Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer (SOFT)
Estrogen Receptor Positive Breast Cancer, Progesterone Receptor Positive Tumor, Recurrent Breast Carcinoma
About this trial
This is an interventional treatment trial for Estrogen Receptor Positive Breast Cancer focused on measuring tamoxifen, ovarian function suppression + tamoxifen, ovarian function suppression + exemestane
Eligibility Criteria
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
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- Providence Alaska Medical Center
- Mayo Clinic in Arizona
- Alta Bates Summit Medical Center-Herrick Campus
- Mills - Peninsula Hospitals
- East Bay Radiation Oncology Center
- Valley Medical Oncology Consultants-Castro Valley
- John Muir Medical Center-Concord Campus
- Bay Area Breast Surgeons Inc
- Kaiser Permanente-Fremont
- Valley Medical Oncology Consultants-Fremont
- Glendale Memorial Hospital and Health Center
- Marin General Hospital
- Scripps Cancer Center
- USC / Norris Comprehensive Cancer Center
- UCLA / Jonsson Comprehensive Cancer Center
- Contra Costa Regional Medical Center
- Memorial Medical Center
- Palo Alto Medical Foundation-Camino Division
- Sutter Cancer Research Consortium
- Bay Area Tumor Institute
- Hematology and Oncology Associates-Oakland
- Tom K Lee Inc
- Kaiser Permanente-Oakland
- Palo Alto Medical Foundation Health Care
- Stanford Cancer Institute
- Valley Medical Oncology Consultants
- Eisenhower Medical Center
- Mercy Regional Cancer Center
- Kaiser Permanente-Redwood City
- Kaiser Permanente-Richmond
- Kaiser Permanente-Roseville
- Mercy General Hospital
- Kaiser Permanente-South Sacramento
- Kaiser Permanente - Sacramento
- Salinas Valley Memorial
- University of California San Diego
- Kaiser Permanente-San Diego Mission
- Veterans Administration-San Diego Medical Center
- San Francisco General Hospital
- California Pacific Medical Center-Pacific Campus
- Kaiser Permanente-San Francisco
- UCSF Medical Center-Mount Zion
- Kaiser Permanente-Santa Teresa-San Jose
- Kaiser Permanente San Leandro
- Kaiser Permanente-San Rafael
- Kaiser Permanente Medical Center - Santa Clara
- Kaiser Permanente-Santa Rosa
- Santa Rosa Memorial Hospital
- Kaiser Permanente-South San Francisco
- Kaiser Permanente-Vallejo
- Kaiser Permanente-Walnut Creek
- John Muir Medical Center-Walnut Creek
- The Medical Center of Aurora
- Boulder Community Hospital
- Penrose-Saint Francis Healthcare
- Memorial Hospital Colorado Springs
- Denver Health Medical Center
- Porter Adventist Hospital
- Presbyterian - Saint Lukes Medical Center - Health One
- SCL Health Saint Joseph Hospital
- Denver Veterans Administration Medical Center
- Rose Medical Center
- Colorado Cancer Research Program NCORP
- The Shaw Regional Cancer Center
- Swedish Medical Center
- Poudre Valley Hospital
- Front Range Cancer Specialists
- North Colorado Medical Center
- Saint Anthony Hospital
- Sky Ridge Medical Center
- Longmont United Hospital
- Saint Mary Corwin Medical Center
- North Suburban Medical Center
- SCL Health Lutheran Medical Center
- Hartford Hospital
- Norwalk Hospital
- Eastern Connecticut Hematology and Oncology Associates
- Stamford Hospital/Bennett Cancer Center
- Charlotte Hungerford Hospital Center for Cancer Care
- Bayhealth Medical Center at Kent General
- Beebe Medical Center
- Christiana Care Health System-Christiana Hospital
- Nanticoke Memorial Hospital
- MedStar Georgetown University Hospital
- MedStar Washington Hospital Center
- Sibley Memorial Hospital
- Cancer Research Network Inc
- Holy Cross Hospital
- Memorial Regional Hospital/Joe DiMaggio Children's Hospital
- Baptist MD Anderson Cancer Center
- Mayo Clinic in Florida
- Jupiter Medical Center
- Mount Sinai Medical Center
- Florida Cancer Specialists - Sarasota Downtown
- Piedmont Hospital
- Emory University/Winship Cancer Institute
- Atlanta Regional CCOP
- Northside Hospital
- Saint Joseph's Hospital of Atlanta
- Augusta Oncology Associates PC-Saint Sebastian
- Well Star Cobb Hospital
- John B Amos Cancer Center
- Dekalb Medical Center
- Gwinnett Medical Center
- Wellstar Kennestone Hospital
- Southern Regional Medical Center
- Harbin Clinic Medical Oncology and Clinical Research
- Memorial University Medical Center
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
- University of Hawaii Cancer Center
- Tripler Army Medical Center
- Saint Joseph Medical Center
- Graham Hospital Association
- Memorial Hospital
- John H Stroger Jr Hospital of Cook County
- Rush University Medical Center
- University of Chicago Comprehensive Cancer Center
- Weiss Memorial Hospital
- Decatur Memorial Hospital
- Heartland Cancer Research NCORP
- Eureka Hospital
- Galesburg Cottage Hospital
- Illinois CancerCare-Galesburg
- Western Illinois Cancer Treatment Center
- Ingalls Memorial Hospital
- Mason District Hospital
- Hopedale Medical Complex - Hospital
- Kewanee Hospital
- Mcdonough District Hospital
- Loyola University Medical Center
- Edward Hospital/Cancer Center
- Bromenn Regional Medical Center
- Community Cancer Center Foundation
- Ottawa Regional Hospital and Healthcare Center
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
- Pekin Hospital
- Methodist Medical Center of Illinois
- Proctor Hospital
- Illinois CancerCare-Peoria
- OSF Saint Francis Medical Center
- Illinois Valley Hospital
- Valley Radiation Oncology
- Perry Memorial Hospital
- OSF Saint Anthony Medical Center
- Sarah Culbertson Memorial Hospital
- Saint Margaret's Hospital
- Memorial Medical Center
- Carle Cancer Center
- Elkhart General Hospital
- Fort Wayne Medical Oncology and Hematology Inc-Parkview
- Sidney and Lois Eskenazi Hospital
- Community Hospital East
- Community Regional Cancer Care-North
- Saint Vincent Hospital and Health Care Center
- IU Health La Porte Hospital
- IU Health Arnett Cancer Care
- Horizon Oncology Center
- Saint Joseph Regional Medical Center - Mishawaka
- Memorial Hospital of South Bend
- Northern Indiana Cancer Research Consortium
- McFarland Clinic PC-William R Bliss Cancer Center
- Physicians' Clinic of Iowa PC
- Saint Luke's Hospital
- Mercy Hospital
- Oncology Associates at Mercy Medical Center
- Medical Oncology and Hematology Associates-West Des Moines
- Genesis Medical Center - East Campus
- Mercy Capitol
- Iowa Methodist Medical Center
- Iowa-Wide Oncology Research Coalition NCORP
- Medical Oncology and Hematology Associates-Des Moines
- Medical Oncology and Hematology Associates-Laurel
- Mercy Medical Center - Des Moines
- Iowa Lutheran Hospital
- Finley Hospital
- Medical Associates Clinic PC
- Mercy Medical Center - North Iowa
- Siouxland Regional Cancer Center
- Memorial Hospital of Arkansas City
- Cancer Center of Kansas - Chanute
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- Cancer Center of Kansas-Independence
- Cancer Center of Kansas-Kingman
- Lawrence Memorial Hospital
- Cancer Center of Kansas - McPherson
- Cancer Center of Kansas - Newton
- Cancer Center of Kansas - Parsons
- Cancer Center of Kansas - Salina
- Saint Francis Hospital and Medical Center - Topeka
- Cancer Center of Kansas - Wellington
- Associates In Womens Health
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Cancer Center of Kansas - Main Office
- Via Christi Regional Medical Center
- Wichita NCI Community Oncology Research Program
- Cancer Center of Kansas - Winfield
- Louisiana State University Health Sciences Center Shreveport
- Eastern Maine Medical Center
- Mercy Hospital
- Anne Arundel Medical Center
- Harbor Hospital Center
- Johns Hopkins University/Sidney Kimmel Cancer Center
- Suburban Hospital
- Union Hospital of Cecil County
- Kaiser Permanente - Largo Medical Center
- Kaiser Permanente - Towson Medical Center
- Kaiser Permanente - Shady Grove Medical Center
- Tufts Medical Center
- Massachusetts General Hospital Cancer Center
- Brigham and Women's Hospital
- Dana-Farber Cancer Institute
- Brigham and Women's Faulkner Hospital
- Beth Israel Deaconess Medical Center
- Lahey Hospital and Medical Center
- Emerson Hospital/MGH Cancer Center
- Mass General/North Shore Cancer Center
- MetroWest Medical Center-Framingham Union Hospital
- Lowell General Hospital
- Newton-Wellesley Hospital
- South Shore Hospital
- Bixby Medical Center
- Hickman Cancer Center
- Saint Joseph Mercy Hospital
- Michigan Cancer Research Consortium NCORP
- University of Michigan Comprehensive Cancer Center
- Wayne State University/Karmanos Cancer Institute
- Saint John Hospital and Medical Center
- Green Bay Oncology - Escanaba
- Genesys Regional Medical Center-West Flint Campus
- Cancer Research Consortium of West Michigan NCORP
- Green Bay Oncology - Iron Mountain
- Allegiance Health
- Marquette General Hospital
- Mid-Michigan Medical Center - Midland
- Mercy Memorial Hospital
- Toledo Clinic Cancer Centers-Monroe
- William Beaumont Hospital-Royal Oak
- Saint Mary's of Michigan
- Lakeland Hospital
- Saint John Macomb-Oakland Hospital
- Fairview Ridges Hospital
- Mercy Hospital
- Essentia Health Cancer Center
- Fairview-Southdale Hospital
- Unity Hospital
- Hutchinson Area Health Care
- Meeker County Memorial Hospital
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Virginia Piper Cancer Institute
- Hennepin County Medical Center
- North Memorial Medical Health Center
- Mayo Clinic
- Metro Minnesota Community Oncology Research Consortium
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- Saint Joseph's Hospital - Healtheast
- United Hospital
- Saint Francis Regional Medical Center
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology and Hematology PA-Woodbury
- Woodwinds Health Campus
- Keesler Medical Center
- Washington University School of Medicine
- Saint Anthony's Medical Center
- Missouri Baptist Medical Center
- Mercy Hospital Springfield
- Montana Cancer Consortium NCORP
- Benefis Healthcare- Sletten Cancer Institute
- Benefis Healthcare-West Campus
- Great Falls Clinic
- Nebraska Methodist Hospital
- Renown Regional Medical Center
- New Hampshire Oncology Hematology PA-Concord
- Exeter Hospital
- New Hampshire Oncology Hematology PA-Hooksett
- Cheshire Medical Center-Dartmouth-Hitchcock Keene
- Dartmouth Hitchcock Medical Center
- Elliot Hospital
- Frisbie Hospital
- Cooper Hospital University Medical Center
- The Cancer Institute of New Jersey Hamilton
- Saint Barnabas Medical Center
- Monmouth Medical Center
- Morristown Medical Center
- Virtua Memorial
- Rutgers Cancer Institute of New Jersey
- Inspira Medical Center Vineland
- Virtua Voorhees
- University of New Mexico Cancer Center
- Hematology Oncology Associates
- Presbyterian Kaseman Hospital
- Montefiore Medical Center-Weiler Hospital
- Montefiore Medical Center - Moses Campus
- Kings County Hospital
- State University of New York Downstate Medical Center
- University Hospital of Brooklyn
- Brookdale Hospital Medical Center
- Roswell Park Cancer Institute
- Adirondack Cancer Center
- Northwell Health NCORP
- North Shore University Hospital
- Long Island Jewish Medical Center
- Saint Vincent's Hospital and Medical Center of New York
- Memorial Sloan-Kettering Cancer Center
- Weill Medical College of Cornell University
- Staten Island University Hospital
- Mission Hospital-Memorial Campus
- Hope Women's Cancer Centers-Asheville
- Cone Health Cancer Center at Alamance Regional
- UNC Lineberger Comprehensive Cancer Center
- Carolinas HealthCare System NorthEast
- Wayne Memorial Hospital
- FirstHealth of the Carolinas-Moore Regional Hosiptal
- Rutherford Hospital
- Novant Health Forsyth Medical Center
- Southeast Clinical Oncology Research (SCOR) Consortium NCORP
- Mid Dakota Clinic
- Sanford Bismarck Medical Center
- Altru Cancer Center
- Altru Hospital
- Trinity Cancer Care Center
- Toledo Clinic Cancer Centers-Bowling Green
- Aultman Health Foundation
- Adena Regional Medical Center
- University of Cincinnati
- Case Western Reserve University
- MetroHealth Medical Center
- Cleveland Clinic Cancer Center/Fairview Hospital
- Cleveland Clinic Foundation
- Ohio State University Comprehensive Cancer Center
- Riverside Methodist Hospital
- Columbus NCI Community Oncology Research Program
- Grant Medical Center
- Mount Carmel Health Center West
- Doctors Hospital
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Samaritan North Health Center
- Dayton NCI Community Oncology Research Program
- Grady Memorial Hospital
- Atrium Medical Center-Middletown Regional Hospital
- Kettering Medical Center
- Fairfield Medical Center
- Lima Memorial Hospital
- Marietta Memorial Hospital
- Toledo Clinic Cancer Centers-Maumee
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
- Licking Memorial Hospital
- Saint Charles Hospital
- Toledo Clinic Cancer Centers-Oregon
- North Coast Cancer Care
- Springfield Regional Medical Center
- Flower Hospital
- The Toledo Hospital/Toledo Children's Hospital
- Saint Vincent Mercy Medical Center
- University of Toledo
- Toledo Community Hospital Oncology Program CCOP
- Mercy Saint Anne Hospital
- Toledo Clinic Cancer Centers-Toledo
- Upper Valley Medical Center
- Fulton County Health Center
- Saint Ann's Hospital
- Cleveland Clinic Wooster Family Health and Surgery Center
- Greene Memorial Hospital
- Tod Children's Hospital - Forum Health
- Genesis Healthcare System Cancer Care Center
- University of Oklahoma Health Sciences Center
- Bend Memorial Clinic
- Saint Charles Medical Center-Bend
- Legacy Mount Hood Medical Center
- Providence Milwaukie Hospital
- Legacy Good Samaritan Hospital and Medical Center
- Providence Portland Medical Center
- Western Oncology Research Consortium
- Providence Saint Vincent Medical Center
- Kaiser Permanente
- Legacy Emanuel Hospital and Health Center
- Legacy Meridian Park Hospital
- Abington Memorial Hospital
- Lehigh Valley Hospital-Cedar Crest
- Saint Luke's University Hospital-Bethlehem Campus
- Geisinger Medical Center
- Geisinger Medical Center-Cancer Center Hazleton
- Penn State Hershey Cancer Institute-Clinical Trials Office
- Lancaster General Hospital
- Saint Mary Medical and Regional Cancer Center
- Lewistown Hospital
- University of Pennsylvania/Abramson Cancer Center
- Thomas Jefferson University Hospital
- Fox Chase Cancer Center
- Aria Health-Torresdale Campus
- Chestnut Hill Health System
- Allegheny General Hospital
- University of Pittsburgh Cancer Institute (UPCI)
- Guthrie Medical Group PC-Robert Packer Hospital
- Scranton Hematology Oncology
- Grand View Hospital
- Geisinger Medical Group
- Mount Nittany Medical Center
- Chester County Hospital
- Geisinger Wyoming Valley/Henry Cancer Center
- WellSpan Health-York Hospital
- Rhode Island Hospital
- Women and Infants Hospital
- Miriam Hospital
- AnMed Health Hospital
- Spartanburg Medical Center
- Sanford Cancer Center-Oncology Clinic
- Avera Cancer Institute
- Avera McKennan Hospital and University Health Center
- Medical X-Ray Center
- Sanford USD Medical Center - Sioux Falls
- Erlanger Medical Center
- Memorial Hospital
- Jones Clinic
- Thompson Cancer Survival Center
- Nashville Oncology Associates PC
- Meharry Medical College
- Medical City Dallas Hospital
- Zale Lipshy University Hospital
- Clements University Hospital
- UT Southwestern/Simmons Cancer Center-Dallas
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
- M D Anderson Cancer Center
- Doctor's Hospital of Laredo
- Covenant Medical Center-Lakeside
- Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
- University of Texas Health Science Center at San Antonio
- Scott and White Memorial Hospital
- Southwestern Vermont Medical Center
- Central Vermont Medical Center/National Life Cancer Treatment
- University of Vermont College of Medicine
- Kaiser Permanente - Fair Oaks Medical Center
- Fredericksburg Oncology Inc
- Virginia Commonwealth University/Massey Cancer Center
- MultiCare Auburn Medical Center
- PeaceHealth Saint Joseph Medical Center
- Providence Regional Cancer System-Centralia
- Saint Francis Hospital
- Saint Clare Hospital
- Providence - Saint Peter Hospital
- MultiCare Good Samaritan Hospital
- Group Health Cooperative of Puget Sound Oncology Consortium
- Group Health Cooperative-Seattle
- Swedish Medical Center-First Hill
- University of Washington Medical Center
- Cancer Care Northwest - Spokane South
- MultiCare Allenmore Hospital
- Northwest NCI Community Oncology Research Program
- Saint Joseph Medical Center
- Multicare Health System
- PeaceHealth Southwest Medical Center
- Edwards Comprehensive Cancer Center
- Langlade Hospital and Cancer Center
- Sacred Heart Hospital
- Midelfort Clinic-Clairemont Campus
- Aurora Cancer Care-Southern Lakes
- Green Bay Oncology at Saint Vincent Hospital
- Saint Vincent Hospital
- Green Bay Oncology Limited at Saint Mary's Hospital
- Saint Mary's Hospital
- Aurora BayCare Medical Center
- Gundersen Lutheran Medical Center
- UW Health Oncology-One South Park
- Dean Hematology and Oncology Clinic
- University of Wisconsin Hospital and Clinics
- Holy Family Memorial Hospital
- Bay Area Medical Center
- Vince Lombardi Cancer Clinic-Marinette
- Marshfield Clinic
- Medical Consultants Limited
- Marshfield Clinic-Minocqua Center
- Green Bay Oncology - Oconto Falls
- Green Bay Oncology - Sturgeon Bay
- Aspirus Regional Cancer Center
- Tom Baker Cancer Centre
- Cross Cancer Institute
- BCCA-Cancer Centre for the Southern Interior
- Penticton Regional Hospital
- BCCA-Fraser Valley Cancer Centre
- BCCA-Vancouver Cancer Centre
- CancerCare Manitoba
- Doctor H. Bliss Murphy Cancer Centre
- Juravinski Cancer Centre at Hamilton Health Sciences
- Cancer Centre of Southeastern Ontario at Kingston General Hospital
- London Regional Cancer Program
- Ottawa Hospital and Cancer Center-General Campus
- Health Sciences North
- Thunder Bay Regional Health Science Centre
- Odette Cancer Centre- Sunnybrook Health Sciences Centre
- CSSS Champlain-Charles Le Moyne
- CHUM-Hotel Dieu du Montreal
- Hopital Du Sacre-Coeur de Montreal
- Allan Blair Cancer Centre
- International Breast Cancer Study Group
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Tamoxifen
T+OFS
E+OFS
Tamoxifen 20mg orally daily for 5 years
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)
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)