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Tidlig kirurgi eller standard palliativ terapi til behandling af patienter med trin IV brystkræft

14. juni 2023 opdateret af: Eastern Cooperative Oncology Group

Et randomiseret fase III-forsøg af værdien af ​​tidlig lokal terapi for den intakte primære tumor hos patienter med metastatisk brystkræft

RATIONALE: Den primære tumor kan være en kilde til gensåning af fjerne steder, og derfor kan eliminering af denne kilde til metastaserende celler ved tidlig lokal terapi være en fordel.

FORMÅL: Dette randomiserede fase III-forsøg studerer tidlig kirurgi for at se, hvor godt det virker sammenlignet med standard palliativ terapi til behandling af patienter med stadium IV brystkræft.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

MÅL:

Primær

  • At evaluere, om tidlig lokal terapi af intakt primær sygdom hos patienter med stadium IV brystkræft, hvis sygdom ikke udvikler sig under initial optimal systemisk terapi, vil resultere i forlænget overlevelse sammenlignet med patienter, der kun modtager lokal terapi til palliation.

Sekundær

  • At sammenligne tiden til ukontrolleret brystvægssygdom mellem patienter, der modtager tidlig lokal terapi versus patienter, der modtager palliativ lokal terapi.
  • At afgøre, om der er forskel i sundhedsrelateret livskvalitet (HRQOL) mellem patienter, der modtager tidlig lokal terapi versus patienter, der modtager palliativ lokal terapi.
  • For at bestemme, om den absolutte værdi af cirkulerende tumorceller (CTC) byrde ved 6 måneder efter randomisering (tid +6) vil være lavere i den palliative terapiarm end i den tidlige lokale terapiarm, og om denne værdi er omvendt relateret til overlevelse (lavere CTC, længere overlevelse).

Udforskende

  • At indsamle tumor- og blodprøver til fremtidig udforskning af de biologiske interaktioner mellem den primære tumor og metastatiske læsioner og effekten af ​​primær tumorresektion.

OVERSIGT: Dette er en multicenterundersøgelse. Patienterne er stratificeret efter hormonreceptor og behandlingsplan (ER+ eller PR+, HER2-, endokrin behandling alene vs. ER+ eller PR+, og HER2-, kemoterapi og/eller endokrin behandling vs. ER- eller PR-, og HER2- vs HER2+). og antallet af involverede organsystemer med fjerntliggende sygdom (regionale knuder i aksillære, supraklavikulære og indre bryster betragtes ikke som fjerne steder) (1 vs. > 1). Patienterne randomiseres til 1 ud af 2 behandlingsarme i forholdet 1:1.

  • Arm I: Patienter modtager standard palliativ behandling, hvis det er nødvendigt, for at imødegå symptomer som tumorulceration, smerte, omfangsrig adenopati, der forårsager armsymptomer og andre lignende situationer. Terapi kan bestå af strålebehandling alene, kirurgi alene eller en kombination af begge.
  • Arm II: Patienter gennemgår kirurgi omfattende brystbevarende terapi (BCT) eller total mastektomi i henhold til patientens og den behandlende læges præference. Kirurgi skal ske senest 10 uger efter afslutning af 32 ugers systemisk behandling. Frie kirurgiske marginer skal opnås med re-excision eller mastektomi for patienter, der gennemgår BCT. Efter afslutning af BCT gennemgår patienter strålebehandling en gang om dagen, 5 dage om ugen. Patienter, der har fået foretaget mastektomi, gennemgår strålebehandling efter den behandlende læges skøn.

Patienter kan gennemgå blod- og tumorvævsprøvetagning for cirkulerende tumorceller (CTC) byrde og fremtidige undersøgelser.

Patienter udfylder den funktionelle vurdering af kræftterapi - Breast Trial Outcome Index (FACT-TOI) og FACT - General (22) og Breast Cancer Subscale (FACT-B) livskvalitetsspørgeskemaer ved baseline og periodisk under undersøgelsen.

Efter afsluttet studieterapi følges patienterne periodisk i 5 år.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

390

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute at University of Alberta
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Saint John Regional Hospital
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Program at London Health Sciences Centre
    • Quebec
      • Montreal, Quebec, Canada, H2W 1S6
        • McGill Cancer Centre at McGill University
  • Forenede Stater
    • Alabama
      • Mobile, Alabama, Forenede Stater, 36604
        • University of South Alabama Mitchell Cancer Institute
    • Alaska
      • Anchorage, Alaska, Forenede Stater, 99508
        • Providence Cancer Center
    • Arizona
      • Scottsdale, Arizona, Forenede Stater, 85259-5499
        • Mayo Clinic Scottsdale
    • California
      • Castro Valley, California, Forenede Stater, 94546
        • East Bay Radiation Oncology Center
      • Chico, California, Forenede Stater, 95926
        • Enloe Cancer Center at Enloe Medical Center
      • Fairfield, California, Forenede Stater, 94533
        • North Bay Cancer Center
      • Greenbrae, California, Forenede Stater, 94904
        • California Cancer Care, Incorporated - Greenbrae
      • Long Beach, California, Forenede Stater, 90806
        • Todd Cancer Institute at Long Beach Memorial Medical Center
      • Martinez, California, Forenede Stater, 94553-3156
        • Contra Costa Regional Medical Center
      • Monterey, California, Forenede Stater, 93940
        • Community Hospital of the Monterey Peninsula Comprehensive Cancer Center
      • Mountain View, California, Forenede Stater, 94040
        • El Camino Hospital Cancer Center
      • Oakland, California, Forenede Stater, 94609
        • CCOP - Bay Area Tumor Institute
      • Orange, California, Forenede Stater, 92868
        • St. Joseph Hospital Regional Cancer Center - Orange
      • San Pablo, California, Forenede Stater, 94806
        • Doctors Medical Center - San Pablo Campus
      • Stanford, California, Forenede Stater, 94305-5824
        • Stanford Cancer Center
    • Colorado
      • Boulder, Colorado, Forenede Stater, 80301-9019
        • Boulder Community Hospital
      • Colorado Springs, Colorado, Forenede Stater, 80933
        • Penrose Cancer Center at Penrose Hospital
      • Denver, Colorado, Forenede Stater, 80218
        • Presbyterian - St. Luke's Medical Center
      • Wheat Ridge, Colorado, Forenede Stater, 80033
        • Exempla Lutheran Medical Center
    • Connecticut
      • Hartford, Connecticut, Forenede Stater, 06105
        • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
      • Norwalk, Connecticut, Forenede Stater, 06856
        • Norwalk Hospital
      • Norwich, Connecticut, Forenede Stater, 06360
        • Eastern Connecticut Hematology and Oncology Associates
    • Delaware
      • Lewes, Delaware, Forenede Stater, 19958
        • Tunnell Cancer Center at Beebe Medical Center
      • Newark, Delaware, Forenede Stater, 19713
        • CCOP - Christiana Care Health Services
    • Florida
      • Daytona Beach, Florida, Forenede Stater, 32114
        • Herbert D. Kerman Regional Oncology Center - Daytona Beach
      • Jacksonville, Florida, Forenede Stater, 32224
        • Mayo Clinic - Jacksonville
      • Orlando, Florida, Forenede Stater, 32803-1273
        • Florida Hospital Cancer Institute at Florida Hospital Orlando
      • Orlando, Florida, Forenede Stater, 32806
        • M.D. Anderson Cancer Center at Orlando
      • Tampa, Florida, Forenede Stater, 33612-9497
        • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Winship Cancer Institute of Emory University
      • Atlanta, Georgia, Forenede Stater, 30309
        • Piedmont Hospital
      • Atlanta, Georgia, Forenede Stater, 30342-1611
        • Northside Hospital Cancer Center
      • Atlanta, Georgia, Forenede Stater, 30342-1701
        • Saint Joseph's Hospital of Atlanta
      • Atlanta, Georgia, Forenede Stater, 30308
        • Emory Crawford Long Hospital
      • Atlanta, Georgia, Forenede Stater, 30303
        • Georgia Cancer Center for Excellence at Grady Memorial Hospital
      • Columbus, Georgia, Forenede Stater, 31904
        • John B. Amos Cancer Center
      • Decatur, Georgia, Forenede Stater, 30033
        • Charles B. Eberhart Cancer Center at DeKalb Medical Center
      • Marietta, Georgia, Forenede Stater, 30060
        • Kennestone Cancer Center at Wellstar Kennestone Hospital
      • Riverdale, Georgia, Forenede Stater, 30274-2600
        • Southern Regional Medical Center
      • Savannah, Georgia, Forenede Stater, 31405
        • Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
    • Hawaii
      • 'Aiea, Hawaii, Forenede Stater, 96701
        • Kapiolani Medical Center at Pali Momi
      • 'Ewa Beach, Hawaii, Forenede Stater, 96706
        • Leeward Radiation Oncology
      • Honolulu, Hawaii, Forenede Stater, 96813
        • Cancer Research Center of Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96817
        • Kuakini Medical Center
      • Honolulu, Hawaii, Forenede Stater, 96813
        • Queen's Cancer Institute at Queen's Medical Center
      • Honolulu, Hawaii, Forenede Stater, 96813
        • Straub Clinic and Hospital, Incorporated
      • Honolulu, Hawaii, Forenede Stater, 96817
        • Hawaii Medical Center - East
    • Idaho
      • Boise, Idaho, Forenede Stater, 83712
        • Mountain States Tumor Institute at St. Luke's Regional Medical Center
      • Boise, Idaho, Forenede Stater, 83706
        • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
      • Fruitland, Idaho, Forenede Stater, 83619
        • Saint Luke's Mountain States Tumor Institute - Fruitland
      • Meridian, Idaho, Forenede Stater, 83642
        • Mountain States Tumor Institute - Meridian
      • Nampa, Idaho, Forenede Stater, 83686
        • Saint Luke's Mountain States Tumor Institute
      • Twin Falls, Idaho, Forenede Stater, 83301
        • Mountain States Tumor Institute at St. Luke's
    • Illinois
      • Bloomington, Illinois, Forenede Stater, 61701
        • St. Joseph Medical Center
      • Canton, Illinois, Forenede Stater, 61520
        • Graham Hospital
      • Carthage, Illinois, Forenede Stater, 62321
        • Memorial Hospital
      • Chicago, Illinois, Forenede Stater, 60637-1470
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, Forenede Stater, 60640
        • Louis A. Weiss Memorial Hospital
      • Chicago, Illinois, Forenede Stater, 60611-3013
        • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
      • Chicago, Illinois, Forenede Stater, 60612-7243
        • University of Illinois Cancer Center
      • Chicago, Illinois, Forenede Stater, 60611
        • Hematology and Oncology Associates
      • Chicago, Illinois, Forenede Stater, 60612-3785
        • John H. Stroger, Jr. Hospital of Cook County
      • Chicago, Illinois, Forenede Stater, 60631
        • Resurrection Medical Center
      • Decatur, Illinois, Forenede Stater, 62526
        • Decatur Memorial Hospital Cancer Care Institute
      • Elmhurst, Illinois, Forenede Stater, 60126
        • Elmhurst Memorial Hospital
      • Eureka, Illinois, Forenede Stater, 61530
        • Eureka Community Hospital
      • Galesburg, Illinois, Forenede Stater, 61401
        • Galesburg Clinic, PC
      • Harvey, Illinois, Forenede Stater, 60426
        • Ingalls Cancer Care Center at Ingalls Memorial Hospital
      • Highland Park, Illinois, Forenede Stater, 60035
        • Kellogg Cancer Care Center
      • Hinsdale, Illinois, Forenede Stater, 60521
        • Hinsdale Hematology Oncology Associates
      • Kankakee, Illinois, Forenede Stater, 60901
        • Provena St. Mary's Regional Cancer Center - Kankakee
      • Libertyville, Illinois, Forenede Stater, 60048
        • North Shore Oncology and Hematology Associates, Limited - Libertyville
      • Macomb, Illinois, Forenede Stater, 61455
        • Mcdonough District Hospital
      • Maywood, Illinois, Forenede Stater, 60153
        • Cardinal Bernardin Cancer Center at Loyola University Medical Center
      • Moline, Illinois, Forenede Stater, 61265
        • Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
      • Niles, Illinois, Forenede Stater, 60714
        • Cancer Care and Hematology Specialists of Chicagoland - Niles
      • Normal, Illinois, Forenede Stater, 61761
        • Bromenn Regional Medical Center
      • Normal, Illinois, Forenede Stater, 61761
        • Community Cancer Center
      • Ottawa, Illinois, Forenede Stater, 61350
        • Community Hospital of Ottawa
      • Ottawa, Illinois, Forenede Stater, 61350
        • Oncology Hematology Associates of Central Illinois, PC - Ottawa
      • Pekin, Illinois, Forenede Stater, 61554
        • Cancer Treatment Center at Pekin Hospital
      • Peoria, Illinois, Forenede Stater, 61636
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, Forenede Stater, 61614
        • Proctor Hospital
      • Peoria, Illinois, Forenede Stater, 61637
        • OSF St. Francis Medical Center
      • Peoria, Illinois, Forenede Stater, 61615
        • CCOP - Illinois Oncology Research Association
      • Peoria, Illinois, Forenede Stater, 61615
        • Oncology Hematology Associates of Central Illinois, PC - Peoria
      • Peru, Illinois, Forenede Stater, 61354
        • Illinois Valley Community Hospital
      • River Forest, Illinois, Forenede Stater, 60305
        • West Suburban Center for Cancer Care
      • Rockford, Illinois, Forenede Stater, 61104-2315
        • Swedish-American Regional Cancer Center
      • Skokie, Illinois, Forenede Stater, 60076
        • Hematology Oncology Associates - Skokie
      • Springfield, Illinois, Forenede Stater, 62781-0001
        • Regional Cancer Center at Memorial Medical Center
    • Indiana
      • Beech Grove, Indiana, Forenede Stater, 46107
        • St. Francis Hospital and Health Centers - Beech Grove Campus
      • Elkhart, Indiana, Forenede Stater, 46515
        • Elkhart General Hospital
      • Goshen, Indiana, Forenede Stater, 46526
        • Center for Cancer Care at Goshen General Hospital
      • Indianapolis, Indiana, Forenede Stater, 46202-5289
        • Indiana University Melvin and Bren Simon Cancer Center
      • Indianapolis, Indiana, Forenede Stater, 46202
        • William N. Wishard Memorial Hospital
      • Kokomo, Indiana, Forenede Stater, 46904
        • Howard Community Hospital
      • La Porte, Indiana, Forenede Stater, 46350
        • Center for Cancer Therapy at LaPorte Hospital and Health Services
      • Mishawaka, Indiana, Forenede Stater, 46545-1470
        • Michiana Hematology-Oncology, PC - South Bend
      • Mishawaka, Indiana, Forenede Stater, 46545-1470
        • Saint Joseph Regional Medical Center
      • Richmond, Indiana, Forenede Stater, 47374
        • Reid Hospital & Health Care Services
      • South Bend, Indiana, Forenede Stater, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, Forenede Stater, 46601
        • CCOP - Northern Indiana CR Consortium
    • Iowa
      • Ames, Iowa, Forenede Stater, 50010
        • McFarland Clinic, PC
      • Clive, Iowa, Forenede Stater, 50325
        • Medical Oncology and Hematology Associates - West Des Moines
      • Des Moines, Iowa, Forenede Stater, 50309
        • CCOP - Iowa Oncology Research Association
      • Des Moines, Iowa, Forenede Stater, 50309
        • John Stoddard Cancer Center at Iowa Methodist Medical Center
      • Des Moines, Iowa, Forenede Stater, 50309
        • Medical Oncology and Hematology Associates at John Stoddard Cancer Center
      • Des Moines, Iowa, Forenede Stater, 50314
        • Medical Oncology and Hematology Associates at Mercy Cancer Center
      • Des Moines, Iowa, Forenede Stater, 50314
        • Mercy Cancer Center at Mercy Medical Center - Des Moines
      • Des Moines, Iowa, Forenede Stater, 50316
        • John Stoddard Cancer Center at Iowa Lutheran Hospital
      • Ottumwa, Iowa, Forenede Stater, 52501
        • McCreery Cancer Center at Ottumwa Regional
      • Sioux City, Iowa, Forenede Stater, 51101
        • Siouxland Hematology-Oncology Associates, LLP
      • Sioux City, Iowa, Forenede Stater, 51102
        • Mercy Medical Center - Sioux City
      • Sioux City, Iowa, Forenede Stater, 51104
        • St. Luke's Regional Medical Center
    • Kansas
      • Chanute, Kansas, Forenede Stater, 66720
        • Cancer Center of Kansas, PA - Chanute
      • Dodge City, Kansas, Forenede Stater, 67801
        • Cancer Center of Kansas, PA - Dodge City
      • El Dorado, Kansas, Forenede Stater, 67042
        • Cancer Center of Kansas, PA - El Dorado
      • Fort Scott, Kansas, Forenede Stater, 66701
        • Cancer Center of Kansas - Fort Scott
      • Independence, Kansas, Forenede Stater, 67301
        • Cancer Center of Kansas-Independence
      • Kingman, Kansas, Forenede Stater, 67068
        • Cancer Center of Kansas, PA - Kingman
      • Lawrence, Kansas, Forenede Stater, 66044
        • Lawrence Memorial Hospital
      • Liberal, Kansas, Forenede Stater, 67901
        • Cancer Center of Kansas, PA - Liberal
      • McPherson, Kansas, Forenede Stater, 67460
        • Cancer Center of Kansas, PA - McPherson
      • Newton, Kansas, Forenede Stater, 67114
        • Cancer Center of Kansas, PA - Newton
      • Parsons, Kansas, Forenede Stater, 67357
        • Cancer Center of Kansas, PA - Parsons
      • Prairie Village, Kansas, Forenede Stater, 66208
        • CCOP - Kansas City
      • Pratt, Kansas, Forenede Stater, 67124
        • Cancer Center of Kansas, PA - Pratt
      • Salina, Kansas, Forenede Stater, 67401
        • Cancer Center of Kansas, PA - Salina
      • Wellington, Kansas, Forenede Stater, 67152
        • Cancer Center of Kansas, PA - Wellington
      • Wichita, Kansas, Forenede Stater, 67208
        • Cancer Center of Kansas, PA - Medical Arts Tower
      • Wichita, Kansas, Forenede Stater, 67214
        • Cancer Center of Kansas, PA - Wichita
      • Wichita, Kansas, Forenede Stater, 67214
        • CCOP - Wichita
      • Wichita, Kansas, Forenede Stater, 67214
        • Via Christi Cancer Center at Via Christi Regional Medical Center
      • Winfield, Kansas, Forenede Stater, 67156
        • Cancer Center of Kansas, PA - Winfield
    • Kentucky
      • Edgewood, Kentucky, Forenede Stater, 41017
        • St. Elizabeth Medical Center
      • Lexington, Kentucky, Forenede Stater, 40536-0093
        • Lucille P. Markey Cancer Center at University of Kentucky
    • Louisiana
      • Alexandria, Louisiana, Forenede Stater, 71315-3198
        • Tulane Cancer Center Office of Clinical Research
    • Maryland
      • Annapolis, Maryland, Forenede Stater, 21401
        • DeCesaris Cancer Institute at Anne Arundel Medical Center
      • Baltimore, Maryland, Forenede Stater, 21231-2410
        • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
      • Baltimore, Maryland, Forenede Stater, 21229
        • St. Agnes Hospital Cancer Center
      • Baltimore, Maryland, Forenede Stater, 21204
        • Greater Baltimore Medical Center Cancer Center
      • Easton, Maryland, Forenede Stater, 21601
        • Shore Regional Cancer Center at Memorial Hospital - Easton
      • Elkton, Maryland, Forenede Stater, 21921
        • Union Hospital of Cecil County
    • Michigan
      • Adrian, Michigan, Forenede Stater, 49221
        • Hickman Cancer Center at Bixby Medical Center
      • Ann Arbor, Michigan, Forenede Stater, 48106-0995
        • Saint Joseph Mercy Cancer Center
      • Ann Arbor, Michigan, Forenede Stater, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Dearborn, Michigan, Forenede Stater, 48123-2500
        • Oakwood Cancer Center at Oakwood Hospital and Medical Center
      • Detroit, Michigan, Forenede Stater, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Escanaba, Michigan, Forenede Stater, 49431
        • Green Bay Oncology, Limited - Escanaba
      • Flint, Michigan, Forenede Stater, 48503
        • Hurley Medical Center
      • Flint, Michigan, Forenede Stater, 48503
        • Genesys Hurley Cancer Institute
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Butterworth Hospital at Spectrum Health
      • Grosse Pointe Woods, Michigan, Forenede Stater, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Iron Mountain, Michigan, Forenede Stater, 49801
        • Dickinson County Healthcare System
      • Jackson, Michigan, Forenede Stater, 49201
        • Foote Memorial Hospital
      • Kalamazoo, Michigan, Forenede Stater, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, Forenede Stater, 49001
        • Borgess Medical Center
      • Kalamazoo, Michigan, Forenede Stater, 49007-3731
        • West Michigan Cancer Center
      • Lansing, Michigan, Forenede Stater, 48912-1811
        • Sparrow Regional Cancer Center
      • Livonia, Michigan, Forenede Stater, 48154
        • St. Mary Mercy Hospital
      • Midland, Michigan, Forenede Stater, 48670
        • MidMichigan Medical Center - Midland
      • Monroe, Michigan, Forenede Stater, 48162
        • Community Cancer Center of Monroe
      • Monroe, Michigan, Forenede Stater, 48162
        • Mercy Memorial Hospital - Monroe
      • Muskegon, Michigan, Forenede Stater, 49444
        • Mercy General Health Partners
      • Pontiac, Michigan, Forenede Stater, 48341-2985
        • St. Joseph Mercy Oakland
      • Port Huron, Michigan, Forenede Stater, 48060
        • Mercy Regional Cancer Center at Mercy Hospital
      • Reed City, Michigan, Forenede Stater, 49677
        • Spectrum Health Reed City Hospital
      • Royal Oak, Michigan, Forenede Stater, 48073
        • William Beaumont Hospital - Royal Oak Campus
      • Saginaw, Michigan, Forenede Stater, 48601
        • Seton Cancer Institute at Saint Mary's - Saginaw
      • Saint Joseph, Michigan, Forenede Stater, 49085
        • Lakeside Cancer Specialists, PLLC
      • Saint Joseph, Michigan, Forenede Stater, 49085
        • Lakeland Regional Cancer Care Center - St. Joseph
      • Southfield, Michigan, Forenede Stater, 48075
        • Providence Cancer Institute at Providence Hospital - Southfield Campus
      • Traverse City, Michigan, Forenede Stater, 49684
        • Munson Medical Center
      • Warren, Michigan, Forenede Stater, 48093
        • St. John Macomb Hospital
    • Minnesota
      • Burnsville, Minnesota, Forenede Stater, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, Forenede Stater, 55433
        • Mercy and Unity Cancer Center at Mercy Hospital
      • Edina, Minnesota, Forenede Stater, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, Forenede Stater, 55432
        • Mercy and Unity Cancer Center at Unity Hospital
      • Hutchinson, Minnesota, Forenede Stater, 55350
        • Hutchinson Area Health Care
      • Mankato, Minnesota, Forenede Stater, 56002
        • Immanuel St. Joseph's
      • Maplewood, Minnesota, Forenede Stater, 55109
        • HealthEast Cancer Care at St. John's Hospital
      • Maplewood, Minnesota, Forenede Stater, 55109
        • Minnesota Oncology - Maplewood
      • Minneapolis, Minnesota, Forenede Stater, 55407
        • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
      • Minneapolis, Minnesota, Forenede Stater, 55415
        • Hennepin County Medical Center - Minneapolis
      • New Ulm, Minnesota, Forenede Stater, 56073
        • New Ulm Medical Center
      • Robbinsdale, Minnesota, Forenede Stater, 55422-2900
        • Humphrey Cancer Center at North Memorial Outpatient Center
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic Cancer Center
      • Saint Louis Park, Minnesota, Forenede Stater, 55416
        • CCOP - Metro-Minnesota
      • Saint Louis Park, Minnesota, Forenede Stater, 55416
        • Park Nicollet Cancer Center
      • Saint Paul, Minnesota, Forenede Stater, 55102
        • United Hospital
      • Saint Paul, Minnesota, Forenede Stater, 55101
        • Regions Hospital Cancer Care Center
      • Shakopee, Minnesota, Forenede Stater, 55379
        • St. Francis Cancer Center at St. Francis Medical Center
      • Stillwater, Minnesota, Forenede Stater, 55082
        • Lakeview Hospital
      • Waconia, Minnesota, Forenede Stater, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, Forenede Stater, 56201
        • Willmar Cancer Center at Rice Memorial Hospital
      • Woodbury, Minnesota, Forenede Stater, 55125
        • Minnesota Oncology - Woodbury
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39216
        • University of Mississippi Cancer Clinic
      • Pascagoula, Mississippi, Forenede Stater, 39581
        • Regional Cancer Center at Singing River Hospital
    • Missouri
      • Cape Girardeau, Missouri, Forenede Stater, 63703
        • Saint Francis Medical Center
      • Kansas City, Missouri, Forenede Stater, 64132
        • Research Medical Center
      • Kansas City, Missouri, Forenede Stater, 64111
        • Saint Luke's Cancer Institute at Saint Luke's Hospital
      • Rolla, Missouri, Forenede Stater, 65401
        • Mercy Clinic Cancer and Hematology - Rolla
      • Saint Joseph, Missouri, Forenede Stater, 64506
        • Heartland Regional Medical Center
      • Saint Joseph, Missouri, Forenede Stater, 64507
        • Saint Joseph Oncology, Incorporated
      • Saint Louis, Missouri, Forenede Stater, 63141
        • David C. Pratt Cancer Center at St. John's Mercy
      • Saint Louis, Missouri, Forenede Stater, 63128
        • St. Anthony's Cancer Center
      • Springfield, Missouri, Forenede Stater, 65804
        • St. John's Regional Health Center
      • Springfield, Missouri, Forenede Stater, 65807
        • Hulston Cancer Center at Cox Medical Center South
    • Montana
      • Billings, Montana, Forenede Stater, 59101
        • CCOP - Montana Cancer Consortium
      • Billings, Montana, Forenede Stater, 59107-7000
        • Billings Clinic - Downtown
      • Great Falls, Montana, Forenede Stater, 59405
        • Great Falls Clinic - Main Facility
      • Great Falls, Montana, Forenede Stater, 59405-5309
        • Big Sky Oncology
      • Great Falls, Montana, Forenede Stater, 59405
        • Sletten Cancer Institute at Benefis Healthcare
    • Nebraska
      • Lincoln, Nebraska, Forenede Stater, 68510
        • Cancer Resource Center - Lincoln
      • Omaha, Nebraska, Forenede Stater, 68106
        • CCOP - Missouri Valley Cancer Consortium
      • Omaha, Nebraska, Forenede Stater, 68122
        • Immanuel Medical Center
      • Omaha, Nebraska, Forenede Stater, 68131-2197
        • Creighton University Medical Center
      • Omaha, Nebraska, Forenede Stater, 68130
        • Lakeside Hospital
    • New Hampshire
      • Lebanon, New Hampshire, Forenede Stater, 03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
      • Manchester, New Hampshire, Forenede Stater, 03102
        • Norris Cotton Cancer Center at Catholic Medical Center
    • New Jersey
      • Flemington, New Jersey, Forenede Stater, 08822
        • Hunterdon Regional Cancer Center at Hunterdon Medical Center
      • Marlton, New Jersey, Forenede Stater, 08053
        • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
      • Newark, New Jersey, Forenede Stater, 07112
        • Newark Beth Israel Medical Center
      • Sewell, New Jersey, Forenede Stater, 08080
        • Radiation Oncology Center at Kennedy Health System - Sewell
      • Toms River, New Jersey, Forenede Stater, 08755
        • J. Phillip Citta Regional Cancer Center at Community Medical Center
      • Voorhees, New Jersey, Forenede Stater, 08043
        • Cancer Institute of New Jersey at Cooper - Voorhees
      • Voorhees, New Jersey, Forenede Stater, 08043
        • Fox Chase Virtua Health Cancer Program at Virtua West Jersey
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87131-5636
        • University of New Mexico Cancer Center
      • Albuquerque, New Mexico, Forenede Stater, 87102
        • Lovelace Medical Center - Downtown
      • Las Cruces, New Mexico, Forenede Stater, 88011
        • University of New Mexico Cancer Center - South
    • New York
      • Buffalo, New York, Forenede Stater, 14263-0001
        • Roswell Park Cancer Institute
      • Cooperstown, New York, Forenede Stater, 13326
        • Bassett Healthcare Regional Cancer Program at Mary Imogene Bassett Hospital
      • Mineola, New York, Forenede Stater, 11501
        • Winthrop University Hospital
      • New York, New York, Forenede Stater, 10065
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, Forenede Stater, 10029
        • Mount Sinai Medical Center
      • New York, New York, Forenede Stater, 10025
        • St. Luke's - Roosevelt Hospital Center - St.Luke's Division
      • New York, New York, Forenede Stater, 10003-3803
        • Beth Israel Medical Center - Petrie Division
      • Poughkeepsie, New York, Forenede Stater, 12601-3990
        • Dyson Center for Cancer Care at Vassar Brothers Medical Center
      • Rochester, New York, Forenede Stater, 14642
        • James P. Wilmot Cancer Center at University of Rochester Medical Center
      • Rochester, New York, Forenede Stater, 14620
        • Highland Hospital of Rochester
      • Staten Island, New York, Forenede Stater, 10305
        • Nalitt Cancer Institute at Staten Island University Hospital
      • White Plains, New York, Forenede Stater, 10601
        • Dickstein Cancer Treatment Center at White Plains Hospital Center
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28232-2861
        • Blumenthal Cancer Center at Carolinas Medical Center
      • Concord, North Carolina, Forenede Stater, 28025
        • Batte Cancer Center at Northeast Medical Center
      • Statesville, North Carolina, Forenede Stater, 28677
        • Iredell Memorial Hospital
      • Winston-Salem, North Carolina, Forenede Stater, 27157-1096
        • Wake Forest University Comprehensive Cancer Center
    • North Dakota
      • Bismarck, North Dakota, Forenede Stater, 58501
        • Medcenter One Hospital Cancer Care Center
      • Bismarck, North Dakota, Forenede Stater, 58501
        • Mid Dakota Clinic, PC
      • Bismarck, North Dakota, Forenede Stater, 58502
        • St. Alexius Medical Center Cancer Center
      • Fargo, North Dakota, Forenede Stater, 58122
        • CCOP - MeritCare Hospital
      • Minot, North Dakota, Forenede Stater, 58701
        • Trinity Cancercare Center
    • Ohio
      • Akron, Ohio, Forenede Stater, 44307
        • McDowell Cancer Center at Akron General Medical Center
      • Akron, Ohio, Forenede Stater, 44309-2090
        • Summa Center for Cancer Care at Akron City Hospital
      • Bowling Green, Ohio, Forenede Stater, 43402
        • Wood County Oncology Center
      • Cleveland, Ohio, Forenede Stater, 44106-5065
        • Case Comprehensive Cancer Center
      • Columbus, Ohio, Forenede Stater, 43214-3998
        • Riverside Methodist Hospital Cancer Care
      • Columbus, Ohio, Forenede Stater, 43222
        • Mount Carmel Health - West Hospital
      • Columbus, Ohio, Forenede Stater, 43215
        • CCOP - Columbus
      • Columbus, Ohio, Forenede Stater, 43215
        • Grant Medical Center Cancer Care
      • Columbus, Ohio, Forenede Stater, 43228
        • Doctors Hospital at Ohio Health
      • Dayton, Ohio, Forenede Stater, 45406
        • Good Samaritan Hospital
      • Dayton, Ohio, Forenede Stater, 45409
        • David L. Rike Cancer Center at Miami Valley Hospital
      • Dayton, Ohio, Forenede Stater, 45415
        • Samaritan North Cancer Care Center
      • Delaware, Ohio, Forenede Stater, 43015
        • Grady Memorial Hospital
      • Elyria, Ohio, Forenede Stater, 44035
        • Community Cancer Center
      • Elyria, Ohio, Forenede Stater, 44035
        • Hematology Oncology Center
      • Findlay, Ohio, Forenede Stater, 45840
        • Blanchard Valley Medical Associates
      • Franklin, Ohio, Forenede Stater, 45005-1066
        • Middletown Regional Hospital
      • Lancaster, Ohio, Forenede Stater, 43130
        • Fairfield Medical Center
      • Lima, Ohio, Forenede Stater, 45804
        • Lima Memorial Hospital
      • Marietta, Ohio, Forenede Stater, 45750
        • Strecker Cancer Center at Marietta Memorial Hospital
      • Maumee, Ohio, Forenede Stater, 43537-1839
        • Northwest Ohio Oncology Center
      • Mount Vernon, Ohio, Forenede Stater, 43050
        • Knox Community Hospital
      • Newark, Ohio, Forenede Stater, 43055
        • Licking Memorial Cancer Care Program at Licking Memorial Hospital
      • Oregon, Ohio, Forenede Stater, 43616
        • St. Charles Mercy Hospital
      • Oregon, Ohio, Forenede Stater, 43616
        • Toledo Clinic - Oregon
      • Portsmouth, Ohio, Forenede Stater, 45662
        • Southern Ohio Medical Center Cancer Center
      • Springfield, Ohio, Forenede Stater, 45505
        • Community Hospital of Springfield and Clark County
      • Sylvania, Ohio, Forenede Stater, 43560
        • Flower Hospital Cancer Center
      • Tiffin, Ohio, Forenede Stater, 44883
        • Mercy Hospital of Tiffin
      • Toledo, Ohio, Forenede Stater, 43608
        • St. Vincent Mercy Medical Center
      • Toledo, Ohio, Forenede Stater, 43606
        • Toledo Hospital
      • Toledo, Ohio, Forenede Stater, 43614
        • Medical University of Ohio Cancer Center
      • Toledo, Ohio, Forenede Stater, 43617
        • CCOP - Toledo Community Hospital
      • Toledo, Ohio, Forenede Stater, 43623
        • Toledo Clinic, Incorporated - Main Clinic
      • Toledo, Ohio, Forenede Stater, 43623
        • St. Anne Mercy Hospital
      • Troy, Ohio, Forenede Stater, 45373-1300
        • UVMC Cancer Care Center at Upper Valley Medical Center
      • Wauseon, Ohio, Forenede Stater, 43567
        • Fulton County Health Center
      • Westerville, Ohio, Forenede Stater, 43081
        • Mount Carmel St. Ann's Cancer Center
      • Zanesville, Ohio, Forenede Stater, 43701
        • Genesis - Good Samaritan Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • Oklahoma University Cancer Institute
    • Pennsylvania
      • Bethlehem, Pennsylvania, Forenede Stater, 18015
        • St. Luke's Cancer Network at St. Luke's Hospital
      • Easton, Pennsylvania, Forenede Stater, 18042
        • Easton Regional Cancer Center at Easton Hospital
      • Hanover, Pennsylvania, Forenede Stater, 17331
        • Cherry Tree Cancer Center
      • Hershey, Pennsylvania, Forenede Stater, 17033-0850
        • Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
      • Lancaster, Pennsylvania, Forenede Stater, 17604
        • Lancaster General Hospital
      • Langhorne, Pennsylvania, Forenede Stater, 19047
        • St. Mary Regional Cancer Center
      • Lewistown, Pennsylvania, Forenede Stater, 17044
        • Lewistown Hospital
      • Meadowbrook, Pennsylvania, Forenede Stater, 19046
        • Charles A. & Betty Bott Cancer Center at Holy Redeemer Hospital
      • Philadelphia, Pennsylvania, Forenede Stater, 19111-2497
        • Fox Chase Cancer Center - Philadelphia
      • Philadelphia, Pennsylvania, Forenede Stater, 19107-5541
        • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
      • Pittsburgh, Pennsylvania, Forenede Stater, 15232
        • UPMC Cancer Centers
      • State College, Pennsylvania, Forenede Stater, 16803
        • Mount Nittany Medical Center
      • Williamsport, Pennsylvania, Forenede Stater, 17701
        • Susquehanna Cancer Center at Divine Providence Hospital
      • York, Pennsylvania, Forenede Stater, 17405
        • York Cancer Center at Apple Hill Medical Center
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Hollings Cancer Center at Medical University of South Carolina
      • Charleston, South Carolina, Forenede Stater, 29401
        • Roper St. Francis Cancer Center at Roper Hospital
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • CCOP - Upstate Carolina
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
    • South Dakota
      • Sioux Falls, South Dakota, Forenede Stater, 57105
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, Forenede Stater, 57117-5039
        • Sanford Cancer Center at Sanford USD Medical Center
    • Tennessee
      • Jackson, Tennessee, Forenede Stater, 38301
        • West Tennessee Cancer Center at Jackson-Madison County General Hospital
    • Texas
      • Galveston, Texas, Forenede Stater, 77555-0361
        • University of Texas Medical Branch
      • Houston, Texas, Forenede Stater, 77030-4009
        • M. D. Anderson Cancer Center at University of Texas
      • Houston, Texas, Forenede Stater, 77030
        • Methodist Hospital
      • Irving, Texas, Forenede Stater, 75061
        • Baylor Medical Center at Irving
      • Laredo, Texas, Forenede Stater, 78045
        • Doctor's Hospital of Laredo
      • Temple, Texas, Forenede Stater, 76508
        • CCOP - Scott and White Hospital
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84112
        • Huntsman Cancer Institute at University of Utah
    • Virginia
      • Fredericksburg, Virginia, Forenede Stater, 22401
        • Fredericksburg Oncology, Incorporated
      • Richmond, Virginia, Forenede Stater, 23298-0037
        • Virginia Commonwealth University Massey Cancer Center
    • Washington
      • Bellingham, Washington, Forenede Stater, 98225
        • St. Joseph Cancer Center
      • Bremerton, Washington, Forenede Stater, 98310
        • Harrison Medical Center
      • Seattle, Washington, Forenede Stater, 98122-4307
        • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
      • Seattle, Washington, Forenede Stater, 98195
        • University Cancer Center at University of Washington Medical Center
      • Walla Walla, Washington, Forenede Stater, 99362
        • St. Mary Regional Cancer Center at St. Mary Medical Center
    • West Virginia
      • Huntington, West Virginia, Forenede Stater, 25702
        • St. Mary's Regional Cancer Center at St. Mary's Medical Center
    • Wisconsin
      • Antigo, Wisconsin, Forenede Stater, 54409
        • Langlade Memorial Hospital
      • Appleton, Wisconsin, Forenede Stater, 54911
        • Theda Care Cancer Institute
      • Appleton, Wisconsin, Forenede Stater, 54911-3496
        • Fox Valley Hematology and Oncology - East Grant Street
      • Appleton, Wisconsin, Forenede Stater, 54911
        • Fox Valley Surgical Associates at Appleton Medical Center
      • Chippewa Falls, Wisconsin, Forenede Stater, 54729
        • Marshfield Clinic - Chippewa Center
      • Eau Claire, Wisconsin, Forenede Stater, 54701
        • Center for Cancer Treatment & Prevention at Sacred Heart Hospital
      • Eau Claire, Wisconsin, Forenede Stater, 54701
        • Marshfield Clinic Cancer Care at Regional Cancer Center
      • Green Bay, Wisconsin, Forenede Stater, 54307-3508
        • St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, Forenede Stater, 54301-3526
        • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, Forenede Stater, 54303
        • Green Bay Oncology, Limited at St. Mary's Hospital
      • Green Bay, Wisconsin, Forenede Stater, 54303
        • St. Mary's Hospital Medical Center - Green Bay
      • Green Bay, Wisconsin, Forenede Stater, 54311
        • Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
      • Johnson Creek, Wisconsin, Forenede Stater, 53038
        • UW Cancer Center Johnson Creek
      • La Crosse, Wisconsin, Forenede Stater, 54601
        • Gundersen Lutheran Center for Cancer and Blood
      • Madison, Wisconsin, Forenede Stater, 53792-6164
        • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
      • Manitowoc, Wisconsin, Forenede Stater, 54221-1450
        • Holy Family Memorial Medical Center Cancer Care Center
      • Marinette, Wisconsin, Forenede Stater, 54143
        • Bay Area Cancer Care Center at Bay Area Medical Center
      • Marinette, Wisconsin, Forenede Stater, 54143
        • Vince Lombardi Cancer Clinic - Marinette
      • Marshfield, Wisconsin, Forenede Stater, 54449
        • Saint Joseph's Hospital
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Medical College of Wisconsin Cancer Center
      • Minocqua, Wisconsin, Forenede Stater, 54548
        • Marshfield Clinic - Lakeland Center
      • Oconomowoc, Wisconsin, Forenede Stater, 53066
        • Regional Cancer Center at Oconomowoc Memorial Hospital
      • Oconto Falls, Wisconsin, Forenede Stater, 54154
        • Green Bay Oncology, Limited - Oconto Falls
      • Oshkosh, Wisconsin, Forenede Stater, 54904
        • Vince Lombardi Cancer Clinic - Oshkosh
      • Rhinelander, Wisconsin, Forenede Stater, 54501
        • Ministry Medical Group at Saint Mary's Hospital
      • Rice Lake, Wisconsin, Forenede Stater, 54868
        • Marshfield Clinic - Indianhead Center
      • Sheboygan, Wisconsin, Forenede Stater, 53081
        • St. Nicholas Hospital
      • Sheboygan, Wisconsin, Forenede Stater, 53081
        • Vince Lombardi Cancer Clinic - Sheboygan
      • Stevens Point, Wisconsin, Forenede Stater, 54481
        • Marshfield Clinic at Saint Michael's Hospital
      • Stevens Point, Wisconsin, Forenede Stater, 54481
        • Saint Michael's Hospital Cancer Center
      • Sturgeon Bay, Wisconsin, Forenede Stater, 54235
        • Green Bay Oncology, Limited - Sturgeon Bay
      • Summit, Wisconsin, Forenede Stater, 53066
        • Aurora Medical Center
      • Two Rivers, Wisconsin, Forenede Stater, 54241
        • Vince Lombardi Cancer Clinic - Two Rivers
      • Waukesha, Wisconsin, Forenede Stater, 53188
        • Waukesha Memorial Hospital Regional Cancer Center
      • Wausau, Wisconsin, Forenede Stater, 54401
        • Marshfield Clinic - Wausau Center
      • Wausau, Wisconsin, Forenede Stater, 54401
        • University of Wisconcin Cancer Center at Aspirus Wausau Hospital
      • Wauwatosa, Wisconsin, Forenede Stater, 53226
        • Oncology Alliance, SC - Milwaukee - West
      • Weston, Wisconsin, Forenede Stater, 54476
        • Diagnostic and Treatment Center
      • Weston, Wisconsin, Forenede Stater, 54476
        • Marshfield Clinic - Weston Center
      • Wisconsin Rapids, Wisconsin, Forenede Stater, 54494
        • Marshfield Clinic - Wisconsin Rapids Center
      • Wisconsin Rapids, Wisconsin, Forenede Stater, 54494
        • Riverview UW Cancer Center at Riverview Hospital
  • Israel
      • Tel Aviv, Israel, 64239
        • Tel-Aviv Sourasky Medical Center
  • Saudi Arabien
      • Riyadh, Saudi Arabien, 11211
        • King Faisal Specialist Hospital and Research Center
  • Sydafrika
      • Pretoria, Sydafrika, 0002
        • Pretoria Academic Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 120 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Diagnose af intakt primært (ikke tilbagevendende) invasivt karcinom i brystet

    • Stadie IV sygdom
    • Bekræftelse af den primære tumor bør ske ved nålebiopsi (foretrukket)
    • Incisional kirurgisk biopsi tilladt, så længe der er resterende palpabelt eller tumorbillede i brystet
  • Patienter skal vurderes at være kandidater til fuldstændig resektion med frie marginer efterfulgt af strålebehandling (hvis strålebehandling er indiceret)
  • For kvinder, der ikke gennemgår aksillær dissektion, bør sentinel node biopsi dokumentere en aksillær nodal byrde på 1-2 involverede lymfeknuder (dvs. ACOSOG Z-11 kriterier kan anvendes)
  • Tidligere ikke-invasiv (Ductal Carcinoma In Situ) cancer tilladt, forudsat at der ikke har været nogen gentagelse
  • Tidligere ipsilateral invasiv cancer tilladt, hvis mere end 5 år tidligere

  • Patienter bør have mindst ét ​​organsystem involveret med fjernmetastatisk sygdom

    • Hvis patienten kun har én metastatisk læsion/fokus, skal dette bevises ved biopsi, og patologirapporten, der bekræfter diagnosen primær brystkræft, samt metastaseringsstedet skal være tilgængelig.
  • Skal have tilgængelige radiologiske rapporter, der dokumenterer sygdomsstatus inden for de seneste 6 uger før påbegyndelse af systemisk behandling
  • CNS-metastaser tilladt forudsat forventet overlevelse > 6 måneder

  • Patienterne skal have gennemført mindst 16 ugers optimal systemisk behandling (passende til den biologiske tumorprofil og patientens alder og overgangsalderen)

    • Hvis systemisk behandling seponeres på grund af toksicitet, men der ikke er nogen fjern progression, og der er afgivet mindst 12 ugers behandling, forbliver patienten kvalificeret
    • Strålebehandling (hvis indiceret) skal påbegyndes inden for 12 uger efter den afsluttende terapeutiske kirurgiske procedure (inklusive re-excision for frie marginer og afslutning af aksillær dissektion)

  • Patienter kan tilmelde sig til enhver tid fra tidspunktet for diagnosticering af stadium IV brystkræft (hvis kriterierne er opfyldt) til det tidspunkt, hvor maksimalt 30 ugers induktionssystemisk behandling er afsluttet

    • Patienter skal randomiseres inden for 16-32 uger efter start af systemisk behandling

  • Patienter må ikke have oplevet sygdomsprogression siden starten af ​​systemisk terapi, hvilket fremgår af radiografisk dokumentation af sygdomsstatus før behandling og inden for 4 uger +/- 2 uger før randomisering, herunder:

    • Ingen nye sygdomssteder
    • Ingen udvidelse af eksisterende lokaliteter med 20 % eller mere i den længste diameter
    • Ingen symptomatisk forværring
  • Patienter, der har behov for strålebehandling af knoglemetastaser under induktionssystemisk behandling, er kvalificerede
  • Lokal sygdom på det primære sted skal være asymptomatisk
  • Hormonreceptorstatus kendt
  • Menopausal status ikke specificeret
  • Patienter skal have tilstrækkelig organfunktion til at gennemgå lokal terapi 4 uger +/- 2 uger før randomisering efter investigator skøn og institutionelle retningslinjer
  • Mere end 5 år siden andre primære kræftformer, der blev behandlet kurativt
  • Negativ graviditetstest
  • Fertile patienter skal anvende en accepteret og effektiv præventionsmetode

Eksklusionskriterier:

  • Synkron kontralateral brystkræft
  • Gravid eller ammende

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Arm I
Patienter modtager standard palliativ behandling, hvis det er nødvendigt, for at imødegå symptomer såsom tumorulceration, smerte, omfangsrig adenopati, der forårsager armsymptomer og andre lignende situationer. Terapi kan bestå af strålebehandling alene, kirurgi alene eller en kombination af begge.
Procedure: palliativ kirurgi
Gennemgå standard palliativ kirurgi
Stråling: palliativ strålebehandling
Gennemgå standard palliativ strålebehandling
Eksperimentel: Arm II
Patienter gennemgår kirurgi omfattende brystbevarende terapi (BCT) eller total mastektomi i henhold til patientens og den behandlende læges præference. Kirurgi skal ske senest 10 uger efter afslutning af 32 ugers systemisk behandling. Frie kirurgiske marginer skal opnås med re-excision eller mastektomi for patienter, der gennemgår BCT. Efter afslutning af BCT gennemgår patienter strålebehandling en gang om dagen, 5 dage om ugen. Patienter, der har fået foretaget mastektomi, gennemgår strålebehandling efter den behandlende læges skøn.
Stråling: strålebehandling
Gennemgå strålebehandling
Procedure: terapeutisk konventionel kirurgi
Gennemgå en tidlig operation

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
3-årig samlet overlevelsesrate
Tidsramme: Vurderet ved baseline, derefter hver 3. måned inden for 2 år og hver 6. måned mellem 2-5 år, op til 5 år
Samlet overlevelse (OS) blev defineret som tiden fra randomisering til død uanset årsag. Alle patienter vil blive fulgt for overlevelse gennem 5 år. Sager med ufuldstændig opfølgning eller uden registrering af vital status vil blive censureret på datoen for sidste kontakt. 3-års OS rate blev estimeret ved hjælp af Kaplan-Meier metode.
Vurderet ved baseline, derefter hver 3. måned inden for 2 år og hver 6. måned mellem 2-5 år, op til 5 år

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
3-års kumulativ forekomst af lokoregionalt tilbagefald/progression
Tidsramme: Vurderet ved baseline, derefter hver 3. måned inden for 2 år og hver 6. måned mellem 2-5 år, op til 5 år
For patienter i arm II (tidlig lokal terapi) blev tid til lokoregionalt recidiv defineret som tiden fra randomisering til dato for lokoregionalt recidiv; for patienter i arm A (fortsat systemisk terapi) blev tid til lokoregional progression defineret som tiden fra randomisering til dato for lokoregional progression. I denne undersøgelse blev lokoregionalt recidiv defineret som den nye udvikling eller klinisk signifikant stigning i størrelsen af ​​enhver supraclavikulær, infraclavikulær, intern bryst- eller aksillær adenopati eller brystvægssygdom eller invasivt recidiv i brystet for patienter på arm B; for patienter på arm A blev lokoregional progression defineret som udviklingen af ​​symptomer, der førte til en beslutning om lokal terapi. Lokoregionalt recidiv/progression og fjernprogression blev fulgt separat i undersøgelsen, og forekomsten af ​​den ene udelukkede ikke, at den anden blev rapporteret. 3-års kumulativ forekomst af lokoregionalt recidiv/progression blev estimeret.
Vurderet ved baseline, derefter hver 3. måned inden for 2 år og hver 6. måned mellem 2-5 år, op til 5 år
Sundhedsrelateret livskvalitet (HRQL)
Tidsramme: Vurderet 18 måneder efter randomisering
Den funktionelle vurdering af udfaldsindeks for kræftterapi-brystforsøg (FACT-B TOI) blev brugt som det primære HRQL-endepunkt, målt ved den forholdsmæssige samlede score af de 24 elementer fra FACT-B (7 funktionelt velvære, 7 fysisk velvære -væsen, 10 brystkræftspecifikke emner). Det teoretiske interval for den forholdsmæssige samlede score var 0-96, højere score indikerer bedre livskvalitet.
Vurderet 18 måneder efter randomisering

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Eastern Cooperative Oncology Group

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Seema A. Khan, MD, Robert H. Lurie Cancer Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

16. maj 2011

Primær færdiggørelse (Faktiske)

10. december 2019

Studieafslutning (Faktiske)

21. december 2022

Datoer for studieregistrering

Først indsendt

16. november 2010

Først indsendt, der opfyldte QC-kriterier

16. november 2010

Først opslået (Anslået)

17. november 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. juni 2023

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juni 2023

Sidst verificeret

1. juni 2023

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • E2108
  • U10CA180794 (U.S. NIH-bevilling/kontrakt)
  • ECOG-E2108 (Anden identifikator: ECOG-ACRIN Cancer Research Group)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Tilgængelige data: Vælg individuelle data på patientniveau fra dette forsøg kan rekvireres fra NCTN/NCORP Data Archive

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