Fulvestrant and/or Anastrozole in Treating Postmenopausal Patients With Stage II-III Breast Cancer Undergoing Surgery
Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Invasive Ductal Breast Carcinoma

About this trial
This is an interventional treatment trial for Estrogen Receptor-positive Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Female ≥18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Postmenopausal, verified by:
- post bilateral surgical oophorectomy or
- no spontaneous menses ≥ 1 year or
- no menses for < 1 year with follicle-stimulating hormone (FSH) and estradiol levels in postmenopausal range, according to institutional standards
- Pathologic confirmation of invasive breast cancer diagnosed by core needle biopsy
Clinical T2-T4c, any N, M0 invasive breast cancer, by AJCC 7th edition clinical staging, with the goal being surgery to complete excision of the tumor in the breast and the lymph node. Primary tumor must be:
- palpable
- its largest diameters is at least 2.0 cm by physical examination or by radiological assessment
Note:
- Patients with contralateral ductal carcinoma in situ and/or invasive breast cancer are not eligible.
- Patients with multi-centric breast cancer (defined as more than one lesion is invasive breast cancer in the same breast separated by ≥ 2 cm of normal breast tissue are not eligible.
- Invasive breast cancer is estrogen receptor positive with an Allred score of 6, 7 or 8 by local institution standard protocol. If an Allred Score is not reported on the diagnostic pathology report, ER positivity in > 66% cells is eligible. If ER positivity is ≤ 66%, the staining intensity (weak, intermediate, strong) is needed to calculate the Allred Score to determine eligibility.
Invasive breast cancer is Human Epidermal Growth Factor Receptor 2 (HER2)- A patient is considered to have HER2 negative breast cancer if one of the following applies:
- 0 or 1+ by immunohistochemistry (IHC) and ISH not done
- 0 or 1+ by IHC and ISH ratio (HER2 gene copy/chromosome 17) < 2
- 2+ by IHC and ISH ratio (HER2 gene copy/chromosome 17) < 2
- Documentation of mammogram and ultrasound (including ductal carcinoma in situ (DCIS) and invasive cancer) of the diseased breast performed within 56 days prior to registration. Mammogram for the unaffected contralateral breast is required within 12 months prior to registration.
Laboratory values (≤ 14 days prior to registration):
- Absolute Neutrophil Count (ANC) > 1000/mm^3
- Platelet Count > 100,000/mm^3
- Total Bilirubin < 1.5 x upper limits of normal (ULN)
- Creatinine < 1.5 x ULN
- Serum alanine transaminase (ALT) < 2.5 x ULN
- Tissue acquisition: Patient must agree to provide the required research biopsies at baseline, week 4 and at surgery for integral and integrated biomarker and correlative studies.
Exclusion Criteria:
- Premenopausal status
- Inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d' orange without erythema).
- An excisional biopsy of this breast cancer.
- Hormone replacement therapy of any type, megestrol acetate, or raloxifene within one week prior to registration.
- Tumor estrogen receptor (ER) Allred score between 0-5 or HER2 positive by IHC (3+) or amplified by FISH > 2.0.
- Surgical axillary staging procedure prior to study entry. Note: Fine needle aspiration (FNA) or core needle biopsy of axillary node is permitted.
- Clinical or radiographic evidence of metastatic disease. Metastatic workup is not required, but is recommended for patients with clinical stage III disease. Note: Isolated ipsilateral supraclavicular node involvement is permitted.
- Breast implants are contraindicated only if the implant precludes the required research biopsies or interferes with palpating the breast lesion.
- Treatment for this cancer including surgery, radiation therapy, chemotherapy, biotherapy, hormonal therapy or investigational agent prior to study entry.
- History of invasive breast cancer or contralateral DCIS.
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- University of South Alabama Mitchell Cancer Institute
- Anchorage Associates in Radiation Medicine
- Anchorage Radiation Therapy Center
- Alaska Breast Care and Surgery LLC
- Alaska Oncology and Hematology LLC
- Alaska Regional Hospital
- Alaska Women's Cancer Care
- Anchorage Oncology Centre
- Katmai Oncology Group
- Providence Alaska Medical Center
- University of Arizona Cancer Center at Saint Joseph's
- Mayo Clinic Hospital
- Mayo Clinic in Arizona
- Banner University Medical Center - Tucson
- University of Arizona Cancer Center-North Campus
- Yuma Cancer Center
- Mercy Hospital Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs
- Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
- Highlands Oncology Group-Rogers
- Kaiser Permanente-Deer Valley Medical Center
- PCR Oncology
- Sutter Auburn Faith Hospital
- Sutter Cancer Centers Radiation Oncology Services-Auburn
- Alta Bates Summit Medical Center-Herrick Campus
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Mills-Peninsula Medical Center
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park
- East Bay Radiation Oncology Center
- Eden Hospital Medical Center
- Valley Medical Oncology Consultants-Castro Valley
- Community Cancer Institute
- University Oncology Associates
- Sutter Davis Hospital
- Epic Care-Dublin
- Bay Area Breast Surgeons Inc
- Epic Care Partners in Cancer Care
- Kaiser Permanente-Fremont
- Palo Alto Medical Foundation-Fremont
- Valley Medical Oncology Consultants-Fremont
- Kaiser Permanente-Fresno
- Saint Jude Medical Center
- Loma Linda University Medical Center
- Cedars Sinai Medical Center
- Contra Costa Regional Medical Center
- Memorial Medical Center
- Kaiser Permanente-Modesto
- El Camino Hospital
- Palo Alto Medical Foundation-Camino Division
- Palo Alto Medical Foundation-Gynecologic Oncology
- Sutter Cancer Research Consortium
- Highland General Hospital
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Tumor Institute
- Hematology and Oncology Associates-Oakland
- Tom K Lee Inc
- Kaiser Permanente-Oakland
- Palo Alto Medical Foundation Health Care
- East Bay Medical Oncology Hematology Medical Associates Inc-Pleasant Hill
- Valley Medical Oncology Consultants
- Kaiser Permanente-Redwood City
- Kaiser Permanente-Richmond
- Kaiser Permanente-Roseville
- Sutter Cancer Centers Radiation Oncology Services-Roseville
- Sutter Roseville Medical Center
- Kaiser Permanente Downtown Commons
- Sutter Medical Center Sacramento
- Kaiser Permanente-South Sacramento
- Kaiser Permanente - Sacramento
- Saint Helena Hospital
- California Pacific Medical Center-Pacific Campus
- Kaiser Permanente-San Francisco
- Kaiser Permanente-Santa Teresa-San Jose
- Kaiser Permanente San Leandro
- Doctors Medical Center- JC Robinson Regional Cancer Center
- Kaiser Permanente-San Rafael
- Kaiser San Rafael-Gallinas
- Kaiser Permanente Medical Center - Santa Clara
- Palo Alto Medical Foundation-Santa Cruz
- Kaiser Permanente-Santa Rosa
- Sutter Pacific Medical Foundation
- Kaiser Permanente-South San Francisco
- Kaiser Permanente-Stockton
- Palo Alto Medical Foundation-Sunnyvale
- Sutter Cancer Centers Radiation Oncology Services-Vacaville
- Kaiser Permanente Medical Center-Vacaville
- Kaiser Permanente-Vallejo
- Sutter Solano Medical Center/Cancer Center
- Kaiser Permanente-Walnut Creek
- Epic Care Cyberknife Center
- Rocky Mountain Cancer Centers-Aurora
- The Medical Center of Aurora
- University of Colorado Hospital
- Boulder Community Hospital
- Rocky Mountain Cancer Centers-Boulder
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- UCHealth Memorial Hospital Central
- Memorial Hospital North
- Denver Health Medical Center
- The Women's Imaging Center
- Porter Adventist Hospital
- Colorado Blood Cancer Institute
- Presbyterian - Saint Lukes Medical Center - Health One
- Rocky Mountain Cancer Centers-Midtown
- SCL Health Saint Joseph Hospital
- Rocky Mountain Cancer Centers-Rose
- Rose Medical Center
- Mercy Medical Center
- Southwest Oncology PC
- Comprehensive Cancer Care and Research Institute of Colorado LLC
- Swedish Medical Center
- Poudre Valley Hospital
- Mountain Blue Cancer Care Center
- National Jewish Health-Western Hematology Oncology
- Saint Mary's Hospital and Regional Medical Center
- North Colorado Medical Center
- Rocky Mountain Cancer Centers-Greenwood Village
- Good Samaritan Medical Center
- Rocky Mountain Cancer Centers-Lakewood
- Saint Anthony Hospital
- Rocky Mountain Cancer Centers-Littleton
- Littleton Adventist Hospital
- Rocky Mountain Cancer Centers-Sky Ridge
- Sky Ridge Medical Center
- Longmont United Hospital
- Rocky Mountain Cancer Centers-Longmont
- McKee Medical Center
- Parker Adventist Hospital
- Rocky Mountain Cancer Centers-Parker
- Saint Mary Corwin Medical Center
- Rocky Mountain Cancer Centers - Pueblo
- National Jewish Health-Northern Hematology Oncology
- Rocky Mountain Cancer Centers-Thornton
- SCL Health Lutheran Medical Center
- Smilow Cancer Hospital Care Center-Fairfield
- Yale-New Haven Shoreline Medical Center
- Smilow Cancer Hospital Care Center at Saint Francis
- Smilow Cancer Center/Yale-New Haven Hospital
- Yale University
- Yale-New Haven Hospital North Haven Medical Center
- Smilow Cancer Hospital-Torrington Care Center
- Smilow Cancer Hospital Care Center-Trumbull
- Smilow Cancer Hospital-Waterbury Care Center
- Lawrence and Memorial Cancer Center
- Beebe Medical Center
- Delaware Clinical and Laboratory Physicians PA
- Helen F Graham Cancer Center
- Medical Oncology Hematology Consultants PA
- Regional Hematology and Oncology PA
- Christiana Care Health System-Christiana Hospital
- Beebe Health Campus
- Nanticoke Memorial Hospital
- Christiana Care Health System-Wilmington Hospital
- MedStar Georgetown University Hospital
- MedStar Washington Hospital Center
- Morton Plant Hospital
- Baptist MD Anderson Cancer Center
- University Cancer and Blood Center LLC
- Augusta Oncology Associates PC-D'Antignac
- Augusta Oncology Associates PC-Wheeler
- Augusta University Medical Center
- John B Amos Cancer Center
- Dekalb Medical Center
- Kaiser Permanente Moanalua Medical Center
- Saint Alphonsus Cancer Care Center-Boise
- Saint Luke's Mountain States Tumor Institute
- Saint Alphonsus Cancer Care Center-Caldwell
- Kootenai Medical Center
- Walter Knox Memorial Hospital
- Saint Luke's Mountain States Tumor Institute - Fruitland
- Idaho Urologic Institute-Meridian
- Saint Luke's Mountain States Tumor Institute - Meridian
- Saint Alphonsus Medical Center-Nampa
- Saint Luke's Mountain States Tumor Institute - Nampa
- Kootenai Cancer Center
- Kootenai Cancer Clinic
- Saint Luke's Mountain States Tumor Institute-Twin Falls
- Rush - Copley Medical Center
- Saint Joseph Medical Center
- Illinois CancerCare-Bloomington
- Illinois CancerCare-Canton
- Memorial Hospital of Carbondale
- SIH Cancer Institute
- Illinois CancerCare-Carthage
- Centralia Oncology Clinic
- Mount Sinai Hospital Medical Center
- University of Illinois
- Swedish Covenant Hospital
- University of Chicago Comprehensive Cancer Center
- Advocate Illinois Masonic Medical Center
- Carle on Vermilion
- Cancer Care Specialists of Illinois - Decatur
- Decatur Memorial Hospital
- Carle Physician Group-Effingham
- Crossroads Cancer Center
- Illinois CancerCare-Eureka
- NorthShore University HealthSystem-Evanston Hospital
- Saint Francis Hospital
- Illinois CancerCare-Galesburg
- Western Illinois Cancer Treatment Center
- Northwestern Medicine Cancer Center Delnor
- NorthShore University HealthSystem-Glenbrook Hospital
- Ingalls Memorial Hospital
- NorthShore University HealthSystem-Highland Park Hospital
- Presence Saint Mary's Hospital
- Illinois CancerCare-Kewanee Clinic
- Illinois CancerCare-Macomb
- Carle Physician Group-Mattoon/Charleston
- Loyola University Medical Center
- Illinois CancerCare-Monmouth
- Good Samaritan Regional Health Center
- UC Comprehensive Cancer Center at Silver Cross
- Community Cancer Center Foundation
- Advocate Christ Medical Center
- University of Chicago Medicine-Orland Park
- Illinois CancerCare-Ottawa Clinic
- Ottawa Regional Hospital and Healthcare Center
- Radiation Oncology of Northern Illinois
- Illinois CancerCare-Pekin
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
- Proctor Hospital
- Illinois CancerCare-Peoria
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
- Methodist Medical Center of Illinois
- OSF Saint Francis Medical Center
- Illinois CancerCare-Peru
- Valley Radiation Oncology
- Illinois CancerCare-Princeton
- SwedishAmerican Regional Cancer Center/ACT
- North Shore Medical Center
- Central Illinois Hematology Oncology Center
- Southern Illinois University School of Medicine
- Springfield Clinic
- Memorial Medical Center
- Cancer Care Specialists of Illinois-Swansea
- Southwest Illinois Health Services LLP
- Carle Cancer Center
- The Carle Foundation Hospital
- Northwestern Medicine Cancer Center Warrenville
- Rush-Copley Healthcare Center
- IU Health North Hospital
- Michiana Hematology Oncology PC-Crown Point
- Elkhart Clinic
- Michiana Hematology Oncology PC-Elkhart
- Elkhart General Hospital
- Deaconess Clinic Downtown
- IU Health Central Indiana Cancer Centers-Fishers
- Parkview Hospital Randallia
- Parkview Regional Medical Center
- Indiana University/Melvin and Bren Simon Cancer Center
- IU Health Methodist Hospital
- Sidney and Lois Eskenazi Hospital
- IU Health Central Indiana Cancer Centers-East
- Springmill Medical Center
- Community Howard Regional Health
- IU Health La Porte Hospital
- Franciscan Saint Anthony Health-Michigan City
- Woodland Cancer Care Center
- Memorial Regional Cancer Center Day Road
- Michiana Hematology Oncology PC-Mishawaka
- Saint Joseph Regional Medical Center-Mishawaka
- Chancellor Center for Oncology
- Michiana Hematology Oncology PC-Plymouth
- Reid Health
- Memorial Hospital of South Bend
- Michiana Hematology Oncology PC-South Bend
- Michiana Hematology Oncology PC-Westville
- Mercy Hospital
- Oncology Associates at Mercy Medical Center
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Alegent Health Mercy Hospital
- Greater Regional Medical Center
- Medical Oncology and Hematology Associates-Laurel
- Mercy Medical Center - Des Moines
- Siouxland Regional Cancer Center
- Mercy Medical Center-Sioux City
- Saint Luke's Regional Medical Center
- Mercy Medical Center-West Lakes
- Central Care Cancer Center - Garden City
- Central Care Cancer Center - Great Bend
- Kansas Institute of Medicine Cancer and Blood Center
- Minimally Invasive Surgery Hospital
- Menorah Medical Center
- Saint Luke's South Hospital
- Cotton O'Neil Cancer Center / Stormont Vail Health
- Flaget Memorial Hospital
- Baptist Health Corbin
- Commonwealth Cancer Center-Corbin
- Oncology Hematology Care Inc-Crestview
- Saint Elizabeth Medical Center South
- Saint Elizabeth Fort Thomas
- Baptist Health Lexington
- Saint Joseph Radiation Oncology Resource Center
- Saint Joseph Hospital East
- Saint Joseph London
- Jewish Hospital
- Baptist Health Louisville
- Saints Mary and Elizabeth Hospital
- Jewish Hospital Medical Center Northeast
- Baptist Health Madisonville/Merle Mahr Cancer Center
- Baptist Health Paducah
- Jewish Hospital Medical Center South
- Harold Alfond Center for Cancer Care
- Eastern Maine Medical Center
- Lafayette Family Cancer Center-EMMC
- Penobscot Bay Medical Center
- Greater Baltimore Medical Center
- Sinai Hospital of Baltimore
- MedStar Union Memorial Hospital
- MedStar Franklin Square Medical Center/Weinberg Cancer Institute
- MedStar Good Samaritan Hospital
- Walter Reed National Military Medical Center
- Western Maryland Regional Medical Center
- UM Baltimore Washington Medical Center/Tate Cancer Center
- Northwest Hospital Center
- Peninsula Regional Medical Center
- Holy Cross Hospital
- William E Kahlert Regional Cancer Center/Sinai Hospital
- Brigham and Women's Hospital
- Beth Israel Deaconess Medical Center
- Dana-Farber Cancer Institute
- MetroWest Medical Center-Framingham Union Hospital
- Mercy Medical Center
- Saint Joseph Mercy Hospital
- Bronson Battle Creek
- IHA Hematology Oncology Consultants-Brighton
- Saint Joseph Mercy Brighton
- IHA Hematology Oncology Consultants-Canton
- Saint Joseph Mercy Canton
- Caro Cancer Center
- IHA Hematology Oncology Consultants-Chelsea
- Saint Joseph Mercy Chelsea
- Hematology Oncology Consultants-Clarkston
- Newland Medical Associates-Clarkston
- Beaumont Hospital ? Dearborn
- Henry Ford Hospital
- Ascension Saint John Hospital
- Great Lakes Cancer Management Specialists-Doctors Park
- Beaumont Hospital - Farmington Hills
- Genesee Cancer and Blood Disease Treatment Center
- Genesee Hematology Oncology PC
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Helen DeVos Children's Hospital at Spectrum Health
- Mercy Health Saint Mary's
- Spectrum Health at Butterworth Campus
- Academic Hematology Oncology Specialists
- Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
- Michigan Breast Specialists-Grosse Pointe Woods
- William Beaumont Hospital-Grosse Point
- Allegiance Health
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Borgess Medical Center
- Sparrow Hospital
- Hope Cancer Clinic
- Saint Mary Mercy Hospital
- Great Lakes Cancer Management Specialists-Macomb Medical Campus
- Michigan Breast Specialists-Macomb Township
- Saint Mary's Oncology/Hematology Associates of Marlette
- Mid-Michigan Medical Center - Midland
- Monroe Cancer Center
- Mercy Health Mercy Campus
- Lakeland Hospital Niles
- Ascension Providence Hospitals - Novi
- 21st Century Oncology-Pontiac
- Hope Cancer Center
- Newland Medical Associates-Pontiac
- Saint Joseph Mercy Oakland
- Huron Medical Center PC
- Lake Huron Medical Center
- Spectrum Health Reed City Hospital
- Great Lakes Cancer Management Specialists-Rochester Hills
- Michigan Cancer Specialists
- Oakland Colon and Rectal Association
- Cancer Care Associates PC
- Comprehensive Medical Center PLLC
- Hematology Oncology Consultants PC
- Oakland Medical Group
- William Beaumont Hospital-Royal Oak
- Ascension Saint Mary's Hospital
- Oncology Hematology Associates of Saginaw Valley PC
- Lakeland Medical Center Saint Joseph
- Marie Yeager Cancer Center
- Ascension Providence Hospitals - Southfield
- Bhadresh Nayak MD PC-Sterling Heights
- Premier Hematology Oncology Care
- Mitchell Folbe MD PC
- Ascension Saint Joseph Hospital
- Munson Medical Center
- Michigan Institute of Urology-Town Center
- Claudia BR Herke MD PC
- William Beaumont Hospital - Troy
- Hematology Oncology Consultants PC-Troy
- Advanced Breast Care Center PLLC
- Great Lakes Cancer Management Specialists-Macomb Professional Building
- Macomb Hematology Oncology PC
- Michigan Breast Specialists-Warren
- Saint John Macomb-Oakland Hospital
- Saint Mary's Oncology/Hematology Associates of West Branch
- Metro Health Hospital
- Huron Gastroenterology PC
- IHA Hematology Oncology Consultants-Ann Arbor
- Fairview Ridges Hospital
- Mercy Hospital
- Fairview-Southdale Hospital
- Unity Hospital
- Hutchinson Area Health Care
- Fairview Maple Grove Medical Center
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical Center
- Health Partners Inc
- Monticello Cancer Center
- New Ulm Medical Center
- North Memorial Medical Health Center
- Mayo Clinic
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- Fairview Lakes Medical Center
- Baptist Memorial Hospital and Cancer Center-Golden Triangle
- Baptist Cancer Center-Grenada
- Baptist Memorial Hospital and Cancer Center-Union County
- Baptist Memorial Hospital and Cancer Center-Oxford
- Baptist Memorial Hospital and Cancer Center-Desoto
- Saint Louis Cancer and Breast Institute-Ballwin
- Central Care Cancer Center - Bolivar
- Parkland Health Center-Bonne Terre
- Cox Cancer Center Branson
- Saint Francis Medical Center
- Southeast Cancer Center
- Saint Luke's Hospital
- University of Missouri - Ellis Fischel
- Siteman Cancer Center at West County Hospital
- Centerpoint Medical Center LLC
- Capital Region Southwest Campus
- Freeman Health System
- Mercy Hospital Joplin
- Saint Luke's Hospital of Kansas City
- Heartland Hematology and Oncology Associates Incorporated
- Research Medical Center
- Saint Luke's East - Lee's Summit
- Liberty Radiation Oncology Center
- Delbert Day Cancer Institute at PCRMC
- Mercy Clinic-Rolla-Cancer and Hematology
- Heartland Regional Medical Center
- Saint Louis Cancer and Breast Institute-South City
- Washington University School of Medicine
- Mercy Hospital South
- Siteman Cancer Center-South County
- Missouri Baptist Medical Center
- Siteman Cancer Center at Christian Hospital
- Mercy Hospital Saint Louis
- Siteman Cancer Center at Saint Peters Hospital
- Sainte Genevieve County Memorial Hospital
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Missouri Baptist Sullivan Hospital
- Missouri Baptist Outpatient Center-Sunset Hills
- Community Hospital of Anaconda
- Billings Clinic Cancer Center
- Saint Vincent Healthcare
- Saint Vincent Frontier Cancer Center
- Bozeman Deaconess Hospital
- Saint James Community Hospital and Cancer Treatment Center
- Benefis Healthcare- Sletten Cancer Institute
- Great Falls Clinic
- Saint Peter's Community Hospital
- Kalispell Regional Medical Center
- Saint Patrick Hospital - Community Hospital
- Community Medical Hospital
- Nebraska Medicine-Bellevue
- CHI Health Saint Francis
- Heartland Hematology and Oncology
- CHI Health Good Samaritan
- Nebraska Hematology and Oncology
- Nebraska Cancer Research Center
- Saint Elizabeth Regional Medical Center
- Southeast Nebraska Cancer Center
- Faith Regional Health Services Carson Cancer Center
- Great Plains Health Callahan Cancer Center
- Nebraska Medicine-Village Pointe
- Alegent Health Immanuel Medical Center
- Hematology and Oncology Consultants PC
- Alegent Health Bergan Mercy Medical Center
- Nebraska Cancer Specialists - Omaha
- Alegent Health Lakeside Hospital
- Oncology Hematology West PC
- Creighton University Medical Center
- University of Nebraska Medical Center
- Midlands Community Hospital
- Regional West Medical Center Cancer Center
- Carson Tahoe Regional Medical Center
- Cancer and Blood Specialists-Henderson
- Comprehensive Cancer Centers of Nevada - Henderson
- Comprehensive Cancer Centers of Nevada-Horizon Ridge
- Las Vegas Cancer Center-Henderson
- OptumCare Cancer Care at Seven Hills
- 21st Century Oncology-Henderson
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
- Desert West Surgery
- University Medical Center of Southern Nevada
- Hope Cancer Care of Nevada
- Cancer and Blood Specialists-Shadow
- OptumCare Cancer Care at Oakey
- Radiation Oncology Centers of Nevada Central
- 21st Century Oncology
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
- Sunrise Hospital and Medical Center
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
- Radiation Oncology Centers of Nevada Southeast
- Cancer Therapy and Integrative Medicine
- 21st Century Oncology-Vegas Tenaya
- Ann M Wierman MD LTD
- Cancer and Blood Specialists-Tenaya
- Comprehensive Cancer Centers of Nevada - Northwest
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
- OptumCare Cancer Care at MountainView
- Comprehensive Cancer Centers of Nevada - Town Center
- Comprehensive Cancer Centers of Nevada-Summerlin
- Summerlin Hospital Medical Center
- Las Vegas Cancer Center-Medical Center
- 21st Century Oncology-Fort Apache
- Comprehensive Cancer Centers of Nevada
- OptumCare Cancer Care at Fort Apache
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
- Comprehensive Cancer Centers of Nevada - Central Valley
- University Cancer Center
- Hope Cancer Care of Nevada-Pahrump
- Renown Regional Medical Center
- Saint Mary's Regional Medical Center
- Radiation Oncology Associates
- New Hampshire Oncology Hematology PA-Concord
- New Hampshire Oncology Hematology PA-Hooksett
- LRGHealthcare-Lakes Region General Hospital
- Dartmouth Hitchcock Medical Center
- Hackensack University Medical Center
- Virtua Memorial
- Kennedy Health Systems-Cancer Center
- Holy Name Hospital
- Inspira Medical Center Vineland
- Virtua Voorhees
- Inspira Medical Center Woodbury
- University of New Mexico Cancer Center
- New Mexico Oncology Hematology Consultants
- Presbyterian Kaseman Hospital
- Presbyterian Rust Medical Center/Jorgensen Cancer Center
- Christus Saint Vincent Regional Cancer Center
- Montefiore Medical Center-Einstein Campus
- Montefiore Medical Center-Weiler Hospital
- Montefiore Medical Center - Moses Campus
- State University of New York Downstate Medical Center
- Roswell Park Cancer Institute
- Arnot Ogden Medical Center/Falck Cancer Center
- Glens Falls Hospital
- Mount Sinai Union Square
- Mount Sinai West
- Mount Sinai Hospital
- University of Rochester
- State University of New York Upstate Medical University
- SUNY Upstate Medical Center-Community Campus
- Dickstein Cancer Treatment Center
- AdventHealth Infusion Center Asheville
- UNC Lineberger Comprehensive Cancer Center
- Novant Health Presbyterian Medical Center
- Carolina Surgical Clinic of Charlotte PA
- Oncology Specialists of Charlotte
- Southern Oncology Specialists-Charlotte
- Sampson Radiation Oncology
- Southeastern Medical Oncology Center-Clinton
- AdventHealth Infusion Center Haywood
- Southeastern Medical Oncology Center-Goldsboro
- Wayne Memorial Hospital
- Wayne Radiation Oncology
- East Carolina University
- AdventHealth Hendersonville
- University of North Carolina-Hillsborough Campus
- Lake Norman Hematology Oncology Specialists-Huntersville
- Southern Oncology Specialists-Huntersville
- Onslow Memorial Hospital
- Southeastern Medical Oncology Center-Jacksonville
- Vidant Oncology-Kenansville
- Vidant Oncology-Kinston
- Matthews Radiation Oncology Center
- Novant Health Cancer Specialists-Matthews
- Lake Norman Hematology Oncology Specialists-Mooresville
- Vidant Oncology-Richlands
- Iredell Memorial Hospital
- Southeastern Medical Oncology Center-Wilson
- Wake Forest University Health Sciences
- UHHS-Chagrin Highlands Medical Center
- Indu and Raj Soin Medical Center
- Strecker Cancer Center-Belpre
- Saint Elizabeth Boardman Hospital
- Dayton Physicians LLC-Miami Valley South
- Miami Valley Hospital South
- Geauga Hospital
- Adena Regional Medical Center
- Oncology Hematology Care Inc-Eden Park
- Oncology Hematology Care Inc-Mercy West
- Good Samaritan Hospital - Cincinnati
- Oncology Hematology Care Inc - Anderson
- Oncology Hematology Care Inc-Kenwood
- Bethesda North Hospital
- Oncology Hematology Care Inc-Blue Ash
- TriHealth Cancer Institute-Westside
- TriHealth Cancer Institute-Anderson
- Case Western Reserve University
- Ohio State University Comprehensive Cancer Center
- Mount Carmel East Hospital
- Columbus Oncology and Hematology Associates Inc
- Riverside Methodist Hospital
- Grant Medical Center
- The Mark H Zangmeister Center
- Mount Carmel Health Center West
- Doctors Hospital
- Good Samaritan Hospital - Dayton
- Miami Valley Hospital
- Dayton Physician LLC-Miami Valley Hospital North
- Miami Valley Hospital North
- Delaware Health Center-Grady Cancer Center
- Delaware Radiation Oncology
- Grady Memorial Hospital
- Mercy Cancer Center-Elyria
- Oncology Hematology Care Inc-Healthplex
- Armes Family Cancer Center
- Blanchard Valley Hospital
- Orion Cancer Care
- Atrium Medical Center-Middletown Regional Hospital
- Dayton Physicians LLC-Atrium
- Dayton Physicians LLC-Wayne
- Wayne Hospital
- Greater Dayton Cancer Center
- First Dayton Cancer Care
- Kettering Medical Center
- Fairfield Medical Center
- OhioHealth Mansfield Hospital
- Marietta Memorial Hospital
- OhioHealth Marion General Hospital
- UH Seidman Cancer Center at Landerbrook Health Center
- UH Seidman Cancer Center at Lake Health Mentor Campus
- UH Seidman Cancer Center at Southwest General Hospital
- Dayton Physicians LLC-Signal Point
- Knox Community Hospital
- Licking Memorial Hospital
- Newark Radiation Oncology
- University Hospitals Parma Medical Center
- Southern Ohio Medical Center
- UH Seidman Cancer Center at Firelands Regional Medical Center
- Dayton Physicians LLC-Wilson
- Springfield Regional Cancer Center
- Springfield Regional Medical Center
- ProMedica Flower Hospital
- The Toledo Hospital/Toledo Children's Hospital
- Dayton Physicians LLC-Upper Valley
- Upper Valley Medical Center
- University Hospitals Sharon Health Center
- Saint Joseph Warren Hospital
- Saint Ann's Hospital
- UH Seidman Cancer Center at Saint John Medical Center
- UHHS-Westlake Medical Center
- Wright-Patterson Medical Center
- Saint Elizabeth Youngstown Hospital
- Genesis Healthcare System Cancer Care Center
- Cancer Centers of Southwest Oklahoma Research
- University of Oklahoma Health Sciences Center
- Mercy Hospital Oklahoma City
- Saint Alphonsus Medical Center-Baker City
- Saint Charles Health System
- Clackamas Radiation Oncology Center
- Providence Oncology and Hematology Care Southeast
- Bay Area Hospital
- Legacy Mount Hood Medical Center
- Providence Newberg Medical Center
- Saint Alphonsus Medical Center-Ontario
- Providence Willamette Falls Medical Center
- Legacy Good Samaritan Hospital and Medical Center
- Providence Portland Medical Center
- Providence Saint Vincent Medical Center
- Kaiser Permanente Northwest
- Saint Charles Health System-Redmond
- Legacy Meridian Park Hospital
- Lehigh Valley Hospital-Cedar Crest
- UPMC-Heritage Valley Health System Beaver
- Lehigh Valley Hospital - Muhlenberg
- Christiana Care Health System-Concord Health Center
- Geisinger Medical Center
- Pocono Medical Center
- UPMC Cancer Centers - Arnold Palmer Pavilion
- Geisinger Medical Center-Cancer Center Hazleton
- Lehigh Valley Hospital-Hazleton
- Penn State Milton S Hershey Medical Center
- UPMC-Johnstown/John P. Murtha Regional Cancer Center
- Armstrong Center for Medicine and Health
- Geisinger Medical Oncology-Lewisburg
- Lewistown Hospital
- UPMC Cancer Center at UPMC McKeesport
- Forbes Hospital
- UPMC-Coraopolis/Heritage Valley Radiation Oncology
- Allegheny General Hospital
- UPMC-Magee Womens Hospital
- UPMC-Presbyterian Hospital
- UPMC-Saint Margaret
- West Penn Hospital
- University of Pittsburgh Cancer Institute (UPCI)
- UPMC-Shadyside Hospital
- UPMC Jefferson Regional Radiation Oncology
- UPMC-Passavant Hospital
- UPMC-Saint Clair Hospital Cancer Center
- Geisinger Cancer Services-Pottsville
- Community Medical Center
- Geisinger Medical Oncology-Selinsgrove
- UPMC Cancer Center at UPMC Northwest
- Geisinger Medical Group
- UPMC Uniontown Hospital Radiation Oncology
- UPMC Washington Hospital Radiation Oncology
- Geisinger Wyoming Valley/Henry Cancer Center
- Women and Infants Hospital
- Kent Hospital
- AnMed Health Cancer Center
- Roper Hospital
- Charleston Hematology Oncology Associates-Roper
- Lowcountry Hematology Oncology PA-North Charleston
- Bon Secours Saint Francis Hospital
- Charleston Hematology Oncology Associates PA-Saint Francis
- Lowcountry Hematology Oncology PA-West Ashley
- Medical University of South Carolina
- Greenville Health System Cancer Institute-Easley
- Gibbs Cancer Center-Gaffney
- Greenville Health System Cancer Institute-Andrews
- Saint Francis Hospital
- Greenville Health System Cancer Institute-Butternut
- Greenville Health System Cancer Institute-Faris
- Greenville Memorial Hospital
- Saint Francis Cancer Center
- Greenville Health System Cancer Institute-Eastside
- Greenville Health System Cancer Institute-Greer
- Gibbs Cancer Center-Pelham
- Carolina Blood and Cancer Care Associates PA-Lancaster
- Lowcountry Hematology Oncology PA-Mount Pleasant
- Carolina Blood and Cancer Care Associates PA
- Greenville Health System Cancer Institute-Seneca
- Spartanburg Medical Center
- Greenville Health System Cancer Institute-Spartanburg
- MGC Hematology Oncology-Union
- Memorial Hospital
- Pulmonary Medicine Center of Chattanooga-Hixson
- Baptist Memorial Hospital and Cancer Center-Memphis
- Baptist Memorial Hospital for Women
- Family Cancer Center-Memphis
- Nashville Breast Center
- Meharry Medical College
- Memorial GYN Plus
- Hendrick Medical Center
- Austin Cancer Centers-Central Austin
- Austin Cancer Centers-Central Park
- Austin Cancer Centers-Saint David's
- Austin Cancer Centers-Northwest
- Saint Joseph Regional Cancer Center
- Parkland Memorial Hospital
- UT Southwestern/Simmons Cancer Center-Dallas
- Texas Tech University Health Sciences Center-El Paso
- UT Southwestern/Simmons Cancer Center-Fort Worth
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
- Ben Taub General Hospital
- M D Anderson Cancer Center
- MD Anderson in Katy
- Doctor's Hospital of Laredo
- MD Anderson League City
- MD Anderson in Sugar Land
- MD Anderson in The Woodlands
- Central Vermont Medical Center/National Life Cancer Treatment
- University of Vermont Medical Center
- University of Vermont and State Agricultural College
- IMG Hematology Oncology 8501
- Hematology Oncology Associates of Fredericksburg Inc
- Virginia Commonwealth University/Massey Cancer Center
- Shenandoah Oncology PC
- Providence Regional Cancer System-Aberdeen
- Cancer Care Center at Island Hospital
- Swedish Cancer Institute-Eastside Oncology Hematology
- PeaceHealth Saint Joseph Medical Center
- Harrison HealthPartners Hematology and Oncology-Bremerton
- Harrison Medical Center
- Highline Medical Center-Main Campus
- Providence Regional Cancer System-Centralia
- Swedish Cancer Institute-Edmonds
- Saint Elizabeth Hospital
- Providence Regional Cancer Partnership
- Saint Francis Hospital
- Swedish Cancer Institute-Issaquah
- Kadlec Clinic Hematology and Oncology
- Providence Regional Cancer System-Lacey
- Saint Clare Hospital
- PeaceHealth Saint John Medical Center
- Harrison HealthPartners Hematology and Oncology-Poulsbo
- Minor and James Medical PLLC
- Pacific Gynecology Specialists
- Swedish Medical Center-Ballard Campus
- Kaiser Permanente Washington
- Swedish Medical Center-First Hill
- Swedish Medical Center-Cherry Hill
- PeaceHealth United General Medical Center
- Providence Regional Cancer System-Shelton
- Rockwood Clinic Cancer Treatment Center-Valley
- Rockwood Cancer Treatment Center-DHEC-Downtown
- Evergreen Hematology and Oncology PS
- Rockwood North Cancer Treatment Center
- Franciscan Research Center-Northwest Medical Plaza
- Northwest Medical Specialties PLLC
- Madigan Army Medical Center
- PeaceHealth Southwest Medical Center
- Legacy Salmon Creek Hospital
- Providence Saint Mary Regional Cancer Center
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- Providence Regional Cancer System-Yelm
- West Virginia University Charleston Division
- Langlade Hospital and Cancer Center
- Aurora Cancer Care-Southern Lakes VLCC
- Aurora Health Center-Fond du Lac
- Aurora Health Care Germantown Health Center
- Aurora Cancer Care-Grafton
- Aurora BayCare Medical Center
- Mercy Health System
- Aurora Cancer Care-Kenosha South
- University of Wisconsin Hospital and Clinics
- Aurora Bay Area Medical Group-Marinette
- Bay Area Medical Center
- Aurora Cancer Care-Milwaukee
- Aurora Saint Luke's Medical Center
- Aurora Sinai Medical Center
- Cancer Center of Western Wisconsin
- Vince Lombardi Cancer Clinic - Oshkosh
- Aurora Cancer Care-Racine
- Vince Lombardi Cancer Clinic-Sheboygan
- Aurora Medical Center in Summit
- Vince Lombardi Cancer Clinic-Two Rivers
- Aspirus Regional Cancer Center
- Aurora Cancer Care-Milwaukee West
- Aurora West Allis Medical Center
- Aspirus UW Cancer Center
- Rocky Mountain Oncology
- Cheyenne Regional Medical Center-West
- Big Horn Basin Cancer Center
- Billings Clinic-Cody
- Welch Cancer Center
- Cancer Center-Metro Medical Center Bayamon
- Doctors Cancer Center
- San Juan Community Oncology Group
- San Juan City Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Arm I (anastrozole)
Arm II (fulvestrant)
Arm III (anastrozole and fulvestrant)
Patients receive anastrozole daily for 6 cycles followed by surgery. A treatment cycle is 4 weeks in length. After completion of analysis of endocrine resistant data, patients will continue treatment as defined in the protocol.
Patients receive fulvestrant on days 1 and 15 of cycle 1 and day 1 of cycles 2-6 followed by surgery. A treatment cycle is 4 weeks in length. After completion of analysis of endocrine resistant data, patients will continue treatment as defined in the protocol.
Patients receive anastrozole daily in combination with fulvestrant on days 1 and 15 of cycle 1, and on day 1 of cycles 2-6 followed by surgery. A treatment cycle is 4 weeks in length. After completion of analysis of endocrine resistant data, patients will continue treatment as defined in the protocol.