Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring stage I breast cancer, stage II breast cancer, stage IIIA breast cancer
Eligibility Criteria
Eligibility Criteria
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (0 = fully active, able to carry on all pre-disease performance without restriction; 1 = restricted in physically strenuous activity but ambulatory).
- Patients must be postmenopausal at the time of randomization. (Note: Premenopausal or perimenopausal women requiring therapy with luteinizing hormone-releasing hormone [LHRH] analogs to suppress ovarian function are not eligible.) For study purposes, postmenopausal is defined as: age 56 or older with no spontaneous menses for at least 12 months prior to study entry, or age 55 or younger with no spontaneous menses for at least 12 months prior to study entry (e.g., spontaneous or secondary to hysterectomy) AND with a documented estradiol level in the postmenopausal range according to local institutional/laboratory standards, or a prior documented bilateral oophorectomy.
- The patient must have remained disease-free from the time of initial breast cancer diagnosis until the time of randomization.
- The patient must have had histologically-confirmed invasive carcinoma of the breast by diagnostic core needle biopsy or by final pathologic evaluation of the surgical specimen.
- Patients who received neoadjuvant chemotherapy must have been clinical Stage I, II, or IIIA. For patients who received adjuvant chemotherapy, the primary tumor must have been T1-3 on pathologic evaluation and ipsilateral nodes must have been pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN3a, or pN3b.
- The primary tumor must have been estrogen receptor (ER)-positive and/or progesterone receptor (PgR)-positive. (Patients who had a tumor that was considered to be borderline for hormone receptor positivity and who were treated with tamoxifen and/or an aromatases inhibitor (AI) are eligible for this study.)
- Patients must have undergone either a lumpectomy with axillary nodal staging followed by breast radiotherapy or a total mastectomy with axillary nodal staging. (Acceptable axillary nodal staging procedures include sentinel node biopsy alone, if sentinel nodes were negative on hematoxylin and eosin (H&E) staining.)
- The duration of the patient's hormonal therapy following breast cancer diagnosis must have been 57-63 months from the first dose regardless of the number of missed doses. Hormonal therapy must have consisted of an AI or a combination of up to 3 years of tamoxifen followed by an AI. Tamoxifen may not have been given during years 4 and 5 of the 5 years of adjuvant hormonal therapy. (Note: Patients must discontinue their adjuvant AI therapy at the time of randomization.)
- Optional Letrozole Registration Program for patients who have not yet completed 5 years of hormonal therapy. (Note: As of September 5, 2008, the optional NSABP B-42 Registration Program closed to patient enrollment. Accrual and data collection for the NSABP B-42 randomized treatment trial continues as planned.) In order to have a predominantly letrozole-treated population for B-42 study entry, patients who have had a minimum of 2 years of hormonal therapy and who are currently on tamoxifen (for up to 3 years) or an AI may be offered letrozole at no cost until they complete 5 total years of initial adjuvant hormonal therapy.
- B-42 randomization must be within 6 months following completion of 5 years (57-63 months) of initial adjuvant hormonal therapy.
At the time of randomization, the patient must have had the following: history and physical exam within 3 months demonstrating no findings suggestive of recurrent breast cancer; bilateral mammogram within 1 year (unilateral if patient had a mastectomy); mammogram not required if patient had a prophylactic contralateral mastectomy; bone mineral density (BMD) testing within 1 year; and fasting lipid profile (total cholesterol, LDL-C, HDL-C, and triglycerides) with a total cholesterol value less than or equal to grade 1 (according to CTCAE v3.0), with or without cholesterol-lowering therapy.
- within 1 year if the patient has a history of hypercholesterolemia controlled with cholesterol-lowering therapy and/or therapeutic lifestyle changes or if the patient has a history of one or more of the following risk factors for future cardiovascular events: diabetes, hypertension, obesity, tobacco use, hypertriglyceridemia, documented coronary artery disease, or family history of premature coronary heart disease.
- within 2 years for all other patients.
Ineligibility Criteria
- Patients with one or more of the following conditions will be ineligible for this study:
- History of non-traumatic osteoporotic fracture of wrist, hip, or spine.
- Diagnosis of bilateral breast cancer including ductal carcinoma in situ (DCIS)[(synchronous or metachronous].
- Other malignancies unless the patient is considered to be disease-free for 5 or more years prior to randomization, and is deemed by their physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, colon carcinoma in situ, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
- Sex hormonal therapy, e.g., estrogen- or progesterone-replacement therapy or oral contraceptives. These patients are eligible only if this therapy is discontinued prior to randomization.
- Therapy with any hormonal agent such as raloxifene for management of osteoporosis. Patients are eligible only if these medications are discontinued prior to study entry.
- Administration of any investigational agent within 30 days before study entry.
Sites / Locations
- Regional Medical Center
- Providence Cancer Center at Providence Hospital
- Providence Cancer Center
- Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Alta Bates Summit Comprehensive Cancer Center
- Providence Saint Joseph Medical Center - Burbank
- Peninsula Medical Center
- East Bay Radiation Oncology Center
- Eden Medical Center
- Valley Medical Oncology Consultants - Castro Valley
- Cancer Care Center at John Muir Health - Concord Campus
- City of Hope Comprehensive Cancer Center
- North Bay Cancer Center
- Kaiser Permanente - Fremont
- Valley Medical Oncology
- Cancer Care Associates
- Virginia K. Crosson Cancer Center at St. Jude Medical Center
- Glendale Memorial Hospital Comprehensive Cancer Center
- Marin Cancer Institute at Marin General Hospital
- Sutter Health - Western Division Cancer Research Group
- Kaiser Permanente Medical Center - Hayward
- Scripps Cancer Center - San Diego
- Rebecca and John Moores UCSD Cancer Center
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
- Breastlink Medical Group, Incorporated at Long Beach Memorial Medical Center
- Pacific Shores Medical Group - Long Beach
- USC/Norris Comprehensive Cancer Center and Hospital
- Jonsson Comprehensive Cancer Center at UCLA
- Contra Costa Regional Medical Center
- El Camino Hospital Cancer Center
- Highland General Hospital
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Breast Surgeons, Incorporated
- CCOP - Bay Area Tumor Institute
- Larry G Strieff MD Medical Corporation
- Tom K Lee, Incorporated
- Kaiser Permanente Medical Center - Oakland
- Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
- St. Joseph Hospital Regional Cancer Center - Orange
- Desert Regional Medical Center Comprehensive Cancer Center
- Valley Care Medical Center
- Valley Medical Oncology Consultants - Pleasanton
- Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
- Lucy Curci Cancer Center at Eisenhower Memorial Hospital and Medical Center
- North Valley Breast Clinic
- Kaiser Permanente Medical Center - Redwood City
- Kaiser Permanente Medical Center - Richmond
- Kaiser Permanente Medical Center - Roseville
- Sutter Cancer Center at Roseville Medical Center
- Sutter Cancer Center
- South Sacramento Kaiser-Permanente Medical Center
- Kaiser Permanente Medical Center - Sacramento
- Salinas Valley Memorial Hospital
- Kaiser Permanente Medical Office -Vandever Medical Office
- San Francisco General Hospital Medical Center
- Kaiser Permanente Medical Center - San Francisco Geary Campus
- California Pacific Medical Center - California Campus
- Kaiser Permanente Medical Center - Santa Teresa
- Doctors Medical Center - San Pablo Campus
- Kaiser Foundation Hospital - San Rafael
- Kaiser Permanente Medical Center - Santa Clara Kiely Campus
- Kaiser Permanente Medical Center - Santa Rosa
- Kaiser Permanente Medical Center - South San Francisco
- Stanford Cancer Center
- Kaiser Permanente Medical Facility - Stockton
- Kaiser Permanente Medical Center - Vallejo
- Sutter Solano Medical Center
- Kaiser Permanente Medical Center - Walnut Creek
- John Muir/Mt. Diablo Comprehensive Cancer Center
- Aurora Presbyterian Hospital
- University of Colorado Cancer Center at UC Health Sciences Center
- Boulder Community Hospital
- Memorial Hospital Cancer Center - Colorado Springs
- Penrose Cancer Center at Penrose Hospital
- Denver Health Medical Center
- St. Anthony Central Hospital
- Porter Adventist Hospital
- Presbyterian - St. Luke's Medical Center
- St. Joseph Hospital
- Rose Medical Center
- Veterans Affairs Medical Center - Denver
- CCOP - Colorado Cancer Research Program
- Shaw Regional Cancer Center
- Swedish Medical Center
- Poudre Valley Hospital
- Front Range Cancer Specialists
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
- North Colorado Medical Center
- Sky Ridge Medical Center
- Hope Cancer Care Center at Longmont United Hospital
- McKee Medical Center
- St. Mary - Corwin Regional Medical Center
- North Suburban Medical Center
- Exempla Lutheran Medical Center
- Bridgeport Hospital
- Bristol Hospital
- Praxair Cancer Center at Danbury Hospital
- Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
- Helen and Harry Gray Cancer Center at Hartford Hospital
- Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
- Middlesex Hospital Cancer Center
- Norwalk Hospital
- Eastern Connecticut Hematology and Oncology Associates
- Carl and Dorothy Bennett Cancer Center at Stamford Hospital
- Connecticut Oncology & Hematology - Torrington
- Harold Leever Regional Cancer Center
- Tunnell Cancer Center at Beebe Medical Center
- CCOP - Christiana Care Health Services
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
- Washington Cancer Institute at Washington Hospital Center
- Sibley Memorial Hospital
- Walter Reed Army Medical Center
- Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - West
- Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus
- Morton Plant Hospital
- Herbert D. Kerman Regional Oncology Center - Daytona Beach
- North Broward Medical Center
- Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
- University of Florida Shands Cancer Center
- Memorial Cancer Institute at Memorial Regional Hospital
- Baptist Cancer Institute - Jacksonville
- Center for Cancer Care and Research at Watson Clinic, LLP
- CCOP - Mount Sinai Medical Center
- Integrated Community Oncology Network - Orange Park
- M.D. Anderson Cancer Center at Orlando
- Florida Cancer Specialists - Sarasota Downtown
- Cleveland Clinic Florida - Weston
- Phoebe Cancer Center at Phoebe Putney Memorial Hospital
- Northeast Georgia Cancer Care, LLC - Medical Oncology
- Georgia Cancer Center for Excellence at Grady Memorial Hospital
- Emory Crawford Long Hospital
- Piedmont Hospital
- Winship Cancer Institute of Emory University
- Northside Hospital Cancer Center
- Saint Joseph's Hospital of Atlanta
- CCOP - Atlanta Regional
- Augusta Oncology Associates - Walton Way
- MBCCOP - Medical College of Georgia Cancer Center
- WellStar Cobb Hospital
- John B. Amos Cancer Center
- Charles B. Eberhart Cancer Center at DeKalb Medical Center
- Northeast Georgia Medical Center
- Gwinnett Medical Center
- Kennestone Cancer Center at Wellstar Kennestone Hospital
- Harbin Clinic Cancer Center - Medical Oncology
- Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
- Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
- Kapiolani Medical Center at Pali Momi
- Cancer Research Center of Hawaii
- OnCare Hawaii, Incorporated - Lusitana
- Queen's Cancer Institute at Queen's Medical Center
- Straub Clinic and Hospital, Incorporated
- Hawaii Medical Center - East
- OnCare Hawaii, Incorporated - Kuakini
- Kapiolani Medical Center for Women and Children
- Maui Memorial Medical Center
- Pacific Cancer Institute - Maui
- Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
- Mountain States Tumor Institute at St. Luke's Regional Medical Center
- Kootenai Cancer Center - Coeur d'Alene
- Saint Anthony's Hospital at Saint Anthony's Health Center
- St. Joseph Medical Center
- Graham Hospital
- Rush University Medical Center
- Resurrection Medical Center
- University of Chicago Cancer Research Center
- Louis A. Weiss Memorial Hospital
- Creticos Cancer Center at Advocate Illinois Masonic Medical Center
- Decatur Memorial Hospital Cancer Care Institute
- Sherman Hospital
- Alexian Brothers Radiation Oncology
- Elmhurst Memorial Hospital
- Eureka Community Hospital
- Evanston Hospital
- Galesburg Clinic, PC
- Galesburg Cottage Hospital
- Mason District Hospital
- Hinsdale Hematology Oncology Associates
- Provena St. Mary's Regional Cancer Center - Kankakee
- La Grange Memorial Hospital
- McDonough District Hospital
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
- OSF Holy Family Medical Center
- Good Samaritan Regional Health Center
- Edward Hospital Cancer Center
- Hematology Oncology Consultants - Naperville
- BroMenn Regional Medical Center
- Community Cancer Center
- Advocate Christ Medical Center
- Community Hospital of Ottawa
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
- Advocate Lutheran General Cancer Care Center
- Cancer Treatment Center at Pekin Hospital
- Proctor Hospital
- CCOP - Illinois Oncology Research Association
- Oncology Hematology Associates of Central Illinois, PC - Peoria
- Methodist Medical Center of Illinois
- OSF St. Francis Medical Center
- Illinois Valley Community Hospital
- Perry Memorial Hospital
- Swedish-American Regional Cancer Center
- Center for Cancer Care at OSF Saint Anthony Medical Center
- St. Margaret's Hospital
- Regional Cancer Center at Memorial Medical Center
- Central Dupage Cancer Center
- St. Francis Hospital and Health Centers - Beech Grove Campus
- Elkhart General Hospital
- Center for Cancer Care at Goshen General Hospital
- Community Regional Cancer Care at Community Hospital East
- Community Regional Cancer Care at Community Hospital North
- St. Vincent Indianapolis Hospital
- Howard Community Hospital
- Center for Cancer Therapy at LaPorte Hospital and Health Services
- Horizon Oncology Center
- Community Hospital
- Reid Hospital & Health Care Services
- CCOP - Northern Indiana CR Consortium
- Memorial Hospital of South Bend
- Saint Joseph Regional Medical Center
- South Bend Clinic
- McFarland Clinic, PC
- Hematology Oncology Associates of the Quad Cities
- Iowa Blood and Cancer Care
- St. Luke's Hospital
- Cedar Rapids Oncology Associates
- Mercy Regional Cancer Center at Mercy Medical Center
- Heartland Oncology and Hematology
- Genesis Regional Cancer Center at Genesis Medical Center
- Genesis Medical Center - West Campus
- Mercy Capitol Hospital
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- John Stoddard Cancer Center at Iowa Lutheran Hospital
- Holden Comprehensive Cancer Center at University of Iowa
- McCreery Cancer Center at Ottumwa Regional
- Siouxland Hematology-Oncology Associates, LLP
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Cedar Valley Medical Specialists, PC - West Ridgeway Avenue
- Covenant Cancer Treatment Center
- Hospital District Sixth of Harper County
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Cancer Center of Kansas - Fort Scott
- Cancer Center of Kansas-Independence
- Cancer Center of Kansas, PA - Kingman
- Lawrence Memorial Hospital
- Southwest Medical Center
- Cancer Center of Kansas, PA - Newton
- Cancer Center of Kansas, PA - Parsons
- Mount Carmel Regional Cancer Center
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Cotton-O'Neil Cancer Center
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, PA - Winfield
- Cancer Resource Center at King's Daughters Medical Center
- Cancer Care at Our Lady of Bellefonte Hospital
- Central Baptist Hospital
- Lucille P. Markey Cancer Center at University of Kentucky
- Louisville Oncology at Norton Cancer Institute - Louisville
- Consultants in Blood Disorders and Cancer
- Drs. Carrol, Sheth, Raghavan
- Pennington Cancer Center at Baton Rouge General
- Mary Bird Perkins Cancer Center - Baton Rouge
- Ochsner Health Center - Bluebonnet
- Terrebonne General Medical Center
- Drs Gurtler Brinz and Russo APMC-Metairie Oncologists
- MBCCOP - LSU Health Sciences Center
- Medical Center of Louisiana - New Orleans
- CCOP - Ochsner
- Ochsner Cancer Institute at Ochsner Clinic Foundation
- Christus Schumpert Cancer Treatment Center
- CancerCare of Maine at Eastern Maine Medical Center
- Central Maine Comprehensive Cancer Center at Central Maine Medical Center
- Mercy Hospital
- York Hospital's Oncology Treatment Center
- Mercy Medical Center
- Greater Baltimore Medical Center Cancer Center
- St. Agnes Hospital Cancer Center
- Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
- Suburban Hospital
- Shore Regional Cancer Center at Memorial Hospital - Easton
- Union Hospital Cancer Program at Union Hospital
- Frederick Memorial Hospital Regional Cancer Therapy Center
- St. Mary's Hospital
- Peninsula Regional Medical Center
- Sturdy Memorial Hospital
- Tufts-NEMC Cancer Center
- Boston University Cancer Research Center
- Lahey Clinic Medical Center - Burlington
- Commonwealth Hematology-Oncology, PC - Concord
- Commonwealth Hematology Oncology PC - Dorchester
- Hudner Oncology Center at Saint Anne's Hospital - Fall River
- Simonds-Sinon Regional Cancer Center at HealthAlliance Hospital - Burbank Campus
- Addison Gilbert Hospital
- Commonwealth Hematology-Oncology, PC - Lawrence
- Commonwealth Hematology Oncology PC - Leominster
- Caritas Holy Family Hospital
- NSMC Cancer Center - Peabody
- Berkshire Hematology Oncology, PC
- Jordan Hospital Club Cancer Center
- Commonwealth Hematology-Oncology, PC - Quincy
- Baystate Regional Cancer Program at D'Amour Center for Cancer Care
- Commonwealth Hematology-Oncology, PC - Stoneham
- Commonwealth Hematology-Oncology, PC - Weymouth
- Commonwealth Hematology-Oncology, PC - Worcester
- UMASS Memorial Cancer Center - University Campus
- Hickman Cancer Center at Bixby Medical Center
- Saint Joseph Mercy Cancer Center
- CCOP - Michigan Cancer Research Consortium
- Battle Creek Health System Cancer Care Center
- Bay Regional Medical Center
- Mecosta County Medical Center
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Barbara Ann Karmanos Cancer Institute
- Josephine Ford Cancer Center at Henry Ford Hospital
- Green Bay Oncology, Limited - Escanaba
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Great Lakes Cancer Institute at McLaren Regional Medical Center
- Butterworth Hospital at Spectrum Health
- CCOP - Grand Rapids
- Lacks Cancer Center at Saint Mary's Health Care
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Dickinson County Healthcare System
- Foote Memorial Hospital
- Borgess Medical Center
- West Michigan Cancer Center
- Bronson Methodist Hospital
- Haematology-Oncology Associates of Ohio and Michigan, PC
- Breslin Cancer Center at Ingham Regional Medical Center
- Sparrow Regional Cancer Center
- Lapeer Regional Hospital
- St. Mary Mercy Hospital
- Upper Michigan Cancer Center at Marquette General Hospital
- MidMichigan Medical Center - Midland
- Community Cancer Center of Monroe
- Mercy Memorial Hospital - Monroe
- Clemens Regional Medical Center
- Mercy General Health Partners
- St. Joseph Mercy Oakland
- Mercy Regional Cancer Center at Mercy Hospital
- William Beaumont Hospital - Royal Oak Campus
- Seton Cancer Institute at Saint Mary's - Saginaw
- Lakeland Regional Cancer Care Center - St. Joseph
- Providence Cancer Institute at Providence Hospital - Southfield Campus
- Munson Medical Center
- St. John Macomb Hospital
- Metro Health Hospital
- MeritCare Bemidji
- Fairview Ridges Hospital
- Mercy and Unity Cancer Center at Mercy Hospital
- Duluth Clinic Cancer Center - Duluth
- CCOP - Duluth
- Miller - Dwan Medical Center
- St. Luke's Hospital Cancer Care Center
- Fairview Southdale Hospital
- Mercy and Unity Cancer Center at Unity Hospital
- Hutchinson Area Health Care
- Immanuel St. Joseph's
- HealthEast Cancer Care at St. John's Hospital
- Minnesota Oncology Hematology, PA - Maplewood
- Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
- Hennepin County Medical Center - Minneapolis
- Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
- CCOP - Metro-Minnesota
- Park Nicollet Cancer Center
- Regions Hospital Cancer Care Center
- United Hospital
- St. Francis Cancer Center at St. Francis Medical Center
- Ridgeview Medical Center
- Minnesota Oncology Hematology, PA - Woodbury
- Hattiesburg Clinic, PA at Forrest General
- Keesler Air Force Base Medical Center
- Regional Cancer Center at Singing River Hospital
- Saint Francis Medical Center
- Saint Luke's Hospital
- Ellis Fischel Cancer Center at University of Missouri - Columbia
- Freeman Cancer Institute at Freeman Health System
- St. John's Regional Medical Center
- Midwest Hematology Oncology Group, Incorporated
- Saint Louis University Cancer Center
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
- St. Anthony's Cancer Center
- Missouri Baptist Cancer Center
- Arch Medical Services, Incorporated at Center for Cancer Care and Research
- CCOP - St. Louis-Cape Girardeau
- David C. Pratt Cancer Center at St. John's Mercy
- CCOP - Cancer Research for the Ozarks
- St. John's Regional Health Center
- Hulston Cancer Center at Cox Medical Center South
- CCOP - Montana Cancer Consortium
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Northern Rockies Radiation Oncology Center
- St. Vincent Healthcare Cancer Care Services
- Billings Clinic - Downtown
- Bozeman Deaconess Cancer Center
- St. James Healthcare Cancer Care
- Big Sky Oncology
- Sletten Cancer Institute at Benefis Healthcare
- Northern Montana Hospital
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology at KRMC
- Kalispell Regional Medical Center
- Community Medical Center
- Guardian Oncology and Center for Wellness
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
- Good Samaritan Cancer Center at Good Samaritan Hospital
- Cancer Resource Center - Lincoln
- Callahan Cancer Center at Great Plains Regional Medical Center
- CCOP - Missouri Valley Cancer Consortium
- Methodist Estabrook Cancer Center
- Immanuel Medical Center
- Alegant Health Cancer Center at Bergan Mercy Medical Center
- Creighton University Medical Center
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
- University Medical Center of Southern Nevada
- CCOP - Nevada Cancer Research Foundation
- New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
- Seacoast Cancer Center at Wentworth - Douglass Hospital
- Center for Cancer Care at Exeter Hospital
- New Hampshire Oncology - Hematology, PA - Hooksett
- Lakes Region General Hospital
- Portsmouth Regional Hospital
- Ocean Medical Center at Meridian Health
- Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center
- Hunterdon Regional Cancer Center at Hunterdon Medical Center
- CentraState Medical Center
- Cancer Institute of New Jersey at Hamilton
- St. Barnabas Medical Center Cancer Center
- Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
- Saint Peter's University Hospital
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
- Newark Beth Israel Medical Center
- AtlantiCare Cancer Care Institute at AtlantiCare Regional Medical Center - Mainland Campus
- University Medical Center at Princeton
- Booker Cancer Center at Riverview Medical Center
- Valley Hospital - Ridgewood
- Somerset Medical Center
- Frederick R. and Betty M. Smith Cancer Treatment Center
- Capital Health Regional Cancer Center
- St. Francis Regional Cancer Center
- Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
- Cancer Institute of New Jersey at Cooper - Voorhees
- Fox Chase Virtua Health Cancer Program at Virtua West Jersey
- Lovelace Medical Center - Downtown
- Hematology Oncology Associates, PC
- New Mexico Cancer Center
- University of New Mexico Cancer Center
- New York Oncology Hematology, PC at Albany Regional Cancer Care
- New York Oncology Hematology, PC at Albany Medical Center
- Amsterdam Community Cancer Program
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
- Coney Island Hospital
- Roswell Park Cancer Institute
- CCOP - Hematology-Oncology Associates of Central New York
- Adirondack Cancer Care - Glens Falls
- Charles R. Wood Cancer Center at Glens Falls Hospital
- New York Oncology Hematology, PC - Hudson
- Monter Cancer Center of the North Shore-LIJ Health System
- New York Oncology Hematology, PC - Latham
- CCOP - North Shore University Hospital
- Don Monti Comprehensive Cancer Center at North Shore University Hospital
- Northern Westchester Hospital
- Long Island Jewish Medical Center
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
- Dyson Center for Cancer Care at Vassar Brothers Medical Center
- Cancer Center of Poughkeepsie
- Hudson Valley Oncology Associates
- Saint Francis Hospital Cancer Center
- Riverview Cancer Care Medical Associates, PC
- Lipson Cancer and Blood Center at Rochester General Hospital
- Interlakes Oncology/Hematology PC
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- Nalitt Cancer Institute at Staten Island University Hospital
- Stony Brook University Cancer Center
- SUNY Upstate Medical University Hospital
- Samaritan Hospital at Northeast Health
- Dickstein Cancer Treatment Center at White Plains Hospital Center
- Randolph Hospital
- Hope A Women's Cancer Center
- Mission Hospitals - Memorial Campus
- Alamance Cancer Center at Alamance Regional Medical Center
- Waverly Hematology Oncology
- Blumenthal Cancer Center at Carolinas Medical Center
- Presbyterian Cancer Center at Presbyterian Hospital
- Batte Cancer Center at Northeast Medical Center
- CaroMont Cancer Center at Gaston Memorial Hospital
- Wayne Memorial Hospital, Incorporated
- Moses Cone Regional Cancer Center at Wesley Long Community Hospital
- Leo W. Jenkins Cancer Center at ECU Medical School
- Pardee Memorial Hospital
- High Point Regional Hospital
- Kinston Medical Specialists
- Annie Penn Cancer Center
- Rutherford Hospital
- Iredell Memorial Hospital
- Marion L. Shepard Cancer Center at Beaufort County Hospital
- Forsyth Regional Cancer Center at Forsyth Medical Center
- Wake Forest University Comprehensive Cancer Center
- Bismarck Cancer Center
- Medcenter One Hospital Cancer Care Center
- Mid Dakota Clinic, PC
- St. Alexius Medical Center Cancer Center
- Dakota Cancer Institute at Dakota Clinic - South University
- CCOP - MeritCare Hospital
- MeritCare Broadway
- Altru Cancer Center at Altru Hospital
- McDowell Cancer Center at Akron General Medical Center
- Summa Center for Cancer Care at Akron City Hospital
- Barberton Citizens Hospital
- Cleveland Clinic Beachwood Family Health and Surgery Center
- Mary Rutan Hospital
- Wood County Oncology Center
- Mercy Cancer Center at Mercy Medical Center
- Aultman Cancer Center at Aultman Hospital
- Adena Regional Medical Center
- Christ Hospital Cancer Center
- Oncology Hematology Care, Incorporated - Blue Ash
- Case Comprehensive Cancer Center
- MetroHealth Cancer Care Center at MetroHealth Medical Center
- Cleveland Clinic Cancer Center at Fairview Hospital
- Cleveland Clinic Taussig Cancer Center
- North Coast Cancer Care - Clyde
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
- Riverside Methodist Hospital Cancer Care
- CCOP - Columbus
- Grant Medical Center Cancer Care
- Mount Carmel Health - West Hospital
- Doctors Hospital at Ohio Health
- Grandview Hospital
- Good Samaritan Hospital
- David L. Rike Cancer Center at Miami Valley Hospital
- Samaritan North Cancer Care Center
- CCOP - Dayton
- Grady Memorial Hospital
- Hematology Oncology Center
- Blanchard Valley Medical Associates
- Middletown Regional Hospital
- Wayne Hospital
- Cleveland Clinic Cancer Center
- Charles F. Kettering Memorial Hospital
- Fairfield Medical Center
- St. Rita's Medical Center
- Lima Memorial Hospital
- MedCentral - Mansfield Hospital
- Strecker Cancer Center at Marietta Memorial Hospital
- Northwest Ohio Oncology Center
- St. Luke's Hospital
- Hillcrest Cancer Center at Hillcrest Hospital
- Licking Memorial Cancer Care Program at Licking Memorial Hospital
- St. Charles Mercy Hospital
- Toledo Clinic - Oregon
- Cancer Care Center, Incorporated
- North Coast Cancer Care, Incorporated
- Mercy Medical Center
- Community Hospital of Springfield and Clark County
- Flower Hospital Cancer Center
- Mercy Hospital of Tiffin
- Toledo Hospital
- St. Vincent Mercy Medical Center
- Medical University of Ohio Cancer Center
- CCOP - Toledo Community Hospital
- St. Anne Mercy Hospital
- Toledo Clinic, Incorporated - Main Clinic
- UVMC Cancer Care Center at Upper Valley Medical Center
- Fulton County Health Center
- Mount Carmel St. Ann's Cancer Center
- Clinton Memorial Hospital
- Cancer Treatment Center
- Cleveland Clinic - Wooster
- United States Air Force Medical Center - Wright-Patterson
- Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Genesis - Good Samaritan Hospital
- Cleo Craig Cancer Research Clinic
- Natalie Warren Bryant Cancer Center at St. Francis Hospital
- St. Charles Medical Center - Bend
- Bay Area Hospital
- Three Rivers Community Hospital
- Legacy Mount Hood Medical Center
- Dubs Cancer Center at Rogue Valley Medical Center
- Providence Cancer Center at PMCC
- Providence Milwaukie Hospital
- Legacy Good Samaritan Hospital & Comprehensive Cancer Center
- Providence Cancer Center at Providence Portland Medical Center
- CCOP - Columbia River Oncology Program
- Providence St. Vincent Medical Center
- Legacy Emanuel Hospital and Health Center and Children's Hospital
- Northwest Cancer Specialists at Rose Quarter Cancer Center
- Kaiser Permanente Health Care - Portland
- Knight Cancer Institute at Oregon Health and Science University
- Salem Hospital Regional Cancer Care Services
- Legacy Meridian Park Hospital
- Sacred Heart Hospital
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
- St. Luke's Cancer Network at St. Luke's Hospital
- Bryn Mawr Hospital
- Geisinger Cancer Institute at Geisinger Health
- Mercy Fitzgerald Hospital
- Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center
- Dale and Frances Hughes Cancer Center at Pocono Medical Center
- Geisinger Hazleton Cancer Center
- Penn State Cancer Institute at Milton S. Hershey Medical Center
- Lancaster General Hospital
- St. Mary Regional Cancer Center
- Charles A. & Betty Bott Cancer Center at Holy Redeemer Hospital
- Riddle Memorial Hospital Cancer Center
- Cancer Center of Paoli Memorial Hospital
- Abramson Cancer Center of the University of Pennsylvania
- Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
- Frankford Hospital Cancer Center - Torresdale Campus
- Albert Einstein Cancer Center
- Cancer Center at Phoenixville Hospital
- Allegheny Cancer Center at Allegheny General Hospital
- Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
- UPMC Cancer Centers
- St. Joseph Medical Center
- McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
- Mercy Hospital Cancer Center - Scranton
- Hematology and Oncology Associates of Northeastern Pennsylvania
- Geisinger Medical Group - Scenery Park
- Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center
- Chester County Hospital
- Jennersville Regional Hospital
- Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
- CCOP - Main Line Health
- Lankenau Cancer Center at Lankenau Hospital
- York Cancer Center at Apple Hill Medical Center
- Rhode Island Hospital Comprehensive Cancer Center
- Women and Infants Hospital of Rhode Island
- Miriam Hospital
- AnMed Cancer Center
- Roper St. Francis Cancer Center at Roper Hospital
- Hollings Cancer Center at Medical University of South Carolina
- McLeod Regional Medical Center
- Georgetown Memorial Hospital
- CCOP - Greenville
- Carolina Blood and Cancer Care Associates, PA
- Carolina Blood and Cancer Care
- CCOP - Upstate Carolina
- Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
- Lexington Medical Center
- Rapid City Regional Hospital
- Avera Cancer Institute
- Medical X-Ray Center, PC
- Sanford Cancer Center at Sanford USD Medical Center
- Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
- Thompson Cancer Survival Center
- U.T. Medical Center Cancer Institute
- University of Tennessee Cancer Institute - Memphis
- Southwest Regional Cancer Center - Central
- Texas Oncology, PA at Texas Oncology Cancer Center - Central
- Texas Oncology, PA - Austin Northwest
- Texas Oncology, PA - Austin North
- St. Joseph Regional Cancer Center
- Texas Oncology, PA - Cedar Park
- Medical City Dallas Hospital
- Presbyterian Hospital of Dallas
- M. D. Anderson Cancer Center at University of Texas
- Baylor University Medical Center - Houston
- Joe Arrington Cancer Research and Treatment Center
- UMC Southwest Cancer and Research Center
- Texas Oncology, PA - Seton Williamson
- Texas Oncology, PA at Texas Cancer Center Round Rock
- University of Texas Health Science Center at San Antonio
- Texas Oncology, PA - San Marcos
- American Fork Hospital
- Sandra L. Maxwell Cancer Center
- Logan Regional Hospital
- Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
- Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
- Utah Valley Regional Medical Center - Provo
- Dixie Regional Medical Center - East Campus
- LDS Hospital
- Utah Cancer Specialists at UCS Cancer Center
- Mountainview Medical
- Fletcher Allen Health Care - University Health Center Campus
- Fredericksburg Oncology, Incorporated
- Lynchburg Hematology-Oncology Clinic
- Southwest Virginia Regional Cancer Center at Wellmonth Health
- Virginia Commonwealth University Massey Cancer Center
- Carilion Cancer Center of Western Virginia
- Auburn Regional Center for Cancer Care
- Overlake Cancer Center at Overlake Hospital Medical Center
- St. Joseph Cancer Center
- Olympic Hematology and Oncology
- Providence Centralia Hospital
- St. Francis Hospital
- Cascade Cancer Center at Evergreen Hospital Medical Center
- Providence St. Peter Hospital Regional Cancer Center
- Good Samaritan Cancer Center
- Valley Medical Center
- CCOP - Virginia Mason Research Center
- Fred Hutchinson Cancer Research Center
- Group Health Central Hospital
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- Rockwood Clinic Cancer Treatment Center
- Cancer Care Northwest - North
- Franciscan Cancer Center at St. Joseph Medical Center
- Allenmore Hospital
- CCOP - Northwest
- MultiCare Regional Cancer Center at Tacoma General Hospital
- Madigan Army Medical Center - Tacoma
- St. Clare Hospital
- Southwest Washington Medical Center Cancer Center
- St. Mary Regional Cancer Center at St. Mary Medical Center
- Wenatchee Valley Medical Center
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- Washington Hematology-Oncology Specialists
- West Virginia University Health Sciences Center - Charleston
- United Hospital Center
- Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
- St. Mary's Regional Cancer Center at St. Mary's Medical Center
- Mary Babb Randolph Cancer Center at West Virginia University Hospitals
- Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
- Schiffler Cancer Center at Wheeling Hospital
- Marshfield Clinic - Chippewa Center
- Marshfield Clinic Cancer Care at Regional Cancer Center
- Luther Midlelfort Hospital
- Midelfort Clinic - Luther
- Vince Lombardi Cancer Center at Aurora Lakeland Medical Center - Elkhorn
- Oncology Alliance, SC - Milwaukee - East
- Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
- Green Bay Oncology, Limited at St. Mary's Hospital
- St. Mary's Hospital Medical Center - Green Bay
- St. Vincent Hospital Regional Cancer Center
- Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
- Mercy Regional Cancer Center
- Gundersen Lutheran Center for Cancer and Blood
- Dean Medical Center - Madison
- Holy Family Memorial Medical Center Cancer Care Center
- Bay Area Cancer Care Center at Bay Area Medical Center
- Vince Lombardi Cancer Clinic - Marinette
- Marshfield Clinic - Marshfield Center
- Saint Joseph's Hospital
- Columbia Saint Mary's Hospital - Ozaukee
- Aurora Sinai Medical Center
- Columbia-Saint Mary's Cancer Care Center
- Medical Consultants, Limited
- Medical College of Wisconsin Cancer Center
- Marshfield Clinic - Lakeland Center
- Regional Cancer Center at Oconomowoc Memorial Hospital
- Green Bay Oncology, Limited - Oconto Falls
- Vince Lombardi Cancer Clinic - Oshkosh
- All Saints Cancer Center at Wheaton Franciscan Healthcare
- Ministry Medical Group at Saint Mary's Hospital
- Marshfield Clinic - Indianhead Center
- Vince Lombardi Cancer Clinic - Sheboygan
- Saint Michael's Hospital Cancer Center
- Green Bay Oncology, Limited - Sturgeon Bay
- Vince Lombardi Cancer Clinic - Two Rivers
- Waukesha Memorial Hospital Regional Cancer Center
- Marshfield Clinic - Wausau Center
- University of Wisconcin Cancer Center at Aspirus Wausau Hospital
- Aurora Women's Pavilion of West Allis Memorial Hospital
- Diagnostic and Treatment Center
- Marshfield Clinic - Weston Center
- Marshfield Clinic - Wisconsin Rapids Center
- Riverview UW Cancer Center at Riverview Hospital
- Welch Cancer Center at Sheridan Memorial Hospital
- British Columbia Cancer Agency - Centre for the Southern Interior
- BCCA - Fraser Valley Cancer Centre
- British Columbia Cancer Agency - Vancouver Cancer Centre
- British Columbia Cancer Agency - Vancouver Island Centre
- CancerCare Manitoba
- Cancer Centre of Southeastern Ontario at Kingston General Hospital
- Carlo Fidani Peel Regional Cancer Centre at Credit Valley Hospital
- Northeastern Ontario Regional Cancer Centre
- Cancer Care Program at Thunder Bay Regional Health Sciences
- Mount Sinai Hospital - Toronto
- Princess Margaret Hospital
- Hopital Notre-Dame du CHUM
- CHUM - Hotel Dieu Hospital
- CHUM - Hopital Saint-Luc
- Royal Victoria Hospital - Montreal
- Jewish General Hospital - Montreal
- St. Mary's Hospital Center
- Hopital du Saint-Sacrement - Quebec
- Cork University Hospital
- South Infirmary Victoria Hospital
- Beaumont Hospital
- Adelaide and Meath Hospital, Dublin Incorporating the National Children's Hospital
- St. Vincent's University Hospital
- Mater Misericordiae University Hospital
- St. James's Hospital
- University College Hospital
- Mid-Western Cancer Centre at Mid-Western Regional Hospital
- Sligo General Hospital
- Waterford Regional Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Group 2 Letrozole
Group 1 Placebo
Patients receive oral letrozole once daily for up to 5 years.
Patients receive oral placebo once daily for up to 5 years.