- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02115282
Exemestan med eller utan entinostat vid behandling av patienter med återkommande hormonreceptorpositiv bröstcancer som är lokalt avancerad eller metastaserad
En randomiserad fas III-studie av endokrin terapi plus entinostat/placebo hos patienter med hormonreceptorpositiv avancerad bröstcancer
This randomized phase III trial studies exemestane and entinostat to see how well they work compared to exemestane alone in treating patients with hormone receptor-positive breast cancer that has spread to nearby tissue or lymph nodes (locally advanced) or another place in the body (metastatic). Estrogen can cause the growth of breast cancer cells. Endocrine therapy using exemestane may fight breast cancer by lowering the amount of estrogen the body makes. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether exemestane is more effective with or without entinostat in treating breast cancer.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
PRIMARY OBJECTIVES:
I. To evaluate whether the addition of entinostat to endocrine therapy (exemestane) improves progression-free survival (PFS) and/or overall survival (OS) in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have previously progressed on a non-steroidal aromatase inhibitor (Al).
SECONDARY OBJECTIVES:
I. To evaluate the safety and tolerability of entinostat in combination with exemestane, and to compare the safety profile to that of endocrine therapy with placebo.
II. To evaluate the objective response rate of exemestane in combination with entinostat or placebo.
III. To evaluate whether the efficacy of exemestane with entinostat varies with changes in acetylation status in peripheral blood mononuclear cells (PBMCs).
IV. To evaluate the time to treatment deterioration (as defined by decrease in health-related quality of life [HRQL], progression, death) of exemestane + entinostat versus exemestane + placebo arms.
V. To evaluate the differences in overall health-related quality of life (HRQL) between the exemestane + entinostat versus exemestane + placebo arms.
VI. To evaluate the difference with respect to specific symptoms that are associated with entinostat, i.e., fatigue, nausea, anorexia and diarrhea, between the exemestane + entinostat versus exemestane + placebo arms.
VII. To measure adherence to protocol therapy. VIII. To evaluate the pharmacokinetics of entinostat in patients with advanced breast cancer.
IX. To evaluate what, if any, patient variables alter the pharmacokinetic profile of entinostat in patients with advanced breast cancer.
EXPLORATORY OBJECTIVES:
I. To collect archival tumor samples and germline deoxyribonucleic acid (DNA) to explore other potential biomarkers of therapeutic efficacy.
II. To collect patient ratings of adverse events (AEs) using select patient-reported outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) items to evaluate the psychometric properties of PRO-CTCAE items and explore the incorporation of PRO-CTCAE items into a phase III double-blind placebo-controlled trial.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive exemestane orally (PO) once daily (QD) on days 1-28 and entinostat PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) at baseline, at the end of cycle 3, every 3 cycles, at treatment discontinuation, and during follow-up, collection of blood samples at baseline and day 15 of cycle 1, and collection of archived tissue at baseline.
ARM B: Patients receive exemestane as in Arm A and placebo PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI at baseline, at the end of cycle 3, every 3 cycles, at treatment discontinuation, and during follow-up, collection of blood samples at baseline and day 15 of cycle 1, and collection of archived tissue at baseline.
In both arms, pre/perimenopausal female patients and all male patients also receive goserelin acetate subcutaneously (SC) on day 1.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Kontakter och platser
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35233
- University of Alabama at Birmingham Cancer Center
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Arkansas
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Jonesboro, Arkansas, Förenta staterna, 72401
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
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California
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Carmichael, California, Förenta staterna, 95608
- Mercy San Juan Medical Center
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Chico, California, Förenta staterna, 95973
- Adventist Health Cancer Care Center Chico
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Chico, California, Förenta staterna, 95926
- Enloe Medical Center
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Clovis, California, Förenta staterna, 93611
- Community Cancer Institute
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Clovis, California, Förenta staterna, 93611
- University Oncology Associates
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Rancho Mirage, California, Förenta staterna, 92270
- Eisenhower Medical Center
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Sacramento, California, Förenta staterna, 95816
- Mercy Cancer Center - Sacramento
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St. Helena, California, Förenta staterna, 94574
- Saint Helena Hospital
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Whittier, California, Förenta staterna, 90602
- Presbyterian Intercommunity Hospital
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Woodland, California, Förenta staterna, 95695
- Woodland Memorial Hospital
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Colorado
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Aurora, Colorado, Förenta staterna, 80012
- Rocky Mountain Cancer Centers-Aurora
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Aurora, Colorado, Förenta staterna, 80012
- The Medical Center of Aurora
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Boulder, Colorado, Förenta staterna, 80303
- Boulder Community Foothills Hospital
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Boulder, Colorado, Förenta staterna, 80304
- Rocky Mountain Cancer Centers-Boulder
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Colorado Springs, Colorado, Förenta staterna, 80907
- Penrose-Saint Francis Healthcare
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Colorado Springs, Colorado, Förenta staterna, 80909
- UCHealth Memorial Hospital Central
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Colorado Springs, Colorado, Förenta staterna, 80907
- Rocky Mountain Cancer Centers-Penrose
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Denver, Colorado, Förenta staterna, 80218
- Presbyterian - Saint Lukes Medical Center - Health One
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Denver, Colorado, Förenta staterna, 80220
- Rose Medical Center
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Denver, Colorado, Förenta staterna, 80218
- Rocky Mountain Cancer Centers-Midtown
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Denver, Colorado, Förenta staterna, 80220
- Rocky Mountain Cancer Centers-Rose
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Denver, Colorado, Förenta staterna, 80218
- Colorado Blood Cancer Institute
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Denver, Colorado, Förenta staterna, 80218
- Saint Joseph Hospital - Cancer Centers of Colorado
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Denver, Colorado, Förenta staterna, 80210
- AdventHealth Porter
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Durango, Colorado, Förenta staterna, 81301
- Mercy Medical Center
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Durango, Colorado, Förenta staterna, 81301
- CommonSpirit Cancer Center Mercy
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Englewood, Colorado, Förenta staterna, 80113
- Mountain Blue Cancer Care Center - Swedish
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Englewood, Colorado, Förenta staterna, 80113
- Swedish Medical Center
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Golden, Colorado, Förenta staterna, 80401
- Mountain Blue Cancer Care Center
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Greeley, Colorado, Förenta staterna, 80631
- Banner North Colorado Medical Center
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Greenwood Village, Colorado, Förenta staterna, 80111
- Rocky Mountain Cancer Centers-Greenwood Village
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Lakewood, Colorado, Förenta staterna, 80228
- Rocky Mountain Cancer Centers-Lakewood
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Lakewood, Colorado, Förenta staterna, 80228
- CommonSpirit Saint Anthony Hospital Cancer Center
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Littleton, Colorado, Förenta staterna, 80120
- Rocky Mountain Cancer Centers-Littleton
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Littleton, Colorado, Förenta staterna, 80122
- AdventHealth Littleton
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Lone Tree, Colorado, Förenta staterna, 80124
- Sky Ridge Medical Center
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Lone Tree, Colorado, Förenta staterna, 80124
- Rocky Mountain Cancer Centers-Sky Ridge
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Longmont, Colorado, Förenta staterna, 80501
- Longmont United Hospital
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Longmont, Colorado, Förenta staterna, 80501
- Rocky Mountain Cancer Centers-Longmont
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Loveland, Colorado, Förenta staterna, 80539
- Banner North Colorado Medical Center - Loveland Campus
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Parker, Colorado, Förenta staterna, 80138
- Rocky Mountain Cancer Centers-Parker
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Parker, Colorado, Förenta staterna, 80138
- AdventHealth Parker
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Pueblo, Colorado, Förenta staterna, 81004
- Saint Mary Corwin Medical Center
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Pueblo, Colorado, Förenta staterna, 81008
- Rocky Mountain Cancer Centers - Pueblo
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Thornton, Colorado, Förenta staterna, 80260
- Rocky Mountain Cancer Centers-Thornton
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Wheat Ridge, Colorado, Förenta staterna, 80401
- Intermountain Health Lutheran Hospital
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Connecticut
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Guilford, Connecticut, Förenta staterna, 06437
- Smilow Cancer Hospital Care Center - Guilford
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Hartford, Connecticut, Förenta staterna, 06105
- Smilow Cancer Hospital Care Center at Saint Francis
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Manchester, Connecticut, Förenta staterna, 06040
- Manchester Memorial Hospital
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Middletown, Connecticut, Förenta staterna, 06457
- Middlesex Hospital
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New Britain, Connecticut, Förenta staterna, 06050
- The Hospital of Central Connecticut
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New Haven, Connecticut, Förenta staterna, 06520
- Yale University
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Orange, Connecticut, Förenta staterna, 06477
- Smilow Cancer Hospital-Orange Care Center
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Torrington, Connecticut, Förenta staterna, 06790
- Smilow Cancer Hospital-Torrington Care Center
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Waterford, Connecticut, Förenta staterna, 06385
- Smilow Cancer Hospital Care Center - Waterford
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Delaware
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Dover, Delaware, Förenta staterna, 19901
- Bayhealth Hospital Kent Campus
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Lewes, Delaware, Förenta staterna, 19958
- Beebe Medical Center
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Newark, Delaware, Förenta staterna, 19713
- Helen F Graham Cancer Center
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Newark, Delaware, Förenta staterna, 19713
- Medical Oncology Hematology Consultants PA
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Newark, Delaware, Förenta staterna, 19718
- Christiana Care Health System-Christiana Hospital
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Rehoboth Beach, Delaware, Förenta staterna, 19971
- Beebe Health Campus
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Seaford, Delaware, Förenta staterna, 19973
- TidalHealth Nanticoke / Allen Cancer Center
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Wilmington, Delaware, Förenta staterna, 19801
- Christiana Care Health System-Wilmington Hospital
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District of Columbia
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Washington D.C., District of Columbia, Förenta staterna, 20010
- MedStar Washington Hospital Center
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Washington D.C., District of Columbia, Förenta staterna, 20007
- MedStar Georgetown University Hospital
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Washington D.C., District of Columbia, Förenta staterna, 20016
- Sibley Memorial Hospital
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Florida
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Deerfield Beach, Florida, Förenta staterna, 33442
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach
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Gainesville, Florida, Förenta staterna, 32610
- UF Health Cancer Institute - Gainesville
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Jacksonville, Florida, Förenta staterna, 32207
- Baptist MD Anderson Cancer Center
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Lakeland, Florida, Förenta staterna, 33805
- Lakeland Regional Health Hollis Cancer Center
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Miami, Florida, Förenta staterna, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
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Miami, Florida, Förenta staterna, 33176
- UM Sylvester Comprehensive Cancer Center at Kendall
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Plantation, Florida, Förenta staterna, 33324
- UM Sylvester Comprehensive Cancer Center at Plantation
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Weston, Florida, Förenta staterna, 33331
- Cleveland Clinic-Weston
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Georgia
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Atlanta, Georgia, Förenta staterna, 30308
- Emory University Hospital Midtown
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Atlanta, Georgia, Förenta staterna, 30322
- Emory University Hospital/Winship Cancer Institute
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Atlanta, Georgia, Förenta staterna, 30342
- Emory Saint Joseph's Hospital
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Atlanta, Georgia, Förenta staterna, 30303
- Grady Health System
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Columbus, Georgia, Förenta staterna, 31904
- John B Amos Cancer Center
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Macon, Georgia, Förenta staterna, 31201
- Atrium Health Navicent
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Savannah, Georgia, Förenta staterna, 31405
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
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Hawaii
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Honolulu, Hawaii, Förenta staterna, 96813
- Queen's Medical Center
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Honolulu, Hawaii, Förenta staterna, 96813
- Hawaii Cancer Care Inc - Waterfront Plaza
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Honolulu, Hawaii, Förenta staterna, 96813
- Queen's Cancer Cenrer - POB I
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Honolulu, Hawaii, Förenta staterna, 96813
- Straub Clinic and Hospital
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Honolulu, Hawaii, Förenta staterna, 96813
- University of Hawaii Cancer Center
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Honolulu, Hawaii, Förenta staterna, 96817
- Hawaii Cancer Care Inc-Liliha
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Honolulu, Hawaii, Förenta staterna, 96817
- Queen's Cancer Center - Kuakini
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‘Aiea, Hawaii, Förenta staterna, 96701
- Pali Momi Medical Center
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‘Aiea, Hawaii, Förenta staterna, 96701
- Queen's Cancer Center - Pearlridge
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Idaho
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Boise, Idaho, Förenta staterna, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Boise, Idaho, Förenta staterna, 83712
- Saint Luke's Cancer Institute - Boise
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Coeur d'Alene, Idaho, Förenta staterna, 83814
- Kootenai Health - Coeur d'Alene
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Fruitland, Idaho, Förenta staterna, 83619
- Saint Luke's Cancer Institute - Fruitland
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Post Falls, Idaho, Förenta staterna, 83854
- Kootenai Clinic Cancer Services - Post Falls
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Sandpoint, Idaho, Förenta staterna, 83864
- Kootenai Clinic Cancer Services - Sandpoint
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Twin Falls, Idaho, Förenta staterna, 83301
- Saint Luke's Cancer Institute - Twin Falls
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Illinois
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Aurora, Illinois, Förenta staterna, 60504
- Rush-Copley Medical Center
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Bloomington, Illinois, Förenta staterna, 61704
- Illinois CancerCare-Bloomington
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Bloomington, Illinois, Förenta staterna, 61701
- OSF Saint Joseph Medical Center
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Canton, Illinois, Förenta staterna, 61520
- Illinois CancerCare-Canton
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Carbondale, Illinois, Förenta staterna, 62902
- Memorial Hospital of Carbondale
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Carthage, Illinois, Förenta staterna, 62321
- Illinois CancerCare-Carthage
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Centralia, Illinois, Förenta staterna, 62801
- Centralia Oncology Clinic
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Chicago, Illinois, Förenta staterna, 60611
- Northwestern University
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Chicago, Illinois, Förenta staterna, 60637
- University of Chicago Comprehensive Cancer Center
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Chicago, Illinois, Förenta staterna, 60612
- John H Stroger Jr Hospital of Cook County
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Chicago, Illinois, Förenta staterna, 60657
- UChicago Medicine Comprehensive Cancer Center - Saint Joseph Hospital
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Chicago, Illinois, Förenta staterna, 60625
- Swedish Covenant Hospital
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Chicago, Illinois, Förenta staterna, 60640
- Weiss Memorial Hospital
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Danville, Illinois, Förenta staterna, 61832
- Carle at The Riverfront
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Decatur, Illinois, Förenta staterna, 62526
- Decatur Memorial Hospital
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Decatur, Illinois, Förenta staterna, 62526
- Cancer Care Specialists of Illinois - Decatur
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Effingham, Illinois, Förenta staterna, 62401
- Crossroads Cancer Center
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Effingham, Illinois, Förenta staterna, 62401
- Carle Physician Group-Effingham
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Elk Grove Village, Illinois, Förenta staterna, 60007
- Ascension Alexian Brothers - Elk Grove Village
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Elmhurst, Illinois, Förenta staterna, 60126
- Elmhurst Memorial Hospital
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Eureka, Illinois, Förenta staterna, 61530
- Illinois CancerCare-Eureka
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Evanston, Illinois, Förenta staterna, 60202
- Saint Francis Hospital
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Freeport, Illinois, Förenta staterna, 61032
- Freeport Memorial Hospital/Leonard C Ferguson Cancer Center
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Galesburg, Illinois, Förenta staterna, 61401
- Western Illinois Cancer Treatment Center
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Galesburg, Illinois, Förenta staterna, 61401
- Illinois CancerCare-Galesburg
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Geneva, Illinois, Förenta staterna, 60134
- Northwestern Medicine Cancer Center Delnor
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Harvey, Illinois, Förenta staterna, 60426
- Ingalls Memorial Hospital
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Joliet, Illinois, Förenta staterna, 60435
- Duly Health and Care Joliet
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Kankakee, Illinois, Förenta staterna, 60901
- Presence Saint Mary's Hospital
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Kewanee, Illinois, Förenta staterna, 61443
- Illinois CancerCare-Kewanee Clinic
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Macomb, Illinois, Förenta staterna, 61455
- Illinois CancerCare-Macomb
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Mattoon, Illinois, Förenta staterna, 61938
- Carle Physician Group-Mattoon/Charleston
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Maywood, Illinois, Förenta staterna, 60153
- Loyola University Medical Center
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Mount Vernon, Illinois, Förenta staterna, 62864
- SSM Health Good Samaritan
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Naperville, Illinois, Förenta staterna, 60540
- Edward Hospital/Cancer Center
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Normal, Illinois, Förenta staterna, 61761
- Carle Cancer Institute Normal
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Oak Lawn, Illinois, Förenta staterna, 60453-2699
- Advocate Christ Medical Center
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Ottawa, Illinois, Förenta staterna, 61350
- Illinois CancerCare-Ottawa Clinic
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Ottawa, Illinois, Förenta staterna, 61350
- Radiation Oncology of Northern Illinois
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Pekin, Illinois, Förenta staterna, 61554
- Illinois CancerCare-Pekin
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Pekin, Illinois, Förenta staterna, 61554
- OSF Saint Francis Radiation Oncology at Pekin
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Peoria, Illinois, Förenta staterna, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Förenta staterna, 61637
- OSF Saint Francis Medical Center
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Peoria, Illinois, Förenta staterna, 61615
- Illinois CancerCare-Peoria
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Peoria, Illinois, Förenta staterna, 61615
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
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Peru, Illinois, Förenta staterna, 61354
- Illinois CancerCare-Peru
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Peru, Illinois, Förenta staterna, 61354
- Valley Radiation Oncology
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Plainfield, Illinois, Förenta staterna, 60585
- Edward Hospital/Cancer Center?Plainfield
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Princeton, Illinois, Förenta staterna, 61356
- Illinois CancerCare-Princeton
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River Forest, Illinois, Förenta staterna, 60305
- West Suburban Medical Center
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Rockford, Illinois, Förenta staterna, 61114
- UW Health Carbone Cancer Center Rockford
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Springfield, Illinois, Förenta staterna, 62702
- Southern Illinois University School of Medicine
-
Springfield, Illinois, Förenta staterna, 62702
- Springfield Clinic
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Springfield, Illinois, Förenta staterna, 62702
- Central Illinois Hematology Oncology Center
-
Springfield, Illinois, Förenta staterna, 62781
- Springfield Memorial Hospital
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Urbana, Illinois, Förenta staterna, 61801
- Carle Cancer Center
-
Urbana, Illinois, Förenta staterna, 61801
- The Carle Foundation Hospital
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Warrenville, Illinois, Förenta staterna, 60555
- Northwestern Medicine Cancer Center Warrenville
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Yorkville, Illinois, Förenta staterna, 60560
- Rush-Copley Healthcare Center
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Indiana
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Carmel, Indiana, Förenta staterna, 46032
- IU Health North Hospital
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Fishers, Indiana, Förenta staterna, 46037
- IU Health Central Indiana Cancer Centers-Fishers
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Fort Wayne, Indiana, Förenta staterna, 46845
- Fort Wayne Medical Oncology and Hematology Inc-Parkview
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Indianapolis, Indiana, Förenta staterna, 46237
- Franciscan Health Indianapolis
-
Indianapolis, Indiana, Förenta staterna, 46202
- Indiana University/Melvin and Bren Simon Cancer Center
-
Indianapolis, Indiana, Förenta staterna, 46202
- Sidney and Lois Eskenazi Hospital
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Indianapolis, Indiana, Förenta staterna, 46219
- IU Health Central Indiana Cancer Centers-East
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Indianapolis, Indiana, Förenta staterna, 46290
- Springmill Medical Center
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Indianapolis, Indiana, Förenta staterna, 46202
- IU Health Methodist Hospital
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Lafayette, Indiana, Förenta staterna, 47904
- IU Health Arnett Cancer Care
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Michigan City, Indiana, Förenta staterna, 46360
- Woodland Cancer Care Center
-
Mooresville, Indiana, Förenta staterna, 46158
- Franciscan Health Mooresville
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Muncie, Indiana, Förenta staterna, 47303
- IU Health Ball Memorial Hospital
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Richmond, Indiana, Förenta staterna, 47374
- Reid Health
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Terre Haute, Indiana, Förenta staterna, 47804
- Union Hospital
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Iowa
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Ames, Iowa, Förenta staterna, 50010
- Mary Greeley Medical Center
-
Ames, Iowa, Förenta staterna, 50010
- McFarland Clinic - Ames
-
Bettendorf, Iowa, Förenta staterna, 52722
- University of Iowa Healthcare Cancer Services Quad Cities
-
Boone, Iowa, Förenta staterna, 50036
- McFarland Clinic - Boone
-
Cedar Rapids, Iowa, Förenta staterna, 52403
- Mercy Hospital
-
Cedar Rapids, Iowa, Förenta staterna, 52403
- Oncology Associates at Mercy Medical Center
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Clive, Iowa, Förenta staterna, 50325
- Mercy Cancer Center-West Lakes
-
Clive, Iowa, Förenta staterna, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
-
Council Bluffs, Iowa, Förenta staterna, 51503
- Alegent Health Mercy Hospital
-
Davenport, Iowa, Förenta staterna, 52803
- MercyOne Genesis Davenport Medical Center
-
Des Moines, Iowa, Förenta staterna, 50309
- Iowa Methodist Medical Center
-
Des Moines, Iowa, Förenta staterna, 50314
- Mercy Medical Center - Des Moines
-
Des Moines, Iowa, Förenta staterna, 50314
- Broadlawns Medical Center
-
Des Moines, Iowa, Förenta staterna, 50309
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
-
Des Moines, Iowa, Förenta staterna, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
-
Fort Dodge, Iowa, Förenta staterna, 50501
- McFarland Clinic - Trinity Cancer Center
-
Fort Dodge, Iowa, Förenta staterna, 50501
- UI Healthcare Mission Cancer and Blood - Fort Dodge
-
Iowa City, Iowa, Förenta staterna, 52242
- University of Iowa/Holden Comprehensive Cancer Center
-
Jefferson, Iowa, Förenta staterna, 50129
- McFarland Clinic - Jefferson
-
Marshalltown, Iowa, Förenta staterna, 50158
- McFarland Clinic - Marshalltown
-
Mason City, Iowa, Förenta staterna, 50401
- Mercy Medical Center - North Iowa
-
Sioux City, Iowa, Förenta staterna, 51101
- Siouxland Regional Cancer Center
-
West Des Moines, Iowa, Förenta staterna, 50266
- Mercy Medical Center-West Lakes
-
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Kansas
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Chanute, Kansas, Förenta staterna, 66720
- Cancer Center of Kansas - Chanute
-
Dodge City, Kansas, Förenta staterna, 67801
- Cancer Center of Kansas - Dodge City
-
El Dorado, Kansas, Förenta staterna, 67042
- Cancer Center of Kansas - El Dorado
-
Fort Scott, Kansas, Förenta staterna, 66701
- Cancer Center of Kansas - Fort Scott
-
Garden City, Kansas, Förenta staterna, 67846
- Saint Catherine Hospital
-
Great Bend, Kansas, Förenta staterna, 67530
- Central Care Cancer Center - Great Bend
-
Great Bend, Kansas, Förenta staterna, 67530
- Saint Rose Ambulatory and Surgery Center
-
Hays, Kansas, Förenta staterna, 67601
- HaysMed
-
Independence, Kansas, Förenta staterna, 67301
- Cancer Center of Kansas-Independence
-
Kansas City, Kansas, Förenta staterna, 66112
- University of Kansas Cancer Center-West
-
Kingman, Kansas, Förenta staterna, 67068
- Cancer Center of Kansas-Kingman
-
Lawrence, Kansas, Förenta staterna, 66044
- Lawrence Memorial Hospital
-
Lenexa, Kansas, Förenta staterna, 66219
- Kansas Institute of Medicine Cancer and Blood Center
-
Lenexa, Kansas, Förenta staterna, 66219
- Minimally Invasive Surgery Hospital
-
Liberal, Kansas, Förenta staterna, 67905
- Cancer Center of Kansas-Liberal
-
Manhattan, Kansas, Förenta staterna, 66502
- Cancer Center of Kansas-Manhattan
-
McPherson, Kansas, Förenta staterna, 67460
- Cancer Center of Kansas - McPherson
-
Newton, Kansas, Förenta staterna, 67114
- Cancer Center of Kansas - Newton
-
Olathe, Kansas, Förenta staterna, 66061
- The University of Kansas Cancer Center - Olathe
-
Overland Park, Kansas, Förenta staterna, 66210
- University of Kansas Cancer Center-Overland Park
-
Overland Park, Kansas, Förenta staterna, 66209
- Menorah Medical Center
-
Parsons, Kansas, Förenta staterna, 67357
- Cancer Center of Kansas - Parsons
-
Pratt, Kansas, Förenta staterna, 67124
- Cancer Center of Kansas - Pratt
-
Salina, Kansas, Förenta staterna, 67401
- Salina Regional Health Center
-
Salina, Kansas, Förenta staterna, 67401
- Cancer Center of Kansas - Salina
-
Topeka, Kansas, Förenta staterna, 66606
- University of Kansas Health System Saint Francis Campus
-
Wellington, Kansas, Förenta staterna, 67152
- Cancer Center of Kansas - Wellington
-
Wichita, Kansas, Förenta staterna, 67214
- Ascension Via Christi Hospitals Wichita
-
Wichita, Kansas, Förenta staterna, 67208
- Cancer Center of Kansas-Wichita Medical Arts Tower
-
Wichita, Kansas, Förenta staterna, 67214
- Cancer Center of Kansas - Wichita
-
Wichita, Kansas, Förenta staterna, 67208
- Associates In Womens Health
-
Winfield, Kansas, Förenta staterna, 67156
- Cancer Center of Kansas - Winfield
-
-
Kentucky
-
Bardstown, Kentucky, Förenta staterna, 40004
- CommonSpirit Saint Joseph Hospital - Bardstown
-
Corbin, Kentucky, Förenta staterna, 40701
- Baptist Health Corbin
-
Crestview Hills, Kentucky, Förenta staterna, 41017
- Oncology Hematology Care Inc-Crestview
-
Edgewood, Kentucky, Förenta staterna, 41017
- Saint Elizabeth Healthcare Edgewood
-
Elizabethtown, Kentucky, Förenta staterna, 42701
- Baptist Health Hardin
-
Fort Thomas, Kentucky, Förenta staterna, 41075
- Saint Elizabeth Healthcare Fort Thomas
-
Lexington, Kentucky, Förenta staterna, 40536
- University of Kentucky/Markey Cancer Center
-
Lexington, Kentucky, Förenta staterna, 40504
- Saint Joseph Radiation Oncology Resource Center
-
Lexington, Kentucky, Förenta staterna, 40503
- Baptist Health Lexington
-
Lexington, Kentucky, Förenta staterna, 40509
- CommonSpirit Saint Joseph Medical Center - East Lexington
-
Louisville, Kentucky, Förenta staterna, 40202
- Jewish Hospital
-
Louisville, Kentucky, Förenta staterna, 40245
- UofL Health Medical Center Northeast
-
Louisville, Kentucky, Förenta staterna, 40207
- Baptist Health Louisville
-
Madisonville, Kentucky, Förenta staterna, 42431
- Baptist Health Madisonville/Merle Mahr Cancer Center
-
Paducah, Kentucky, Förenta staterna, 42003
- Baptist Health Paducah
-
-
Louisiana
-
Baton Rouge, Louisiana, Förenta staterna, 70805
- LSU Health Baton Rouge-North Clinic
-
Baton Rouge, Louisiana, Förenta staterna, 70809
- Louisiana Hematology Oncology Associates LLC
-
Baton Rouge, Louisiana, Förenta staterna, 70809
- Mary Bird Perkins Cancer Center
-
Baton Rouge, Louisiana, Förenta staterna, 70809
- Ochsner Health Center-Summa
-
Baton Rouge, Louisiana, Förenta staterna, 70816
- Medical Center of Baton Rouge
-
Baton Rouge, Louisiana, Förenta staterna, 70809
- Hematology/Oncology Clinic PLLC
-
Baton Rouge, Louisiana, Förenta staterna, 70808
- Our Lady of the Lake Physician Group
-
Covington, Louisiana, Förenta staterna, 70433
- Mary Bird Perkins Cancer Center - Covington
-
Covington, Louisiana, Förenta staterna, 70433
- Northshore Oncology Associates-Covington
-
Houma, Louisiana, Förenta staterna, 70360
- Mary Bird Perkins Cancer Center - Houma
-
Houma, Louisiana, Förenta staterna, 70360
- Oncology Center of The South Incorporated
-
New Orleans, Louisiana, Förenta staterna, 70121
- Ochsner Medical Center Jefferson
-
New Orleans, Louisiana, Förenta staterna, 70112
- University Medical Center New Orleans
-
New Orleans, Louisiana, Förenta staterna, 70112
- Louisiana State University Health Science Center
-
-
Maine
-
Augusta, Maine, Förenta staterna, 04330
- Harold Alfond Center for Cancer Care
-
Bangor, Maine, Förenta staterna, 04401
- Eastern Maine Medical Center
-
Brewer, Maine, Förenta staterna, 04412
- Lafayette Family Cancer Center-EMMC
-
Rockport, Maine, Förenta staterna, 04856
- Penobscot Bay Medical Center
-
York Village, Maine, Förenta staterna, 03909
- York Hospital
-
-
Maryland
-
Annapolis, Maryland, Förenta staterna, 21401
- Luminis Health Anne Arundel Medical Center
-
Baltimore, Maryland, Förenta staterna, 21237
- MedStar Franklin Square Medical Center/Weinberg Cancer Institute
-
Baltimore, Maryland, Förenta staterna, 21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
-
Baltimore, Maryland, Förenta staterna, 21215
- Sinai Hospital of Baltimore
-
Baltimore, Maryland, Förenta staterna, 21204
- Greater Baltimore Medical Center
-
Baltimore, Maryland, Förenta staterna, 21201
- University of Maryland/Greenebaum Cancer Center
-
Bel Air, Maryland, Förenta staterna, 21014
- UM Upper Chesapeake Medical Center
-
Cumberland, Maryland, Förenta staterna, 21502
- UPMC Western Maryland
-
Easton, Maryland, Förenta staterna, 21601
- University of Maryland Shore Medical Center at Easton
-
Olney, Maryland, Förenta staterna, 20832
- MedStar Montgomery Medical Center
-
Randallstown, Maryland, Förenta staterna, 21133
- Northwest Hospital Center
-
-
Massachusetts
-
Beverly, Massachusetts, Förenta staterna, 01915
- Beverly Hospital
-
Burlington, Massachusetts, Förenta staterna, 01805
- Lahey Clinic
-
Fall River, Massachusetts, Förenta staterna, 02721
- Saint Anne's Hospital
-
Gloucester, Massachusetts, Förenta staterna, 01930
- Addison Gilbert Hospital
-
Newton, Massachusetts, Förenta staterna, 02462
- Newton-Wellesley Hospital
-
Pittsfield, Massachusetts, Förenta staterna, 01201
- Berkshire Medical Center - Cancer Center
-
Winchester, Massachusetts, Förenta staterna, 01890
- Beth Israel Deaconess Medical Center/Winchester Center for Cancer Care
-
Worcester, Massachusetts, Förenta staterna, 01655
- UMass Memorial Medical Center - University Campus
-
-
Michigan
-
Adrian, Michigan, Förenta staterna, 49221
- Hickman Cancer Center
-
Ann Arbor, Michigan, Förenta staterna, 48106
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor
-
Brownstown, Michigan, Förenta staterna, 48183
- Henry Ford Cancer Institute-Downriver
-
Chelsea, Michigan, Förenta staterna, 48118
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
-
Clinton Township, Michigan, Förenta staterna, 48038
- Henry Ford Macomb Hospital-Clinton Township
-
Dearborn, Michigan, Förenta staterna, 48126
- Henry Ford Medical Center-Fairlane
-
Dearborn, Michigan, Förenta staterna, 48124
- Corewell Health Dearborn Hospital
-
Detroit, Michigan, Förenta staterna, 48202
- Henry Ford Hospital
-
Detroit, Michigan, Förenta staterna, 48201
- Wayne State University/Karmanos Cancer Institute
-
Detroit, Michigan, Förenta staterna, 48236
- Henry Ford Health Saint John Hospital
-
Escanaba, Michigan, Förenta staterna, 49829
- OSF Saint Francis Hospital and Medical Group
-
Farmington Hills, Michigan, Förenta staterna, 48334
- Weisberg Cancer Treatment Center
-
Flint, Michigan, Förenta staterna, 48503
- Hurley Medical Center
-
Flint, Michigan, Förenta staterna, 48503
- Genesys Hurley Cancer Institute
-
Grand Rapids, Michigan, Förenta staterna, 49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
-
Grosse Pointe, Michigan, Förenta staterna, 48230
- William Beaumont Hospital-Grosse Pointe
-
Jackson, Michigan, Förenta staterna, 49201
- Allegiance Health
-
Kalamazoo, Michigan, Förenta staterna, 49007
- West Michigan Cancer Center
-
Kalamazoo, Michigan, Förenta staterna, 49048
- Beacon Kalamazoo
-
Livonia, Michigan, Förenta staterna, 48154
- Trinity Health Saint Mary Mercy Livonia Hospital
-
Novi, Michigan, Förenta staterna, 48377
- Henry Ford Medical Center-Columbus
-
Pontiac, Michigan, Förenta staterna, 48341
- Trinity Health Saint Joseph Mercy Oakland Hospital
-
Port Huron, Michigan, Förenta staterna, 48060
- Lake Huron Medical Center
-
Royal Oak, Michigan, Förenta staterna, 48073
- Corewell Health William Beaumont University Hospital
-
Saginaw, Michigan, Förenta staterna, 48601
- MyMichigan Medical Center Saginaw
-
Troy, Michigan, Förenta staterna, 48085
- Corewell Health Beaumont Troy Hospital
-
Warren, Michigan, Förenta staterna, 48093
- Henry Ford Health Warren Hospital
-
West Bloomfield, Michigan, Förenta staterna, 48322
- Henry Ford West Bloomfield Hospital
-
-
Minnesota
-
Bemidji, Minnesota, Förenta staterna, 56601
- Sanford Joe Lueken Cancer Center
-
Brainerd, Minnesota, Förenta staterna, 56401
- Essentia Health Saint Joseph's Medical Center
-
Coon Rapids, Minnesota, Förenta staterna, 55433
- Mercy Hospital
-
Duluth, Minnesota, Förenta staterna, 55805
- Essentia Health Cancer Center
-
Fergus Falls, Minnesota, Förenta staterna, 56537
- Lake Region Healthcare Corporation-Cancer Care
-
Maplewood, Minnesota, Förenta staterna, 55109
- Saint John's Hospital - Healtheast
-
Maplewood, Minnesota, Förenta staterna, 55109
- Minnesota Oncology Hematology PA-Maplewood
-
Minneapolis, Minnesota, Förenta staterna, 55407
- Abbott-Northwestern Hospital
-
Minneapolis, Minnesota, Förenta staterna, 55454
- Health Partners Inc
-
New Ulm, Minnesota, Förenta staterna, 56073
- New Ulm Medical Center
-
Saint Cloud, Minnesota, Förenta staterna, 56303
- Coborn Cancer Center at Saint Cloud Hospital
-
Saint Paul, Minnesota, Förenta staterna, 55101
- Regions Hospital
-
Stillwater, Minnesota, Förenta staterna, 55082
- Lakeview Hospital
-
Willmar, Minnesota, Förenta staterna, 56201
- Rice Memorial Hospital
-
-
Mississippi
-
Columbus, Mississippi, Förenta staterna, 39705
- Baptist Memorial Hospital and Cancer Center-Golden Triangle
-
Grenada, Mississippi, Förenta staterna, 38901
- Baptist Cancer Center-Grenada
-
Hattiesburg, Mississippi, Förenta staterna, 39401
- Hattiesburg Clinic - Hematology/Oncology Clinic
-
Hattiesburg, Mississippi, Förenta staterna, 39404
- Forrest General Hospital / Cancer Center
-
Jackson, Mississippi, Förenta staterna, 39216
- University of Mississippi Medical Center
-
New Albany, Mississippi, Förenta staterna, 38652
- Baptist Memorial Hospital and Cancer Center-Union County
-
Oxford, Mississippi, Förenta staterna, 38655
- Baptist Memorial Hospital and Cancer Center-Oxford
-
Pascagoula, Mississippi, Förenta staterna, 39581
- Singing River Hospital
-
Southhaven, Mississippi, Förenta staterna, 38671
- Baptist Memorial Hospital and Cancer Center-Desoto
-
-
Missouri
-
Ballwin, Missouri, Förenta staterna, 63011
- Mercy Oncology and Hematology - Clayton-Clarkson
-
Bonne Terre, Missouri, Förenta staterna, 63628
- Parkland Health Center-Bonne Terre
-
Branson, Missouri, Förenta staterna, 65616
- Cox Cancer Center Branson
-
Cape Girardeau, Missouri, Förenta staterna, 63703
- Saint Francis Medical Center
-
Cape Girardeau, Missouri, Förenta staterna, 63703
- Mercy Cancer Center - Cape Girardeau
-
Chesterfield, Missouri, Förenta staterna, 63017
- Saint Luke's Hospital
-
City of Saint Peters, Missouri, Förenta staterna, 63376
- Siteman Cancer Center at Saint Peters Hospital
-
Columbia, Missouri, Förenta staterna, 65212
- MU Health - University Hospital/Ellis Fischel Cancer Center
-
Creve Coeur, Missouri, Förenta staterna, 63141
- Siteman Cancer Center at West County Hospital
-
Independence, Missouri, Förenta staterna, 64057
- Centerpoint Medical Center LLC
-
Jefferson City, Missouri, Förenta staterna, 65109
- MU Health Care Goldschmidt Cancer Center
-
Kansas City, Missouri, Förenta staterna, 64154
- University of Kansas Cancer Center - North
-
Kansas City, Missouri, Förenta staterna, 64131
- The University of Kansas Cancer Center-South
-
Kansas City, Missouri, Förenta staterna, 64132
- Research Medical Center
-
Kansas City, Missouri, Förenta staterna, 64108
- University Health Truman Medical Center
-
Lee's Summit, Missouri, Förenta staterna, 64064
- University of Kansas Cancer Center - Lee's Summit
-
Sainte Genevieve, Missouri, Förenta staterna, 63670
- Sainte Genevieve County Memorial Hospital
-
Springfield, Missouri, Förenta staterna, 65807
- CoxHealth South Hospital
-
Springfield, Missouri, Förenta staterna, 65804
- Mercy Hospital Springfield
-
St Louis, Missouri, Förenta staterna, 63110
- Washington University School of Medicine
-
St Louis, Missouri, Förenta staterna, 63131
- Missouri Baptist Medical Center
-
St Louis, Missouri, Förenta staterna, 63109
- Mercy Infusion Center - Chippewa
-
St Louis, Missouri, Förenta staterna, 63141
- Mercy Hospital Saint Louis
-
Sullivan, Missouri, Förenta staterna, 63080
- Missouri Baptist Sullivan Hospital
-
-
Montana
-
Billings, Montana, Förenta staterna, 59101
- Saint Vincent Healthcare
-
Bozeman, Montana, Förenta staterna, 59715
- Bozeman Health Deaconess Hospital
-
Butte, Montana, Förenta staterna, 59701
- Saint James Community Hospital and Cancer Treatment Center
-
Great Falls, Montana, Förenta staterna, 59405
- Benefis Sletten Cancer Institute
-
Helena, Montana, Förenta staterna, 59601
- Saint Peter's Community Hospital
-
Kalispell, Montana, Förenta staterna, 59901
- Logan Health Medical Center
-
Missoula, Montana, Förenta staterna, 59802
- Saint Patrick Hospital - Community Hospital
-
-
Nebraska
-
Grand Island, Nebraska, Förenta staterna, 68803
- Nebraska Cancer Specialists/Oncology Hematology West PC
-
Kearney, Nebraska, Förenta staterna, 68847
- CHI Health Good Samaritan
-
Omaha, Nebraska, Förenta staterna, 68124
- Alegent Health Bergan Mercy Medical Center
-
Omaha, Nebraska, Förenta staterna, 68122
- Alegent Health Immanuel Medical Center
-
Omaha, Nebraska, Förenta staterna, 68130
- Alegent Health Lakeside Hospital
-
-
New Hampshire
-
Dover, New Hampshire, Förenta staterna, 03820
- Wentworth-Douglass Hospital
-
Keene, New Hampshire, Förenta staterna, 03431
- Cheshire Medical Center-Dartmouth-Hitchcock Keene
-
Lebanon, New Hampshire, Förenta staterna, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
-
Manchester, New Hampshire, Förenta staterna, 03104
- Dartmouth Cancer Center - Manchester/ DCC Manchester
-
Nashua, New Hampshire, Förenta staterna, 03060
- Saint Joseph Hospital
-
Nashua, New Hampshire, Förenta staterna, 03063
- Dartmouth Cancer Center - Nashua
-
-
New Jersey
-
Cape May Court House, New Jersey, Förenta staterna, 08210
- AtlantiCare Health Park-Cape May Court House
-
Egg Harbor, New Jersey, Förenta staterna, 08234
- AtlantiCare Surgery Center
-
Englewood, New Jersey, Förenta staterna, 07631
- Englewood Hospital and Medical Center
-
Hackensack, New Jersey, Förenta staterna, 07601
- Hackensack University Medical Center
-
Hamilton, New Jersey, Förenta staterna, 08690
- The Cancer Institute of New Jersey Hamilton
-
Long Branch, New Jersey, Förenta staterna, 07740
- Monmouth Medical Center
-
Mount Holly, New Jersey, Förenta staterna, 08060
- Virtua Memorial
-
Mullica Hill, New Jersey, Förenta staterna, 08062
- Inspira Medical Center Mullica Hill
-
Neptune City, New Jersey, Förenta staterna, 07753
- Jersey Shore Medical Center
-
Somerville, New Jersey, Förenta staterna, 08876
- Robert Wood Johnson University Hospital Somerset
-
Vineland, New Jersey, Förenta staterna, 08360
- Inspira Medical Center Vineland
-
Voorhees Township, New Jersey, Förenta staterna, 08043
- Virtua Voorhees
-
-
New Mexico
-
Albuquerque, New Mexico, Förenta staterna, 87109
- New Mexico Oncology Hematology Consultants
-
Albuquerque, New Mexico, Förenta staterna, 87106
- University of New Mexico Cancer Center
-
Albuquerque, New Mexico, Förenta staterna, 87110
- Presbyterian Kaseman Hospital
-
Las Cruces, New Mexico, Förenta staterna, 88011
- Memorial Medical Center-Las Cruces
-
Santa Fe, New Mexico, Förenta staterna, 87505
- Christus Saint Vincent Regional Cancer Center
-
-
New York
-
Auburn, New York, Förenta staterna, 13021
- Hematology Oncology Associates of Central New York-Auburn
-
Brooklyn, New York, Förenta staterna, 11203
- Kings County Hospital
-
Brooklyn, New York, Förenta staterna, 11203
- State University of New York Downstate Medical Center
-
Buffalo, New York, Förenta staterna, 14263
- Roswell Park Cancer Institute
-
Camillus, New York, Förenta staterna, 13031
- Hematology Oncology Associates of CNY at Camillus
-
East Syracuse, New York, Förenta staterna, 13057
- Hematology Oncology Associates of Central New York-East Syracuse
-
Elmira, New York, Förenta staterna, 14905
- Arnot Ogden Medical Center/Falck Cancer Center
-
New York, New York, Förenta staterna, 10019
- Mount Sinai West
-
New York, New York, Förenta staterna, 10032
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
-
New York, New York, Förenta staterna, 10065
- NYP/Weill Cornell Medical Center
-
New York, New York, Förenta staterna, 10003
- Mount Sinai Union Square
-
Rochester, New York, Förenta staterna, 14642
- University of Rochester
-
Staten Island, New York, Förenta staterna, 10305
- Staten Island University Hospital
-
The Bronx, New York, Förenta staterna, 10461
- Montefiore Medical Center-Einstein Campus
-
The Bronx, New York, Förenta staterna, 10467
- Montefiore Medical Center - Moses Campus
-
The Bronx, New York, Förenta staterna, 10461
- Montefiore Medical Center-Weiler Hospital
-
White Plains, New York, Förenta staterna, 10601
- Dickstein Cancer Treatment Center
-
-
North Carolina
-
Asheboro, North Carolina, Förenta staterna, 27203
- Randolph Hospital
-
Asheville, North Carolina, Förenta staterna, 28801
- Mission Hospital
-
Asheville, North Carolina, Förenta staterna, 28816
- Hope Women's Cancer Centers-Asheville
-
Asheville, North Carolina, Förenta staterna, 28806
- Messino Cancer Centers
-
Burlington, North Carolina, Förenta staterna, 27215
- Cone Health Cancer Center at Alamance Regional
-
Chapel Hill, North Carolina, Förenta staterna, 27599
- UNC Lineberger Comprehensive Cancer Center
-
Clinton, North Carolina, Förenta staterna, 28328
- Southeastern Medical Oncology Center-Clinton
-
Goldsboro, North Carolina, Förenta staterna, 27534
- Southeastern Medical Oncology Center-Goldsboro
-
Goldsboro, North Carolina, Förenta staterna, 27534
- Wayne Memorial Hospital
-
Greensboro, North Carolina, Förenta staterna, 27403
- Cone Health Cancer Center
-
Hendersonville, North Carolina, Förenta staterna, 28791
- Margaret R Pardee Memorial Hospital
-
Jacksonville, North Carolina, Förenta staterna, 28546
- Southeastern Medical Oncology Center-Jacksonville
-
Kinston, North Carolina, Förenta staterna, 28501
- ECU Health Oncology Kinston
-
Mebane, North Carolina, Förenta staterna, 27302
- Cone Heath Cancer Center at Mebane
-
Reidsville, North Carolina, Förenta staterna, 27320
- Annie Penn Memorial Hospital
-
Washington, North Carolina, Förenta staterna, 27889
- Marion L Shepard Cancer Center - ECU Health Beaufort Hospital
-
Winston-Salem, North Carolina, Förenta staterna, 27157
- Wake Forest University Health Sciences
-
-
North Dakota
-
Bismarck, North Dakota, Förenta staterna, 58501
- Sanford Bismarck Medical Center
-
Fargo, North Dakota, Förenta staterna, 58122
- Sanford Roger Maris Cancer Center
-
Fargo, North Dakota, Förenta staterna, 58103
- Essentia Health Cancer Center-South University Clinic
-
Fargo, North Dakota, Förenta staterna, 58122
- Sanford Broadway Medical Center
-
Grand Forks, North Dakota, Förenta staterna, 58201
- Altru Cancer Center
-
Minot, North Dakota, Förenta staterna, 58701
- Trinity Cancer Care Center
-
-
Ohio
-
Akron, Ohio, Förenta staterna, 44307
- Cleveland Clinic Akron General
-
Akron, Ohio, Förenta staterna, 44304
- Summa Health System - Akron Campus
-
Belpre, Ohio, Förenta staterna, 45714
- Strecker Cancer Center-Belpre
-
Bowling Green, Ohio, Förenta staterna, 43402
- Toledo Clinic Cancer Centers-Bowling Green
-
Chillicothe, Ohio, Förenta staterna, 45601
- Adena Regional Medical Center
-
Cincinnati, Ohio, Förenta staterna, 45220
- Good Samaritan Hospital - Cincinnati
-
Cincinnati, Ohio, Förenta staterna, 45242
- Bethesda North Hospital
-
Cincinnati, Ohio, Förenta staterna, 45242
- Oncology Hematology Care Inc-Blue Ash
-
Cincinnati, Ohio, Förenta staterna, 45202
- Oncology Hematology Care Inc-Eden Park
-
Cincinnati, Ohio, Förenta staterna, 45211
- Oncology Hematology Care Inc-Mercy West
-
Cincinnati, Ohio, Förenta staterna, 45230
- Oncology Hematology Care Inc-Anderson
-
Cincinnati, Ohio, Förenta staterna, 45236
- Oncology Hematology Care Inc-Kenwood
-
Cincinnati, Ohio, Förenta staterna, 45247
- TriHealth Cancer Institute-Westside
-
Cincinnati, Ohio, Förenta staterna, 45255
- TriHealth Cancer Institute-Anderson
-
Cleveland, Ohio, Förenta staterna, 44195
- Cleveland Clinic Foundation
-
Cleveland, Ohio, Förenta staterna, 44111
- Cleveland Clinic Cancer Center/Fairview Hospital
-
Columbus, Ohio, Förenta staterna, 43214
- Riverside Methodist Hospital
-
Columbus, Ohio, Förenta staterna, 43210
- Ohio State University Comprehensive Cancer Center
-
Columbus, Ohio, Förenta staterna, 43219
- The Mark H Zangmeister Center
-
Columbus, Ohio, Förenta staterna, 43214
- Columbus Oncology and Hematology Associates Inc
-
Columbus, Ohio, Förenta staterna, 43228
- Doctors Hospital
-
Columbus, Ohio, Förenta staterna, 43213
- Mount Carmel East Hospital
-
Columbus, Ohio, Förenta staterna, 43215
- Grant Medical Center
-
Columbus, Ohio, Förenta staterna, 43222
- Mount Carmel Health Center West
-
Delaware, Ohio, Förenta staterna, 43015
- Delaware Health Center-Grady Cancer Center
-
Delaware, Ohio, Förenta staterna, 43015
- Delaware Radiation Oncology
-
Delaware, Ohio, Förenta staterna, 43015
- Grady Memorial Hospital
-
Fairfield, Ohio, Förenta staterna, 45014
- Oncology Hematology Care Inc-Healthplex
-
Independence, Ohio, Förenta staterna, 44131
- Cleveland Clinic Cancer Center Independence
-
Lancaster, Ohio, Förenta staterna, 43130
- Fairfield Medical Center
-
Lima, Ohio, Förenta staterna, 45801
- Saint Rita's Medical Center
-
Mansfield, Ohio, Förenta staterna, 44906
- Cleveland Clinic Cancer Center Mansfield
-
Marietta, Ohio, Förenta staterna, 45750
- Marietta Memorial Hospital
-
Marion, Ohio, Förenta staterna, 43302
- OhioHealth Marion General Hospital
-
Maumee, Ohio, Förenta staterna, 43537
- Toledo Clinic Cancer Centers-Maumee
-
Mayfield Heights, Ohio, Förenta staterna, 44124
- Hillcrest Hospital Cancer Center
-
Mount Vernon, Ohio, Förenta staterna, 43050
- Knox Community Hospital
-
Newark, Ohio, Förenta staterna, 43055
- Licking Memorial Hospital
-
Newark, Ohio, Förenta staterna, 43055
- Newark Radiation Oncology
-
Oregon, Ohio, Förenta staterna, 43616
- Saint Charles Hospital
-
Oregon, Ohio, Förenta staterna, 43616
- Toledo Clinic Cancer Centers-Oregon
-
Perrysburg, Ohio, Förenta staterna, 43551
- Mercy Health - Perrysburg Hospital
-
Portsmouth, Ohio, Förenta staterna, 45662
- Southern Ohio Medical Center
-
Sandusky, Ohio, Förenta staterna, 44870
- North Coast Cancer Care
-
Springfield, Ohio, Förenta staterna, 45504
- Springfield Regional Cancer Center
-
Springfield, Ohio, Förenta staterna, 45504
- Springfield Regional Medical Center
-
Strongsville, Ohio, Förenta staterna, 44136
- Cleveland Clinic Cancer Center Strongsville
-
Sylvania, Ohio, Förenta staterna, 43560
- ProMedica Flower Hospital
-
Toledo, Ohio, Förenta staterna, 43623
- Mercy Health - Saint Anne Hospital
-
Toledo, Ohio, Förenta staterna, 43623
- Toledo Clinic Cancer Centers-Toledo
-
Toledo, Ohio, Förenta staterna, 43617
- Toledo Community Hospital Oncology Program CCOP
-
Troy, Ohio, Förenta staterna, 45373
- Upper Valley Medical Center
-
Warrensville Heights, Ohio, Förenta staterna, 44122
- South Pointe Hospital
-
Westerville, Ohio, Förenta staterna, 43081
- Saint Ann's Hospital
-
Wooster, Ohio, Förenta staterna, 44691
- Cleveland Clinic Wooster Family Health and Surgery Center
-
Wright-Patterson Air Force Base, Ohio, Förenta staterna, 45433
- Wright-Patterson Medical Center
-
Zanesville, Ohio, Förenta staterna, 43701
- Genesis Healthcare System Cancer Care Center
-
-
Oklahoma
-
Lawton, Oklahoma, Förenta staterna, 73505
- Cancer Centers of Southwest Oklahoma Research
-
Oklahoma City, Oklahoma, Förenta staterna, 73104
- University of Oklahoma Health Sciences Center
-
-
Oregon
-
Bend, Oregon, Förenta staterna, 97701
- Saint Charles Health System
-
Clackamas, Oregon, Förenta staterna, 97015
- Providence Cancer Institute Clackamas Clinic
-
Coos Bay, Oregon, Förenta staterna, 97420
- Bay Area Hospital
-
Medford, Oregon, Förenta staterna, 97504
- Asante Rogue Regional Medical Center
-
Newberg, Oregon, Förenta staterna, 97132
- Providence Newberg Medical Center
-
Oregon City, Oregon, Förenta staterna, 97045
- Providence Willamette Falls Medical Center
-
Portland, Oregon, Förenta staterna, 97213
- Providence Portland Medical Center
-
Portland, Oregon, Förenta staterna, 97225
- Providence Saint Vincent Medical Center
-
-
Pennsylvania
-
Bryn Mawr, Pennsylvania, Förenta staterna, 19010
- Bryn Mawr Hospital
-
Chadds Ford, Pennsylvania, Förenta staterna, 19317
- Christiana Care Health System-Concord Health Center
-
Danville, Pennsylvania, Förenta staterna, 17822
- Geisinger Medical Center
-
Doylestown, Pennsylvania, Förenta staterna, 18901
- Doylestown Hospital
-
Harrisburg, Pennsylvania, Förenta staterna, 17109
- UPMC Pinnacle Cancer Center/Community Osteopathic Campus
-
Hazleton, Pennsylvania, Förenta staterna, 18201
- Geisinger Medical Center-Cancer Center Hazleton
-
Hershey, Pennsylvania, Förenta staterna, 17033-0850
- Penn State Milton S Hershey Medical Center
-
Jefferson Hills, Pennsylvania, Förenta staterna, 15025
- Jefferson Hospital
-
Lancaster, Pennsylvania, Förenta staterna, 17602
- Lancaster General Hospital
-
Lewisburg, Pennsylvania, Förenta staterna, 17837
- Geisinger Medical Oncology-Lewisburg
-
Lewistown, Pennsylvania, Förenta staterna, 17044
- Lewistown Hospital
-
Media, Pennsylvania, Förenta staterna, 19063
- Riddle Memorial Hospital
-
Monroeville, Pennsylvania, Förenta staterna, 15146
- Forbes Hospital
-
Natrona Heights, Pennsylvania, Förenta staterna, 15065
- Allegheny Valley Hospital
-
Paoli, Pennsylvania, Förenta staterna, 19301
- Paoli Memorial Hospital
-
Philadelphia, Pennsylvania, Förenta staterna, 19111
- Fox Chase Cancer Center
-
Philadelphia, Pennsylvania, Förenta staterna, 19140
- Temple University Hospital
-
Philadelphia, Pennsylvania, Förenta staterna, 19141
- Einstein Medical Center Philadelphia
-
Phoenixville, Pennsylvania, Förenta staterna, 19460
- Reading Hospital McGlinn Cancer Institute at Phoenixville
-
Pittsburgh, Pennsylvania, Förenta staterna, 15212
- Allegheny General Hospital
-
Pittsburgh, Pennsylvania, Förenta staterna, 15224
- West Penn Hospital
-
Pittsburgh, Pennsylvania, Förenta staterna, 15232
- UPMC Hillman Cancer Center
-
Pottsville, Pennsylvania, Förenta staterna, 17901
- Geisinger Cancer Services-Pottsville
-
Reading, Pennsylvania, Förenta staterna, 19605
- Penn State Health Saint Joseph Medical Center
-
Sayre, Pennsylvania, Förenta staterna, 18840
- Guthrie Medical Group PC-Robert Packer Hospital
-
State College, Pennsylvania, Förenta staterna, 16801
- Geisinger Medical Group
-
State College, Pennsylvania, Förenta staterna, 16803
- Mount Nittany Medical Center
-
West Chester, Pennsylvania, Förenta staterna, 19380
- Chester County Hospital
-
West Reading, Pennsylvania, Förenta staterna, 19611
- Reading Hospital
-
Wexford, Pennsylvania, Förenta staterna, 15090
- Wexford Health and Wellness Pavilion
-
Wilkes-Barre, Pennsylvania, Förenta staterna, 18711
- Geisinger Wyoming Valley/Henry Cancer Center
-
Williamsport, Pennsylvania, Förenta staterna, 17701
- UPMC Susquehanna
-
Wynnewood, Pennsylvania, Förenta staterna, 19096
- Lankenau Medical Center
-
-
Rhode Island
-
Providence, Rhode Island, Förenta staterna, 02905
- Women and Infants Hospital
-
-
South Carolina
-
Anderson, South Carolina, Förenta staterna, 29621
- AnMed Health Cancer Center
-
Boiling Springs, South Carolina, Förenta staterna, 29316
- Prisma Health Cancer Institute - Spartanburg
-
Charleston, South Carolina, Förenta staterna, 29425
- Medical University of South Carolina
-
Easley, South Carolina, Förenta staterna, 29640
- Prisma Health Cancer Institute - Easley
-
Gaffney, South Carolina, Förenta staterna, 29341
- Gibbs Cancer Center-Gaffney
-
Greenville, South Carolina, Förenta staterna, 29605
- Prisma Health Cancer Institute - Faris
-
Greenville, South Carolina, Förenta staterna, 29607
- Saint Francis Cancer Center
-
Greenville, South Carolina, Förenta staterna, 29615
- Prisma Health Cancer Institute - Eastside
-
Greenville, South Carolina, Förenta staterna, 29605
- Prisma Health Cancer Institute - Butternut
-
Greenville, South Carolina, Förenta staterna, 29601
- Saint Francis Hospital
-
Greer, South Carolina, Förenta staterna, 29650
- Prisma Health Cancer Institute - Greer
-
Greer, South Carolina, Förenta staterna, 29651
- Gibbs Cancer Center-Pelham
-
Seneca, South Carolina, Förenta staterna, 29672
- Prisma Health Cancer Institute - Seneca
-
Spartanburg, South Carolina, Förenta staterna, 29303
- Spartanburg Medical Center
-
-
South Dakota
-
Aberdeen, South Dakota, Förenta staterna, 57401
- Avera Cancer Institute-Aberdeen
-
Rapid City, South Dakota, Förenta staterna, 57701
- Rapid City Regional Hospital
-
Sioux Falls, South Dakota, Förenta staterna, 57105
- Avera Cancer Institute
-
Sioux Falls, South Dakota, Förenta staterna, 57117-5134
- Sanford USD Medical Center - Sioux Falls
-
Sioux Falls, South Dakota, Förenta staterna, 57104
- Sanford Cancer Center Oncology Clinic
-
-
Tennessee
-
Jackson, Tennessee, Förenta staterna, 38301
- Jackson-Madison County General Hospital
-
Kingsport, Tennessee, Förenta staterna, 37660
- Ballad Health Cancer Care - Kingsport
-
Kingsport, Tennessee, Förenta staterna, 37660
- Wellmont Holston Valley Hospital and Medical Center
-
Memphis, Tennessee, Förenta staterna, 38120
- Baptist Memorial Hospital and Cancer Center-Memphis
-
Memphis, Tennessee, Förenta staterna, 38120
- Baptist Memorial Hospital for Women
-
Memphis, Tennessee, Förenta staterna, 38120
- Family Cancer Center-Memphis
-
Nashville, Tennessee, Förenta staterna, 37208
- Meharry Medical College
-
-
Texas
-
Abilene, Texas, Förenta staterna, 79601
- Hendrick Medical Center
-
Dallas, Texas, Förenta staterna, 75235
- Parkland Memorial Hospital
-
Dallas, Texas, Förenta staterna, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
-
El Paso, Texas, Förenta staterna, 79905
- Texas Tech University Health Sciences Center-El Paso
-
Fort Worth, Texas, Förenta staterna, 76104
- UT Southwestern/Simmons Cancer Center-Fort Worth
-
Tyler, Texas, Förenta staterna, 75708
- University of Texas Health Science Center at Tyler
-
-
Vermont
-
Saint Johnsbury, Vermont, Förenta staterna, 05819
- Dartmouth Cancer Center - North
-
-
Virginia
-
Charlottesville, Virginia, Förenta staterna, 22908
- University of Virginia Cancer Center
-
Fredericksburg, Virginia, Förenta staterna, 22408
- Hematology Oncology Associates of Fredericksburg Inc
-
Lynchburg, Virginia, Förenta staterna, 24501
- Centra Alan B Pearson Regional Cancer Center
-
Martinsville, Virginia, Förenta staterna, 24112
- Sovah Health Martinsville
-
Mechanicsville, Virginia, Förenta staterna, 23116
- Bon Secours Memorial Regional Medical Center
-
Midlothian, Virginia, Förenta staterna, 23114
- Bon Secours Saint Francis Medical Center
-
Norton, Virginia, Förenta staterna, 24273
- Ballad Health Cancer Care - Norton
-
Richmond, Virginia, Förenta staterna, 23229
- Virginia Cancer Institute
-
Richmond, Virginia, Förenta staterna, 23226
- Bon Secours Saint Mary's Hospital
-
Richmond, Virginia, Förenta staterna, 23298
- VCU Massey Comprehensive Cancer Center
-
South Hill, Virginia, Förenta staterna, 23970
- VCU Community Memorial Health Center
-
Winchester, Virginia, Förenta staterna, 22601
- Shenandoah Oncology PC
-
-
Washington
-
Burien, Washington, Förenta staterna, 98166
- Saint Anne Hospital
-
Edmonds, Washington, Förenta staterna, 98026
- Swedish Cancer Institute-Edmonds
-
Issaquah, Washington, Förenta staterna, 98029
- Swedish Cancer Institute-Issaquah
-
Kennewick, Washington, Förenta staterna, 99336
- Kadlec Clinic Hematology and Oncology
-
Kirkland, Washington, Förenta staterna, 98034
- FHCC at EvergreenHealth
-
Longview, Washington, Förenta staterna, 98632
- PeaceHealth Saint John Medical Center
-
Mount Vernon, Washington, Förenta staterna, 98274
- Skagit Valley Hospital
-
Mount Vernon, Washington, Förenta staterna, 98274
- Skagit Regional Health Cancer Care Center
-
Poulsbo, Washington, Förenta staterna, 98370
- Harrison HealthPartners Hematology and Oncology-Poulsbo
-
Seattle, Washington, Förenta staterna, 98107
- Swedish Medical Center-Ballard Campus
-
Seattle, Washington, Förenta staterna, 98122
- Swedish Medical Center-First Hill
-
Seattle, Washington, Förenta staterna, 98195
- University of Washington Medical Center - Montlake
-
Seattle, Washington, Förenta staterna, 98112
- Kaiser Permanente Washington
-
Seattle, Washington, Förenta staterna, 98104
- Minor and James Medical PLLC
-
Seattle, Washington, Förenta staterna, 98109
- Fred Hutchinson Cancer Center
-
Silverdale, Washington, Förenta staterna, 98383
- Saint Joseph Medical Center Hematology and Oncology - Silverdale
-
Tacoma, Washington, Förenta staterna, 98405
- Northwest Medical Specialties PLLC
-
Tacoma, Washington, Förenta staterna, 98405
- Franciscan Research Center-Northwest Medical Plaza
-
Vancouver, Washington, Förenta staterna, 98664
- PeaceHealth Southwest Medical Center
-
Walla Walla, Washington, Förenta staterna, 99362
- Providence Saint Mary Regional Cancer Center
-
Yakima, Washington, Förenta staterna, 98902
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
-
-
West Virginia
-
Charleston, West Virginia, Förenta staterna, 25304
- Vandalia Health/CAMC Institute for Academic Medicine
-
Huntington, West Virginia, Förenta staterna, 25701
- Edwards Comprehensive Cancer Center
-
Morgantown, West Virginia, Förenta staterna, 26506
- West Virginia University Healthcare
-
-
Wisconsin
-
Antigo, Wisconsin, Förenta staterna, 54409
- Aspirus Cancer Care-Antigo-Volm Cancer Center
-
Burlington, Wisconsin, Förenta staterna, 53105
- Aurora Cancer Care-Southern Lakes VLCC
-
Chippewa Falls, Wisconsin, Förenta staterna, 54729
- Marshfield Clinic-Chippewa Center
-
Eau Claire, Wisconsin, Förenta staterna, 54701
- Marshfield Clinic Cancer Center at Sacred Heart
-
Fond du Lac, Wisconsin, Förenta staterna, 54937
- Aurora Health Center-Fond du Lac
-
Germantown, Wisconsin, Förenta staterna, 53022
- Aurora Health Care Germantown Health Center
-
Grafton, Wisconsin, Förenta staterna, 53024
- Aurora Cancer Care-Grafton
-
Green Bay, Wisconsin, Förenta staterna, 54311
- Aurora BayCare Medical Center
-
Green Bay, Wisconsin, Förenta staterna, 54301
- Saint Vincent Hospital Cancer Center Green Bay
-
Green Bay, Wisconsin, Förenta staterna, 54303
- Saint Vincent Hospital Cancer Center at Saint Mary's
-
Green Bay, Wisconsin, Förenta staterna, 54301
- Bellin Memorial Hospital
-
Janesville, Wisconsin, Förenta staterna, 53548
- Mercyhealth Hospital and Cancer Center - Janesville
-
Johnson Creek, Wisconsin, Förenta staterna, 53038
- University of Wisconsin Carbone Cancer Center - Johnson Creek
-
Kenosha, Wisconsin, Förenta staterna, 53142
- Aurora Cancer Care-Kenosha South
-
La Crosse, Wisconsin, Förenta staterna, 54601
- Gundersen Lutheran Medical Center
-
Madison, Wisconsin, Förenta staterna, 53792
- University of Wisconsin Carbone Cancer Center - University Hospital
-
Manitowoc, Wisconsin, Förenta staterna, 54221
- Holy Family Memorial Hospital
-
Marinette, Wisconsin, Förenta staterna, 54143
- Aurora Bay Area Medical Group-Marinette
-
Marinette, Wisconsin, Förenta staterna, 54143
- Saint Vincent Hospital Cancer Center at Marinette
-
Marshfield, Wisconsin, Förenta staterna, 54449
- Marshfield Medical Center-Marshfield
-
Milwaukee, Wisconsin, Förenta staterna, 53209
- Aurora Cancer Care-Milwaukee
-
Milwaukee, Wisconsin, Förenta staterna, 53215
- Aurora Saint Luke's Medical Center
-
Milwaukee, Wisconsin, Förenta staterna, 53233
- Aurora Sinai Medical Center
-
Minocqua, Wisconsin, Förenta staterna, 54548
- Marshfield Medical Center - Minocqua
-
Mukwonago, Wisconsin, Förenta staterna, 53149
- ProHealth D N Greenwald Center
-
New Richmond, Wisconsin, Förenta staterna, 54017
- Cancer Center of Western Wisconsin
-
Oconomowoc, Wisconsin, Förenta staterna, 53066
- ProHealth Oconomowoc Memorial Hospital
-
Oconto Falls, Wisconsin, Förenta staterna, 54154
- Saint Vincent Hospital Cancer Center at Oconto Falls
-
Oshkosh, Wisconsin, Förenta staterna, 54904
- Vince Lombardi Cancer Clinic - Oshkosh
-
Racine, Wisconsin, Förenta staterna, 53406
- Aurora Cancer Care-Racine
-
Racine, Wisconsin, Förenta staterna, 53405
- Ascension All Saints Hospital-Spring Street-Racine
-
Rhinelander, Wisconsin, Förenta staterna, 54501
- Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
-
Rice Lake, Wisconsin, Förenta staterna, 54868
- Marshfield Medical Center-Rice Lake
-
Sheboygan, Wisconsin, Förenta staterna, 53081
- Vince Lombardi Cancer Clinic-Sheboygan
-
Sheboygan, Wisconsin, Förenta staterna, 53081
- HSHS Saint Nicholas Hospital
-
Stevens Point, Wisconsin, Förenta staterna, 54482
- Marshfield Medical Center-River Region at Stevens Point
-
Stevens Point, Wisconsin, Förenta staterna, 54481
- Aspirus Cancer Care - Stevens Point
-
Sturgeon Bay, Wisconsin, Förenta staterna, 54235-1495
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
-
Summit, Wisconsin, Förenta staterna, 53066
- Aurora Medical Center in Summit
-
Two Rivers, Wisconsin, Förenta staterna, 54241
- Vince Lombardi Cancer Clinic-Two Rivers
-
Waukesha, Wisconsin, Förenta staterna, 53188
- UW Cancer Center at ProHealth Care
-
Waukesha, Wisconsin, Förenta staterna, 53188
- ProHealth Waukesha Memorial Hospital
-
Waukesha, Wisconsin, Förenta staterna, 53188
- Aurora Cancer Care-Waukesha
-
Wausau, Wisconsin, Förenta staterna, 54401
- Marshfield Clinic-Wausau Center
-
Wausau, Wisconsin, Förenta staterna, 54401
- Aspirus Cancer Care-Wausau
-
Wauwatosa, Wisconsin, Förenta staterna, 53226
- Aurora Cancer Care-Milwaukee West
-
West Allis, Wisconsin, Förenta staterna, 53227
- Aurora West Allis Medical Center
-
Weston, Wisconsin, Förenta staterna, 54476
- Marshfield Medical Center - Weston
-
Wisconsin Rapids, Wisconsin, Förenta staterna, 54494
- Aspirus Cancer Care - Wisconsin Rapids
-
Wisconsin Rapids, Wisconsin, Förenta staterna, 54494
- Marshfield Clinic - Wisconsin Rapids Center
-
-
Wyoming
-
Cheyenne, Wyoming, Förenta staterna, 82001
- Cheyenne Regional Medical Center-West
-
-
-
-
-
Pretoria, Sydafrika, 0002
- University Of Pretoria
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
-
Estrogen receptor (ER) and/or progesterone receptor (PR) positive histologically confirmed adenocarcinoma of the breast with staining of >= 1% cells will be considered positive; receptor status may be based on any time during treatment prior to study randomization, and from any site (i.e. primary, recurrent, or metastatic)
-
Patients whose tumors have HER2 immunohistochemistry (IHC) 3+, in situ hybridization (ISH) >= 2.0, or average HER2 copy number >= 6.0 signals per cell are not eligible; receptor status may be based on any time during treatment prior to study randomization, and from any site (i.e. primary, recurrent, or metastatic)
-
Patients must have measurable or non-measurable stage III/locally advanced or metastatic carcinoma of the breast where local therapy with curative intent is not possible; lesions must be evaluated =< 4 weeks prior to study randomization; diagnostic-quality computed tomography (CT) scans with both oral and intravenous (IV) contrast are the expected radiologic method, unless an alternative is approved
- NOTE: Where baseline imaging has already been performed =< 6 weeks prior to study randomization, repeat imaging may not be required
- NOTE: As of October 16, 2016, accrual of new patients having non-measurable disease has stopped; the planned accrual for this target population has been reached
-
Pre/peri- and postmenopausal women and all men are eligible for this trial; postmenopausal is defined as:
-
Age >= 55 years and one year or more of amenorrhea
-
Age < 55 years and one year or more of amenorrhea, with estradiol < 20 pg/ml
-
Age < 55 with prior hysterectomy but intact ovaries, with estradiol < 20 pg/ml
-
Prior bilateral oophorectomy
- NOTE: Women who do not fit the criteria for being postmenopausal as above are deemed pre-or peri-menopausal; pre/perimenopausal women and all men can enroll provided they agree to receive concomitant luteinizing hormone-releasing hormone (LHRH) agonist; pre/perimenopausal women must have commenced treatment with LHRH agonist at least 4 weeks prior to randomization; if patients have received alternative LHRH agonist prior to study entry, they must switch to goserelin for the duration of the trial
-
-
Sexually active males and pre/perimenopausal women must agree to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study and for 3 months after discontinuation of therapy
-
Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study =< 2 weeks prior to randomization
- A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
-
Patients must not have known central nervous system metastasis or a history of central nervous system (CNS) metastases; patients with leptomeningeal disease are not eligible
-
Patients must be disease-free of prior invasive malignancies for > 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- NOTE: If there is a history of prior malignancy, patients must not be receiving other specific treatment for that cancer
-
Patients must meet at least one of the following criteria:
- Disease progression any time after non-steroidal AI use in the advanced disease setting
- Relapse while on or within =< 12 months of end of adjuvant non-steroidal AI therapy with or without prior endocrine therapy for advanced disease
- NOTE: In either setting, treatment with any prior endocrine therapy must be completed >= 2 weeks prior to cycle 1 day 1 (C1D1) of study treatment with the exception of exemestane which is permitted in the advanced disease setting within =< 4 weeks immediately prior to C1D1; prior adjuvant exemestane is allowed if the disease free interval is > 12 months from the discontinuation of exemestane; prior faslodex, everolimus, palbociclib or other cyclin-dependent kinase (CDK) inhibitor (e.g. ribociclib, abemaciclib) use are allowed and must have been completed >= 2 weeks prior to C1D1; failure to adhere to this washout guideline will result in a protocol violation
-
Patients may have received only one prior chemotherapy regimen for metastatic disease provided treatment was completed >= 3 weeks prior to randomization
-
Patients may be treated with bone modifying agents such as bisphosphonates or RANK-ligand agents (e.g. denosumab) per American Society of Clinical Oncology (ASCO) guidelines; whenever possible, patients requiring bone modifying agents should start treatment >= 7 days prior to study therapy and should continue the same agent throughout study unless clinically compelled to change
-
Prior radiotherapy must in general have been completed >= 2 weeks prior to randomization and patients must have recovered from the toxicity of the radiation
- NOTE: Patients may receive concurrent radiation therapy to painful sites of bony disease or areas of impending fracture as long as sites of measurable or non-measurable disease outside the radiation therapy port are available to follow
-
Patients must NOT receive concurrent anti-cancer therapy or investigational agent unless specified in protocol
-
Patients must NOT be receiving valproic acid, an histone deacetylase (HDAC) inhibitor, and may not have previously received any HDAC inhibitor prior to enrollment (e.g. valproic acid, entinostat, vorinostat) unless discussed with the study chair; patients must not have received prior HDAC therapy for the treatment of their malignancy
-
Patients must have no known allergies to exemestane, entinostat, or medications that have a benzamide structure (e.g., tiapride, remoxipride, clebropride)
-
Patients must NOT suffer from medical or psychiatric conditions that would interfere with protocol compliance, the ability to provide informed consent, or assessment of response or anticipated toxicities; this includes uncontrolled intercurrent illness including, but not limited to ongoing or active infection
-
Patients must have recovered from all clinically relevant adverse events to grade 1 or baseline due to previous agents administered (except alopecia)
-
Patients must have adequate hematologic, liver and renal function =< 28 days prior to randomization
- NOTE: It is preferred that laboratory values for eligibility be assessed after the last dose of prior treatment, especially in cases where most-recent treatment prior to study entry is chemotherapy
-
Hemoglobin (HgB) >= 9.0 g/dL (=< 28 days prior to randomization)
-
Platelet count >= 100,000/mcL (=< 28 days prior to randomization)
-
Absolute neutrophil count >= 1,500/mcL (=< 28 days prior to randomization)
-
Creatinine =< 2.0 mg/dL (=< 28 days prior to randomization)
-
Total bilirubin < 1.5 x institutional upper limit of normal (=< 3 mg/dL in case of Gilbert's syndrome) (=< 28 days prior to randomization)
-
Transaminases (alanine aminotransferase [ALT], aspartate aminotransferase [AST]) =< 2.5 x institutional upper limit normal (=< 28 days prior to randomization)
-
Known human immunodeficiency virus (HIV)-positive patients should have a cluster of differentiation (CD)4 count > 250/mm^3
-
Patients must have Eastern Cooperative Oncology Group (ECOG) performance status 0-1
-
Patients must have a life expectancy >= 12 weeks
-
Patients must be able to swallow tablets
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Arm A (exemestane, entinostat)
Patients receive exemestane PO QD on days 1-28 and entinostat PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI at baseline, at the end of cycle 3, every 3 cycles, at treatment discontinuation, and during follow-up, collection of blood samples at baseline and day 15 of cycle 1, and collection of archived tissue at baseline. Pre/perimenopausal female patients and all male patients also receive goserelin acetate SC on day 1. |
Given PO
Andra namn:
Ancillary studies
Andra namn:
Undergo CT
Andra namn:
Undergo MRI
Andra namn:
Given SC
Andra namn:
Undergo collection of blood and archived tissue samples
Andra namn:
Given PO
Andra namn:
Given PO
Andra namn:
|
|
Placebo-jämförare: Arm B (exemestane, placebo)
Patients receive exemestane as in Arm A and placebo PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI at baseline, at the end of cycle 3, every 3 cycles, at treatment discontinuation, and during follow-up, collection of blood samples at baseline and day 15 of cycle 1, and collection of archived tissue at baseline. Pre/perimenopausal female patients and all male patients also receive goserelin acetate SC on day 1. |
Given PO
Andra namn:
Ancillary studies
Andra namn:
Undergo CT
Andra namn:
Undergo MRI
Andra namn:
Given PO Given SC
Andra namn:
Undergo collection of blood and archived tissue samples
Andra namn:
Given PO
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Progression-free Survival (PFS)
Tidsram: Assessed at baseline, then every 12 weeks until treatment discontinuation, then every 3 months within 2 years from study entry, every 6 months between 2-5 years and annually between 6-10 years from study entry, until first disease progression
|
Progression-free survival (PFS) was defined to be time from randomization to the earliest documented disease progression as defined by the RECIST criteria, new primary breast cancer, or death without progression. Disease assessment was to continue until disease progression, even after non-protocol anti-cancer therapy was started. Cases with incomplete follow up or without adequate disease evaluations were censored at the date last documented to be free of progression, regardless of whether non-protocol anti-cancer therapy was started or not. Disease progression was based on central review, and defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. In addition, the appearance of one or more new lesions was also considered progression. Kaplan-Meier method was used to estimate PFS rate. |
Assessed at baseline, then every 12 weeks until treatment discontinuation, then every 3 months within 2 years from study entry, every 6 months between 2-5 years and annually between 6-10 years from study entry, until first disease progression
|
|
Overall Survival (OS)
Tidsram: Assessed every 3 months within 2 years from study entry, every 6 months between 2-5 years and annually between 6-10 years from study entry, until death
|
Overall survival (OS) was defined to be time from randomization to death from any cause. Cases who were still alive were censored at the date last known alive. |
Assessed every 3 months within 2 years from study entry, every 6 months between 2-5 years and annually between 6-10 years from study entry, until death
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Objective Response Rate (ORR)
Tidsram: Assessed at baseline, then every 12 weeks until treatment discontinuation, then every 3 months within 2 years from study entry, every 6 months between 2-5 years and annually between 6-10 years from study entry, until first disease progression
|
Objective response rate was defined as number of patients with complete response (CR) or partial response (PR) divided by all randomized patients. Responses were evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline. CR was defined as disappearance of all target and non-target lesions. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameters), and/or persistence of one or more non-target lesion(s). |
Assessed at baseline, then every 12 weeks until treatment discontinuation, then every 3 months within 2 years from study entry, every 6 months between 2-5 years and annually between 6-10 years from study entry, until first disease progression
|
|
Time-to-treatment Deterioration (TTD)
Tidsram: Disease assessed at baseline, then every 12 weeks until treatment discontinuation, then every 3 months within 2 years from study entry, every 6 months between 2-5 years and annually between 6-10 years from study entry, until first disease progression
|
Time-to-treatment deterioration (TTD) was defined as time from randomization to disease progression or death or worsening of symptoms, whichever occurred first. Disease progression was assessed per RECIST v1.1. Symptoms deterioration was measured by 6 items (GP1, GP2, GP4, GF7, B1, P2, scored 0-24) from the 8-item FACT-Breast Symptom Index (FBSI). Symptom deterioration was defined as two consecutive available decreases of at least 3 points from baseline using the 6-item FBSI in this trial, and the second visit time was used as the time of symptom deterioration in this case, unless it was the final score, for which one decrease was sufficient. Kaplan-Meier method was used to estimate the median TTD and TTD rate at a certain time point. Symptoms were assessed every cycle for the first six months after randomization, every two cycles between 6 months and 1 year. It then were assessed based on the same schedule for tumor assessments until disease progression as specified below. |
Disease assessed at baseline, then every 12 weeks until treatment discontinuation, then every 3 months within 2 years from study entry, every 6 months between 2-5 years and annually between 6-10 years from study entry, until first disease progression
|
|
Lysine Acetylation Change in CD45 Blood Mononuclear Cells Between C1D1 and C1D15 and PFS in Patients on Arm A
Tidsram: Disease assessed at baseline, then every 12 weeks until treatment discontinuation, then every 3 months within 2 years from study entry, every 6 months between 2-5 years and annually between 6-10 years from study entry, until first disease progression
|
Peripheral blood samples (PBMCs) were collected prior to therapy and on Days 8 and 15 of cycle 1, for assessment of lysine acetylation, using an assay developed by the Trepel Laboratory, NCI/NIH. CD45 blood mononuclear cells were measured. Patients with lysine acetylation change of 1.5 folds or higher were compared to patients with lysine acetylation change of less than 1.5 folds. |
Disease assessed at baseline, then every 12 weeks until treatment discontinuation, then every 3 months within 2 years from study entry, every 6 months between 2-5 years and annually between 6-10 years from study entry, until first disease progression
|
|
Patient-reported Health-related Quality of Life
Tidsram: Assessed at baseline and end of cycle 3
|
Health-related quality of life (HRQL) was measured using Functional Assessment of Cancer Therapy - General (FACT-G). The primary endpoint for HRQL was the FACT-G Trial Outcome Index (TOI) which was an aggregate score of 5 items from the FACT-G-Physical subscale (GP2, GP3, GP4, GP6, and GP7) and 6 items from the FACT-G-Functional subscale (GF1, GF2, GF3, GF4, GF6, and GF7). All items were rated on a 5-point Likert scale from 0 to 4. FACT-G TOI subscale score was calculated based on the scoring manual, subscale score ranges from 0 to 44, and higher scores indicate better quality of life. The primary comparison of HRQL between treatment arms was based on the end of cycle 3 assessment. |
Assessed at baseline and end of cycle 3
|
|
Patient-reported Diarrhea
Tidsram: Assessed at baseline and end of cycle 3
|
Diarrhea was measured by Functional Assessment of Chronic Illness Therapy for Patients With Diarrhea (FACIT-Diarrhea) subscale form, which had 11 items, all items were rated on a 5-point Likert scale from 0 to 4. FACIT-Diarrhea subscale score was calculated based on the scoring manual, subscale score ranges from 0 to 44, and higher score indicates less diarrhea. The primary comparison of patient-reported diarrhea between treatment arms was based on the end of cycle 3 assessment. |
Assessed at baseline and end of cycle 3
|
|
Patient-reported Fatigue
Tidsram: Assessed at baseline and end of cycle 3
|
Fatigue was measured by PROMIS Fatigue short form, it had 7 items and all items were rated on a 5-point Likert scale from 1 to 5. The PROMIS Fatigue total score and T score were calculated based on the scoring manual. The total score ranges from 7 to 35, the T score ranges from 29.4 to 83.2, higher scores indicate more fatigue. The PROMIS Fatigue T score was used for arm comparison. The primary comparison of patient-reported fatigue between treatment arms was based on the end of cycle 3 assessment. |
Assessed at baseline and end of cycle 3
|
|
Patient-reported Nausea and Anorexia
Tidsram: Assessed at baseline and end of cycle 3
|
Nausea and anorexia were measured by The Functional Assessment of Anorexia/Cachexia Treatment (FAACT)-additional concerns, which had 12 items, all items were rated on a 5-point Likert scale from 0 to 4. FAACT-additional concerns subscale score was calculated based on scoring manual. Subscale score ranges from 0 to 48, and higher scores indicate less nausea and anorexia. The primary comparison of patient-reported nausea and anorexia between treatment arms was based on the end of cycle 3 assessment. |
Assessed at baseline and end of cycle 3
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Roisin M Connolly, ECOG-ACRIN Cancer Research Group
Publikationer och användbara länkar
Studieavstämningsdatum
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Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Beräknad)
Uppdateringar av studier
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Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter plats
- Neoplasmer
- Hudsjukdomar
- Bröstsjukdomar
- Hud- och bindvävssjukdomar
- Bröstneoplasmer
- Hormoner
- Hormoner, hormonsubstitut och hormonantagonister
- Hypofyshormonfrisättande hormoner
- Hypotalamiska hormoner
- Peptidhormoner
- Neuropeptider
- Peptider
- Aminosyror, peptider och proteiner
- Oligopeptider
- Nervvävnadsproteiner
- Proteiner
- Undersökningstekniker
- Kliniska laboratorietekniker
- Diagnostiska tekniker och procedurer
- Diagnos
- Kemitekniker, analytiska
- Spektrumanalys
- Gonadotropinfrisättande hormon
- Goserelin
- Provhantering
- Magnetresonansspektroskopi
- exemestan
- entinostat
Andra studie-ID-nummer
- NCI-2014-00746
- U10CA180820 (U.S.S. NIH-anslag/kontrakt)
- U24CA196172 (U.S.S. NIH-anslag/kontrakt)
- U10CA021115 (U.S.S. NIH-anslag/kontrakt)
- NCI-2014-00746 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
- E2112 (Annan identifierare: CTEP)
- ECOG-E2112
- E2112 (Annan identifierare: ECOG-ACRIN Cancer Research Group)
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