Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer (SOFT)

December 14, 2023 updated by: ETOP IBCSG Partners Foundation

A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women With Endocrine Responsive Breast Cancer

RATIONALE: Estrogen can stimulate the growth of breast tumor cells. Ovarian function suppression combined with hormone therapy using tamoxifen or exemestane may fight breast cancer by reducing the production of estrogen. It is not yet known whether suppression of ovarian function plus either tamoxifen or exemestane is more effective than tamoxifen alone in preventing the recurrence of hormone-responsive breast cancer.

PURPOSE: This randomized phase III trial studies ovarian suppression with either tamoxifen or exemestane to see how well they work compared to tamoxifen alone in treating premenopausal women who have undergone surgery for hormone-responsive breast cancer.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the disease-free survival, breast cancer-free interval, distant recurrence-free interval and overall survival of premenopausal women with endocrine-responsive breast cancer when treated with tamoxifen + ovarian function suppression (by triptorelin, oophorectomy, or ovarian irradiation) or exemestane + ovarian function suppression vs. tamoxifen alone. The primary comparison is ovarian function suppression with either tamoxifen or exemestane vs. tamoxifen alone.
  • Compare the quality of life, including late side effects of early menopause, of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, prior adjuvant/neoadjuvant chemotherapy (yes vs no), and number of positive axillary and/or internal mammary lymph nodes (0 vs 1 or more) and intended initial method of ovarian function suppression (triptorelin vs oophorectomy vs ovarian irradiation). Treatment duration is 5 years. Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter. Quality of life is assessed at baseline, every 6 months for 2 years, and then annually for 4 years.

Study Type

Interventional

Enrollment (Actual)

3066

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • BCCA-Cancer Centre for the Southern Interior
      • Penticton, British Columbia, Canada, V2A 3G6
        • Penticton Regional Hospital
      • Surrey, British Columbia, Canada, V3V 1Z2
        • BCCA-Fraser Valley Cancer Centre
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BCCA-Vancouver Cancer Centre
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Doctor H. Bliss Murphy Cancer Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Juravinski Cancer Centre at Hamilton Health Sciences
      • Kingston, Ontario, Canada, K7L 5P9
        • Cancer Centre of Southeastern Ontario At Kingston General Hospital
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Program
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital and Cancer Center-General Campus
      • Sudbury, Ontario, Canada, P3E 5J1
        • Health Sciences North
      • Thunder Bay, Ontario, Canada, P7B 6V4
        • Thunder Bay Regional Health Science Centre
      • Toronto, Ontario, Canada, M4N 3M5
        • Odette Cancer Centre- Sunnybrook Health Sciences Centre
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • CSSS Champlain-Charles Le Moyne
      • Montreal, Quebec, Canada, H4J 1C5
        • Hopital du Sacre-Coeur de Montreal
      • Montreal, Quebec, Canada, H2W 1T8
        • CHUM-Hotel Dieu du Montreal
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre
  • Switzerland
      • Bern, Switzerland, 3008
        • International Breast Cancer Study Group
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham Cancer Center
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Providence Alaska Medical Center
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic in Arizona
    • California
      • Berkeley, California, United States, 94704
        • Alta Bates Summit Medical Center-Herrick Campus
      • Burlingame, California, United States, 94010
        • Mills - Peninsula Hospitals
      • Castro Valley, California, United States, 94546
        • East Bay Radiation Oncology Center
      • Castro Valley, California, United States, 94546
        • Valley Medical Oncology Consultants-Castro Valley
      • Concord, California, United States, 94520
        • John Muir Medical Center-Concord Campus
      • Emeryville, California, United States, 94608
        • Bay Area Breast Surgeons Inc
      • Fremont, California, United States, 94538
        • Kaiser Permanente-Fremont
      • Fremont, California, United States, 94538
        • Valley Medical Oncology Consultants-Fremont
      • Glendale, California, United States, 91204
        • Glendale Memorial Hospital and Health Center
      • Greenbrae, California, United States, 94904
        • Marin General Hospital
      • La Jolla, California, United States, 92037
        • Scripps Cancer Center
      • Los Angeles, California, United States, 90033
        • USC / Norris Comprehensive Cancer Center
      • Los Angeles, California, United States, 90095
        • UCLA / Jonsson Comprehensive Cancer Center
      • Martinez, California, United States, 94553-3156
        • Contra Costa Regional Medical Center
      • Modesto, California, United States, 95355
        • Memorial Medical Center
      • Mountain View, California, United States, 94040
        • Palo Alto Medical Foundation-Camino Division
      • Novato, California, United States, 94945
        • Sutter Cancer Research Consortium
      • Oakland, California, United States, 94611
        • Kaiser Permanente-Oakland
      • Oakland, California, United States, 94609
        • Hematology and Oncology Associates-Oakland
      • Oakland, California, United States, 94609
        • Tom K Lee Inc
      • Oakland, California, United States, 94609
        • Bay Area Tumor Institute
      • Palo Alto, California, United States, 94301
        • Palo Alto Medical Foundation Health Care
      • Palo Alto, California, United States, 94304
        • Stanford Cancer Institute
      • Pleasanton, California, United States, 94588
        • Valley Medical Oncology Consultants
      • Rancho Mirage, California, United States, 92270
        • Eisenhower Medical Center
      • Redding, California, United States, 96001
        • Mercy Regional Cancer Center
      • Redwood City, California, United States, 94063
        • Kaiser Permanente-Redwood City
      • Richmond, California, United States, 94801
        • Kaiser Permanente-Richmond
      • Roseville, California, United States, 95661
        • Kaiser Permanente-Roseville
      • Sacramento, California, United States, 95823
        • Kaiser Permanente-South Sacramento
      • Sacramento, California, United States, 95825
        • Kaiser Permanente - Sacramento
      • Sacramento, California, United States, 95819
        • Mercy General Hospital
      • Salinas, California, United States, 93901
        • Salinas Valley Memorial
      • San Diego, California, United States, 92108
        • Kaiser Permanente-San Diego Mission
      • San Diego, California, United States, 92103
        • University of California San Diego
      • San Diego, California, United States, 92161
        • Veterans Administration-San Diego Medical Center
      • San Francisco, California, United States, 94110
        • San Francisco General Hospital
      • San Francisco, California, United States, 94115
        • Kaiser Permanente-San Francisco
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center-Pacific Campus
      • San Francisco, California, United States, 94115
        • UCSF Medical Center-Mount Zion
      • San Jose, California, United States, 95119
        • Kaiser Permanente-Santa Teresa-San Jose
      • San Leandro, California, United States, 94577
        • Kaiser Permanente San Leandro
      • San Rafael, California, United States, 94903
        • Kaiser Permanente-San Rafael
      • Santa Clara, California, United States, 95051
        • Kaiser Permanente Medical Center - Santa Clara
      • Santa Rosa, California, United States, 95403
        • Kaiser Permanente-Santa Rosa
      • Santa Rosa, California, United States, 95405
        • Santa Rosa Memorial Hospital
      • South San Francisco, California, United States, 94080
        • Kaiser Permanente-South San Francisco
      • Vallejo, California, United States, 94589
        • Kaiser Permanente-Vallejo
      • Walnut Creek, California, United States, 94596
        • Kaiser Permanente-Walnut Creek
      • Walnut Creek, California, United States, 94598
        • John Muir Medical Center-Walnut Creek
    • Colorado
      • Aurora, Colorado, United States, 80012
        • The Medical Center of Aurora
      • Boulder, Colorado, United States, 80301
        • Boulder Community Hospital
      • Colorado Springs, Colorado, United States, 80907
        • Penrose-Saint Francis Healthcare
      • Colorado Springs, Colorado, United States, 80909
        • Memorial Hospital Colorado Springs
      • Denver, Colorado, United States, 80210
        • Porter Adventist Hospital
      • Denver, Colorado, United States, 80218
        • Presbyterian - Saint Lukes Medical Center - Health One
      • Denver, Colorado, United States, 80218
        • SCL Health Saint Joseph Hospital
      • Denver, Colorado, United States, 80220
        • Rose Medical Center
      • Denver, Colorado, United States, 80204
        • Denver Health Medical Center
      • Denver, Colorado, United States, 80222
        • Colorado Cancer Research Program NCORP
      • Denver, Colorado, United States, 80220
        • Denver Veterans Administration Medical Center
      • Edwards, Colorado, United States, 81632
        • The Shaw Regional Cancer Center
      • Englewood, Colorado, United States, 80113
        • Swedish Medical Center
      • Fort Collins, Colorado, United States, 80524
        • Poudre Valley Hospital
      • Fort Collins, Colorado, United States, 80528
        • Front Range Cancer Specialists
      • Greeley, Colorado, United States, 80631
        • North Colorado Medical Center
      • Lakewood, Colorado, United States, 80228
        • Saint Anthony Hospital
      • Lone Tree, Colorado, United States, 80124
        • Sky Ridge Medical Center
      • Longmont, Colorado, United States, 80501
        • Longmont United Hospital
      • Pueblo, Colorado, United States, 81004
        • Saint Mary Corwin Medical Center
      • Thornton, Colorado, United States, 80229
        • North Suburban Medical Center
      • Wheat Ridge, Colorado, United States, 80033
        • SCL Health Lutheran Medical Center
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
      • Norwalk, Connecticut, United States, 06856
        • Norwalk Hospital
      • Norwich, Connecticut, United States, 06360
        • Eastern Connecticut Hematology and Oncology Associates
      • Stamford, Connecticut, United States, 06904
        • Stamford Hospital/Bennett Cancer Center
      • Torrington, Connecticut, United States, 06790
        • Charlotte Hungerford Hospital Center for Cancer Care
    • Delaware
      • Dover, Delaware, United States, 19901
        • Bayhealth Medical Center at Kent General
      • Lewes, Delaware, United States, 19958
        • Beebe Medical Center
      • Newark, Delaware, United States, 19718
        • Christiana Care Health System-Christiana Hospital
      • Seaford, Delaware, United States, 19973
        • Nanticoke Memorial Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • MedStar Washington Hospital Center
      • Washington, District of Columbia, United States, 20007
        • MedStar Georgetown University Hospital
      • Washington, District of Columbia, United States, 20016
        • Sibley Memorial Hospital
    • Florida
      • Boca Raton, Florida, United States, 33428
        • Cancer Research Network Inc
      • Fort Lauderdale, Florida, United States, 33308
        • Holy Cross Hospital
      • Hollywood, Florida, United States, 33021
        • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
      • Jacksonville, Florida, United States, 32207
        • Baptist MD Anderson Cancer Center
      • Jacksonville, Florida, United States, 32224-9980
        • Mayo Clinic in Florida
      • Jupiter, Florida, United States, 33458
        • Jupiter Medical Center
      • Miami Beach, Florida, United States, 33140
        • Mount Sinai Medical Center
      • Sarasota, Florida, United States, 34236
        • Florida Cancer Specialists - Sarasota Downtown
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Hospital
      • Atlanta, Georgia, United States, 30322
        • Emory University/Winship Cancer Institute
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital
      • Atlanta, Georgia, United States, 30342
        • Saint Joseph's Hospital of Atlanta
      • Atlanta, Georgia, United States, 30342
        • Atlanta Regional CCOP
      • Augusta, Georgia, United States, 30901
        • Augusta Oncology Associates PC-Saint Sebastian
      • Austell, Georgia, United States, 30106
        • Well Star Cobb Hospital
      • Columbus, Georgia, United States, 31904
        • John B Amos Cancer Center
      • Decatur, Georgia, United States, 30033
        • Dekalb Medical Center
      • Lawrenceville, Georgia, United States, 30045
        • Gwinnett Medical Center
      • Marietta, Georgia, United States, 30060
        • WellStar Kennestone Hospital
      • Riverdale, Georgia, United States, 30274
        • Southern Regional Medical Center
      • Rome, Georgia, United States, 30165
        • Harbin Clinic Medical Oncology and Clinical Research
      • Savannah, Georgia, United States, 31405
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
      • Savannah, Georgia, United States, 31404
        • Memorial University Medical Center
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • University of Hawaii Cancer Center
      • Honolulu, Hawaii, United States, 96859
        • Tripler Army Medical Center
    • Illinois
      • Bloomington, Illinois, United States, 61701
        • Saint Joseph Medical Center
      • Canton, Illinois, United States, 61520
        • Graham Hospital Association
      • Carthage, Illinois, United States, 62321
        • Memorial Hospital
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60637
        • University of Chicago Comprehensive Cancer Center
      • Chicago, Illinois, United States, 60612
        • John H Stroger Jr Hospital of Cook County
      • Chicago, Illinois, United States, 60640
        • Weiss Memorial Hospital
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital
      • Decatur, Illinois, United States, 62526
        • Heartland Cancer Research NCORP
      • Eureka, Illinois, United States, 61530
        • Eureka Hospital
      • Galesburg, Illinois, United States, 61401
        • Western Illinois Cancer Treatment Center
      • Galesburg, Illinois, United States, 61401
        • Illinois CancerCare-Galesburg
      • Galesburg, Illinois, United States, 61401
        • Galesburg Cottage Hospital
      • Harvey, Illinois, United States, 60426
        • Ingalls Memorial Hospital
      • Havana, Illinois, United States, 62644
        • Mason District Hospital
      • Hopedale, Illinois, United States, 61747
        • Hopedale Medical Complex - Hospital
      • Kewanee, Illinois, United States, 61443
        • Kewanee Hospital
      • Macomb, Illinois, United States, 61455
        • Mcdonough District Hospital
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
      • Naperville, Illinois, United States, 60540
        • Edward Hospital/Cancer Center
      • Normal, Illinois, United States, 61761
        • Community Cancer Center Foundation
      • Normal, Illinois, United States, 61761
        • Bromenn Regional Medical Center
      • Ottawa, Illinois, United States, 61350
        • Ottawa Regional Hospital and Healthcare Center
      • Pekin, Illinois, United States, 61554
        • OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
      • Pekin, Illinois, United States, 61554
        • Pekin Hospital
      • Peoria, Illinois, United States, 61637
        • OSF Saint Francis Medical Center
      • Peoria, Illinois, United States, 61615
        • Illinois CancerCare-Peoria
      • Peoria, Illinois, United States, 61614
        • Proctor Hospital
      • Peoria, Illinois, United States, 61603
        • Methodist Medical Center of Illinois
      • Peru, Illinois, United States, 61354
        • Valley Radiation Oncology
      • Peru, Illinois, United States, 61354
        • Illinois Valley Hospital
      • Princeton, Illinois, United States, 61356
        • Perry Memorial Hospital
      • Rockford, Illinois, United States, 61108
        • OSF Saint Anthony Medical Center
      • Rushville, Illinois, United States, 62681
        • Sarah Culbertson Memorial Hospital
      • Spring Valley, Illinois, United States, 61362
        • Saint Margaret's Hospital
      • Springfield, Illinois, United States, 62781
        • Memorial Medical Center
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
    • Indiana
      • Elkhart, Indiana, United States, 46515
        • Elkhart General Hospital
      • Fort Wayne, Indiana, United States, 46845
        • Fort Wayne Medical Oncology and Hematology Inc-Parkview
      • Indianapolis, Indiana, United States, 46202
        • Sidney and Lois Eskenazi Hospital
      • Indianapolis, Indiana, United States, 46260
        • Saint Vincent Hospital and Health Care Center
      • Indianapolis, Indiana, United States, 46219
        • Community Hospital East
      • Indianapolis, Indiana, United States, 46256
        • Community Regional Cancer Care-North
      • La Porte, Indiana, United States, 46350
        • IU Health La Porte Hospital
      • Lafayette, Indiana, United States, 47904
        • IU Health Arnett Cancer Care
      • Lafayette, Indiana, United States, 47905
        • Horizon Oncology Center
      • Mishawaka, Indiana, United States, 46545
        • Saint Joseph Regional Medical Center - Mishawaka
      • South Bend, Indiana, United States, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, United States, 46628
        • Northern Indiana Cancer Research Consortium
    • Iowa
      • Ames, Iowa, United States, 50010
        • McFarland Clinic PC-William R Bliss Cancer Center
      • Cedar Rapids, Iowa, United States, 52403
        • Mercy Hospital
      • Cedar Rapids, Iowa, United States, 52403
        • Oncology Associates at Mercy Medical Center
      • Cedar Rapids, Iowa, United States, 52402
        • Saint Luke's Hospital
      • Cedar Rapids, Iowa, United States, 52402
        • Physicians' Clinic of Iowa PC
      • Clive, Iowa, United States, 50325
        • Medical Oncology and Hematology Associates-West Des Moines
      • Davenport, Iowa, United States, 52803
        • Genesis Medical Center - East Campus
      • Des Moines, Iowa, United States, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, United States, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, United States, 50309
        • Medical Oncology and Hematology Associates-Des Moines
      • Des Moines, Iowa, United States, 50316
        • Iowa Lutheran Hospital
      • Des Moines, Iowa, United States, 50309
        • Iowa-Wide Oncology Research Coalition NCORP
      • Des Moines, Iowa, United States, 50314
        • Medical Oncology and Hematology Associates-Laurel
      • Des Moines, Iowa, United States, 50307
        • Mercy Capitol
      • Dubuque, Iowa, United States, 52001
        • Finley Hospital
      • Dubuque, Iowa, United States, 52001
        • Medical Associates Clinic PC
      • Mason City, Iowa, United States, 50401
        • Mercy Medical Center - North Iowa
      • Sioux City, Iowa, United States, 51101
        • Siouxland Regional Cancer Center
    • Kansas
      • Arkansas City, Kansas, United States, 67005
        • Memorial Hospital of Arkansas City
      • Chanute, Kansas, United States, 66720
        • Cancer Center of Kansas - Chanute
      • Dodge City, Kansas, United States, 67801
        • Cancer Center of Kansas - Dodge City
      • El Dorado, Kansas, United States, 67042
        • Cancer Center of Kansas - El Dorado
      • Independence, Kansas, United States, 67301
        • Cancer Center of Kansas-Independence
      • Kingman, Kansas, United States, 67068
        • Cancer Center of Kansas-Kingman
      • Lawrence, Kansas, United States, 66044
        • Lawrence Memorial Hospital
      • McPherson, Kansas, United States, 67460
        • Cancer Center of Kansas - McPherson
      • Newton, Kansas, United States, 67114
        • Cancer Center of Kansas - Newton
      • Parsons, Kansas, United States, 67357
        • Cancer Center of Kansas - Parsons
      • Salina, Kansas, United States, 67401
        • Cancer Center of Kansas - Salina
      • Topeka, Kansas, United States, 66606
        • Saint Francis Hospital and Medical Center - Topeka
      • Wellington, Kansas, United States, 67152
        • Cancer Center of Kansas - Wellington
      • Wichita, Kansas, United States, 67208
        • Cancer Center of Kansas-Wichita Medical Arts Tower
      • Wichita, Kansas, United States, 67208
        • Associates In Womens Health
      • Wichita, Kansas, United States, 67214
        • Wichita NCI Community Oncology Research Program
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas - Main Office
      • Wichita, Kansas, United States, 67214
        • Via Christi Regional Medical Center
      • Winfield, Kansas, United States, 67156
        • Cancer Center of Kansas - Winfield
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Louisiana State University Health Sciences Center Shreveport
    • Maine
      • Bangor, Maine, United States, 04401
        • Eastern Maine Medical Center
      • Portland, Maine, United States, 04101
        • Mercy Hospital
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Anne Arundel Medical Center
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University/Sidney Kimmel Cancer Center
      • Baltimore, Maryland, United States, 21225
        • Harbor Hospital Center
      • Bethesda, Maryland, United States, 20814
        • Suburban Hospital
      • Elkton, Maryland, United States, 21921
        • Union Hospital of Cecil County
      • Largo, Maryland, United States, 20774
        • Kaiser Permanente - Largo Medical Center
      • Lutherville, Maryland, United States, 21093
        • Kaiser Permanente - Towson Medical Center
      • Rockville, Maryland, United States, 20850
        • Kaiser Permanente - Shady Grove Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Cancer Center
      • Boston, Massachusetts, United States, 02130
        • Brigham and Women's Faulkner Hospital
      • Burlington, Massachusetts, United States, 01805
        • Lahey Hospital and Medical Center
      • Concord, Massachusetts, United States, 01742
        • Emerson Hospital/MGH Cancer Center
      • Danvers, Massachusetts, United States, 01923
        • Mass General/North Shore Cancer Center
      • Framingham, Massachusetts, United States, 01702
        • MetroWest Medical Center-Framingham Union Hospital
      • Lowell, Massachusetts, United States, 01854
        • Lowell General Hospital
      • Newton, Massachusetts, United States, 02462
        • Newton-Wellesley Hospital
      • South Weymouth, Massachusetts, United States, 02190
        • South Shore Hospital
    • Michigan
      • Adrian, Michigan, United States, 49221
        • Bixby Medical Center
      • Adrian, Michigan, United States, 49221
        • Hickman Cancer Center
      • Ann Arbor, Michigan, United States, 48106-0995
        • Saint Joseph Mercy Hospital
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Comprehensive Cancer Center
      • Ann Arbor, Michigan, United States, 48106
        • Michigan Cancer Research Consortium NCORP
      • Detroit, Michigan, United States, 48236
        • Saint John Hospital and Medical Center
      • Detroit, Michigan, United States, 48201
        • Wayne State University/Karmanos Cancer Institute
      • Escanaba, Michigan, United States, 49829
        • Green Bay Oncology - Escanaba
      • Flint, Michigan, United States, 48532
        • Genesys Regional Medical Center-West Flint Campus
      • Grand Rapids, Michigan, United States, 49503
        • Cancer Research Consortium of West Michigan NCORP
      • Iron Mountain, Michigan, United States, 49801
        • Green Bay Oncology - Iron Mountain
      • Jackson, Michigan, United States, 49201
        • Allegiance Health
      • Marquette, Michigan, United States, 49855
        • Marquette General Hospital
      • Midland, Michigan, United States, 48670
        • Mid-Michigan Medical Center - Midland
      • Monroe, Michigan, United States, 48162
        • Mercy Memorial Hospital
      • Monroe, Michigan, United States, 48162
        • Toledo Clinic Cancer Centers-Monroe
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital-Royal Oak
      • Saginaw, Michigan, United States, 48601
        • Saint Mary's of Michigan
      • Saint Joseph, Michigan, United States, 49085
        • Lakeland Hospital
      • Warren, Michigan, United States, 48093
        • Saint John Macomb-Oakland Hospital
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy Hospital
      • Duluth, Minnesota, United States, 55805
        • Essentia Health Cancer Center
      • Edina, Minnesota, United States, 55435
        • Fairview-Southdale Hospital
      • Fridley, Minnesota, United States, 55432
        • Unity Hospital
      • Hutchinson, Minnesota, United States, 55350
        • Hutchinson Area Health Care
      • Litchfield, Minnesota, United States, 55355
        • Meeker County Memorial Hospital
      • Maplewood, Minnesota, United States, 55109
        • Saint John's Hospital - Healtheast
      • Maplewood, Minnesota, United States, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, United States, 55407
        • Abbott-Northwestern Hospital
      • Minneapolis, Minnesota, United States, 55407
        • Virginia Piper Cancer Institute
      • Robbinsdale, Minnesota, United States, 55422
        • North Memorial Medical Health Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
      • Saint Louis Park, Minnesota, United States, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Louis Park, Minnesota, United States, 55416
        • Metro Minnesota Community Oncology Research Consortium
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, United States, 55102
        • United Hospital
      • Saint Paul, Minnesota, United States, 55102
        • Saint Joseph's Hospital - Healtheast
      • Shakopee, Minnesota, United States, 55379
        • Saint Francis Regional Medical Center
      • Waconia, Minnesota, United States, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, United States, 56201
        • Rice Memorial Hospital
      • Woodbury, Minnesota, United States, 55125
        • Woodwinds Health Campus
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Oncology and Hematology PA-Woodbury
    • Mississippi
      • Keesler Air Force Base, Mississippi, United States, 39534
        • Keesler Medical Center
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63131
        • Missouri Baptist Medical Center
      • Saint Louis, Missouri, United States, 63128
        • Saint Anthony's Medical Center
      • Springfield, Missouri, United States, 65804
        • Mercy Hospital Springfield
    • Montana
      • Billings, Montana, United States, 59101
        • Montana Cancer Consortium NCORP
      • Great Falls, Montana, United States, 59405
        • Great Falls Clinic
      • Great Falls, Montana, United States, 59405
        • Benefis Healthcare- Sletten Cancer Institute
      • Great Falls, Montana, United States, 59405
        • Benefis Healthcare-West Campus
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Nebraska Methodist Hospital
    • Nevada
      • Reno, Nevada, United States, 89502
        • Renown Regional Medical Center
    • New Hampshire
      • Concord, New Hampshire, United States, 03301
        • New Hampshire Oncology Hematology PA-Concord
      • Exeter, New Hampshire, United States, 03833
        • Exeter Hospital
      • Hooksett, New Hampshire, United States, 03106
        • New Hampshire Oncology Hematology PA-Hooksett
      • Keene, New Hampshire, United States, 03431
        • Cheshire Medical Center-Dartmouth-Hitchcock Keene
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
      • Manchester, New Hampshire, United States, 03103
        • Elliot Hospital
      • Rochester, New Hampshire, United States, 03867
        • Frisbie Hospital
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper Hospital University Medical Center
      • Hamilton, New Jersey, United States, 08690
        • The Cancer Institute of New Jersey Hamilton
      • Livingston, New Jersey, United States, 07039
        • Saint Barnabas Medical Center
      • Long Branch, New Jersey, United States, 07740
        • Monmouth Medical Center
      • Morristown, New Jersey, United States, 07960
        • Morristown Medical Center
      • Mount Holly, New Jersey, United States, 08060
        • Virtua Memorial
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers Cancer Institute of New Jersey
      • Vineland, New Jersey, United States, 08360
        • Inspira Medical Center Vineland
      • Voorhees, New Jersey, United States, 08043
        • Virtua Voorhees
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • University of New Mexico Cancer Center
      • Albuquerque, New Mexico, United States, 87106
        • Hematology Oncology Associates
      • Albuquerque, New Mexico, United States, 87110
        • Presbyterian Kaseman Hospital
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center-Weiler Hospital
      • Bronx, New York, United States, 10467-2490
        • Montefiore Medical Center - Moses Campus
      • Brooklyn, New York, United States, 11203
        • Kings County Hospital
      • Brooklyn, New York, United States, 11203
        • University Hospital of Brooklyn
      • Brooklyn, New York, United States, 11203
        • State University of New York Downstate Medical Center
      • Brooklyn, New York, United States, 11212
        • Brookdale Hospital Medical Center
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • Glens Falls, New York, United States, 12801
        • Adirondack Cancer Center
      • Lake Success, New York, United States, 11042
        • Northwell Health NCORP
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • New Hyde Park, New York, United States, 11040
        • Long Island Jewish Medical Center
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, United States, 10065
        • Weill Medical College of Cornell University
      • New York, New York, United States, 10011
        • Saint Vincent's Hospital and Medical Center of New York
      • Staten Island, New York, United States, 10305
        • Staten Island University Hospital
    • North Carolina
      • Asheville, North Carolina, United States, 28816
        • Hope Women's Cancer Centers-Asheville
      • Asheville, North Carolina, United States, 28801
        • Mission Hospital-Memorial Campus
      • Burlington, North Carolina, United States, 27216
        • Cone Health Cancer Center at Alamance Regional
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Lineberger Comprehensive Cancer Center
      • Concord, North Carolina, United States, 28025
        • Carolinas HealthCare System NorthEast
      • Goldsboro, North Carolina, United States, 27534
        • Wayne Memorial Hospital
      • Pinehurst, North Carolina, United States, 28374
        • FirstHealth of the Carolinas-Moore Regional Hosiptal
      • Rutherfordton, North Carolina, United States, 28139
        • Rutherford Hospital
      • Winston-Salem, North Carolina, United States, 27103
        • Novant Health Forsyth Medical Center
      • Winston-Salem, North Carolina, United States, 27104
        • Southeast Clinical Oncology Research (SCOR) Consortium NCORP
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Sanford Bismarck Medical Center
      • Bismarck, North Dakota, United States, 58501
        • Mid Dakota Clinic
      • Grand Forks, North Dakota, United States, 58201
        • Altru Cancer Center
      • Grand Forks, North Dakota, United States, 58201
        • Altru Hospital
      • Minot, North Dakota, United States, 58701
        • Trinity Cancer Care Center
    • Ohio
      • Bowling Green, Ohio, United States, 43402
        • Toledo Clinic Cancer Centers-Bowling Green
      • Canton, Ohio, United States, 44710
        • Aultman Health Foundation
      • Chillicothe, Ohio, United States, 45601
        • Adena Regional Medical Center
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44111
        • Cleveland Clinic Cancer Center/Fairview Hospital
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center
      • Columbus, Ohio, United States, 43228
        • Doctors Hospital
      • Columbus, Ohio, United States, 43215
        • Grant Medical Center
      • Columbus, Ohio, United States, 43222
        • Mount Carmel Health Center West
      • Columbus, Ohio, United States, 43215
        • Columbus NCI Community Oncology Research Program
      • Dayton, Ohio, United States, 45406
        • Good Samaritan Hospital - Dayton
      • Dayton, Ohio, United States, 45409
        • Miami Valley Hospital
      • Dayton, Ohio, United States, 45415
        • Samaritan North Health Center
      • Dayton, Ohio, United States, 45420
        • Dayton NCI Community Oncology Research Program
      • Delaware, Ohio, United States, 43015
        • Grady Memorial Hospital
      • Franklin, Ohio, United States, 45005-1066
        • Atrium Medical Center-Middletown Regional Hospital
      • Kettering, Ohio, United States, 45429
        • Kettering Medical Center
      • Lancaster, Ohio, United States, 43130
        • Fairfield Medical Center
      • Lima, Ohio, United States, 45804
        • Lima Memorial Hospital
      • Marietta, Ohio, United States, 45750
        • Marietta Memorial Hospital
      • Maumee, Ohio, United States, 43537
        • Toledo Clinic Cancer Centers-Maumee
      • Maumee, Ohio, United States, 43537
        • Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
      • Newark, Ohio, United States, 43055
        • Licking Memorial Hospital
      • Oregon, Ohio, United States, 43616
        • Saint Charles Hospital
      • Oregon, Ohio, United States, 43616
        • Toledo Clinic Cancer Centers-Oregon
      • Sandusky, Ohio, United States, 44870
        • North Coast Cancer Care
      • Springfield, Ohio, United States, 45505
        • Springfield Regional Medical Center
      • Sylvania, Ohio, United States, 43560
        • Flower Hospital
      • Toledo, Ohio, United States, 43608
        • Saint Vincent Mercy Medical Center
      • Toledo, Ohio, United States, 43623
        • Toledo Clinic Cancer Centers-Toledo
      • Toledo, Ohio, United States, 43614
        • University of Toledo
      • Toledo, Ohio, United States, 43617
        • Toledo Community Hospital Oncology Program CCOP
      • Toledo, Ohio, United States, 43606
        • The Toledo Hospital/Toledo Children's Hospital
      • Toledo, Ohio, United States, 43623
        • Mercy Saint Anne Hospital
      • Troy, Ohio, United States, 45373
        • Upper Valley Medical Center
      • Wauseon, Ohio, United States, 43567
        • Fulton County Health Center
      • Westerville, Ohio, United States, 43081
        • Saint Ann's Hospital
      • Wooster, Ohio, United States, 44691
        • Cleveland Clinic Wooster Family Health and Surgery Center
      • Xenia, Ohio, United States, 45385
        • Greene Memorial Hospital
      • Youngstown, Ohio, United States, 44501
        • Tod Children's Hospital - Forum Health
      • Zanesville, Ohio, United States, 43701
        • Genesis Healthcare System Cancer Care Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
    • Oregon
      • Bend, Oregon, United States, 97701
        • Bend Memorial Clinic
      • Bend, Oregon, United States, 97701
        • Saint Charles Medical Center-Bend
      • Gresham, Oregon, United States, 97030
        • Legacy Mount Hood Medical Center
      • Milwaukie, Oregon, United States, 97222
        • Providence Milwaukie Hospital
      • Portland, Oregon, United States, 97210
        • Legacy Good Samaritan Hospital and Medical Center
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, United States, 97225
        • Providence Saint Vincent Medical Center
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente
      • Portland, Oregon, United States, 97227
        • Legacy Emanuel Hospital and Health Center
      • Portland, Oregon, United States, 97213
        • Western Oncology Research Consortium
      • Tualatin, Oregon, United States, 97062
        • Legacy Meridian Park Hospital
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Memorial Hospital
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital-Cedar Crest
      • Bethlehem, Pennsylvania, United States, 18015
        • Saint Luke's University Hospital-Bethlehem Campus
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Hazleton, Pennsylvania, United States, 18201
        • Geisinger Medical Center-Cancer Center Hazleton
      • Hershey, Pennsylvania, United States, 17033-0850
        • Penn State Hershey Cancer Institute-Clinical Trials Office
      • Lancaster, Pennsylvania, United States, 17604
        • Lancaster General Hospital
      • Langhorne, Pennsylvania, United States, 19047
        • Saint Mary Medical and Regional Cancer Center
      • Lewistown, Pennsylvania, United States, 17044
        • Lewistown Hospital
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania/Abramson Cancer Center
      • Philadelphia, Pennsylvania, United States, 19114
        • Aria Health-Torresdale Campus
      • Philadelphia, Pennsylvania, United States, 19118
        • Chestnut Hill Health System
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Cancer Institute (UPCI)
      • Sayre, Pennsylvania, United States, 18840
        • Guthrie Medical Group PC-Robert Packer Hospital
      • Scranton, Pennsylvania, United States, 18510
        • Scranton Hematology Oncology
      • Sellersville, Pennsylvania, United States, 18960
        • Grand View Hospital
      • State College, Pennsylvania, United States, 16801
        • Geisinger Medical Group
      • State College, Pennsylvania, United States, 16803
        • Mount Nittany Medical Center
      • West Chester, Pennsylvania, United States, 19380
        • Chester County Hospital
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Geisinger Wyoming Valley/Henry Cancer Center
      • York, Pennsylvania, United States, 17403
        • WellSpan Health-York Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
      • Providence, Rhode Island, United States, 02905
        • Women and Infants Hospital
      • Providence, Rhode Island, United States, 02906
        • Miriam Hospital
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Health Hospital
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Medical Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, United States, 57117-5134
        • Sanford USD Medical Center - Sioux Falls
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Cancer Center-Oncology Clinic
      • Sioux Falls, South Dakota, United States, 57105
        • Medical X-Ray Center
      • Sioux Falls, South Dakota, United States, 57105
        • Avera McKennan Hospital and University Health Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Memorial Hospital
      • Chattanooga, Tennessee, United States, 37403
        • Erlanger Medical Center
      • Germantown, Tennessee, United States, 38138
        • Jones Clinic
      • Knoxville, Tennessee, United States, 37916
        • Thompson Cancer Survival Center
      • Nashville, Tennessee, United States, 37208
        • Meharry Medical College
      • Nashville, Tennessee, United States, 37203
        • Nashville Oncology Associates PC
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern/Simmons Cancer Center-Dallas
      • Dallas, Texas, United States, 75230
        • Medical City Dallas Hospital
      • Dallas, Texas, United States, 75390
        • Clements University Hospital
      • Dallas, Texas, United States, 75235
        • Zale Lipshy University Hospital
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
      • Laredo, Texas, United States, 78041
        • Doctor's Hospital of Laredo
      • Lubbock, Texas, United States, 79410
        • Covenant Medical Center-Lakeside
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio
      • San Antonio, Texas, United States, 78229
        • Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
      • Temple, Texas, United States, 76508
        • Scott and White Memorial Hospital
    • Vermont
      • Bennington, Vermont, United States, 05201
        • Southwestern Vermont Medical Center
      • Berlin, Vermont, United States, 05602
        • Central Vermont Medical Center/National Life Cancer Treatment
      • Burlington, Vermont, United States, 05405
        • University of Vermont College of Medicine
    • Virginia
      • Fairfax, Virginia, United States, 22033
        • Kaiser Permanente - Fair Oaks Medical Center
      • Fredericksburg, Virginia, United States, 22401
        • Fredericksburg Oncology Inc
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University/Massey Cancer Center
    • Washington
      • Auburn, Washington, United States, 98001
        • MultiCare Auburn Medical Center
      • Bellingham, Washington, United States, 98225
        • PeaceHealth Saint Joseph Medical Center
      • Centralia, Washington, United States, 98531
        • Providence Regional Cancer System-Centralia
      • Federal Way, Washington, United States, 98003
        • Saint Francis Hospital
      • Lakewood, Washington, United States, 98499
        • Saint Clare Hospital
      • Olympia, Washington, United States, 98506-5166
        • Providence - Saint Peter Hospital
      • Puyallup, Washington, United States, 98372
        • MultiCare Good Samaritan Hospital
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center
      • Seattle, Washington, United States, 98112
        • Group Health Cooperative-Seattle
      • Seattle, Washington, United States, 98122-4307
        • Swedish Medical Center-First Hill
      • Seattle, Washington, United States, 98112
        • Group Health Cooperative of Puget Sound Oncology Consortium
      • Spokane, Washington, United States, 99202
        • Cancer Care Northwest - Spokane South
      • Tacoma, Washington, United States, 98405
        • MultiCare Allenmore Hospital
      • Tacoma, Washington, United States, 98405
        • Northwest NCI Community Oncology Research Program
      • Tacoma, Washington, United States, 98405
        • Saint Joseph Medical Center
      • Tacoma, Washington, United States, 98415
        • MultiCare Health System
      • Vancouver, Washington, United States, 98664
        • PeaceHealth Southwest Medical Center
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • Edwards Comprehensive Cancer Center
    • Wisconsin
      • Antigo, Wisconsin, United States, 54409
        • Langlade Hospital and Cancer Center
      • Eau Claire, Wisconsin, United States, 54701
        • Sacred Heart Hospital
      • Eau Claire, Wisconsin, United States, 54702
        • Midelfort Clinic-Clairemont Campus
      • Elkhorn, Wisconsin, United States, 53121
        • Aurora Cancer Care-Southern Lakes
      • Green Bay, Wisconsin, United States, 54301
        • Saint Vincent Hospital
      • Green Bay, Wisconsin, United States, 54303
        • Green Bay Oncology Limited at Saint Mary's Hospital
      • Green Bay, Wisconsin, United States, 54303
        • Saint Mary's Hospital
      • Green Bay, Wisconsin, United States, 54301-3526
        • Green Bay Oncology at Saint Vincent Hospital
      • Green Bay, Wisconsin, United States, 54311-6519
        • Aurora BayCare Medical Center
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Lutheran Medical Center
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospital and Clinics
      • Madison, Wisconsin, United States, 53717
        • Dean Hematology and Oncology Clinic
      • Madison, Wisconsin, United States, 53715
        • UW Health Oncology-One South Park
      • Manitowoc, Wisconsin, United States, 54221
        • Holy Family Memorial Hospital
      • Marinette, Wisconsin, United States, 54143
        • Bay Area Medical Center
      • Marinette, Wisconsin, United States, 54143
        • Vince Lombardi Cancer Clinic-Marinette
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic
      • Milwaukee, Wisconsin, United States, 53215
        • Medical Consultants Limited
      • Minocqua, Wisconsin, United States, 54548
        • Marshfield Clinic-Minocqua Center
      • Oconto Falls, Wisconsin, United States, 54154
        • Green Bay Oncology - Oconto Falls
      • Sturgeon Bay, Wisconsin, United States, 54235
        • Green Bay Oncology - Sturgeon Bay
      • Wausau, Wisconsin, United States, 54401
        • Aspirus Regional Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Premenopausal women (estradiol [E2] in the premenopausal range [according to institution parameters]) who meet the following criteria:

    • Patients who did not receive chemotherapy should be randomized within 12 weeks after definitive surgery; such patients should have estradiol (E2) in the premenopausal range following surgery; the only patients who do not require testing of estradiol (E2) to confirm premenopausal status are those who have been menstruating regularly during the 6 months prior to randomization and have not used any form of hormonal contraception or any other hormonal treatments during the 6 months prior to randomization
    • Patients who received prior adjuvant and/or neoadjuvant chemotherapy should be randomized after completing chemotherapy and within 8 months of the final dose of chemotherapy as soon as premenopausal status is confirmed; all such patients should have premenopausal status confirmed by an estradiol (E2) in the premenopausal range between 2 weeks and 8 months after completing chemotherapy
    • Adjuvant trastuzumab (Herceptin ®) is allowable, and is not considered to be chemotherapy for eligibility timing determination
    • Patients with temporary chemotherapy-induced amenorrhea who regain premenopausal status within eight months of the final dose of chemotherapy are eligible; (please note that some patients taking tamoxifen or aromatase inhibitors, even without evidence of menses, may have ovarian function recovery following chemotherapy and resume estradiol secretion); in patients wishing to participate in the study, with postmenopausal hormone levels shortly after chemotherapy, it is recommended to recheck their estradiol level at a later timepoint within 8 months of completing chemotherapy, even in the absence of return of menses
  • Histologically proven, resected breast cancer; pathology material should be available for submission for central review as part of the quality control measures for this protocol
  • Patients must have hormone receptor positive tumors; if there is more than one breast tumor, each tumor must be hormone receptor positive; hormone receptors must be determined using immunohistochemistry; estrogen receptor (ER) and/or progesterone receptor (PgR) must be greater than or equal to 10% of the tumor cells positive by immunohistochemical evaluation; biochemical determination alone is not acceptable
  • The tumor must be confined to the breast and axillary nodes without detected metastases elsewhere, with the exception of tumor detected in internal mammary chain nodes by sentinel node procedure; patients who received neoadjuvant therapy must have had operable disease prior to neoadjuvant treatment to be eligible; patients who had a pathological evaluation with tru cut or core biopsy of invasive breast cancer prior to neoadjuvant therapy and were found to have no invasive tumor in the pathological specimen from definitive surgery are eligible; for these patients, pre-neoadjuvant tumor characteristics will be used for defining eligibility; in case of persistent disease, pathology findings from the definitive surgery should be used

  • Patients must have had proper surgery for primary breast cancer with no known clinical residual loco-regional disease:

    • A total mastectomy; radiotherapy is optional after mastectomy OR
    • A breast-conserving procedure (lumpectomy, quadrantectomy or partial mastectomy with margins clear of invasive cancer and ductal breast carcinoma in situ [DCIS]); the local pathologist must document negative margins of resection in the pathology report; if all other margins are clear, a positive posterior (deep) margin is permitted, provided the surgeon documents that the excision was performed down to the pectoral fascia and all tumor has been removed; likewise, if all other margins are clear, a positive anterior (superficial; abutting skin) margin is permitted provided the surgeon documents that all tumor has been removed; radiation therapy to the conserved breast is required; patients may be randomized before, during or after completion of radiation therapy to the breast
  • Either axillary lymph node dissection (pathological examination of at least 6 nodes recommended) or a negative axillary sentinel node biopsy (pN0[sn]) is required; patients with negative or microscopically axillary positive sentinel nodes (pN1mi: micrometastasis none > 2.0 mm) do not require further axillary therapy; those with positive sentinel nodes must have either an axillary dissection or radiation of axillary nodes
  • For International Breast Cancer Study Groups (IBCSG) centers, patients must have completed baseline Quality of Life (QL) Forms prior to randomization; the only exceptions are cognitive or physical impairment that interferes with QL assessment or inability to read any of the languages available on IBCSG QL forms; for non-IBCSG centers, extent of participation in the QL study is to be determined at the activation of the trial for each cooperative group
  • Written informed consent must be signed and dated by the patient and the investigator prior to randomization
  • Patients must be accessible for follow-up
  • Patients must be informed of and agree to data and tissue material transfer and handling, in accordance with national data protection guidelines

Exclusion Criteria:

  • Patients who are postmenopausal (i.e., do not have an estradiol [E2] level in the premenopausal range) after surgery or after chemotherapy, whichever is later
  • Patients with distant metastatic disease
  • Patients with locally advanced inoperable breast cancer including inflammatory breast cancer or supraclavicular node involvement or with enlarged internal mammary nodes (unless pathologically negative) are not eligible; patients with involved internal mammary nodes detected by sentinel node biopsy that are not enlarged are eligible
  • Patients with positive final margins (referring to only DCIS and invasive cancer, not lobular breast carcinoma in situ [LCIS]), except as noted; DCIS at a margin is permitted if a complete mastectomy has been performed
  • Patients with clinically detectable residual axillary disease
  • Patients with a history of prior ipsilateral or contralateral invasive breast cancer; patients with synchronous bilateral invasive breast cancer (diagnosed histologically within 2 months) are eligible if the bilateral disease meets all other eligibility criteria

  • Patients with previous or concomitant invasive malignancy are not eligible; the exceptions are patients with the following (and only the following) malignancies (previous or concomitant) who are eligible if adequately treated:

    • Basal or squamous cell carcinoma of the skin
    • In situ non-breast carcinoma without invasion
    • Contra- or ipsilateral in situ breast carcinoma

    • Non-breast invasive malignancy diagnosed at least 5 years ago and without recurrence:

      • Stage I papillary thyroid cancer
      • Stage Ia carcinoma of the cervix
      • Stage Ia or b endometrioid endometrial cancer
      • Borderline or stage I ovarian cancer
  • Patients with other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung, etc.) that would prevent prolonged follow-up; patients with previous thrombosis (e.g., deep vein thrombosis [DVT]) and/or embolism can be included only if medically suitable
  • Patients who have had a bilateral oophorectomy or ovarian irradiation; patients who will be recommended to undergo oophorectomy within 5 years (e.g., breast cancer susceptibility gene [BRCA]1/2 gene carriers) and therefore for whom randomization to a treatment arm without OFS is inappropriate
  • Patients with a history of noncompliance to medical regimens and patients who are considered potentially unreliable
  • Patients who are pregnant or lactating at the time of randomization or who desire a pregnancy within 5 years; patients planning to use additional hormonal therapy apart from the randomized treatment during the next five years including all types of hormonal contraception; a pregnancy test is recommended for women of child-bearing potential who are sexually active and not using reliable contraceptive methods
  • Patients who received endocrine therapy (including neoadjuvant and adjuvant) for more than 8 months after their breast cancer diagnosis; patients who are receiving endocrine therapy at randomization (and have received it for less than 8 months) may continue such therapy until protocol-specified tamoxifen/exemestane is initiated
  • Patients who were taking tamoxifen or other selective estrogen receptor modulator (SERM) (e.g. Raloxifene) or hormone replacement therapy (HRT) within one year prior to their breast cancer diagnosis; prior oral contraceptives are allowed
  • Patients who have received GnRH analogues as part of their breast cancer treatment prior to randomization
  • Patients with psychiatric, addictive, or any disorder that would prevent compliance with protocol requirements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tamoxifen
Tamoxifen 20mg orally daily for 5 years
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Drug: Tamoxifen
Tamoxifen 20mg orally daily for 5 years
Other Names:
  • Nolvadex
  • TAM
  • Soltamox
  • Apo-Tamox
  • Clonoxifen
  • Dignotamoxi
  • Ebefen
  • Emblon
  • Estroxyn
  • Fentamox
  • Gen-Tamoxifen
  • Genox
  • ICI 46,474
  • ICI-46474
  • Jenoxifen
  • Kessar
  • Ledertam
  • Lesporene
  • Nolgen
  • Noltam
  • Nolvadex-D
  • Nourytam
  • Novo-Tamoxifen
  • Novofen
  • Noxitem
  • Oestrifen
  • Oncotam
  • PMS-Tamoxifen
  • Tamax
  • Tamaxin
  • Tamifen
  • Tamizam
  • Tamofen
  • Tamoxasta
  • Tamoxifeni Citras
  • Zemide
  • TAMOXIFEN CITRATE
Experimental: T+OFS
Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Drug: Tamoxifen
Tamoxifen 20mg orally daily for 5 years
Other Names:
  • Nolvadex
  • TAM
  • Soltamox
  • Apo-Tamox
  • Clonoxifen
  • Dignotamoxi
  • Ebefen
  • Emblon
  • Estroxyn
  • Fentamox
  • Gen-Tamoxifen
  • Genox
  • ICI 46,474
  • ICI-46474
  • Jenoxifen
  • Kessar
  • Ledertam
  • Lesporene
  • Nolgen
  • Noltam
  • Nolvadex-D
  • Nourytam
  • Novo-Tamoxifen
  • Novofen
  • Noxitem
  • Oestrifen
  • Oncotam
  • PMS-Tamoxifen
  • Tamax
  • Tamaxin
  • Tamifen
  • Tamizam
  • Tamofen
  • Tamoxasta
  • Tamoxifeni Citras
  • Zemide
  • TAMOXIFEN CITRATE
Procedure: Oophorectomy
Undergo bilateral surgical oophorectomy
Other Names:
  • Female Castration
  • Ovariectomy
Radiation: Radiation Therapy
Undergo ovarian irradiation
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • Irradiation
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation
  • RADIATION
Drug: Triptorelin
3.75 mg by im injection q28 days for 5 years
Other Names:
  • Decapeptyl
  • 6-D-Tryptophan-LH-RH
  • 6-D-Tryptophanluteinizing Hormone-releasing Factor
  • AY-25650
  • CL-118,532
  • Detryptoreline
  • GnRH analogue
  • Trelstar Depot
  • Decapeptyl Depot
Experimental: E+OFS
Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Procedure: Oophorectomy
Undergo bilateral surgical oophorectomy
Other Names:
  • Female Castration
  • Ovariectomy
Radiation: Radiation Therapy
Undergo ovarian irradiation
Other Names:
  • Cancer Radiotherapy
  • Irradiate
  • Irradiated
  • Irradiation
  • Radiotherapeutics
  • Radiotherapy
  • RT
  • Therapy, Radiation
  • RADIATION
Drug: Triptorelin
3.75 mg by im injection q28 days for 5 years
Other Names:
  • Decapeptyl
  • 6-D-Tryptophan-LH-RH
  • 6-D-Tryptophanluteinizing Hormone-releasing Factor
  • AY-25650
  • CL-118,532
  • Detryptoreline
  • GnRH analogue
  • Trelstar Depot
  • Decapeptyl Depot
Drug: Exemestane
Exemestane 25mg orally daily for 5 years plus ovarian function suppression
Other Names:
  • Aromasin
  • FCE-24304

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free Survival
Time Frame: 5-year estimates, reported at a median follow-up of 67 months.
Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to the first appearance of one of the following: invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow-up.
5-year estimates, reported at a median follow-up of 67 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breast Cancer-free Interval
Time Frame: 5-year estimates, reported at a median follow-up of 67 months.
Estimated percentage of patients alive and disease-free at 5 years from randomization, where breast cancer-free interval is defined as the time from randomization to invasive breast cancer recurrence at local, regional, or distant site, or invasive contralateral breast cancer; or censored at date of last follow up.
5-year estimates, reported at a median follow-up of 67 months.
Distant Recurrence-free Interval
Time Frame: 5-year estimates, reported at a median follow-up of 67 months.
Estimated percentage of patients alive and disease-free at 5 years from randomization, where distant recurrence-free Interval is defined as the time from randomization to invasive breast cancer recurrence at distant site, or invasive contralateral breast cancer; or censored at date of last follow up.
5-year estimates, reported at a median follow-up of 67 months.
Overall Survival
Time Frame: 8-year estimates, reported at a median follow-up of 8 years
Estimated percentage of patients alive at 8 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive.
8-year estimates, reported at a median follow-up of 8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ETOP IBCSG Partners Foundation

Collaborators

National Cancer Institute (NCI)
NCIC Clinical Trials Group
Cancer and Leukemia Group B
North Central Cancer Treatment Group
Breast International Group
NSABP Foundation Inc
SWOG Cancer Research Network

Investigators

  • Principal Investigator: Gini Fleming, ETOP IBCSG Partners Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2003

Primary Completion (Actual)

May 1, 2014

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

August 6, 2003

First Submitted That Met QC Criteria

August 6, 2003

First Posted (Estimated)

August 7, 2003

Study Record Updates

Last Update Posted (Estimated)

January 1, 2024

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBCSG 24-02 / BIG 2-02
  • NCI-2009-01086 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • CDR0000316456
  • BIG 2-02
  • 2004-000166-13
  • IBCSG-24-02 (Other Identifier: CTEP)
  • U24CA075362 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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