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Vurdering af nøjagtigheden af ​​tumorbiopsier efter kemoterapi for at afgøre, om patienter kan undgå brystkirurgi

19. maj 2025 opdateret af: NRG Oncology

Et fase II-forsøg, der vurderer nøjagtigheden af ​​tumorbedsbiopsier til at forudsige patologisk respons hos patienter med klinisk/radiologisk komplet respons efter neoadjuverende kemoterapi for at udforske muligheden for brystbevarende behandling uden kirurgi

Dette fase II-forsøg undersøger, hvor godt biopsi af bryst efter kemoterapi virker til at forudsige patologisk respons hos patienter med stadium II-IIIA brystkræft, der gennemgår brystbevarende operation. Tumorvæv indsamlet fra biopsi før operation kan hjælpe med at kontrollere, om kemoterapi ødelagde brystkræftcellerne og kan sammenlignes med tumoren, der blev fjernet under operationen, for at kontrollere, om de er de samme.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

PRIMÆRE MÅL:

I. At vurdere nøjagtigheden af ​​post-neoadjuverende systemisk terapi (NST) billedrettet tumorbed biopsi for patologisk komplet respons (pCR), defineret som opløsning af både invasiv sygdom og duktalt carcinoma in situ (DCIS), i tilfælde af klinisk og radiologisk komplet respons med trimodalitetsbilleddannelse.

SEKUNDÆRE MÅL:

I. At indsamle aksillære patologiresultater, kirurgiske stadieinddelingsmetoder (sentinel lymfeknudebiopsi og/eller aksillær lymfeknudedissektion) og behandling (kirurgi og/eller stråling) for at bestemme aksillær nodal respons på neoadjuverende kemoterapi og dets forhold til bryst-pCR .

II. At korrelere billeddannelsesresultater med patologisk nodalstatus efter neoadjuverende kemoterapi til fremtidig planlægning af aksillær behandling i den næste undersøgelse.

III. Til retrospektiv vurdering af den negative prædiktive værdi (NPV) af en trimodalitetsbilleddannelsesalgoritme i kombination med tumorbed-biopsien til forudsigelse af pCR.

IV. At indsamle alle trimodalitetsbilleddannelsesdata for at bestemme, hvilken kombination af trimodalitetsbilleddannelsen bedst identificerer gruppen, der opnår pCR.

V. At korrelere antallet af nålekerner og genindhentning af tumorbed-clips med NPV for tumorstedsbiopsien.

VI. For at bestemme de kliniske, billeddannende, patologiske og molekylære tumorfaktorer forbundet med de højeste NPV'er af post-NST tumorbed biopsier.

VII. For at forbedre identifikation og udvælgelse af patienter med bryst og mulig aksillær pCR til fremtidig forsøgsplanlægning, vil rutinemæssige biomarkører (østrogenreceptor [ER], progesteronreceptor [PR], HER2 neu og Ki67) blive indsamlet for at muliggøre sammenligning med billede/klinisk komplet respons (CR) og tumorbed-biopsier.

OMRIDS:

Efter afslutning af neoadjuverende terapi gennemgår patienter stereotaktisk biopsi af brysttumor når som helst før brystbevarende operation. Patienterne gennemgår derefter brystbevarende operation i henhold til standardbehandling. Patienter kan også gennemgå postoperativ strålebehandling efter standardbehandling eller adjuverende terapi efter investigators skøn.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

105

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network-Princess Margaret Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital
      • Montreal, Quebec, Canada, H3H 2R9
        • The Research Institute of the McGill University Health Centre (MUHC)
      • Montreal, Quebec, Canada, H2X 3E4
        • CHUM - Centre Hospitalier de l'Universite de Montreal
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35233
        • University of Alabama at Birmingham Cancer Center
      • Mobile, Alabama, Forenede Stater, 36688
        • University of South Alabama Mitchell Cancer Institute
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85004
        • Cancer Center at Saint Joseph's
      • Tucson, Arizona, Forenede Stater, 85719
        • Banner University Medical Center - Tucson
      • Tucson, Arizona, Forenede Stater, 85719
        • University of Arizona Cancer Center-North Campus
    • Arkansas
      • Fort Smith, Arkansas, Forenede Stater, 72903
        • Mercy Hospital Fort Smith
    • California
      • Antioch, California, Forenede Stater, 94531
        • Kaiser Permanente-Deer Valley Medical Center
      • Auburn, California, Forenede Stater, 95602
        • Sutter Auburn Faith Hospital
      • Auburn, California, Forenede Stater, 95603
        • Sutter Cancer Centers Radiation Oncology Services-Auburn
      • Berkeley, California, Forenede Stater, 94704
        • Alta Bates Summit Medical Center-Herrick Campus
      • Burlingame, California, Forenede Stater, 94010
        • Mills-Peninsula Medical Center
      • Cameron Park, California, Forenede Stater, 95682
        • Sutter Cancer Centers Radiation Oncology Services-Cameron Park
      • Castro Valley, California, Forenede Stater, 94546
        • Eden Hospital Medical Center
      • Davis, California, Forenede Stater, 95616
        • Sutter Davis Hospital
      • Dublin, California, Forenede Stater, 94568
        • Epic Care-Dublin
      • Emeryville, California, Forenede Stater, 94608
        • Bay Area Breast Surgeons Inc
      • Emeryville, California, Forenede Stater, 94608
        • Epic Care Partners in Cancer Care
      • Fremont, California, Forenede Stater, 94538
        • Kaiser Permanente-Fremont
      • Fremont, California, Forenede Stater, 94538
        • Palo Alto Medical Foundation-Fremont
      • Fresno, California, Forenede Stater, 93720
        • Kaiser Permanente-Fresno
      • Fresno, California, Forenede Stater, 93720
        • Fresno Cancer Center
      • Los Angeles, California, Forenede Stater, 90033
        • USC / Norris Comprehensive Cancer Center
      • Los Angeles, California, Forenede Stater, 90033
        • Los Angeles County-USC Medical Center
      • Martinez, California, Forenede Stater, 94553-3156
        • Contra Costa Regional Medical Center
      • Modesto, California, Forenede Stater, 95355
        • Memorial Medical Center
      • Modesto, California, Forenede Stater, 95356
        • Kaiser Permanente-Modesto
      • Mountain View, California, Forenede Stater, 94040
        • Palo Alto Medical Foundation-Camino Division
      • Mountain View, California, Forenede Stater, 94040
        • Palo Alto Medical Foundation-Gynecologic Oncology
      • Novato, California, Forenede Stater, 94945
        • Sutter Cancer Research Consortium
      • Oakland, California, Forenede Stater, 94611
        • Kaiser Permanente-Oakland
      • Oakland, California, Forenede Stater, 94611
        • Kaiser Permanente Oakland-Broadway
      • Oakland, California, Forenede Stater, 94609
        • Alta Bates Summit Medical Center - Summit Campus
      • Oakland, California, Forenede Stater, 94609
        • Bay Area Tumor Institute
      • Palo Alto, California, Forenede Stater, 94304
        • Stanford Cancer Institute Palo Alto
      • Palo Alto, California, Forenede Stater, 94301
        • Palo Alto Medical Foundation Health Care
      • Pasadena, California, Forenede Stater, 91105
        • Keck Medical Center of USC Pasadena
      • Rancho Cordova, California, Forenede Stater, 95670
        • Kaiser Permanente-Rancho Cordova Cancer Center
      • Redwood City, California, Forenede Stater, 94063
        • Kaiser Permanente-Redwood City
      • Richmond, California, Forenede Stater, 94801
        • Kaiser Permanente-Richmond
      • Rohnert Park, California, Forenede Stater, 94928
        • Rohnert Park Cancer Center
      • Roseville, California, Forenede Stater, 95678
        • The Permanente Medical Group-Roseville Radiation Oncology
      • Roseville, California, Forenede Stater, 95661
        • Kaiser Permanente-Roseville
      • Roseville, California, Forenede Stater, 95661
        • Sutter Cancer Centers Radiation Oncology Services-Roseville
      • Roseville, California, Forenede Stater, 95661
        • Sutter Roseville Medical Center
      • Sacramento, California, Forenede Stater, 95816
        • Sutter Medical Center Sacramento
      • Sacramento, California, Forenede Stater, 95814
        • Kaiser Permanente Downtown Commons
      • Sacramento, California, Forenede Stater, 95823
        • Kaiser Permanente-South Sacramento
      • Sacramento, California, Forenede Stater, 95823
        • South Sacramento Cancer Center
      • Sacramento, California, Forenede Stater, 95825
        • Kaiser Permanente - Sacramento
      • San Diego, California, Forenede Stater, 92134
        • Naval Medical Center -San Diego
      • San Francisco, California, Forenede Stater, 94115
        • Kaiser Permanente-San Francisco
      • San Francisco, California, Forenede Stater, 94115
        • California Pacific Medical Center-Pacific Campus
      • San Jose, California, Forenede Stater, 95119
        • Kaiser Permanente-Santa Teresa-San Jose
      • San Leandro, California, Forenede Stater, 94577
        • Kaiser Permanente San Leandro
      • San Rafael, California, Forenede Stater, 94903
        • Kaiser San Rafael-Gallinas
      • San Rafael, California, Forenede Stater, 94903
        • Kaiser Permanente-San Rafael
      • Santa Clara, California, Forenede Stater, 95051
        • Kaiser Permanente Medical Center - Santa Clara
      • Santa Cruz, California, Forenede Stater, 95065
        • Palo Alto Medical Foundation-Santa Cruz
      • Santa Rosa, California, Forenede Stater, 95403
        • Kaiser Permanente-Santa Rosa
      • Santa Rosa, California, Forenede Stater, 95403
        • Sutter Pacific Medical Foundation
      • South San Francisco, California, Forenede Stater, 94080
        • Kaiser Permanente Cancer Treatment Center
      • South San Francisco, California, Forenede Stater, 94080
        • Kaiser Permanente-South San Francisco
      • Stockton, California, Forenede Stater, 95210
        • Kaiser Permanente-Stockton
      • Sunnyvale, California, Forenede Stater, 94086
        • Palo Alto Medical Foundation-Sunnyvale
      • Vacaville, California, Forenede Stater, 95688
        • Kaiser Permanente Medical Center-Vacaville
      • Vacaville, California, Forenede Stater, 95687
        • Sutter Cancer Centers Radiation Oncology Services-Vacaville
      • Vallejo, California, Forenede Stater, 94589
        • Kaiser Permanente-Vallejo
      • Vallejo, California, Forenede Stater, 94589
        • Sutter Solano Medical Center/Cancer Center
      • Walnut Creek, California, Forenede Stater, 94596
        • Kaiser Permanente-Walnut Creek
      • Walnut Creek, California, Forenede Stater, 94597
        • Epic Care Cyberknife Center
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • University of Colorado Hospital
      • Aurora, Colorado, Forenede Stater, 80012
        • Rocky Mountain Cancer Centers-Aurora
      • Boulder, Colorado, Forenede Stater, 80301
        • Boulder Community Hospital
      • Boulder, Colorado, Forenede Stater, 80304
        • Rocky Mountain Cancer Centers-Boulder
      • Denver, Colorado, Forenede Stater, 80218
        • Presbyterian - Saint Lukes Medical Center - Health One
      • Denver, Colorado, Forenede Stater, 80218
        • SCL Health Saint Joseph Hospital
      • Denver, Colorado, Forenede Stater, 80220
        • Rose Medical Center
      • Denver, Colorado, Forenede Stater, 80218
        • Rocky Mountain Cancer Centers-Midtown
      • Denver, Colorado, Forenede Stater, 80220
        • Rocky Mountain Cancer Centers-Rose
      • Denver, Colorado, Forenede Stater, 80204
        • Denver Health Medical Center
      • Denver, Colorado, Forenede Stater, 80218
        • Colorado Blood Cancer Institute
      • Denver, Colorado, Forenede Stater, 80209
        • The Women's Imaging Center
      • Denver, Colorado, Forenede Stater, 80206
        • National Jewish Health-Main Campus
      • Denver, Colorado, Forenede Stater, 80220
        • Western Surgical Care
      • Englewood, Colorado, Forenede Stater, 80113
        • Mountain Blue Cancer Care Center - Swedish
      • Englewood, Colorado, Forenede Stater, 80113
        • Swedish Medical Center
      • Fort Collins, Colorado, Forenede Stater, 80524
        • Poudre Valley Hospital
      • Golden, Colorado, Forenede Stater, 80401
        • National Jewish Health-Western Hematology Oncology
      • Grand Junction, Colorado, Forenede Stater, 81501
        • Saint Mary's Hospital and Regional Medical Center
      • Grand Junction, Colorado, Forenede Stater, 81505
        • Grand Valley Oncology
      • Greeley, Colorado, Forenede Stater, 80631
        • North Colorado Medical Center
      • Lafayette, Colorado, Forenede Stater, 80026
        • Good Samaritan Medical Center
      • Littleton, Colorado, Forenede Stater, 80120
        • Rocky Mountain Cancer Centers-Littleton
      • Lone Tree, Colorado, Forenede Stater, 80124
        • Rocky Mountain Cancer Centers-Sky Ridge
      • Loveland, Colorado, Forenede Stater, 80539
        • McKee Medical Center
      • Thornton, Colorado, Forenede Stater, 80260
        • National Jewish Health-Northern Hematology Oncology
      • Wheat Ridge, Colorado, Forenede Stater, 80033
        • SCL Health Lutheran Medical Center
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06520
        • Yale University
      • New Haven, Connecticut, Forenede Stater, 06510
        • Smilow Cancer Center/Yale-New Haven Hospital
    • Delaware
      • Lewes, Delaware, Forenede Stater, 19958
        • Beebe Medical Center
      • Newark, Delaware, Forenede Stater, 19713
        • Helen F Graham Cancer Center
      • Newark, Delaware, Forenede Stater, 19713
        • Delaware Clinical and Laboratory Physicians PA
      • Newark, Delaware, Forenede Stater, 19713
        • Medical Oncology Hematology Consultants PA
      • Newark, Delaware, Forenede Stater, 19718
        • Christiana Care Health System-Christiana Hospital
      • Rehoboth Beach, Delaware, Forenede Stater, 19971
        • Beebe Health Campus
      • Seaford, Delaware, Forenede Stater, 19973
        • TidalHealth Nanticoke / Allen Cancer Center
      • Wilmington, Delaware, Forenede Stater, 19801
        • Christiana Care Health System-Wilmington Hospital
    • Florida
      • Atlantis, Florida, Forenede Stater, 33462
        • John Fitzgerald Kennedy Medical Center
      • Gainesville, Florida, Forenede Stater, 32610
        • University of Florida Health Science Center - Gainesville
      • Hollywood, Florida, Forenede Stater, 33021
        • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
      • Orlando, Florida, Forenede Stater, 32806
        • Orlando Health Cancer Institute
      • Pembroke Pines, Florida, Forenede Stater, 33028
        • Memorial Hospital West
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30308
        • Emory University Hospital Midtown
      • Atlanta, Georgia, Forenede Stater, 30322
        • Emory University Hospital/Winship Cancer Institute
      • Atlanta, Georgia, Forenede Stater, 30342
        • Emory Saint Joseph's Hospital
      • Atlanta, Georgia, Forenede Stater, 30309
        • Piedmont Hospital
      • Decatur, Georgia, Forenede Stater, 30033
        • Dekalb Medical Center
      • Fayetteville, Georgia, Forenede Stater, 30214
        • Piedmont Fayette Hospital
      • Macon, Georgia, Forenede Stater, 31201
        • Medical Center of Central Georgia
    • Hawaii
      • 'Aiea, Hawaii, Forenede Stater, 96701
        • Pali Momi Medical Center
      • 'Aiea, Hawaii, Forenede Stater, 96701
        • Queen's Cancer Center - Pearlridge
      • 'Aiea, Hawaii, Forenede Stater, 96701
        • The Cancer Center of Hawaii-Pali Momi
      • 'Aiea, Hawaii, Forenede Stater, 96701
        • Hawaii Cancer Care - Westridge
      • Honolulu, Hawaii, Forenede Stater, 96813
        • Queen's Medical Center
      • Honolulu, Hawaii, Forenede Stater, 96817
        • The Cancer Center of Hawaii-Liliha
      • Honolulu, Hawaii, Forenede Stater, 96813
        • Hawaii Cancer Care Inc - Waterfront Plaza
      • Honolulu, Hawaii, Forenede Stater, 96813
        • Queen's Cancer Cenrer - POB I
      • Honolulu, Hawaii, Forenede Stater, 96813
        • Straub Clinic and Hospital
      • Honolulu, Hawaii, Forenede Stater, 96813
        • University of Hawaii Cancer Center
      • Honolulu, Hawaii, Forenede Stater, 96817
        • Hawaii Cancer Care Inc-Liliha
      • Honolulu, Hawaii, Forenede Stater, 96817
        • Kuakini Medical Center
      • Honolulu, Hawaii, Forenede Stater, 96817
        • Queen's Cancer Center - Kuakini
      • Honolulu, Hawaii, Forenede Stater, 96826
        • Kapiolani Medical Center for Women and Children
      • Honolulu, Hawaii, Forenede Stater, 96813
        • Island Urology
      • Honolulu, Hawaii, Forenede Stater, 96819
        • Kaiser Permanente Moanalua Medical Center
      • Lihue, Hawaii, Forenede Stater, 96766
        • Wilcox Memorial Hospital and Kauai Medical Clinic
    • Idaho
      • Boise, Idaho, Forenede Stater, 83706
        • Saint Alphonsus Cancer Care Center-Boise
      • Caldwell, Idaho, Forenede Stater, 83605
        • Saint Alphonsus Cancer Care Center-Caldwell
      • Coeur d'Alene, Idaho, Forenede Stater, 83814
        • Kootenai Health - Coeur d'Alene
      • Emmett, Idaho, Forenede Stater, 83617
        • Walter Knox Memorial Hospital
      • Meridian, Idaho, Forenede Stater, 83642
        • Idaho Urologic Institute-Meridian
      • Nampa, Idaho, Forenede Stater, 83687
        • Saint Alphonsus Cancer Care Center-Nampa
      • Post Falls, Idaho, Forenede Stater, 83854
        • Kootenai Clinic Cancer Services - Post Falls
      • Sandpoint, Idaho, Forenede Stater, 83864
        • Kootenai Cancer Clinic
    • Illinois
      • Aurora, Illinois, Forenede Stater, 60504
        • Rush - Copley Medical Center
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwestern University
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush University Medical Center
      • Chicago, Illinois, Forenede Stater, 60637
        • University of Chicago Comprehensive Cancer Center
      • Chicago, Illinois, Forenede Stater, 60612
        • John H Stroger Jr Hospital of Cook County
      • Danville, Illinois, Forenede Stater, 61832
        • Carle at The Riverfront
      • Effingham, Illinois, Forenede Stater, 62401
        • Carle Physician Group-Effingham
      • Lake Forest, Illinois, Forenede Stater, 60045
        • Northwestern Medicine Lake Forest Hospital
      • Mattoon, Illinois, Forenede Stater, 61938
        • Carle Physician Group-Mattoon/Charleston
      • Maywood, Illinois, Forenede Stater, 60153
        • Loyola University Medical Center
      • Melrose Park, Illinois, Forenede Stater, 60160
        • Marjorie Weinberg Cancer Center at Loyola-Gottlieb
      • Moline, Illinois, Forenede Stater, 61265
        • Trinity Medical Center
      • Mount Vernon, Illinois, Forenede Stater, 62864
        • Good Samaritan Regional Health Center
      • New Lenox, Illinois, Forenede Stater, 60451
        • UC Comprehensive Cancer Center at Silver Cross
      • Orland Park, Illinois, Forenede Stater, 60462
        • University of Chicago Medicine-Orland Park
      • Urbana, Illinois, Forenede Stater, 61801
        • Carle Cancer Center
      • Urbana, Illinois, Forenede Stater, 61801
        • The Carle Foundation Hospital
      • Yorkville, Illinois, Forenede Stater, 60560
        • Rush-Copley Healthcare Center
    • Indiana
      • Evansville, Indiana, Forenede Stater, 47713
        • Deaconess Clinic Downtown
      • Fort Wayne, Indiana, Forenede Stater, 46805
        • Parkview Hospital Randallia
      • Fort Wayne, Indiana, Forenede Stater, 46845
        • Parkview Regional Medical Center
      • Goshen, Indiana, Forenede Stater, 46526
        • Goshen Center for Cancer Care
      • Newburgh, Indiana, Forenede Stater, 47630
        • Chancellor Center for Oncology
    • Iowa
      • Iowa City, Iowa, Forenede Stater, 52242
        • University of Iowa/Holden Comprehensive Cancer Center
    • Kansas
      • Coffeyville, Kansas, Forenede Stater, 67337
        • Coffeyville Regional Medical Center
      • Garden City, Kansas, Forenede Stater, 67846
        • Central Care Cancer Center - Garden City
      • Great Bend, Kansas, Forenede Stater, 67530
        • Central Care Cancer Center - Great Bend
      • Hays, Kansas, Forenede Stater, 67601
        • HaysMed University of Kansas Health System
      • Kansas City, Kansas, Forenede Stater, 66160
        • University of Kansas Cancer Center
      • Lenexa, Kansas, Forenede Stater, 66219
        • Kansas Institute of Medicine Cancer and Blood Center
      • Lenexa, Kansas, Forenede Stater, 66219
        • Minimally Invasive Surgery Hospital
      • Olathe, Kansas, Forenede Stater, 66061
        • Olathe Health Cancer Center
      • Overland Park, Kansas, Forenede Stater, 66210
        • University of Kansas Cancer Center-Overland Park
      • Overland Park, Kansas, Forenede Stater, 66209
        • Menorah Medical Center
      • Overland Park, Kansas, Forenede Stater, 66211
        • University of Kansas Hospital-Indian Creek Campus
      • Pittsburg, Kansas, Forenede Stater, 66762
        • Ascension Via Christi - Pittsburg
      • Salina, Kansas, Forenede Stater, 67401
        • Salina Regional Health Center
      • Topeka, Kansas, Forenede Stater, 66606
        • University of Kansas Health System Saint Francis Campus
      • Westwood, Kansas, Forenede Stater, 66205
        • University of Kansas Hospital-Westwood Cancer Center
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112
        • University Medical Center New Orleans
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Louisiana State University Health Science Center
    • Maryland
      • Annapolis, Maryland, Forenede Stater, 21401
        • Anne Arundel Medical Center
      • Baltimore, Maryland, Forenede Stater, 21204
        • Greater Baltimore Medical Center
      • Bel Air, Maryland, Forenede Stater, 21014
        • UM Upper Chesapeake Medical Center
    • Massachusetts
      • Burlington, Massachusetts, Forenede Stater, 01805
        • Lahey Hospital and Medical Center
      • Winchester, Massachusetts, Forenede Stater, 01890
        • Winchester Hospital
    • Michigan
      • Brownstown, Michigan, Forenede Stater, 48183
        • Henry Ford Cancer Institute-Downriver
      • Clinton Township, Michigan, Forenede Stater, 48038
        • Henry Ford Macomb Hospital-Clinton Township
      • Dearborn, Michigan, Forenede Stater, 48126
        • Henry Ford Medical Center-Fairlane
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford Hospital
      • Jackson, Michigan, Forenede Stater, 49201
        • Allegiance Health
      • Novi, Michigan, Forenede Stater, 48377
        • Henry Ford Medical Center-Columbus
      • West Bloomfield, Michigan, Forenede Stater, 48322
        • Henry Ford West Bloomfield Hospital
    • Minnesota
      • Bemidji, Minnesota, Forenede Stater, 56601
        • Sanford Joe Lueken Cancer Center
      • Burnsville, Minnesota, Forenede Stater, 55337
        • Fairview Ridges Hospital
      • Cambridge, Minnesota, Forenede Stater, 55008
        • Cambridge Medical Center
      • Coon Rapids, Minnesota, Forenede Stater, 55433
        • Mercy Hospital
      • Edina, Minnesota, Forenede Stater, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, Forenede Stater, 55432
        • Unity Hospital
      • Maple Grove, Minnesota, Forenede Stater, 55369
        • Fairview Clinics and Surgery Center Maple Grove
      • Maplewood, Minnesota, Forenede Stater, 55109
        • Saint John's Hospital - Healtheast
      • Maplewood, Minnesota, Forenede Stater, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, Forenede Stater, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, Forenede Stater, 55407
        • Abbott-Northwestern Hospital
      • Minneapolis, Minnesota, Forenede Stater, 55454
        • Health Partners Inc
      • Monticello, Minnesota, Forenede Stater, 55362
        • Monticello Cancer Center
      • New Ulm, Minnesota, Forenede Stater, 56073
        • New Ulm Medical Center
      • Robbinsdale, Minnesota, Forenede Stater, 55422
        • North Memorial Medical Health Center
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic in Rochester
      • Saint Louis Park, Minnesota, Forenede Stater, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Paul, Minnesota, Forenede Stater, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, Forenede Stater, 55102
        • United Hospital
      • Shakopee, Minnesota, Forenede Stater, 55379
        • Saint Francis Regional Medical Center
      • Stillwater, Minnesota, Forenede Stater, 55082
        • Lakeview Hospital
      • Waconia, Minnesota, Forenede Stater, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, Forenede Stater, 56201
        • Rice Memorial Hospital
      • Woodbury, Minnesota, Forenede Stater, 55125
        • Minnesota Oncology Hematology PA-Woodbury
      • Wyoming, Minnesota, Forenede Stater, 55092
        • Fairview Lakes Medical Center
    • Missouri
      • Ballwin, Missouri, Forenede Stater, 63011
        • Saint Louis Cancer and Breast Institute-Ballwin
      • Bolivar, Missouri, Forenede Stater, 65613
        • Central Care Cancer Center - Bolivar
      • Branson, Missouri, Forenede Stater, 65616
        • Cox Cancer Center Branson
      • Creve Coeur, Missouri, Forenede Stater, 63141
        • Siteman Cancer Center at West County Hospital
      • Independence, Missouri, Forenede Stater, 64057
        • Centerpoint Medical Center LLC
      • Joplin, Missouri, Forenede Stater, 64804
        • Freeman Health System
      • Joplin, Missouri, Forenede Stater, 64804
        • Mercy Hospital Joplin
      • Kansas City, Missouri, Forenede Stater, 64154
        • University of Kansas Cancer Center - North
      • Kansas City, Missouri, Forenede Stater, 64131
        • The University of Kansas Cancer Center-South
      • Kansas City, Missouri, Forenede Stater, 64132
        • Research Medical Center
      • Kansas City, Missouri, Forenede Stater, 64108
        • Truman Medical Centers
      • Lee's Summit, Missouri, Forenede Stater, 64064
        • University of Kansas Cancer Center - Lee's Summit
      • Rolla, Missouri, Forenede Stater, 65401
        • Delbert Day Cancer Institute at PCRMC
      • Rolla, Missouri, Forenede Stater, 65401
        • Mercy Clinic-Rolla-Cancer and Hematology
      • Saint Joseph, Missouri, Forenede Stater, 64506
        • Heartland Regional Medical Center
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, Forenede Stater, 63141
        • Mercy Hospital Saint Louis
      • Saint Louis, Missouri, Forenede Stater, 63128
        • Mercy Hospital South
      • Saint Louis, Missouri, Forenede Stater, 63129
        • Siteman Cancer Center-South County
      • Saint Louis, Missouri, Forenede Stater, 63136
        • Siteman Cancer Center at Christian Hospital
      • Saint Louis, Missouri, Forenede Stater, 63109
        • Saint Louis Cancer and Breast Institute-South City
      • Saint Peters, Missouri, Forenede Stater, 63376
        • Siteman Cancer Center at Saint Peters Hospital
      • Springfield, Missouri, Forenede Stater, 65807
        • CoxHealth South Hospital
      • Springfield, Missouri, Forenede Stater, 65804
        • Mercy Hospital Springfield
      • Washington, Missouri, Forenede Stater, 63090
        • Mercy Hospital Washington
    • Montana
      • Anaconda, Montana, Forenede Stater, 59711
        • Community Hospital of Anaconda
      • Billings, Montana, Forenede Stater, 59101
        • Billings Clinic Cancer Center
      • Billings, Montana, Forenede Stater, 59101
        • Saint Vincent Healthcare
      • Billings, Montana, Forenede Stater, 59102
        • Saint Vincent Frontier Cancer Center
      • Bozeman, Montana, Forenede Stater, 59715
        • Bozeman Deaconess Hospital
      • Butte, Montana, Forenede Stater, 59701
        • Saint James Community Hospital and Cancer Treatment Center
      • Great Falls, Montana, Forenede Stater, 59405
        • Great Falls Clinic
      • Great Falls, Montana, Forenede Stater, 59405
        • Benefis Healthcare- Sletten Cancer Institute
      • Helena, Montana, Forenede Stater, 59601
        • Saint Peter's Community Hospital
      • Kalispell, Montana, Forenede Stater, 59901
        • Kalispell Regional Medical Center
      • Missoula, Montana, Forenede Stater, 59804
        • Community Medical Hospital
    • New Jersey
      • Hamilton, New Jersey, Forenede Stater, 08690
        • The Cancer Institute of New Jersey Hamilton
      • New Brunswick, New Jersey, Forenede Stater, 08903
        • Rutgers Cancer Institute of New Jersey
      • New Brunswick, New Jersey, Forenede Stater, 08903
        • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87102
        • University of New Mexico Cancer Center
    • New York
      • Bronx, New York, Forenede Stater, 10461
        • Montefiore Medical Center-Einstein Campus
      • Bronx, New York, Forenede Stater, 10467
        • Montefiore Medical Center - Moses Campus
      • Bronx, New York, Forenede Stater, 10461
        • Montefiore Medical Center-Weiler Hospital
      • Buffalo, New York, Forenede Stater, 14263
        • Roswell Park Cancer Institute
      • New York, New York, Forenede Stater, 10019
        • Mount Sinai West
      • New York, New York, Forenede Stater, 10029
        • Mount Sinai Hospital
      • New York, New York, Forenede Stater, 10003
        • Mount Sinai Union Square
      • Syracuse, New York, Forenede Stater, 13210
        • State University of New York Upstate Medical University
      • Syracuse, New York, Forenede Stater, 13215
        • SUNY Upstate Medical Center-Community Campus
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599
        • UNC Lineberger Comprehensive Cancer Center
      • Charlotte, North Carolina, Forenede Stater, 28203
        • Carolinas Medical Center/Levine Cancer Institute
      • Charlotte, North Carolina, Forenede Stater, 28210
        • Atrium Health Pineville/LCI-Pineville
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke University Medical Center
      • Elkin, North Carolina, Forenede Stater, 28521
        • Wake Forest University at Elkin
      • Lexington, North Carolina, Forenede Stater, 27292
        • Wake Forest University at Lexington
      • Monroe, North Carolina, Forenede Stater, 28112
        • Atrium Health Union/LCI-Union
      • Mount Airy, North Carolina, Forenede Stater, 27030
        • Wake Forest University at Mount Airy
      • Winston-Salem, North Carolina, Forenede Stater, 27157
        • Wake Forest University Health Sciences
    • North Dakota
      • Bismarck, North Dakota, Forenede Stater, 58501
        • Sanford Bismarck Medical Center
      • Fargo, North Dakota, Forenede Stater, 58122
        • Sanford Roger Maris Cancer Center
      • Fargo, North Dakota, Forenede Stater, 58122
        • Sanford Broadway Medical Center
    • Ohio
      • Beachwood, Ohio, Forenede Stater, 44122
        • UHHS-Chagrin Highlands Medical Center
      • Cleveland, Ohio, Forenede Stater, 44106
        • Case Western Reserve University
      • Columbus, Ohio, Forenede Stater, 43210
        • Ohio State University Comprehensive Cancer Center
      • Westlake, Ohio, Forenede Stater, 44145
        • UH Seidman Cancer Center at Saint John Medical Center
      • Westlake, Ohio, Forenede Stater, 44145
        • UHHS-Westlake Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • University of Oklahoma Health Sciences Center
      • Oklahoma City, Oklahoma, Forenede Stater, 73120
        • Mercy Hospital Oklahoma City
    • Oregon
      • Baker City, Oregon, Forenede Stater, 97814
        • Saint Alphonsus Medical Center-Baker City
      • Ontario, Oregon, Forenede Stater, 97914
        • Saint Alphonsus Medical Center-Ontario
    • Pennsylvania
      • Abington, Pennsylvania, Forenede Stater, 19001
        • Jefferson Abington Hospital
      • Beaver, Pennsylvania, Forenede Stater, 15009
        • UPMC-Heritage Valley Health System Beaver
      • Chadds Ford, Pennsylvania, Forenede Stater, 19317
        • Christiana Care Health System-Concord Health Center
      • Ephrata, Pennsylvania, Forenede Stater, 17522
        • Ephrata Cancer Center
      • Ephrata, Pennsylvania, Forenede Stater, 17522
        • Ephrata Community Hospital
      • Gettysburg, Pennsylvania, Forenede Stater, 17325
        • Adams Cancer Center
      • Greensburg, Pennsylvania, Forenede Stater, 15601
        • UPMC Cancer Centers - Arnold Palmer Pavilion
      • Hanover, Pennsylvania, Forenede Stater, 17331
        • Cherry Tree Cancer Center
      • Harrisburg, Pennsylvania, Forenede Stater, 17109
        • UPMC Pinnacle Cancer Center/Community Osteopathic Campus
      • Harrisburg, Pennsylvania, Forenede Stater, 17101
        • UPMC Pinnacle Harrisburg
      • Johnstown, Pennsylvania, Forenede Stater, 15901
        • UPMC-Johnstown/John P. Murtha Regional Cancer Center
      • Lebanon, Pennsylvania, Forenede Stater, 17042
        • Sechler Family Cancer Center
      • McKeesport, Pennsylvania, Forenede Stater, 15132
        • UPMC Cancer Center at UPMC McKeesport
      • Moon, Pennsylvania, Forenede Stater, 15108
        • UPMC Hillman Cancer Center in Coraopolis
      • Pittsburgh, Pennsylvania, Forenede Stater, 15212
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • UPMC-Magee Womens Hospital
      • Pittsburgh, Pennsylvania, Forenede Stater, 15232
        • University of Pittsburgh Cancer Institute (UPCI)
      • Pittsburgh, Pennsylvania, Forenede Stater, 15232
        • UPMC-Shadyside Hospital
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • UPMC-Presbyterian Hospital
      • Pittsburgh, Pennsylvania, Forenede Stater, 15215
        • UPMC-Saint Margaret
      • Pittsburgh, Pennsylvania, Forenede Stater, 15237
        • UPMC-Passavant Hospital
      • Pittsburgh, Pennsylvania, Forenede Stater, 15243
        • UPMC-Saint Clair Hospital Cancer Center
      • Seneca, Pennsylvania, Forenede Stater, 16346
        • UPMC Cancer Center at UPMC Northwest
      • Uniontown, Pennsylvania, Forenede Stater, 15401
        • UPMC Uniontown Hospital Radiation Oncology
      • Washington, Pennsylvania, Forenede Stater, 15301
        • UPMC Washington Hospital Radiation Oncology
      • West Reading, Pennsylvania, Forenede Stater, 19611
        • Reading Hospital
      • Wexford, Pennsylvania, Forenede Stater, 15090
        • Wexford Health and Wellness Pavilion
      • York, Pennsylvania, Forenede Stater, 17403
        • WellSpan Health-York Cancer Center
      • York, Pennsylvania, Forenede Stater, 17403
        • WellSpan Health-York Hospital
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02905
        • Women and Infants Hospital
    • South Carolina
      • Boiling Springs, South Carolina, Forenede Stater, 29316
        • Prisma Health Cancer Institute - Spartanburg
      • Easley, South Carolina, Forenede Stater, 29640
        • Prisma Health Cancer Institute - Easley
      • Greenville, South Carolina, Forenede Stater, 29605
        • Prisma Health Cancer Institute - Faris
      • Greenville, South Carolina, Forenede Stater, 29615
        • Prisma Health Cancer Institute - Eastside
      • Greenville, South Carolina, Forenede Stater, 29605
        • Prisma Health Cancer Institute - Butternut
      • Greenville, South Carolina, Forenede Stater, 29605
        • Prisma Health Greenville Memorial Hospital
      • Greer, South Carolina, Forenede Stater, 29650
        • Prisma Health Cancer Institute - Greer
      • Seneca, South Carolina, Forenede Stater, 29672
        • Prisma Health Cancer Institute - Seneca
    • South Dakota
      • Sioux Falls, South Dakota, Forenede Stater, 57105
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, Forenede Stater, 57117-5134
        • Sanford USD Medical Center - Sioux Falls
      • Sioux Falls, South Dakota, Forenede Stater, 57104
        • Sanford Cancer Center Oncology Clinic
    • Tennessee
      • Franklin, Tennessee, Forenede Stater, 37067
        • Vanderbilt-Ingram Cancer Center Cool Springs
      • Memphis, Tennessee, Forenede Stater, 38120
        • Baptist Memorial Hospital and Cancer Center-Memphis
      • Nashville, Tennessee, Forenede Stater, 37232
        • Vanderbilt University/Ingram Cancer Center
      • Nashville, Tennessee, Forenede Stater, 37204
        • Vanderbilt Breast Center at One Hundred Oaks
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • M D Anderson Cancer Center
      • Houston, Texas, Forenede Stater, 77030
        • Houston Methodist Hospital
      • Laredo, Texas, Forenede Stater, 78041
        • Doctor's Hospital of Laredo
      • Round Rock, Texas, Forenede Stater, 78665
        • Scott and White Healthcare Round Rock
      • Sugar Land, Texas, Forenede Stater, 77479
        • Houston Methodist Sugar Land Hospital
      • Temple, Texas, Forenede Stater, 76508
        • Scott and White Memorial Hospital
    • Utah
      • Farmington, Utah, Forenede Stater, 84025
        • Farmington Health Center
      • Salt Lake City, Utah, Forenede Stater, 84112
        • Huntsman Cancer Institute/University of Utah
      • South Jordan, Utah, Forenede Stater, 84009
        • South Jordan Health Center
    • Virginia
      • Hampton, Virginia, Forenede Stater, 23666
        • Sentara Cancer Institute at Sentara CarePlex Hospital
      • Norfolk, Virginia, Forenede Stater, 23507
        • Sentara Norfolk General Hospital
      • Norfolk, Virginia, Forenede Stater, 23502
        • Sentara Leigh Hospital
      • Richmond, Virginia, Forenede Stater, 23298
        • Virginia Commonwealth University/Massey Cancer Center
      • Virginia Beach, Virginia, Forenede Stater, 23454
        • Sentara Virginia Beach General Hospital
      • Virginia Beach, Virginia, Forenede Stater, 23456
        • Sentara Princess Anne Hospital
    • West Virginia
      • Bridgeport, West Virginia, Forenede Stater, 26330
        • United Hospital Center
      • Martinsburg, West Virginia, Forenede Stater, 25401
        • WVUH-Berkely Medical Center
      • Morgantown, West Virginia, Forenede Stater, 26506
        • West Virginia University Healthcare
      • Parkersburg, West Virginia, Forenede Stater, 26101
        • Camden Clark Medical Center
    • Wisconsin
      • Burlington, Wisconsin, Forenede Stater, 53105
        • Aurora Cancer Care-Southern Lakes VLCC
      • Fond Du Lac, Wisconsin, Forenede Stater, 54937
        • Aurora Health Center-Fond du Lac
      • Germantown, Wisconsin, Forenede Stater, 53022
        • Aurora Health Care Germantown Health Center
      • Grafton, Wisconsin, Forenede Stater, 53024
        • Aurora Cancer Care-Grafton
      • Green Bay, Wisconsin, Forenede Stater, 54311
        • Aurora BayCare Medical Center
      • Kenosha, Wisconsin, Forenede Stater, 53142
        • Aurora Cancer Care-Kenosha South
      • Marinette, Wisconsin, Forenede Stater, 54143
        • Aurora Bay Area Medical Group-Marinette
      • Milwaukee, Wisconsin, Forenede Stater, 53209
        • Aurora Cancer Care-Milwaukee
      • Milwaukee, Wisconsin, Forenede Stater, 53215
        • Aurora Saint Luke's Medical Center
      • Milwaukee, Wisconsin, Forenede Stater, 53233
        • Aurora Sinai Medical Center
      • New Richmond, Wisconsin, Forenede Stater, 54017
        • Cancer Center of Western Wisconsin
      • Oshkosh, Wisconsin, Forenede Stater, 54904
        • Vince Lombardi Cancer Clinic - Oshkosh
      • Racine, Wisconsin, Forenede Stater, 53406
        • Aurora Cancer Care-Racine
      • Sheboygan, Wisconsin, Forenede Stater, 53081
        • Vince Lombardi Cancer Clinic-Sheboygan
      • Summit, Wisconsin, Forenede Stater, 53066
        • Aurora Medical Center in Summit
      • Two Rivers, Wisconsin, Forenede Stater, 54241
        • Vince Lombardi Cancer Clinic-Two Rivers
      • Wauwatosa, Wisconsin, Forenede Stater, 53226
        • Aurora Cancer Care-Milwaukee West
      • West Allis, Wisconsin, Forenede Stater, 53227
        • Aurora West Allis Medical Center
    • Wyoming
      • Cheyenne, Wyoming, Forenede Stater, 82001
        • Cheyenne Regional Medical Center-West
      • Cody, Wyoming, Forenede Stater, 82414
        • Billings Clinic-Cody
      • Sheridan, Wyoming, Forenede Stater, 82801
        • Welch Cancer Center

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Patienten skal have underskrevet og dateret en Institutional Review Board (IRB)-godkendt samtykkeformular, der er i overensstemmelse med føderale og institutionelle retningslinjer
  • Patienten skal have en Eastern Cooperative Oncology Group (ECOG) præstationsstatus på 0 eller 1
  • Patienter skal have fået foretaget ER-analyse på den primære brysttumor indsamlet før neoadjuverende terapi i henhold til gældende retningslinjer fra American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) for hormonreceptortestning; hvis negativ for ER, skal vurdering af progesteronreceptor (PgR) også udføres i henhold til gældende ASCO/CAP Guideline Recommendations for hormonreceptortestning. Patienter, der har en primær tumor, der er hormonreceptor-positiv eller hormonreceptor-negativ, er kvalificerede.
  • Patienter skal have fået foretaget HER2-testning på den primære brysttumor indsamlet før neoadjuverende kemoterapi i henhold til de nuværende ASCO/CAP-retningslinjer for testning af human epidermal vækstfaktor receptor 2 ved brystkræft; patienter, der har en primær tumor, der er HER2-positiv, HER2-tvetydig eller HER2-negativ, er kvalificerede
  • Patienterne skal have haft en biopsimarkør placeret i tumorlejet med billeddiagnostisk bekræftelse (helst mammografi, men ultralyd eller magnetisk resonansbilleddannelse [MRI] er acceptabelt) af markørplacering før neoadjuverende kemoterapi
  • Patienter med operabelt fokal eller multifokalt (T1-T3, stadium II eller III invasivt duktalt karcinom [alle receptorfænotyper]), og som har afsluttet neoadjuverende kemoterapi med et klinisk fuldstændigt respons (ved klinisk undersøgelse)
  • Patienter med synkron bilateral brystkræft er berettiget, hvis mindst én af de synkrone brystkræftformer har en cCR, ​​og siden med en cCR opfylder kriterierne. (Patienter med tidligere kontralateral invasiv brystkræft behandlet med anti-cancer terapi er kvalificerede.)

  • Patienter skal have opnået en fuldstændig eller næsten fuldstændig radiologisk tumorrespons på brystbilleddannelse med mammografi, ultralyd og MR under eller efter afslutning af passende neoadjuverende kemoterapi defineret som:

    • Mammogram med malignt forekommende forkalkning eller masse ≤ 1 cm; eller
    • Ultralyd med et hypoekkoisk område ≤ 2 cm; eller
    • Bryst MR viser ikke en resterende masse med hurtig stigning og udvaskning type III kinetik.
  • På tidspunktet for samtykket skal patientens hensigt være at gennemgå brystbevarende behandling.
  • Patienten skal kunne gennemgå stereotaktisk-vakuum-assisteret brystbiopsi med klipsplacering efter afslutning af neoadjuverende kemoterapi. (Patienten skal tilmeldes undersøgelsen, før den post-neoadjuverende stereotaktiske-vakuum-assisteret brystbiopsi udføres.)
  • Patienten skal have gennemført neoadjuverende kemoterapi.
  • Patienter med HER2-positive tumorer skal have modtaget neoadjuverende anti-HER2-behandling (enten med hele eller med en del af det neoadjuverende kemoterapiregime), medmindre det er medicinsk kontraindiceret.
  • Patienter behandlet med PD-1- eller PD-L1-hæmmere, CDK 4/6-hæmmere eller anden immunbaseret terapi er kvalificerede.

Ekskluderingskriterier:

  • T4-tumorer inklusive inflammatorisk brystkræft
  • Patienter med fjernmetastatisk sygdom
  • Lumpektomi udført før studiestart
  • Patienter med tidligere strålebehandling i det berørte bryst
  • Patienter med en tidligere historie med ipsilateral invasiv brystkræft; (patienter med tidligere ipsilateral/kontralateral DCIS eller tidligere kontralateral invasiv brystkræft behandlet med anti-cancer terapi er kvalificerede)
  • Patienter med invasivt lobulært karcinom
  • Patienter med multicentrisk sygdom
  • Patienter, der kun behandles med neoadjuverende hormonbehandling, er ikke kvalificerede
  • Patienter, der er medicinsk uegnede til at gennemgå kirurgisk resektion
  • Patienter uden brystbiopsimarkør dokumenteret ved billeddiagnostik på tumorlejestedet før påbegyndelse af neoadjuverende behandling

  • Patienter med et eller flere af følgende billeddiagnostiske kriterier fra en af ​​de 3 billeddannelsesmodaliteter efter afslutning af NCT, der viser ufuldstændig radiologisk respons, er ikke kvalificerede:

    • Mammogram med maligne forkalkninger eller masse > 1 cm; eller
    • Ultralyd med et hypoekkoisk område > 2 cm; eller
    • Bryst-MR viser en resterende masse med hurtig stigning og udvaskning type III kinetik.
  • Psykiatriske eller vanedannende lidelser eller andre tilstande, der efter investigatorens mening ville forhindre patienten i at opfylde undersøgelseskravene eller forstyrre fortolkningen af ​​undersøgelsesresultaterne
  • Graviditet eller amning på tidspunktet for studieregistrering; (Bemærk: Graviditetstest i henhold til institutionelle standarder for kvinder i den fødedygtige alder skal udføres inden for 2 uger før undersøgelsesregistrering.)

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Diagnostisk (biopsi af bryst)
Efter afslutning af neoadjuverende terapi gennemgår patienter stereotaktisk biopsi af brysttumor når som helst før brystbevarende operation. Patienterne gennemgår derefter brystbevarende operation i henhold til standardbehandling. Patienter kan også gennemgå postoperativ strålebehandling efter standardbehandling eller adjuverende terapi efter investigators skøn.
Procedure: Biopsi af bryst
Gennemgå stereotaktisk biopsi
Andre navne:
  • Brystbiopsi

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Andel af patienter med pCR
Tidsramme: Op til 18 måneder
Andelen af ​​tumorbed-biopsier, der er negative blandt dem, der viser sig at have pCR ved operation, vil blive bestemt. Punktestimatet og 95 % konfidensinterval vil blive beregnet.
Op til 18 måneder

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Forbedring af negativ prædiktiv værdi
Tidsramme: Op til 18 måneder
Analyse vil blive udført for at vurdere forbedringen i den negative prædiktive værdi af trimodalitetsbilleddannelsesalgoritmen, når resultaterne af tumorbed-biopsi tilføjes.
Op til 18 måneder
Forekomst af uønskede hændelser forbundet med tumorbedbiopsi
Tidsramme: Op til 18 måneder
Beskrivende analyse vil blive udført for at bestemme hyppigheden af ​​uønskede hændelser forbundet med tumorbed-biopsi.
Op til 18 måneder
Antal udførte nålekerner
Tidsramme: Op til 18 måneder
Der vil blive udført beskrivende analyse for at bestemme fordelingen af ​​antallet af udførte nålekerner og andelen af ​​clips, der hentes.
Op til 18 måneder
Andel af klip hentet
Tidsramme: Op til 18 måneder
Der vil blive udført beskrivende analyse.
Op til 18 måneder
Restkræftbelastningsscore
Tidsramme: Op til 18 måneder
Deskriptiv analyse vil blive udført for at bestemme fordelingen af ​​resterende cancerbyrdescore.
Op til 18 måneder
Trimodalitetsbilleddannelsesalgoritme +/- biopsi som en prædiktor for pCR
Tidsramme: Op til 18 måneder
Analyse vil blive udført for at vurdere forbedringen i den negative prædiktive værdi af trimodalitetsbilleddannelsesalgoritmen, når resultaterne af tumorbed-biopsi tilføjes.
Op til 18 måneder

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Molekylær maker fra tumor- og blodprøver
Tidsramme: Op til 18 måneder
Analyse for at vurdere sammenhængen af ​​molekylære markører med respons på neoadjuverende terapi.
Op til 18 måneder

Samarbejdspartnere og efterforskere

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

Sponsor

NRG Oncology

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Mark Basik, NRG Oncology

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)

13. april 2017

Primær færdiggørelse (Faktiske)

5. juli 2019

Studieafslutning (Faktiske)

1. december 2022

Datoer for studieregistrering

Først indsendt

13. juni 2017

Først indsendt, der opfyldte QC-kriterier

13. juni 2017

Først opslået (Faktiske)

15. juni 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2025

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. maj 2025

Sidst verificeret

1. maj 2025

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NRG-BR005 (Anden identifikator: CTEP)
  • U10CA180868 (U.S. NIH-bevilling/kontrakt)
  • NCI-2016-01825 (Registry Identifier: CTRP)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Fase II brystkræft

Kliniske forsøg med Biopsi af bryst

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Lebanon

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner