S0226 Anastrozole With or Without Fulvestrant as First-Line Therapy in Postmenopausal Women With Metastatic Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
NCIC Clinical Trials Group
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00075764
First received: January 9, 2004
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using drugs such as anastrozole and fulvestrant may fight breast cancer by blocking the use of estrogen. It is not yet known whether anastrozole is more effective with or without fulvestrant in treating breast cancer.

PURPOSE: This randomized phase III trial is studying giving anastrozole together with fulvestrant to see how well it works compared to anastrozole alone as first-line therapy in treating postmenopausal women with metastatic breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: anastrozole
Drug: fulvestrant
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Time to tumor progression [ Time Frame: 13 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical response rates [ Time Frame: 13 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 690
Study Start Date: April 2004
Estimated Study Completion Date: October 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I
Patients receive oral anastrozole once daily on days 1-28.
Drug: anastrozole
Given orally
Experimental: Arm II
Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.
Drug: anastrozole
Given orally
Drug: fulvestrant
Given intramuscularly

Detailed Description:

OBJECTIVES:

  • Compare the time to tumor progression in postmenopausal women with metastatic breast cancer treated with anastrozole with or without fulvestrant as first-line therapy.
  • Compare the clinical benefit (complete or partial response, confirmed or unconfirmed, or stable disease ≥ 24 weeks) and overall survival of patients treated with these regimens.
  • Compare adverse events in patients treated with these regimens.
  • Determine the prognostic significance of estrogen receptor positivity and HER2/neu status in patients treated with these regimens.
  • Determine parameters of estrogen and clinical pharmacology and estrogen levels in patients treated with these regimens.
  • Compare anastrozole plasma levels at 8, 16, and 24 weeks in patients treated with these regimens (closed as of 4/16/2009).
  • Compare estradiol serum levels at 8, 16, and 24 weeks in patients treated with these regimens (closed as of 4/16/2009).

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior adjuvant tamoxifen therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral anastrozole once daily on days 1-28.
  • Arm II: Patients receive oral anastrozole as in arm I. Patients also receive fulvestrant intramuscularly on days 1, 14, and 28 during course 1 and then on day 28 of the subsequent courses.

In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed for up to 4 years.

PROJECTED ACCRUAL: A total of 690 patients (345 per treatment arm) will be accrued for this study within 3 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed breast cancer meeting 1 of the following criteria:

    • Metastatic disease (M1)
    • Multiple sites of new disease that is clinically obvious metastatic disease (e.g., multiple sites of new osseous disease)
  • Measurable or nonmeasurable disease
  • No known brain or CNS metastases
  • Hormone receptor status:

    • Estrogen-receptor positive* AND/OR
    • Progesterone-receptor positive* NOTE: *Positivity defined as estrogen binding of > 10 fmol/mg cytosol protein by ligand binding assay or positive by immunohistochemistry

PATIENT CHARACTERISTICS:

Age

  • Not specified

Sex

  • Female

Menopausal status

  • Postmenopausal, as defined by 1 of the following:

    • Prior bilateral oophorectomy
    • More than 12 months since last menstrual period with no prior hysterectomy
    • At least 55 years of age with prior hysterectomy
    • Under 55 years of age with a prior hysterectomy without oophorectomy and with estradiol and follicle-stimulating hormone levels consistent with menopause

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • No bleeding diathesis (e.g., disseminated intravascular coagulation or clotting factor deficiency)

Hepatic

  • INR ≤ 1.6

Renal

  • Not specified

Other

  • HIV negative
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior immunotherapy for recurrent or metastatic disease

Chemotherapy

  • No prior chemotherapy for recurrent or metastatic disease
  • More than 12 months since prior adjuvant or neoadjuvant chemotherapy
  • No concurrent chemotherapy for malignancy

Endocrine therapy

  • Prior adjuvant hormonal therapy allowed
  • At least 12 months since prior adjuvant luteinizing hormone-releasing hormone (LHRH) analogues

    • Menstrual periods must not have resumed since LHRH therapy
  • More than 12 months since prior adjuvant or neoadjuvant aromatase inhibitors (e.g., anastrozole, letrozole, or exemestane)
  • More than 12 months since prior fulvestrant
  • No prior hormonal therapy for recurrent or metastatic disease
  • No other concurrent hormonal therapy for malignancy
  • No concurrent hormone replacement therapy

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • No long-term anticoagulant therapy (except antiplatelet therapy)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00075764

  Hide Study Locations
Locations
United States, Alabama
Regional Medical Center
Anniston, Alabama, United States, 36202
Providence Cancer Center at Providence Hospital
Mobile, Alabama, United States, 36608
United States, Alaska
Alaska Regional Hospital Cancer Center
Anchorage, Alaska, United States, 99508
Providence Cancer Center
Anchorage, Alaska, United States, 99508
United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5024
United States, Arkansas
Highlands Oncology Group - Springdale
Bentonville, Arkansas, United States, 72712
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Ft. Smith, Arkansas, United States, 72903
United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Glendale Memorial Hospital Comprehensive Cancer Center
Glendale, California, United States, 91204
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States, 92354
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
Tibotec Therapeutics - Division of Ortho Biotech Products, LP
Marysville, California, United States, 95901
University of California Davis Cancer Center
Sacramento, California, United States, 95817
San Francisco General Hospital Medical Center
San Francisco, California, United States, 94110
CCOP - Santa Rosa Memorial Hospital
Sana Rosa, California, United States, 95405
Tahoe Forest Cancer Center
Truckee, California, United States, 96161
United States, Colorado
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States, 80045
Memorial Hospital Cancer Center - Colorado Springs
Colorado Springs, Colorado, United States, 80909
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States, 80220
Denver Health Medical Center
Denver, Colorado, United States, 80204
Shaw Regional Cancer Center
Edwards, Colorado, United States, 81632
Valley View Hospital Cancer Center
Glenwood Springs, Colorado, United States, 81601
United States, Connecticut
Middlesex Hospital Cancer Center
Middletown, Connecticut, United States, 06457
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5001
United States, Florida
Eugene M. and Christine E. Lynn Cancer Institute at Boca Raton Community Hospital - Main Campus
Boca Raton, Florida, United States, 33486
North Broward Medical Center
Dearfield Beach, Florida, United States, 33064-3596
Sacred Heart Cancer Center at Sacred Heart Hospital
Pensacola, Florida, United States, 32504
West Florida Cancer Institute at West Florida Hospital - Pensacola
Pensacola, Florida, United States, 32514
United States, Georgia
Northeast Georgia Cancer Care, LLC - Medical Oncology
Athens, Georgia, United States, 30607
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342
Northside Hospital Cancer Center
Atlanta, Georgia, United States, 30342-1611
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States, 30342-1701
MBCCOP - Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912
WellStar Cobb Hospital
Austell, Georgia, United States, 30106
Charles B. Eberhart Cancer Center at DeKalb Medical Center
Decatur, Georgia, United States, 30033
Gwinnett Medical Center
Lawrenceville, Georgia, United States, 30045
Kennestone Cancer Center at Wellstar Kennestone Hospital
Marietta, Georgia, United States, 30060
Southern Regional Medical Center
Riverdale, Georgia, United States, 30274-2600
Harbin Clinic Cancer Center - Medical Oncology
Rome, Georgia, United States, 30165
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
Savannah, Georgia, United States, 31405
United States, Idaho
Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise, Idaho, United States, 83712
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
Portneuf Cancer Center at Portneuf Medical Center
Pocatello, Idaho, United States, 83201
United States, Illinois
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, United States, 62002
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
Graham Hospital
Canton, Illinois, United States, 61520
Memorial Hospital
Carthage, Illinois, United States, 62321
Resurrection Medical Center
Chicago, Illinois, United States, 60631
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612-7243
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Sherman Hospital
Elgin, Illinois, United States, 60120
Eureka Community Hospital
Eureka, Illinois, United States, 61530
Galesburg Cottage Hospital
Galesburg, Illinois, United States, 61401
Galesburg Clinic, PC
Galesburg, Illinois, United States, 61401
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Mason District Hospital
Havana, Illinois, United States, 62644
Hopedale Medical Complex
Hopedale, Illinois, United States, 61747
Provena St. Mary's Regional Cancer Center - Kankakee
Kankakee, Illinois, United States, 60901
La Grange Memorial Hospital
La Grange, Illinois, United States, 60525
McDonough District Hospital
Macomb, Illinois, United States, 61455
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Good Samaritan Regional Health Center
Mt. Vernon, Illinois, United States, 62864
Hematology Oncology Consultants - Naperville
Naperville, Illinois, United States, 60540
Edward Hospital Cancer Center
Naperville, Illinois, United States, 60540
BroMenn Regional Medical Center
Normal, Illinois, United States, 61761
Community Cancer Center
Normal, Illinois, United States, 61761
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, United States, 61350
Community Hospital of Ottawa
Ottawa, Illinois, United States, 61350
Advocate Lutheran General Cancer Care Center
Park Ridge, Illinois, United States, 60068-1174
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States, 61554
OSF St. Francis Medical Center
Peoria, Illinois, United States, 61637
Proctor Hospital
Peoria, Illinois, United States, 61614
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States, 61615
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615
Illinois Valley Community Hospital
Peru, Illinois, United States, 61354
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
St. Margaret's Hospital
Spring Valley, Illinois, United States, 61362
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
United States, Indiana
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, United States, 46260
Howard Community Hospital
Kokomo, Indiana, United States, 46904
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Clarian Arnett Cancer Care
Lafayette, Indiana, United States, 47904
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Saint Joseph Regional Medical Center
South Bend, Indiana, United States, 46617
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
South Bend Clinic
South Bend, Indiana, United States, 46617
United States, Iowa
McFarland Clinic, PC
Ames, Iowa, United States, 50010
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, United States, 52722
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, United States, 52403
Heartland Oncology and Hematology
Council Bluffs, Iowa, United States, 51503
Genesis Regional Cancer Center at Genesis Medical Center
Davenport, Iowa, United States, 52803
Genesis Medical Center - West Campus
Davenport, Iowa, United States, 52804
McCreery Cancer Center at Ottumwa Regional
Ottumwa, Iowa, United States, 52501
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51104
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
United States, Kansas
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Southwest Medical Center
Liberal, Kansas, United States, 67901
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Menorah Medical Center
Overland Park, Kansas, United States, 66209
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67042
Shawnee Mission Medical Center
Shawnee Mission, Kansas, United States, 66204
St. Francis Comprehensive Cancer Center
Topeka, Kansas, United States, 66606
Cotton-O'Neil Cancer Center
Topeka, Kansas, United States, 66606
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
CCOP - Wichita
Wichita, Kansas, United States, 67214
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
United States, Louisiana
Mary Bird Perkins Cancer Center - Baton Rouge
Baton Rouge, Louisiana, United States, 70809
Pennington Cancer Center at Baton Rouge General
Baton Rouge, Louisiana, United States, 70806
Medical Center of Louisiana - New Orleans
New Orleans, Louisiana, United States, 70112
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Maine
Central Maine Comprehensive Cancer Center at Central Maine Medical Center
Lewiston, Maine, United States, 04240
York Hospital's Oncology Treatment Center
York, Maine, United States, 03909
United States, Maryland
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
Baltimore, Maryland, United States, 21215
United States, Massachusetts
Caritas St. Elizabeth's Medical Center
Brighton, Massachusetts, United States, 02135-2997
Caritas Holy Family Hospital
Methuen, Massachusetts, United States, 01844
United States, Michigan
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States, 49221
Saint Joseph Mercy Cancer Center
Ann Arbor, Michigan, United States, 48106-0995
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
Battle Creek Health System Cancer Care Center
Battle Creek, Michigan, United States, 49017
Mecosta County Medical Center
Big Rapids, Michigan, United States, 49307
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48123-2500
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, United States, 49431
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Hurley Medical Center
Flint, Michigan, United States, 48503
Butterworth Hospital at Spectrum Health
Grand Rapids, Michigan, United States, 49503
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids, Michigan, United States, 49503
CCOP - Grand Rapids
Grand Rapids, Michigan, United States, 49503
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
Dickinson County Healthcare System
Iron Mountain, Michigan, United States, 49801
Foote Memorial Hospital
Jackson, Michigan, United States, 49201
Haematology-Oncology Associates of Ohio and Michigan, PC
Lambertville, Michigan, United States, 48144
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48912-1811
St. Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Upper Michigan Cancer Center at Marquette General Hospital
Marquette, Michigan, United States, 49855
Mercy Memorial Hospital - Monroe
Monroe, Michigan, United States, 48162
Community Cancer Center of Monroe
Monroe, Michigan, United States, 48162
Mercy General Health Partners
Muskegon, Michigan, United States, 49443
Northern Michigan Hospital
Petoskey, Michigan, United States, 49770
St. Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
Mercy Regional Cancer Center at Mercy Hospital
Port Huron, Michigan, United States, 48060
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
Seton Cancer Institute at Saint Mary's - Saginaw
Saginaw, Michigan, United States, 48601
Providence Cancer Institute at Providence Hospital - Southfield Campus
Southfield, Michigan, United States, 48075
Lakeland Regional Cancer Care Center - St. Joseph
St. Joseph, Michigan, United States, 49085
Munson Medical Center
Traverse City, Michigan, United States, 49684
St. John Macomb Hospital
Warren, Michigan, United States, 48093
Metro Health Hospital
Wyoming, Michigan, United States, 49519
United States, Minnesota
MeritCare Bemidji
Bemidji, Minnesota, United States, 56601
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Miller - Dwan Medical Center
Duluth, Minnesota, United States, 55805
St. Luke's Hospital Cancer Care Center
Duluth, Minnesota, United States, 55805
CCOP - Duluth
Duluth, Minnesota, United States, 55805
Duluth Clinic Cancer Center - Duluth
Duluth, Minnesota, United States, 55805-1983
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Minnesota Oncology Hematology, PA - Maplewood
Maplewood, Minnesota, United States, 55109
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States, 55422-2900
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States, 55416
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United Hospital
Saint Paul, Minnesota, United States, 55102
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, United States, 55379
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Willmar Cancer Center at Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, United States, 55125
United States, Mississippi
Keesler Air Force Base Medical Center
Kessler AFB, Mississippi, United States, 39534
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, United States, 39581
United States, Missouri
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
Cape Girardeau, Missouri, United States, 63701
Saint Francis Medical Center
Cape Girardeau, Missouri, United States, 63703
Independence Regional Health Center
Independence, Missouri, United States, 64050
Freeman Cancer Institute at Freeman Health System
Joplin, Missouri, United States, 64804
St. Joseph Medical Center
Kansas City, Missouri, United States, 64114
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
Truman Medical Center - Hospital Hill
Kansas City, Missouri, United States, 64108
Research Medical Center
Kansas City, Missouri, United States, 64132
Parvin Radiation Oncology
Kansas City, Missouri, United States, 64116
Saint Luke's Cancer Institute at Saint Luke's Hospital
Kansas City, Missouri, United States, 64111
North Kansas City Hospital
Kansas City, Missouri, United States, 64116
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States, 64086
Liberty Hospital
Liberty, Missouri, United States, 64068
Heartland Regional Medical Center
Saint Joseph, Missouri, United States, 64506
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
CCOP - St. Louis-Cape Girardeau
Saint Louis, Missouri, United States, 63141
Saint Louis University Cancer Center
Saint Louis, Missouri, United States, 63110
Midwest Hematology Oncology Group, Incorporated
Saint Louis, Missouri, United States, 63109
David C. Pratt Cancer Center at St. John's Mercy
Saint Louis, Missouri, United States, 63141
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65802
United States, Montana
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59101
Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
St. Vincent Healthcare Cancer Care Services
Billings, Montana, United States, 59101
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
St. James Healthcare Cancer Care
Butte, Montana, United States, 59701
Big Sky Oncology
Great Falls, Montana, United States, 59405-5309
Great Falls Clinic - Main Facility
Great Falls, Montana, United States, 59405
Sletten Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States, 59405
Great Falls, Montana, United States, 59405
Northern Montana Hospital
Havre, Montana, United States, 59501
Kalispell Medical Oncology at KRMC
Kalispell, Montana, United States, 59901
Glacier Oncology, PLLC
Kalispell, Montana, United States, 59901
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Guardian Oncology and Center for Wellness
Missoula, Montana, United States, 59804
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59807
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59807-7877
Community Medical Center
Missoula, Montana, United States, 59801
United States, Nebraska
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney, Nebraska, United States, 68848-1990
Cancer Resource Center - Lincoln
Lincoln, Nebraska, United States, 68510
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States, 68114
United States, Nevada
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
United States, New Hampshire
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
Concord, New Hampshire, United States, 03301
Center for Cancer Care at Exeter Hospital
Exeter, New Hampshire, United States, 03833
New Hampshire Oncology - Hematology, PA - Hooksett
Hooksett, New Hampshire, United States, 03106
Lakes Region General Hospital
Laconia, New Hampshire, United States, 03246
Elliot Regional Cancer Center at Elliot Hospital
Manchester, New Hampshire, United States, 03103
United States, New Jersey
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740-6395
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, United States, 07503
Overlook Hospital
Summit, New Jersey, United States, 07902
St. Francis Regional Cancer Center
Trenton, New Jersey, United States, 08629
Capital Health Regional Cancer Center
Trenton, New Jersey, United States, 08618
United States, New Mexico
Hematology Oncology Associates, PC
Albuquerque, New Mexico, United States, 87106
Lovelace Medical Center - Downtown
Albuquerque, New Mexico, United States, 87102
Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital
Albuquerque, New Mexico, United States, 87110
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131-5636
New Mexico Cancer Care Associates
Santa Fe, New Mexico, United States, 87505
St. Vincent Cancer Center at St. Vincent Regional Medical Center
Santa Fe, New Mexico, United States, 87505
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Finger Lakes Hematology and Oncology
Clifton Springs, New York, United States, 14432
Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital
Cooperstown, New York, United States, 13326
Adirondack Cancer Care - Glens Falls
Glens Falls, New York, United States, 12801
Union State Bank Cancer Center at Nyack Hospital
Nyack, New York, United States, 10960-1998
Cancer Center of Poughkeepsie
Poughkeepsie, New York, United States, 12601
Hudson Valley Oncology Associates
Poughkeepsie, New York, United States, 12601
Dyson Center for Cancer Care at Vassar Brothers Medical Center
Poughkeepsie, New York, United States, 12601-3990
Highland Hospital of Rochester
Rochester, New York, United States, 14620
Interlakes Oncology/Hematology PC
Rochester, New York, United States, 14623
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, North Carolina
Hope A Women's Cancer Center
Asheville, North Carolina, United States, 28801
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States, 28801
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Kinston Medical Specialists
Kinston, North Carolina, United States, 28501
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
Pinehurst, North Carolina, United States, 28374
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
Zimmer Cancer Center at New Hanover Regional Medical Center
Wilmington, North Carolina, United States, 28401
United States, North Dakota
Mid Dakota Clinic, PC
Bismarck, North Dakota, United States, 58501
Bismarck Cancer Center
Bismarck, North Dakota, United States, 58501
Medcenter One Hospital Cancer Care Center
Bismarck, North Dakota, United States, 58501
St. Alexius Medical Center Cancer Center
Bismarck, North Dakota, United States, 58502
CCOP - MeritCare Hospital
Fargo, North Dakota, United States, 58122
MeritCare Broadway
Fargo, North Dakota, United States, 58122
Altru Cancer Center at Altru Hospital
Grand Forks, North Dakota, United States, 58201
Trinity CancerCare Center
Minot, North Dakota, United States, 58701
United States, Ohio
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States, 44307
Cleveland Clinic Beachwood Family Health and Surgery Center
Beachwood, Ohio, United States, 44122
Mary Rutan Hospital
Bellefontaine, Ohio, United States, 43311
Wood County Oncology Center
Bowling Green, Ohio, United States, 43402
Aultman Cancer Center at Aultman Hospital
Canton, Ohio, United States, 44710-1799
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, United States, 44111
Doctors Hospital at Ohio Health
Columbus, Ohio, United States, 43228
CCOP - Columbus
Columbus, Ohio, United States, 43215
Mount Carmel Health - West Hospital
Columbus, Ohio, United States, 43222
Grant Medical Center Cancer Care
Columbus, Ohio, United States, 43215
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Hematology Oncology Center
Elyria, Ohio, United States, 44035
Cleveland Clinic Cancer Center
Independence, Ohio, United States, 44131
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Lima Memorial Hospital
Lima, Ohio, United States, 45804
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
St. Luke's Hospital
Maumee, Ohio, United States, 43537
Northwest Ohio Oncology Center
Maumee, Ohio, United States, 43537-1839
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, United States, 44124
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States, 43055
St. Charles Mercy Hospital
Oregon, Ohio, United States, 43616
Toledo Clinic - Oregon
Oregon, Ohio, United States, 43616
North Coast Cancer Care, Incorporated
Sandusky, Ohio, United States, 44870
Community Hospital of Springfield and Clark County
Springfield, Ohio, United States, 45505
Mercy Medical Center
Springfield, Ohio, United States, 45504
Flower Hospital Cancer Center
Sylvania, Ohio, United States, 43560
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States, 43623
St. Anne Mercy Hospital
Toledo, Ohio, United States, 43623
Medical University of Ohio Cancer Center
Toledo, Ohio, United States, 43614
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
Toledo Hospital
Toledo, Ohio, United States, 43606
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43617
Fulton County Health Center
Wauseon, Ohio, United States, 43567
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, United States, 43081
Tod Children's Hospital
Youngstown, Ohio, United States, 44501
Genesis - Good Samaritan Hospital
Zanesville, Ohio, United States, 43701
United States, Oregon
St. Charles Medical Center - Bend
Bend, Oregon, United States, 97701
Bay Area Hospital
Coos Bay, Oregon, United States, 97420
Three Rivers Community Hospital
Grants Pass, Oregon, United States, 97527
Legacy Mount Hood Medical Center
Gresham, Oregon, United States, 97030
Providence Cancer Center at PMCC
Medford, Oregon, United States, 97504
Dubs Cancer Center at Rogue Valley Medical Center
Medford, Oregon, United States, 97504
Providence Milwaukie Hospital
Milwaukie, Oregon, United States, 97222
Legacy Good Samaritan Hospital & Comprehensive Cancer Center
Portland, Oregon, United States, 97210
Adventist Medical Center
Portland, Oregon, United States, 97216
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
Legacy Emanuel Hospital and Health Center and Children's Hospital
Portland, Oregon, United States, 97227
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
Kaiser Permanente Health Care - Portland
Portland, Oregon, United States, 97232
Providence Cancer Center at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967
Legacy Meridian Park Hospital
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
St. Luke's Cancer Network at St. Luke's Hospital
Bethlehem, Pennsylvania, United States, 18015
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States, 19026
Oncology Hematology Associates of Northern Pennsylvania, PC at Hahne Regional Cancer Center
Dubois, Pennsylvania, United States, 15801
Easton Regional Cancer Center at Easton Hospital
Easton, Pennsylvania, United States, 18042
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17604
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States, 15232
Guthrie Cancer Center at Guthrie Clinic Sayre
Sayre, Pennsylvania, United States, 18840
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, United States, 18501
Hematology and Oncology Associates of Northeastern Pennsylvania
Scranton, Pennsylvania, United States, 18510
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16803
United States, South Carolina
AnMed Cancer Center
Anderson, South Carolina, United States, 29621
McLeod Regional Medical Center
Florence, South Carolina, United States, 29501
Mabry Center for Cancer Care at Regional Medical Center
Orangeburg, South Carolina, United States, 29118
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Medical X-Ray Center, PC
Sioux Falls, South Dakota, United States, 57105
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Tennessee
University of Tennessee Cancer Institute - Memphis
Memphis, Tennessee, United States, 38104
United States, Utah
American Fork Hospital
American Fork, Utah, United States, 84003
Sandra L. Maxwell Cancer Center
Cedar City, Utah, United States, 84720
Logan Regional Hospital
Logan, Utah, United States, 84321
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray, Utah, United States, 84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
Dixie Regional Medical Center - East Campus
Saint George, Utah, United States, 84770
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, United States, 84106
LDS Hospital
Salt Lake City, Utah, United States, 84103
United States, Virginia
Martha Jefferson Hospital Cancer Care Center
Charlottesville, Virginia, United States, 22901
Fredericksburg Oncology, Incorporated
Fredericksburg, Virginia, United States, 22401
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
United States, Washington
Auburn Regional Center for Cancer Care
Auburn, Washington, United States, 98002
St. Joseph Cancer Center
Bellingham, Washington, United States, 98225
Olympic Hematology and Oncology
Bremerton, Washington, United States, 98310
Providence Centralia Hospital
Centralia, Washington, United States, 98531-9027
St. Francis Hospital
Federal Way, Washington, United States, 98003
Columbia Basin Hematology
Kennewick, Washington, United States, 99336
Providence St. Peter Hospital Regional Cancer Center
Olympia, Washington, United States, 98506-5166
Good Samaritan Cancer Center
Puyallup, Washington, United States, 98372
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98104
Polyclinic First Hill
Seattle, Washington, United States, 98122
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States, 98122-4307
Minor and James Medical, PLLC
Seattle, Washington, United States, 98104
Group Health Central Hospital
Seattle, Washington, United States, 98112
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Harborview Medical Center
Seattle, Washington, United States, 98104
Rockwood Clinic Cancer Treatment Center
Spokane, Washington, United States, 99204-2967
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Madigan Army Medical Center - Tacoma
Tacoma, Washington, United States, 98431
Allenmore Hospital
Tacoma, Washington, United States, 98405
St. Clare Hospital
Tacoma, Washington, United States, 98499
Franciscan Cancer Center at St. Joseph Medical Center
Tacoma, Washington, United States, 98405-3004
MultiCare Regional Cancer Center at Tacoma General Hospital
Tacoma, Washington, United States, 98405
CCOP - Northwest
Tacoma, Washington, United States, 98405
Southwest Washington Medical Center Cancer Center
Vancouver, Washington, United States, 98668
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, United States, 98902
United States, West Virginia
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
Huntington, West Virginia, United States, 25701
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
Parkersburg, West Virginia, United States, 26102
United States, Wisconsin
Center for Cancer Treatment & Prevention at Sacred Heart Hospital
Eau Claire, Wisconsin, United States, 54701
Marshfield Clinic Cancer Care at Regional Cancer Center
Eau Claire, Wisconsin, United States, 54701
Vince Lombardi Cancer Center at Aurora Lakeland Medical Center - Elkhorn
Elkhorn, Wisconsin, United States, 53121
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54301-3526
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States, 54303
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
Mercy Regional Cancer Center
Janesville, Wisconsin, United States, 53547
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, United States, 54601
Franciscan Skemp Healthcare - La Crosse Campus
La Crosse, Wisconsin, United States, 54601
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States, 54449
Saint Joseph's Hospital
Marshfield, Wisconsin, United States, 54449
Medical Consultants, Limited
Milwaukee, Wisconsin, United States, 53215
Marshfield Clinic - Lakeland Center
Minocqua, Wisconsin, United States, 54548
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
All Saints Cancer Center at Wheaton Franciscan Healthcare
Racine, Wisconsin, United States, 53405
Ministry Medical Group at Saint Mary's Hospital
Rhinelander, Wisconsin, United States, 54501
Marshfield Clinic - Indianhead Center
Rice Lake, Wisconsin, United States, 54868
Vince Lombardi Cancer Clinic - Sheboygan
Sheboygan, Wisconsin, United States, 53081
Saint Michael's Hospital Cancer Center
Stevens Point, Wisconsin, United States, 54481
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
Marshfield Clinic - Wausau Center
Wausau, Wisconsin, United States, 54401
Marshfield Clinic - Weston Center
Weston, Wisconsin, United States, 54476
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States, 54494
Riverview UW Cancer Center at Riverview Hospital
Wisconsin Rapids, Wisconsin, United States, 54494
Canada, Alberta
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, New Brunswick
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Ontario
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada, N6A 4L6
Southlake Regional Health Centre
Newmarket, Ontario, Canada, L3Y 2P9
Northeastern Ontario Regional Cancer Centre
Sudbury, Ontario, Canada, P3E 5J1
Cancer Care Program at Thunder Bay Regional Health Sciences
Thunder Bay, Ontario, Canada, P7B 6V4
St. Michael's Hospital - Toronto
Toronto, Ontario, Canada, M5B 1W8
Canada, Saskatchewan
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada, S4T 7T1
Sponsors and Collaborators
Southwest Oncology Group
NCIC Clinical Trials Group
Investigators
Study Chair: Rita S. Mehta, MD Chao Family Comprehensive Cancer Center
Study Chair: Theodore A. Vandenberg, MD London Regional Cancer Program at London Health Sciences Centre
  More Information

Additional Information:
No publications provided by Southwest Oncology Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00075764     History of Changes
Other Study ID Numbers: CDR0000349337, U10CA032102, S0226, CAN-NCIC-MAC7
Study First Received: January 9, 2004
Last Updated: May 8, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Southwest Oncology Group:
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Anastrozole
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014