island |
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Pawtucket |
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| Memorial Hospital of Rhode Island |
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| Michele Cyr | |
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Tennessee |
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Memphis |
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| University of Tennessee College of Medicine |
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| Clinical Trials Office - University of Tennessee College of Medicine | |
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Vermont |
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Burlington |
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| Fletcher Allen Health Care - University Health Center Campus |
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| Clinical Trials Office - Fletcher Allen Health Care | |
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Washington |
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Seattle |
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| Fred Hutchinson Cancer Research Center |
|
| Anne McTiernan | |
|
Wisconsin |
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Madison |
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| University of Wisconsin Center for Women's Health Research |
|
| Gloria E. Sarto | |
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Milwaukee |
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| Medical College of Wisconsin Cancer Center |
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| Clinical Trials Office - Medical College of Wisconsin Cancer Center | |
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Canada |
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British Columbia |
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Kelowna |
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| British Columbia Cancer Agency - Centre for the Southern Interior |
|
| Susan Ellard | |
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Vancouver |
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| British Columbia Cancer Agency - Vancouver Cancer Centre |
|
| Karen Gelmon | |
|
Manitoba |
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Winnipeg |
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| CancerCare Manitoba |
|
| Andrew L. Cooke | |
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New Brunswick |
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Saint John |
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| Saint John Regional Hospital |
|
| Hugh M.C. Scarth | |
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Ontario |
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Hamilton |
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| Margaret and Charles Juravinski Cancer Centre |
|
| James R. Wright | |
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|
Kingston |
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| Cancer Centre of Southeastern Ontario at Kingston General Hospital |
|
| Conrad Falkson | |
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|
London |
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| London Regional Cancer Program at London Health Sciences Centre |
|
| Eric W. Winquist | |
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|
Ottawa |
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| Meadowlands Family Health Center |
|
| Barry Dworkin | |
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| Ottawa Hospital Regional Cancer Centre - General Campus |
|
| Shailendra Verma | |
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|
Sault Ste. Marie |
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| Algoma District Cancer Program at Sault Area Hospital |
|
| Silvana Spadafora | |
|
|
Sudbury |
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| Northeastern Ontario Regional Cancer Centre |
|
| Amanda Hey | |
|
|
Toronto |
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| Edmond Odette Cancer Centre at Sunnybrook |
|
| Kathleen I. Pritchard | |
|
| Mount Sinai Hospital - Toronto |
|
| Louise Bordeleau | |
|
| New Women's College Hospital |
|
| Lavina Lickley | |
|
| Princess Margaret Hospital |
|
| Angela M. Cheung | |
|
| Toronto East General Hospital |
|
| Yasmin H. Rahim | |
|
Quebec |
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Montreal |
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|
| CHUM - Hopital Saint-Luc |
|
| Marie-Helen Mayrand | |
|
| Hopital Notre-Dame du CHUM |
|
| Edgard Nassif | |
|
| Maisonneuve-Rosemont Hospital |
|
| Pierre Dube | |
|
|
Quebec City |
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| Hopital du Saint-Sacrement - Quebec |
|
| Louise Provencher | |
|
Puerto Rico |
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Orocovis |
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|
| Orocovis Medical Center |
|
| Jose Sabino Aponte Pagan | |
|
|
San Juan |
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| Altamira Family and Prevention Clinic |
|
| Jamie Claudio | |
|