局所進行性または転移性の再発性ホルモン受容体陽性乳癌患者の治療におけるエンチノスタット併用または非併用のエキセメスタン
ホルモン受容体陽性進行乳癌患者における内分泌療法とエンチノスタット/プラセボの無作為化第III相試験
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
-
-
Alabama
-
Birmingham、Alabama、アメリカ、35233
- University of Alabama at Birmingham Cancer Center
-
-
Arkansas
-
Jonesboro、Arkansas、アメリカ、72401
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
-
-
California
-
Carmichael、California、アメリカ、95608
- Mercy San Juan Medical Center
-
Chico、California、アメリカ、95973
- Adventist Health Cancer Care Center Chico
-
Chico、California、アメリカ、95926
- Enloe Medical Center
-
Clovis、California、アメリカ、93611
- Community Cancer Institute
-
Clovis、California、アメリカ、93611
- University Oncology Associates
-
Rancho Mirage、California、アメリカ、92270
- Eisenhower Medical Center
-
Sacramento、California、アメリカ、95816
- Mercy Cancer Center - Sacramento
-
St. Helena、California、アメリカ、94574
- Saint Helena Hospital
-
Whittier、California、アメリカ、90602
- Presbyterian Intercommunity Hospital
-
Woodland、California、アメリカ、95695
- Woodland Memorial Hospital
-
-
Colorado
-
Aurora、Colorado、アメリカ、80012
- Rocky Mountain Cancer Centers-Aurora
-
Aurora、Colorado、アメリカ、80012
- The Medical Center of Aurora
-
Boulder、Colorado、アメリカ、80303
- Boulder Community Foothills Hospital
-
Boulder、Colorado、アメリカ、80304
- Rocky Mountain Cancer Centers-Boulder
-
Colorado Springs、Colorado、アメリカ、80907
- Penrose-Saint Francis Healthcare
-
Colorado Springs、Colorado、アメリカ、80909
- UCHealth Memorial Hospital Central
-
Colorado Springs、Colorado、アメリカ、80907
- Rocky Mountain Cancer Centers-Penrose
-
Denver、Colorado、アメリカ、80218
- Presbyterian - Saint Lukes Medical Center - Health One
-
Denver、Colorado、アメリカ、80220
- Rose Medical Center
-
Denver、Colorado、アメリカ、80218
- Rocky Mountain Cancer Centers-Midtown
-
Denver、Colorado、アメリカ、80220
- Rocky Mountain Cancer Centers-Rose
-
Denver、Colorado、アメリカ、80218
- Colorado Blood Cancer Institute
-
Denver、Colorado、アメリカ、80218
- Saint Joseph Hospital - Cancer Centers of Colorado
-
Denver、Colorado、アメリカ、80210
- AdventHealth Porter
-
Durango、Colorado、アメリカ、81301
- Mercy Medical Center
-
Durango、Colorado、アメリカ、81301
- CommonSpirit Cancer Center Mercy
-
Englewood、Colorado、アメリカ、80113
- Mountain Blue Cancer Care Center - Swedish
-
Englewood、Colorado、アメリカ、80113
- Swedish Medical Center
-
Golden、Colorado、アメリカ、80401
- Mountain Blue Cancer Care Center
-
Greeley、Colorado、アメリカ、80631
- Banner North Colorado Medical Center
-
Greenwood Village、Colorado、アメリカ、80111
- Rocky Mountain Cancer Centers-Greenwood Village
-
Lakewood、Colorado、アメリカ、80228
- Rocky Mountain Cancer Centers-Lakewood
-
Lakewood、Colorado、アメリカ、80228
- CommonSpirit Saint Anthony Hospital Cancer Center
-
Littleton、Colorado、アメリカ、80120
- Rocky Mountain Cancer Centers-Littleton
-
Littleton、Colorado、アメリカ、80122
- AdventHealth Littleton
-
Lone Tree、Colorado、アメリカ、80124
- Sky Ridge Medical Center
-
Lone Tree、Colorado、アメリカ、80124
- Rocky Mountain Cancer Centers-Sky Ridge
-
Longmont、Colorado、アメリカ、80501
- Longmont United Hospital
-
Longmont、Colorado、アメリカ、80501
- Rocky Mountain Cancer Centers-Longmont
-
Loveland、Colorado、アメリカ、80539
- Banner North Colorado Medical Center - Loveland Campus
-
Parker、Colorado、アメリカ、80138
- Rocky Mountain Cancer Centers-Parker
-
Parker、Colorado、アメリカ、80138
- AdventHealth Parker
-
Pueblo、Colorado、アメリカ、81004
- Saint Mary Corwin Medical Center
-
Pueblo、Colorado、アメリカ、81008
- Rocky Mountain Cancer Centers - Pueblo
-
Thornton、Colorado、アメリカ、80260
- Rocky Mountain Cancer Centers-Thornton
-
Wheat Ridge、Colorado、アメリカ、80401
- Intermountain Health Lutheran Hospital
-
-
Connecticut
-
Guilford、Connecticut、アメリカ、06437
- Smilow Cancer Hospital Care Center - Guilford
-
Hartford、Connecticut、アメリカ、06105
- Smilow Cancer Hospital Care Center at Saint Francis
-
Manchester、Connecticut、アメリカ、06040
- Manchester Memorial Hospital
-
Middletown、Connecticut、アメリカ、06457
- Middlesex Hospital
-
New Britain、Connecticut、アメリカ、06050
- The Hospital of Central Connecticut
-
New Haven、Connecticut、アメリカ、06520
- Yale University
-
Orange、Connecticut、アメリカ、06477
- Smilow Cancer Hospital-Orange Care Center
-
Torrington、Connecticut、アメリカ、06790
- Smilow Cancer Hospital-Torrington Care Center
-
Waterford、Connecticut、アメリカ、06385
- Smilow Cancer Hospital Care Center - Waterford
-
-
Delaware
-
Dover、Delaware、アメリカ、19901
- Bayhealth Hospital Kent Campus
-
Lewes、Delaware、アメリカ、19958
- Beebe Medical Center
-
Newark、Delaware、アメリカ、19713
- Helen F Graham Cancer Center
-
Newark、Delaware、アメリカ、19713
- Medical Oncology Hematology Consultants PA
-
Newark、Delaware、アメリカ、19718
- Christiana Care Health System-Christiana Hospital
-
Rehoboth Beach、Delaware、アメリカ、19971
- Beebe Health Campus
-
Seaford、Delaware、アメリカ、19973
- TidalHealth Nanticoke / Allen Cancer Center
-
Wilmington、Delaware、アメリカ、19801
- Christiana Care Health System-Wilmington Hospital
-
-
District of Columbia
-
Washington D.C.、District of Columbia、アメリカ、20010
- MedStar Washington Hospital Center
-
Washington D.C.、District of Columbia、アメリカ、20007
- MedStar Georgetown University Hospital
-
Washington D.C.、District of Columbia、アメリカ、20016
- Sibley Memorial Hospital
-
-
Florida
-
Deerfield Beach、Florida、アメリカ、33442
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach
-
Gainesville、Florida、アメリカ、32610
- UF Health Cancer Institute - Gainesville
-
Jacksonville、Florida、アメリカ、32207
- Baptist MD Anderson Cancer Center
-
Lakeland、Florida、アメリカ、33805
- Lakeland Regional Health Hollis Cancer Center
-
Miami、Florida、アメリカ、33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
-
Miami、Florida、アメリカ、33176
- UM Sylvester Comprehensive Cancer Center at Kendall
-
Plantation、Florida、アメリカ、33324
- UM Sylvester Comprehensive Cancer Center at Plantation
-
Weston、Florida、アメリカ、33331
- Cleveland Clinic-Weston
-
-
Georgia
-
Atlanta、Georgia、アメリカ、30308
- Emory University Hospital Midtown
-
Atlanta、Georgia、アメリカ、30322
- Emory University Hospital/Winship Cancer Institute
-
Atlanta、Georgia、アメリカ、30342
- Emory Saint Joseph's Hospital
-
Atlanta、Georgia、アメリカ、30303
- Grady Health System
-
Columbus、Georgia、アメリカ、31904
- John B Amos Cancer Center
-
Macon、Georgia、アメリカ、31201
- Atrium Health Navicent
-
Savannah、Georgia、アメリカ、31405
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
-
-
Hawaii
-
Honolulu、Hawaii、アメリカ、96813
- Queen's Medical Center
-
Honolulu、Hawaii、アメリカ、96813
- Hawaii Cancer Care Inc - Waterfront Plaza
-
Honolulu、Hawaii、アメリカ、96813
- Queen's Cancer Cenrer - POB I
-
Honolulu、Hawaii、アメリカ、96813
- Straub Clinic and Hospital
-
Honolulu、Hawaii、アメリカ、96813
- University of Hawaii Cancer Center
-
Honolulu、Hawaii、アメリカ、96817
- Hawaii Cancer Care Inc-Liliha
-
Honolulu、Hawaii、アメリカ、96817
- Queen's Cancer Center - Kuakini
-
‘Aiea、Hawaii、アメリカ、96701
- Pali Momi Medical Center
-
‘Aiea、Hawaii、アメリカ、96701
- Queen's Cancer Center - Pearlridge
-
-
Idaho
-
Boise、Idaho、アメリカ、83706
- Saint Alphonsus Cancer Care Center-Boise
-
Boise、Idaho、アメリカ、83712
- Saint Luke's Cancer Institute - Boise
-
Coeur d'Alene、Idaho、アメリカ、83814
- Kootenai Health - Coeur d'Alene
-
Fruitland、Idaho、アメリカ、83619
- Saint Luke's Cancer Institute - Fruitland
-
Post Falls、Idaho、アメリカ、83854
- Kootenai Clinic Cancer Services - Post Falls
-
Sandpoint、Idaho、アメリカ、83864
- Kootenai Clinic Cancer Services - Sandpoint
-
Twin Falls、Idaho、アメリカ、83301
- Saint Luke's Cancer Institute - Twin Falls
-
-
Illinois
-
Aurora、Illinois、アメリカ、60504
- Rush-Copley Medical Center
-
Bloomington、Illinois、アメリカ、61704
- Illinois CancerCare-Bloomington
-
Bloomington、Illinois、アメリカ、61701
- OSF Saint Joseph Medical Center
-
Canton、Illinois、アメリカ、61520
- Illinois CancerCare-Canton
-
Carbondale、Illinois、アメリカ、62902
- Memorial Hospital of Carbondale
-
Carthage、Illinois、アメリカ、62321
- Illinois CancerCare-Carthage
-
Centralia、Illinois、アメリカ、62801
- Centralia Oncology Clinic
-
Chicago、Illinois、アメリカ、60611
- Northwestern University
-
Chicago、Illinois、アメリカ、60637
- University of Chicago Comprehensive Cancer Center
-
Chicago、Illinois、アメリカ、60612
- John H Stroger Jr Hospital of Cook County
-
Chicago、Illinois、アメリカ、60657
- UChicago Medicine Comprehensive Cancer Center - Saint Joseph Hospital
-
Chicago、Illinois、アメリカ、60625
- Swedish Covenant Hospital
-
Chicago、Illinois、アメリカ、60640
- Weiss Memorial Hospital
-
Danville、Illinois、アメリカ、61832
- Carle at The Riverfront
-
Decatur、Illinois、アメリカ、62526
- Decatur Memorial Hospital
-
Decatur、Illinois、アメリカ、62526
- Cancer Care Specialists of Illinois - Decatur
-
Effingham、Illinois、アメリカ、62401
- Crossroads Cancer Center
-
Effingham、Illinois、アメリカ、62401
- Carle Physician Group-Effingham
-
Elk Grove Village、Illinois、アメリカ、60007
- Ascension Alexian Brothers - Elk Grove Village
-
Elmhurst、Illinois、アメリカ、60126
- Elmhurst Memorial Hospital
-
Eureka、Illinois、アメリカ、61530
- Illinois CancerCare-Eureka
-
Evanston、Illinois、アメリカ、60202
- Saint Francis Hospital
-
Freeport、Illinois、アメリカ、61032
- Freeport Memorial Hospital/Leonard C Ferguson Cancer Center
-
Galesburg、Illinois、アメリカ、61401
- Western Illinois Cancer Treatment Center
-
Galesburg、Illinois、アメリカ、61401
- Illinois CancerCare-Galesburg
-
Geneva、Illinois、アメリカ、60134
- Northwestern Medicine Cancer Center Delnor
-
Harvey、Illinois、アメリカ、60426
- Ingalls Memorial Hospital
-
Joliet、Illinois、アメリカ、60435
- Duly Health and Care Joliet
-
Kankakee、Illinois、アメリカ、60901
- Presence Saint Mary's Hospital
-
Kewanee、Illinois、アメリカ、61443
- Illinois CancerCare-Kewanee Clinic
-
Macomb、Illinois、アメリカ、61455
- Illinois CancerCare-Macomb
-
Mattoon、Illinois、アメリカ、61938
- Carle Physician Group-Mattoon/Charleston
-
Maywood、Illinois、アメリカ、60153
- Loyola University Medical Center
-
Mount Vernon、Illinois、アメリカ、62864
- SSM Health Good Samaritan
-
Naperville、Illinois、アメリカ、60540
- Edward Hospital/Cancer Center
-
Normal、Illinois、アメリカ、61761
- Carle Cancer Institute Normal
-
Oak Lawn、Illinois、アメリカ、60453-2699
- Advocate Christ Medical Center
-
Ottawa、Illinois、アメリカ、61350
- Illinois CancerCare-Ottawa Clinic
-
Ottawa、Illinois、アメリカ、61350
- Radiation Oncology of Northern Illinois
-
Pekin、Illinois、アメリカ、61554
- Illinois CancerCare-Pekin
-
Pekin、Illinois、アメリカ、61554
- OSF Saint Francis Radiation Oncology at Pekin
-
Peoria、Illinois、アメリカ、61636
- Methodist Medical Center of Illinois
-
Peoria、Illinois、アメリカ、61637
- OSF Saint Francis Medical Center
-
Peoria、Illinois、アメリカ、61615
- Illinois CancerCare-Peoria
-
Peoria、Illinois、アメリカ、61615
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
-
Peru、Illinois、アメリカ、61354
- Illinois CancerCare-Peru
-
Peru、Illinois、アメリカ、61354
- Valley Radiation Oncology
-
Plainfield、Illinois、アメリカ、60585
- Edward Hospital/Cancer Center?Plainfield
-
Princeton、Illinois、アメリカ、61356
- Illinois CancerCare-Princeton
-
River Forest、Illinois、アメリカ、60305
- West Suburban Medical Center
-
Rockford、Illinois、アメリカ、61114
- UW Health Carbone Cancer Center Rockford
-
Springfield、Illinois、アメリカ、62702
- Southern Illinois University School of Medicine
-
Springfield、Illinois、アメリカ、62702
- Springfield Clinic
-
Springfield、Illinois、アメリカ、62702
- Central Illinois Hematology Oncology Center
-
Springfield、Illinois、アメリカ、62781
- Springfield Memorial Hospital
-
Urbana、Illinois、アメリカ、61801
- Carle Cancer Center
-
Urbana、Illinois、アメリカ、61801
- The Carle Foundation Hospital
-
Warrenville、Illinois、アメリカ、60555
- Northwestern Medicine Cancer Center Warrenville
-
Yorkville、Illinois、アメリカ、60560
- Rush-Copley Healthcare Center
-
-
Indiana
-
Carmel、Indiana、アメリカ、46032
- IU Health North Hospital
-
Fishers、Indiana、アメリカ、46037
- IU Health Central Indiana Cancer Centers-Fishers
-
Fort Wayne、Indiana、アメリカ、46845
- Fort Wayne Medical Oncology and Hematology Inc-Parkview
-
Indianapolis、Indiana、アメリカ、46237
- Franciscan Health Indianapolis
-
Indianapolis、Indiana、アメリカ、46202
- Indiana University/Melvin and Bren Simon Cancer Center
-
Indianapolis、Indiana、アメリカ、46202
- Sidney and Lois Eskenazi Hospital
-
Indianapolis、Indiana、アメリカ、46219
- IU Health Central Indiana Cancer Centers-East
-
Indianapolis、Indiana、アメリカ、46290
- Springmill Medical Center
-
Indianapolis、Indiana、アメリカ、46202
- IU Health Methodist Hospital
-
Lafayette、Indiana、アメリカ、47904
- IU Health Arnett Cancer Care
-
Michigan City、Indiana、アメリカ、46360
- Woodland Cancer Care Center
-
Mooresville、Indiana、アメリカ、46158
- Franciscan Health Mooresville
-
Muncie、Indiana、アメリカ、47303
- IU Health Ball Memorial Hospital
-
Richmond、Indiana、アメリカ、47374
- Reid Health
-
Terre Haute、Indiana、アメリカ、47804
- Union Hospital
-
-
Iowa
-
Ames、Iowa、アメリカ、50010
- Mary Greeley Medical Center
-
Ames、Iowa、アメリカ、50010
- McFarland Clinic - Ames
-
Bettendorf、Iowa、アメリカ、52722
- University of Iowa Healthcare Cancer Services Quad Cities
-
Boone、Iowa、アメリカ、50036
- McFarland Clinic - Boone
-
Cedar Rapids、Iowa、アメリカ、52403
- Mercy Hospital
-
Cedar Rapids、Iowa、アメリカ、52403
- Oncology Associates at Mercy Medical Center
-
Clive、Iowa、アメリカ、50325
- Mercy Cancer Center-West Lakes
-
Clive、Iowa、アメリカ、50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
-
Council Bluffs、Iowa、アメリカ、51503
- Alegent Health Mercy Hospital
-
Davenport、Iowa、アメリカ、52803
- MercyOne Genesis Davenport Medical Center
-
Des Moines、Iowa、アメリカ、50309
- Iowa Methodist Medical Center
-
Des Moines、Iowa、アメリカ、50314
- Mercy Medical Center - Des Moines
-
Des Moines、Iowa、アメリカ、50314
- Broadlawns Medical Center
-
Des Moines、Iowa、アメリカ、50309
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
-
Des Moines、Iowa、アメリカ、50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
-
Fort Dodge、Iowa、アメリカ、50501
- McFarland Clinic - Trinity Cancer Center
-
Fort Dodge、Iowa、アメリカ、50501
- UI Healthcare Mission Cancer and Blood - Fort Dodge
-
Iowa City、Iowa、アメリカ、52242
- University of Iowa/Holden Comprehensive Cancer Center
-
Jefferson、Iowa、アメリカ、50129
- McFarland Clinic - Jefferson
-
Marshalltown、Iowa、アメリカ、50158
- McFarland Clinic - Marshalltown
-
Mason City、Iowa、アメリカ、50401
- Mercy Medical Center - North Iowa
-
Sioux City、Iowa、アメリカ、51101
- Siouxland Regional Cancer Center
-
West Des Moines、Iowa、アメリカ、50266
- Mercy Medical Center-West Lakes
-
-
Kansas
-
Chanute、Kansas、アメリカ、66720
- Cancer Center of Kansas - Chanute
-
Dodge City、Kansas、アメリカ、67801
- Cancer Center of Kansas - Dodge City
-
El Dorado、Kansas、アメリカ、67042
- Cancer Center of Kansas - El Dorado
-
Fort Scott、Kansas、アメリカ、66701
- Cancer Center of Kansas - Fort Scott
-
Garden City、Kansas、アメリカ、67846
- Saint Catherine Hospital
-
Great Bend、Kansas、アメリカ、67530
- Central Care Cancer Center - Great Bend
-
Great Bend、Kansas、アメリカ、67530
- Saint Rose Ambulatory and Surgery Center
-
Hays、Kansas、アメリカ、67601
- HaysMed
-
Independence、Kansas、アメリカ、67301
- Cancer Center of Kansas-Independence
-
Kansas City、Kansas、アメリカ、66112
- University of Kansas Cancer Center-West
-
Kingman、Kansas、アメリカ、67068
- Cancer Center of Kansas-Kingman
-
Lawrence、Kansas、アメリカ、66044
- Lawrence Memorial Hospital
-
Lenexa、Kansas、アメリカ、66219
- Kansas Institute of Medicine Cancer and Blood Center
-
Lenexa、Kansas、アメリカ、66219
- Minimally Invasive Surgery Hospital
-
Liberal、Kansas、アメリカ、67905
- Cancer Center of Kansas-Liberal
-
Manhattan、Kansas、アメリカ、66502
- Cancer Center of Kansas-Manhattan
-
McPherson、Kansas、アメリカ、67460
- Cancer Center of Kansas - McPherson
-
Newton、Kansas、アメリカ、67114
- Cancer Center of Kansas - Newton
-
Olathe、Kansas、アメリカ、66061
- The University of Kansas Cancer Center - Olathe
-
Overland Park、Kansas、アメリカ、66210
- University of Kansas Cancer Center-Overland Park
-
Overland Park、Kansas、アメリカ、66209
- Menorah Medical Center
-
Parsons、Kansas、アメリカ、67357
- Cancer Center of Kansas - Parsons
-
Pratt、Kansas、アメリカ、67124
- Cancer Center of Kansas - Pratt
-
Salina、Kansas、アメリカ、67401
- Salina Regional Health Center
-
Salina、Kansas、アメリカ、67401
- Cancer Center of Kansas - Salina
-
Topeka、Kansas、アメリカ、66606
- University of Kansas Health System Saint Francis Campus
-
Wellington、Kansas、アメリカ、67152
- Cancer Center of Kansas - Wellington
-
Wichita、Kansas、アメリカ、67214
- Ascension Via Christi Hospitals Wichita
-
Wichita、Kansas、アメリカ、67208
- Cancer Center of Kansas-Wichita Medical Arts Tower
-
Wichita、Kansas、アメリカ、67214
- Cancer Center of Kansas - Wichita
-
Wichita、Kansas、アメリカ、67208
- Associates In Womens Health
-
Winfield、Kansas、アメリカ、67156
- Cancer Center of Kansas - Winfield
-
-
Kentucky
-
Bardstown、Kentucky、アメリカ、40004
- CommonSpirit Saint Joseph Hospital - Bardstown
-
Corbin、Kentucky、アメリカ、40701
- Baptist Health Corbin
-
Crestview Hills、Kentucky、アメリカ、41017
- Oncology Hematology Care Inc-Crestview
-
Edgewood、Kentucky、アメリカ、41017
- Saint Elizabeth Healthcare Edgewood
-
Elizabethtown、Kentucky、アメリカ、42701
- Baptist Health Hardin
-
Fort Thomas、Kentucky、アメリカ、41075
- Saint Elizabeth Healthcare Fort Thomas
-
Lexington、Kentucky、アメリカ、40536
- University of Kentucky/Markey Cancer Center
-
Lexington、Kentucky、アメリカ、40504
- Saint Joseph Radiation Oncology Resource Center
-
Lexington、Kentucky、アメリカ、40503
- Baptist Health Lexington
-
Lexington、Kentucky、アメリカ、40509
- CommonSpirit Saint Joseph Medical Center - East Lexington
-
Louisville、Kentucky、アメリカ、40202
- Jewish Hospital
-
Louisville、Kentucky、アメリカ、40245
- UofL Health Medical Center Northeast
-
Louisville、Kentucky、アメリカ、40207
- Baptist Health Louisville
-
Madisonville、Kentucky、アメリカ、42431
- Baptist Health Madisonville/Merle Mahr Cancer Center
-
Paducah、Kentucky、アメリカ、42003
- Baptist Health Paducah
-
-
Louisiana
-
Baton Rouge、Louisiana、アメリカ、70805
- LSU Health Baton Rouge-North Clinic
-
Baton Rouge、Louisiana、アメリカ、70809
- Louisiana Hematology Oncology Associates LLC
-
Baton Rouge、Louisiana、アメリカ、70809
- Mary Bird Perkins Cancer Center
-
Baton Rouge、Louisiana、アメリカ、70809
- Ochsner Health Center-Summa
-
Baton Rouge、Louisiana、アメリカ、70816
- Medical Center of Baton Rouge
-
Baton Rouge、Louisiana、アメリカ、70809
- Hematology/Oncology Clinic PLLC
-
Baton Rouge、Louisiana、アメリカ、70808
- Our Lady of the Lake Physician Group
-
Covington、Louisiana、アメリカ、70433
- Mary Bird Perkins Cancer Center - Covington
-
Covington、Louisiana、アメリカ、70433
- Northshore Oncology Associates-Covington
-
Houma、Louisiana、アメリカ、70360
- Mary Bird Perkins Cancer Center - Houma
-
Houma、Louisiana、アメリカ、70360
- Oncology Center of The South Incorporated
-
New Orleans、Louisiana、アメリカ、70121
- Ochsner Medical Center Jefferson
-
New Orleans、Louisiana、アメリカ、70112
- University Medical Center New Orleans
-
New Orleans、Louisiana、アメリカ、70112
- Louisiana State University Health Science Center
-
-
Maine
-
Augusta、Maine、アメリカ、04330
- Harold Alfond Center for Cancer Care
-
Bangor、Maine、アメリカ、04401
- Eastern Maine Medical Center
-
Brewer、Maine、アメリカ、04412
- Lafayette Family Cancer Center-EMMC
-
Rockport、Maine、アメリカ、04856
- Penobscot Bay Medical Center
-
York Village、Maine、アメリカ、03909
- York Hospital
-
-
Maryland
-
Annapolis、Maryland、アメリカ、21401
- Luminis Health Anne Arundel Medical Center
-
Baltimore、Maryland、アメリカ、21237
- MedStar Franklin Square Medical Center/Weinberg Cancer Institute
-
Baltimore、Maryland、アメリカ、21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
-
Baltimore、Maryland、アメリカ、21215
- Sinai Hospital of Baltimore
-
Baltimore、Maryland、アメリカ、21204
- Greater Baltimore Medical Center
-
Baltimore、Maryland、アメリカ、21201
- University of Maryland/Greenebaum Cancer Center
-
Bel Air、Maryland、アメリカ、21014
- UM Upper Chesapeake Medical Center
-
Cumberland、Maryland、アメリカ、21502
- UPMC Western Maryland
-
Easton、Maryland、アメリカ、21601
- University of Maryland Shore Medical Center at Easton
-
Olney、Maryland、アメリカ、20832
- MedStar Montgomery Medical Center
-
Randallstown、Maryland、アメリカ、21133
- Northwest Hospital Center
-
-
Massachusetts
-
Beverly、Massachusetts、アメリカ、01915
- Beverly Hospital
-
Burlington、Massachusetts、アメリカ、01805
- Lahey Clinic
-
Fall River、Massachusetts、アメリカ、02721
- Saint Anne's Hospital
-
Gloucester、Massachusetts、アメリカ、01930
- Addison Gilbert Hospital
-
Newton、Massachusetts、アメリカ、02462
- Newton-Wellesley Hospital
-
Pittsfield、Massachusetts、アメリカ、01201
- Berkshire Medical Center - Cancer Center
-
Winchester、Massachusetts、アメリカ、01890
- Beth Israel Deaconess Medical Center/Winchester Center for Cancer Care
-
Worcester、Massachusetts、アメリカ、01655
- UMass Memorial Medical Center - University Campus
-
-
Michigan
-
Adrian、Michigan、アメリカ、49221
- Hickman Cancer Center
-
Ann Arbor、Michigan、アメリカ、48106
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor
-
Brownstown、Michigan、アメリカ、48183
- Henry Ford Cancer Institute-Downriver
-
Chelsea、Michigan、アメリカ、48118
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
-
Clinton Township、Michigan、アメリカ、48038
- Henry Ford Macomb Hospital-Clinton Township
-
Dearborn、Michigan、アメリカ、48126
- Henry Ford Medical Center-Fairlane
-
Dearborn、Michigan、アメリカ、48124
- Corewell Health Dearborn Hospital
-
Detroit、Michigan、アメリカ、48202
- Henry Ford Hospital
-
Detroit、Michigan、アメリカ、48201
- Wayne State University/Karmanos Cancer Institute
-
Detroit、Michigan、アメリカ、48236
- Henry Ford Health Saint John Hospital
-
Escanaba、Michigan、アメリカ、49829
- OSF Saint Francis Hospital and Medical Group
-
Farmington Hills、Michigan、アメリカ、48334
- Weisberg Cancer Treatment Center
-
Flint、Michigan、アメリカ、48503
- Hurley Medical Center
-
Flint、Michigan、アメリカ、48503
- Genesys Hurley Cancer Institute
-
Grand Rapids、Michigan、アメリカ、49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
-
Grosse Pointe、Michigan、アメリカ、48230
- William Beaumont Hospital-Grosse Pointe
-
Jackson、Michigan、アメリカ、49201
- Allegiance Health
-
Kalamazoo、Michigan、アメリカ、49007
- West Michigan Cancer Center
-
Kalamazoo、Michigan、アメリカ、49048
- Beacon Kalamazoo
-
Livonia、Michigan、アメリカ、48154
- Trinity Health Saint Mary Mercy Livonia Hospital
-
Novi、Michigan、アメリカ、48377
- Henry Ford Medical Center-Columbus
-
Pontiac、Michigan、アメリカ、48341
- Trinity Health Saint Joseph Mercy Oakland Hospital
-
Port Huron、Michigan、アメリカ、48060
- Lake Huron Medical Center
-
Royal Oak、Michigan、アメリカ、48073
- Corewell Health William Beaumont University Hospital
-
Saginaw、Michigan、アメリカ、48601
- MyMichigan Medical Center Saginaw
-
Troy、Michigan、アメリカ、48085
- Corewell Health Beaumont Troy Hospital
-
Warren、Michigan、アメリカ、48093
- Henry Ford Health Warren Hospital
-
West Bloomfield、Michigan、アメリカ、48322
- Henry Ford West Bloomfield Hospital
-
-
Minnesota
-
Bemidji、Minnesota、アメリカ、56601
- Sanford Joe Lueken Cancer Center
-
Brainerd、Minnesota、アメリカ、56401
- Essentia Health Saint Joseph's Medical Center
-
Coon Rapids、Minnesota、アメリカ、55433
- Mercy Hospital
-
Duluth、Minnesota、アメリカ、55805
- Essentia Health Cancer Center
-
Fergus Falls、Minnesota、アメリカ、56537
- Lake Region Healthcare Corporation-Cancer Care
-
Maplewood、Minnesota、アメリカ、55109
- Saint John's Hospital - Healtheast
-
Maplewood、Minnesota、アメリカ、55109
- Minnesota Oncology Hematology PA-Maplewood
-
Minneapolis、Minnesota、アメリカ、55407
- Abbott-Northwestern Hospital
-
Minneapolis、Minnesota、アメリカ、55454
- Health Partners Inc
-
New Ulm、Minnesota、アメリカ、56073
- New Ulm Medical Center
-
Saint Cloud、Minnesota、アメリカ、56303
- Coborn Cancer Center at Saint Cloud Hospital
-
Saint Paul、Minnesota、アメリカ、55101
- Regions Hospital
-
Stillwater、Minnesota、アメリカ、55082
- Lakeview Hospital
-
Willmar、Minnesota、アメリカ、56201
- Rice Memorial Hospital
-
-
Mississippi
-
Columbus、Mississippi、アメリカ、39705
- Baptist Memorial Hospital and Cancer Center-Golden Triangle
-
Grenada、Mississippi、アメリカ、38901
- Baptist Cancer Center-Grenada
-
Hattiesburg、Mississippi、アメリカ、39401
- Hattiesburg Clinic - Hematology/Oncology Clinic
-
Hattiesburg、Mississippi、アメリカ、39404
- Forrest General Hospital / Cancer Center
-
Jackson、Mississippi、アメリカ、39216
- University of Mississippi Medical Center
-
New Albany、Mississippi、アメリカ、38652
- Baptist Memorial Hospital and Cancer Center-Union County
-
Oxford、Mississippi、アメリカ、38655
- Baptist Memorial Hospital and Cancer Center-Oxford
-
Pascagoula、Mississippi、アメリカ、39581
- Singing River Hospital
-
Southhaven、Mississippi、アメリカ、38671
- Baptist Memorial Hospital and Cancer Center-Desoto
-
-
Missouri
-
Ballwin、Missouri、アメリカ、63011
- Mercy Oncology and Hematology - Clayton-Clarkson
-
Bonne Terre、Missouri、アメリカ、63628
- Parkland Health Center-Bonne Terre
-
Branson、Missouri、アメリカ、65616
- Cox Cancer Center Branson
-
Cape Girardeau、Missouri、アメリカ、63703
- Saint Francis Medical Center
-
Cape Girardeau、Missouri、アメリカ、63703
- Mercy Cancer Center - Cape Girardeau
-
Chesterfield、Missouri、アメリカ、63017
- Saint Luke's Hospital
-
City of Saint Peters、Missouri、アメリカ、63376
- Siteman Cancer Center at Saint Peters Hospital
-
Columbia、Missouri、アメリカ、65212
- MU Health - University Hospital/Ellis Fischel Cancer Center
-
Creve Coeur、Missouri、アメリカ、63141
- Siteman Cancer Center at West County Hospital
-
Independence、Missouri、アメリカ、64057
- Centerpoint Medical Center LLC
-
Jefferson City、Missouri、アメリカ、65109
- MU Health Care Goldschmidt Cancer Center
-
Kansas City、Missouri、アメリカ、64154
- University of Kansas Cancer Center - North
-
Kansas City、Missouri、アメリカ、64131
- The University of Kansas Cancer Center-South
-
Kansas City、Missouri、アメリカ、64132
- Research Medical Center
-
Kansas City、Missouri、アメリカ、64108
- University Health Truman Medical Center
-
Lee's Summit、Missouri、アメリカ、64064
- University of Kansas Cancer Center - Lee's Summit
-
Sainte Genevieve、Missouri、アメリカ、63670
- Sainte Genevieve County Memorial Hospital
-
Springfield、Missouri、アメリカ、65807
- CoxHealth South Hospital
-
Springfield、Missouri、アメリカ、65804
- Mercy Hospital Springfield
-
St Louis、Missouri、アメリカ、63110
- Washington University School of Medicine
-
St Louis、Missouri、アメリカ、63131
- Missouri Baptist Medical Center
-
St Louis、Missouri、アメリカ、63109
- Mercy Infusion Center - Chippewa
-
St Louis、Missouri、アメリカ、63141
- Mercy Hospital Saint Louis
-
Sullivan、Missouri、アメリカ、63080
- Missouri Baptist Sullivan Hospital
-
-
Montana
-
Billings、Montana、アメリカ、59101
- Saint Vincent Healthcare
-
Bozeman、Montana、アメリカ、59715
- Bozeman Health Deaconess Hospital
-
Butte、Montana、アメリカ、59701
- Saint James Community Hospital and Cancer Treatment Center
-
Great Falls、Montana、アメリカ、59405
- Benefis Sletten Cancer Institute
-
Helena、Montana、アメリカ、59601
- Saint Peter's Community Hospital
-
Kalispell、Montana、アメリカ、59901
- Logan Health Medical Center
-
Missoula、Montana、アメリカ、59802
- Saint Patrick Hospital - Community Hospital
-
-
Nebraska
-
Grand Island、Nebraska、アメリカ、68803
- Nebraska Cancer Specialists/Oncology Hematology West PC
-
Kearney、Nebraska、アメリカ、68847
- CHI Health Good Samaritan
-
Omaha、Nebraska、アメリカ、68124
- Alegent Health Bergan Mercy Medical Center
-
Omaha、Nebraska、アメリカ、68122
- Alegent Health Immanuel Medical Center
-
Omaha、Nebraska、アメリカ、68130
- Alegent Health Lakeside Hospital
-
-
New Hampshire
-
Dover、New Hampshire、アメリカ、03820
- Wentworth-Douglass Hospital
-
Keene、New Hampshire、アメリカ、03431
- Cheshire Medical Center-Dartmouth-Hitchcock Keene
-
Lebanon、New Hampshire、アメリカ、03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
-
Manchester、New Hampshire、アメリカ、03104
- Dartmouth Cancer Center - Manchester/ DCC Manchester
-
Nashua、New Hampshire、アメリカ、03060
- Saint Joseph Hospital
-
Nashua、New Hampshire、アメリカ、03063
- Dartmouth Cancer Center - Nashua
-
-
New Jersey
-
Cape May Court House、New Jersey、アメリカ、08210
- AtlantiCare Health Park-Cape May Court House
-
Egg Harbor、New Jersey、アメリカ、08234
- AtlantiCare Surgery Center
-
Englewood、New Jersey、アメリカ、07631
- Englewood Hospital and Medical Center
-
Hackensack、New Jersey、アメリカ、07601
- Hackensack University Medical Center
-
Hamilton、New Jersey、アメリカ、08690
- The Cancer Institute of New Jersey Hamilton
-
Long Branch、New Jersey、アメリカ、07740
- Monmouth Medical Center
-
Mount Holly、New Jersey、アメリカ、08060
- Virtua Memorial
-
Mullica Hill、New Jersey、アメリカ、08062
- Inspira Medical Center Mullica Hill
-
Neptune City、New Jersey、アメリカ、07753
- Jersey Shore Medical Center
-
Somerville、New Jersey、アメリカ、08876
- Robert Wood Johnson University Hospital Somerset
-
Vineland、New Jersey、アメリカ、08360
- Inspira Medical Center Vineland
-
Voorhees Township、New Jersey、アメリカ、08043
- Virtua Voorhees
-
-
New Mexico
-
Albuquerque、New Mexico、アメリカ、87109
- New Mexico Oncology Hematology Consultants
-
Albuquerque、New Mexico、アメリカ、87106
- University of New Mexico Cancer Center
-
Albuquerque、New Mexico、アメリカ、87110
- Presbyterian Kaseman Hospital
-
Las Cruces、New Mexico、アメリカ、88011
- Memorial Medical Center-Las Cruces
-
Santa Fe、New Mexico、アメリカ、87505
- Christus Saint Vincent Regional Cancer Center
-
-
New York
-
Auburn、New York、アメリカ、13021
- Hematology Oncology Associates of Central New York-Auburn
-
Brooklyn、New York、アメリカ、11203
- Kings County Hospital
-
Brooklyn、New York、アメリカ、11203
- State University of New York Downstate Medical Center
-
Buffalo、New York、アメリカ、14263
- Roswell Park Cancer Institute
-
Camillus、New York、アメリカ、13031
- Hematology Oncology Associates of CNY at Camillus
-
East Syracuse、New York、アメリカ、13057
- Hematology Oncology Associates of Central New York-East Syracuse
-
Elmira、New York、アメリカ、14905
- Arnot Ogden Medical Center/Falck Cancer Center
-
New York、New York、アメリカ、10019
- Mount Sinai West
-
New York、New York、アメリカ、10032
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
-
New York、New York、アメリカ、10065
- NYP/Weill Cornell Medical Center
-
New York、New York、アメリカ、10003
- Mount Sinai Union Square
-
Rochester、New York、アメリカ、14642
- University of Rochester
-
Staten Island、New York、アメリカ、10305
- Staten Island University Hospital
-
The Bronx、New York、アメリカ、10461
- Montefiore Medical Center-Einstein Campus
-
The Bronx、New York、アメリカ、10467
- Montefiore Medical Center - Moses Campus
-
The Bronx、New York、アメリカ、10461
- Montefiore Medical Center-Weiler Hospital
-
White Plains、New York、アメリカ、10601
- Dickstein Cancer Treatment Center
-
-
North Carolina
-
Asheboro、North Carolina、アメリカ、27203
- Randolph Hospital
-
Asheville、North Carolina、アメリカ、28801
- Mission Hospital
-
Asheville、North Carolina、アメリカ、28816
- Hope Women's Cancer Centers-Asheville
-
Asheville、North Carolina、アメリカ、28806
- Messino Cancer Centers
-
Burlington、North Carolina、アメリカ、27215
- Cone Health Cancer Center at Alamance Regional
-
Chapel Hill、North Carolina、アメリカ、27599
- UNC Lineberger Comprehensive Cancer Center
-
Clinton、North Carolina、アメリカ、28328
- Southeastern Medical Oncology Center-Clinton
-
Goldsboro、North Carolina、アメリカ、27534
- Southeastern Medical Oncology Center-Goldsboro
-
Goldsboro、North Carolina、アメリカ、27534
- Wayne Memorial Hospital
-
Greensboro、North Carolina、アメリカ、27403
- Cone Health Cancer Center
-
Hendersonville、North Carolina、アメリカ、28791
- Margaret R Pardee Memorial Hospital
-
Jacksonville、North Carolina、アメリカ、28546
- Southeastern Medical Oncology Center-Jacksonville
-
Kinston、North Carolina、アメリカ、28501
- ECU Health Oncology Kinston
-
Mebane、North Carolina、アメリカ、27302
- Cone Heath Cancer Center at Mebane
-
Reidsville、North Carolina、アメリカ、27320
- Annie Penn Memorial Hospital
-
Washington、North Carolina、アメリカ、27889
- Marion L Shepard Cancer Center - ECU Health Beaufort Hospital
-
Winston-Salem、North Carolina、アメリカ、27157
- Wake Forest University Health Sciences
-
-
North Dakota
-
Bismarck、North Dakota、アメリカ、58501
- Sanford Bismarck Medical Center
-
Fargo、North Dakota、アメリカ、58122
- Sanford Roger Maris Cancer Center
-
Fargo、North Dakota、アメリカ、58103
- Essentia Health Cancer Center-South University Clinic
-
Fargo、North Dakota、アメリカ、58122
- Sanford Broadway Medical Center
-
Grand Forks、North Dakota、アメリカ、58201
- Altru Cancer Center
-
Minot、North Dakota、アメリカ、58701
- Trinity Cancer Care Center
-
-
Ohio
-
Akron、Ohio、アメリカ、44307
- Cleveland Clinic Akron General
-
Akron、Ohio、アメリカ、44304
- Summa Health System - Akron Campus
-
Belpre、Ohio、アメリカ、45714
- Strecker Cancer Center-Belpre
-
Bowling Green、Ohio、アメリカ、43402
- Toledo Clinic Cancer Centers-Bowling Green
-
Chillicothe、Ohio、アメリカ、45601
- Adena Regional Medical Center
-
Cincinnati、Ohio、アメリカ、45220
- Good Samaritan Hospital - Cincinnati
-
Cincinnati、Ohio、アメリカ、45242
- Bethesda North Hospital
-
Cincinnati、Ohio、アメリカ、45242
- Oncology Hematology Care Inc-Blue Ash
-
Cincinnati、Ohio、アメリカ、45202
- Oncology Hematology Care Inc-Eden Park
-
Cincinnati、Ohio、アメリカ、45211
- Oncology Hematology Care Inc-Mercy West
-
Cincinnati、Ohio、アメリカ、45230
- Oncology Hematology Care Inc-Anderson
-
Cincinnati、Ohio、アメリカ、45236
- Oncology Hematology Care Inc-Kenwood
-
Cincinnati、Ohio、アメリカ、45247
- TriHealth Cancer Institute-Westside
-
Cincinnati、Ohio、アメリカ、45255
- TriHealth Cancer Institute-Anderson
-
Cleveland、Ohio、アメリカ、44195
- Cleveland Clinic Foundation
-
Cleveland、Ohio、アメリカ、44111
- Cleveland Clinic Cancer Center/Fairview Hospital
-
Columbus、Ohio、アメリカ、43214
- Riverside Methodist Hospital
-
Columbus、Ohio、アメリカ、43210
- Ohio State University Comprehensive Cancer Center
-
Columbus、Ohio、アメリカ、43219
- The Mark H Zangmeister Center
-
Columbus、Ohio、アメリカ、43214
- Columbus Oncology and Hematology Associates Inc
-
Columbus、Ohio、アメリカ、43228
- Doctors Hospital
-
Columbus、Ohio、アメリカ、43213
- Mount Carmel East Hospital
-
Columbus、Ohio、アメリカ、43215
- Grant Medical Center
-
Columbus、Ohio、アメリカ、43222
- Mount Carmel Health Center West
-
Delaware、Ohio、アメリカ、43015
- Delaware Health Center-Grady Cancer Center
-
Delaware、Ohio、アメリカ、43015
- Delaware Radiation Oncology
-
Delaware、Ohio、アメリカ、43015
- Grady Memorial Hospital
-
Fairfield、Ohio、アメリカ、45014
- Oncology Hematology Care Inc-Healthplex
-
Independence、Ohio、アメリカ、44131
- Cleveland Clinic Cancer Center Independence
-
Lancaster、Ohio、アメリカ、43130
- Fairfield Medical Center
-
Lima、Ohio、アメリカ、45801
- Saint Rita's Medical Center
-
Mansfield、Ohio、アメリカ、44906
- Cleveland Clinic Cancer Center Mansfield
-
Marietta、Ohio、アメリカ、45750
- Marietta Memorial Hospital
-
Marion、Ohio、アメリカ、43302
- OhioHealth Marion General Hospital
-
Maumee、Ohio、アメリカ、43537
- Toledo Clinic Cancer Centers-Maumee
-
Mayfield Heights、Ohio、アメリカ、44124
- Hillcrest Hospital Cancer Center
-
Mount Vernon、Ohio、アメリカ、43050
- Knox Community Hospital
-
Newark、Ohio、アメリカ、43055
- Licking Memorial Hospital
-
Newark、Ohio、アメリカ、43055
- Newark Radiation Oncology
-
Oregon、Ohio、アメリカ、43616
- Saint Charles Hospital
-
Oregon、Ohio、アメリカ、43616
- Toledo Clinic Cancer Centers-Oregon
-
Perrysburg、Ohio、アメリカ、43551
- Mercy Health - Perrysburg Hospital
-
Portsmouth、Ohio、アメリカ、45662
- Southern Ohio Medical Center
-
Sandusky、Ohio、アメリカ、44870
- North Coast Cancer Care
-
Springfield、Ohio、アメリカ、45504
- Springfield Regional Cancer Center
-
Springfield、Ohio、アメリカ、45504
- Springfield Regional Medical Center
-
Strongsville、Ohio、アメリカ、44136
- Cleveland Clinic Cancer Center Strongsville
-
Sylvania、Ohio、アメリカ、43560
- ProMedica Flower Hospital
-
Toledo、Ohio、アメリカ、43623
- Mercy Health - Saint Anne Hospital
-
Toledo、Ohio、アメリカ、43623
- Toledo Clinic Cancer Centers-Toledo
-
Toledo、Ohio、アメリカ、43617
- Toledo Community Hospital Oncology Program CCOP
-
Troy、Ohio、アメリカ、45373
- Upper Valley Medical Center
-
Warrensville Heights、Ohio、アメリカ、44122
- South Pointe Hospital
-
Westerville、Ohio、アメリカ、43081
- Saint Ann's Hospital
-
Wooster、Ohio、アメリカ、44691
- Cleveland Clinic Wooster Family Health and Surgery Center
-
Wright-Patterson Air Force Base、Ohio、アメリカ、45433
- Wright-Patterson Medical Center
-
Zanesville、Ohio、アメリカ、43701
- Genesis Healthcare System Cancer Care Center
-
-
Oklahoma
-
Lawton、Oklahoma、アメリカ、73505
- Cancer Centers of Southwest Oklahoma Research
-
Oklahoma City、Oklahoma、アメリカ、73104
- University of Oklahoma Health Sciences Center
-
-
Oregon
-
Bend、Oregon、アメリカ、97701
- Saint Charles Health System
-
Clackamas、Oregon、アメリカ、97015
- Providence Cancer Institute Clackamas Clinic
-
Coos Bay、Oregon、アメリカ、97420
- Bay Area Hospital
-
Medford、Oregon、アメリカ、97504
- Asante Rogue Regional Medical Center
-
Newberg、Oregon、アメリカ、97132
- Providence Newberg Medical Center
-
Oregon City、Oregon、アメリカ、97045
- Providence Willamette Falls Medical Center
-
Portland、Oregon、アメリカ、97213
- Providence Portland Medical Center
-
Portland、Oregon、アメリカ、97225
- Providence Saint Vincent Medical Center
-
-
Pennsylvania
-
Bryn Mawr、Pennsylvania、アメリカ、19010
- Bryn Mawr Hospital
-
Chadds Ford、Pennsylvania、アメリカ、19317
- Christiana Care Health System-Concord Health Center
-
Danville、Pennsylvania、アメリカ、17822
- Geisinger Medical Center
-
Doylestown、Pennsylvania、アメリカ、18901
- Doylestown Hospital
-
Harrisburg、Pennsylvania、アメリカ、17109
- UPMC Pinnacle Cancer Center/Community Osteopathic Campus
-
Hazleton、Pennsylvania、アメリカ、18201
- Geisinger Medical Center-Cancer Center Hazleton
-
Hershey、Pennsylvania、アメリカ、17033-0850
- Penn State Milton S Hershey Medical Center
-
Jefferson Hills、Pennsylvania、アメリカ、15025
- Jefferson Hospital
-
Lancaster、Pennsylvania、アメリカ、17602
- Lancaster General Hospital
-
Lewisburg、Pennsylvania、アメリカ、17837
- Geisinger Medical Oncology-Lewisburg
-
Lewistown、Pennsylvania、アメリカ、17044
- Lewistown Hospital
-
Media、Pennsylvania、アメリカ、19063
- Riddle Memorial Hospital
-
Monroeville、Pennsylvania、アメリカ、15146
- Forbes Hospital
-
Natrona Heights、Pennsylvania、アメリカ、15065
- Allegheny Valley Hospital
-
Paoli、Pennsylvania、アメリカ、19301
- Paoli Memorial Hospital
-
Philadelphia、Pennsylvania、アメリカ、19111
- Fox Chase Cancer Center
-
Philadelphia、Pennsylvania、アメリカ、19140
- Temple University Hospital
-
Philadelphia、Pennsylvania、アメリカ、19141
- Einstein Medical Center Philadelphia
-
Phoenixville、Pennsylvania、アメリカ、19460
- Reading Hospital McGlinn Cancer Institute at Phoenixville
-
Pittsburgh、Pennsylvania、アメリカ、15212
- Allegheny General Hospital
-
Pittsburgh、Pennsylvania、アメリカ、15224
- West Penn Hospital
-
Pittsburgh、Pennsylvania、アメリカ、15232
- UPMC Hillman Cancer Center
-
Pottsville、Pennsylvania、アメリカ、17901
- Geisinger Cancer Services-Pottsville
-
Reading、Pennsylvania、アメリカ、19605
- Penn State Health Saint Joseph Medical Center
-
Sayre、Pennsylvania、アメリカ、18840
- Guthrie Medical Group PC-Robert Packer Hospital
-
State College、Pennsylvania、アメリカ、16801
- Geisinger Medical Group
-
State College、Pennsylvania、アメリカ、16803
- Mount Nittany Medical Center
-
West Chester、Pennsylvania、アメリカ、19380
- Chester County Hospital
-
West Reading、Pennsylvania、アメリカ、19611
- Reading Hospital
-
Wexford、Pennsylvania、アメリカ、15090
- Wexford Health and Wellness Pavilion
-
Wilkes-Barre、Pennsylvania、アメリカ、18711
- Geisinger Wyoming Valley/Henry Cancer Center
-
Williamsport、Pennsylvania、アメリカ、17701
- UPMC Susquehanna
-
Wynnewood、Pennsylvania、アメリカ、19096
- Lankenau Medical Center
-
-
Rhode Island
-
Providence、Rhode Island、アメリカ、02905
- Women and Infants Hospital
-
-
South Carolina
-
Anderson、South Carolina、アメリカ、29621
- AnMed Health Cancer Center
-
Boiling Springs、South Carolina、アメリカ、29316
- Prisma Health Cancer Institute - Spartanburg
-
Charleston、South Carolina、アメリカ、29425
- Medical University of South Carolina
-
Easley、South Carolina、アメリカ、29640
- Prisma Health Cancer Institute - Easley
-
Gaffney、South Carolina、アメリカ、29341
- Gibbs Cancer Center-Gaffney
-
Greenville、South Carolina、アメリカ、29605
- Prisma Health Cancer Institute - Faris
-
Greenville、South Carolina、アメリカ、29607
- Saint Francis Cancer Center
-
Greenville、South Carolina、アメリカ、29615
- Prisma Health Cancer Institute - Eastside
-
Greenville、South Carolina、アメリカ、29605
- Prisma Health Cancer Institute - Butternut
-
Greenville、South Carolina、アメリカ、29601
- Saint Francis Hospital
-
Greer、South Carolina、アメリカ、29650
- Prisma Health Cancer Institute - Greer
-
Greer、South Carolina、アメリカ、29651
- Gibbs Cancer Center-Pelham
-
Seneca、South Carolina、アメリカ、29672
- Prisma Health Cancer Institute - Seneca
-
Spartanburg、South Carolina、アメリカ、29303
- Spartanburg Medical Center
-
-
South Dakota
-
Aberdeen、South Dakota、アメリカ、57401
- Avera Cancer Institute-Aberdeen
-
Rapid City、South Dakota、アメリカ、57701
- Rapid City Regional Hospital
-
Sioux Falls、South Dakota、アメリカ、57105
- Avera Cancer Institute
-
Sioux Falls、South Dakota、アメリカ、57117-5134
- Sanford USD Medical Center - Sioux Falls
-
Sioux Falls、South Dakota、アメリカ、57104
- Sanford Cancer Center Oncology Clinic
-
-
Tennessee
-
Jackson、Tennessee、アメリカ、38301
- Jackson-Madison County General Hospital
-
Kingsport、Tennessee、アメリカ、37660
- Ballad Health Cancer Care - Kingsport
-
Kingsport、Tennessee、アメリカ、37660
- Wellmont Holston Valley Hospital and Medical Center
-
Memphis、Tennessee、アメリカ、38120
- Baptist Memorial Hospital and Cancer Center-Memphis
-
Memphis、Tennessee、アメリカ、38120
- Baptist Memorial Hospital for Women
-
Memphis、Tennessee、アメリカ、38120
- Family Cancer Center-Memphis
-
Nashville、Tennessee、アメリカ、37208
- Meharry Medical College
-
-
Texas
-
Abilene、Texas、アメリカ、79601
- Hendrick Medical Center
-
Dallas、Texas、アメリカ、75235
- Parkland Memorial Hospital
-
Dallas、Texas、アメリカ、75390
- UT Southwestern/Simmons Cancer Center-Dallas
-
El Paso、Texas、アメリカ、79905
- Texas Tech University Health Sciences Center-El Paso
-
Fort Worth、Texas、アメリカ、76104
- UT Southwestern/Simmons Cancer Center-Fort Worth
-
Tyler、Texas、アメリカ、75708
- University of Texas Health Science Center at Tyler
-
-
Vermont
-
Saint Johnsbury、Vermont、アメリカ、05819
- Dartmouth Cancer Center - North
-
-
Virginia
-
Charlottesville、Virginia、アメリカ、22908
- University of Virginia Cancer Center
-
Fredericksburg、Virginia、アメリカ、22408
- Hematology Oncology Associates of Fredericksburg Inc
-
Lynchburg、Virginia、アメリカ、24501
- Centra Alan B Pearson Regional Cancer Center
-
Martinsville、Virginia、アメリカ、24112
- Sovah Health Martinsville
-
Mechanicsville、Virginia、アメリカ、23116
- Bon Secours Memorial Regional Medical Center
-
Midlothian、Virginia、アメリカ、23114
- Bon Secours Saint Francis Medical Center
-
Norton、Virginia、アメリカ、24273
- Ballad Health Cancer Care - Norton
-
Richmond、Virginia、アメリカ、23229
- Virginia Cancer Institute
-
Richmond、Virginia、アメリカ、23226
- Bon Secours Saint Mary's Hospital
-
Richmond、Virginia、アメリカ、23298
- VCU Massey Comprehensive Cancer Center
-
South Hill、Virginia、アメリカ、23970
- VCU Community Memorial Health Center
-
Winchester、Virginia、アメリカ、22601
- Shenandoah Oncology PC
-
-
Washington
-
Burien、Washington、アメリカ、98166
- Saint Anne Hospital
-
Edmonds、Washington、アメリカ、98026
- Swedish Cancer Institute-Edmonds
-
Issaquah、Washington、アメリカ、98029
- Swedish Cancer Institute-Issaquah
-
Kennewick、Washington、アメリカ、99336
- Kadlec Clinic Hematology and Oncology
-
Kirkland、Washington、アメリカ、98034
- FHCC at EvergreenHealth
-
Longview、Washington、アメリカ、98632
- PeaceHealth Saint John Medical Center
-
Mount Vernon、Washington、アメリカ、98274
- Skagit Valley Hospital
-
Mount Vernon、Washington、アメリカ、98274
- Skagit Regional Health Cancer Care Center
-
Poulsbo、Washington、アメリカ、98370
- Harrison HealthPartners Hematology and Oncology-Poulsbo
-
Seattle、Washington、アメリカ、98107
- Swedish Medical Center-Ballard Campus
-
Seattle、Washington、アメリカ、98122
- Swedish Medical Center-First Hill
-
Seattle、Washington、アメリカ、98195
- University of Washington Medical Center - Montlake
-
Seattle、Washington、アメリカ、98112
- Kaiser Permanente Washington
-
Seattle、Washington、アメリカ、98104
- Minor and James Medical PLLC
-
Seattle、Washington、アメリカ、98109
- Fred Hutchinson Cancer Center
-
Silverdale、Washington、アメリカ、98383
- Saint Joseph Medical Center Hematology and Oncology - Silverdale
-
Tacoma、Washington、アメリカ、98405
- Northwest Medical Specialties PLLC
-
Tacoma、Washington、アメリカ、98405
- Franciscan Research Center-Northwest Medical Plaza
-
Vancouver、Washington、アメリカ、98664
- PeaceHealth Southwest Medical Center
-
Walla Walla、Washington、アメリカ、99362
- Providence Saint Mary Regional Cancer Center
-
Yakima、Washington、アメリカ、98902
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
-
-
West Virginia
-
Charleston、West Virginia、アメリカ、25304
- Vandalia Health/CAMC Institute for Academic Medicine
-
Huntington、West Virginia、アメリカ、25701
- Edwards Comprehensive Cancer Center
-
Morgantown、West Virginia、アメリカ、26506
- West Virginia University Healthcare
-
-
Wisconsin
-
Antigo、Wisconsin、アメリカ、54409
- Aspirus Cancer Care-Antigo-Volm Cancer Center
-
Burlington、Wisconsin、アメリカ、53105
- Aurora Cancer Care-Southern Lakes VLCC
-
Chippewa Falls、Wisconsin、アメリカ、54729
- Marshfield Clinic-Chippewa Center
-
Eau Claire、Wisconsin、アメリカ、54701
- Marshfield Clinic Cancer Center at Sacred Heart
-
Fond du Lac、Wisconsin、アメリカ、54937
- Aurora Health Center-Fond du Lac
-
Germantown、Wisconsin、アメリカ、53022
- Aurora Health Care Germantown Health Center
-
Grafton、Wisconsin、アメリカ、53024
- Aurora Cancer Care-Grafton
-
Green Bay、Wisconsin、アメリカ、54311
- Aurora BayCare Medical Center
-
Green Bay、Wisconsin、アメリカ、54301
- Saint Vincent Hospital Cancer Center Green Bay
-
Green Bay、Wisconsin、アメリカ、54303
- Saint Vincent Hospital Cancer Center at Saint Mary's
-
Green Bay、Wisconsin、アメリカ、54301
- Bellin Memorial Hospital
-
Janesville、Wisconsin、アメリカ、53548
- Mercyhealth Hospital and Cancer Center - Janesville
-
Johnson Creek、Wisconsin、アメリカ、53038
- University of Wisconsin Carbone Cancer Center - Johnson Creek
-
Kenosha、Wisconsin、アメリカ、53142
- Aurora Cancer Care-Kenosha South
-
La Crosse、Wisconsin、アメリカ、54601
- Gundersen Lutheran Medical Center
-
Madison、Wisconsin、アメリカ、53792
- University of Wisconsin Carbone Cancer Center - University Hospital
-
Manitowoc、Wisconsin、アメリカ、54221
- Holy Family Memorial Hospital
-
Marinette、Wisconsin、アメリカ、54143
- Aurora Bay Area Medical Group-Marinette
-
Marinette、Wisconsin、アメリカ、54143
- Saint Vincent Hospital Cancer Center at Marinette
-
Marshfield、Wisconsin、アメリカ、54449
- Marshfield Medical Center-Marshfield
-
Milwaukee、Wisconsin、アメリカ、53209
- Aurora Cancer Care-Milwaukee
-
Milwaukee、Wisconsin、アメリカ、53215
- Aurora Saint Luke's Medical Center
-
Milwaukee、Wisconsin、アメリカ、53233
- Aurora Sinai Medical Center
-
Minocqua、Wisconsin、アメリカ、54548
- Marshfield Medical Center - Minocqua
-
Mukwonago、Wisconsin、アメリカ、53149
- ProHealth D N Greenwald Center
-
New Richmond、Wisconsin、アメリカ、54017
- Cancer Center of Western Wisconsin
-
Oconomowoc、Wisconsin、アメリカ、53066
- ProHealth Oconomowoc Memorial Hospital
-
Oconto Falls、Wisconsin、アメリカ、54154
- Saint Vincent Hospital Cancer Center at Oconto Falls
-
Oshkosh、Wisconsin、アメリカ、54904
- Vince Lombardi Cancer Clinic - Oshkosh
-
Racine、Wisconsin、アメリカ、53406
- Aurora Cancer Care-Racine
-
Racine、Wisconsin、アメリカ、53405
- Ascension All Saints Hospital-Spring Street-Racine
-
Rhinelander、Wisconsin、アメリカ、54501
- Aspirus Cancer Care-Rhinelander-James Beck Cancer Center
-
Rice Lake、Wisconsin、アメリカ、54868
- Marshfield Medical Center-Rice Lake
-
Sheboygan、Wisconsin、アメリカ、53081
- Vince Lombardi Cancer Clinic-Sheboygan
-
Sheboygan、Wisconsin、アメリカ、53081
- HSHS Saint Nicholas Hospital
-
Stevens Point、Wisconsin、アメリカ、54482
- Marshfield Medical Center-River Region at Stevens Point
-
Stevens Point、Wisconsin、アメリカ、54481
- Aspirus Cancer Care - Stevens Point
-
Sturgeon Bay、Wisconsin、アメリカ、54235-1495
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
-
Summit、Wisconsin、アメリカ、53066
- Aurora Medical Center in Summit
-
Two Rivers、Wisconsin、アメリカ、54241
- Vince Lombardi Cancer Clinic-Two Rivers
-
Waukesha、Wisconsin、アメリカ、53188
- UW Cancer Center at ProHealth Care
-
Waukesha、Wisconsin、アメリカ、53188
- ProHealth Waukesha Memorial Hospital
-
Waukesha、Wisconsin、アメリカ、53188
- Aurora Cancer Care-Waukesha
-
Wausau、Wisconsin、アメリカ、54401
- Marshfield Clinic-Wausau Center
-
Wausau、Wisconsin、アメリカ、54401
- Aspirus Cancer Care-Wausau
-
Wauwatosa、Wisconsin、アメリカ、53226
- Aurora Cancer Care-Milwaukee West
-
West Allis、Wisconsin、アメリカ、53227
- Aurora West Allis Medical Center
-
Weston、Wisconsin、アメリカ、54476
- Marshfield Medical Center - Weston
-
Wisconsin Rapids、Wisconsin、アメリカ、54494
- Aspirus Cancer Care - Wisconsin Rapids
-
Wisconsin Rapids、Wisconsin、アメリカ、54494
- Marshfield Clinic - Wisconsin Rapids Center
-
-
Wyoming
-
Cheyenne、Wyoming、アメリカ、82001
- Cheyenne Regional Medical Center-West
-
-
-
-
-
Pretoria、南アフリカ、0002
- University Of Pretoria
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
他の名前：
Ancillary studies
他の名前：
Undergo CT
他の名前：
Undergo MRI
他の名前：
Given SC
他の名前：
Undergo collection of blood and archived tissue samples
他の名前：
Given PO
他の名前：
Given PO
他の名前：
|
|
プラセボコンパレーター：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
他の名前：
Ancillary studies
他の名前：
Undergo CT
他の名前：
Undergo MRI
他の名前：
Given PO Given SC
他の名前：
Undergo collection of blood and archived tissue samples
他の名前：
Given PO
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Progression-free Survival (PFS)
時間枠：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)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Objective Response Rate (ORR)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Roisin M Connolly、ECOG-ACRIN Cancer Research Group
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (推定)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- NCI-2014-00746
- U10CA180820 (米国 NIH グラント/契約)
- U24CA196172 (米国 NIH グラント/契約)
- U10CA021115 (米国 NIH グラント/契約)
- NCI-2014-00746 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
- E2112 (その他の識別子：CTEP)
- ECOG-E2112
- E2112 (その他の識別子：ECOG-ACRIN Cancer Research Group)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。