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Stråleterapi med eller uden valgfri Tamoxifen til behandling af kvinder med duktalt karcinom in situ

23. maj 2022 opdateret af: Radiation Therapy Oncology Group

Fase III-forsøg med Tamoxifen alene vs. Tamoxifen Plus strålebehandling for Good Risk Duct Carcinoma In-Situ (DCIS) af det kvindelige bryst

RATIONALE: Strålebehandling bruger højenergi-røntgenstråler til at beskadige tumorceller. Østrogen kan stimulere væksten af ​​brystkræftceller. Hormonbehandling med tamoxifen kan bekæmpe brystkræft ved at blokere tumorcellernes optagelse af østrogen. Det vides endnu ikke, om strålebehandling er mere effektiv end observation, med eller uden tamoxifen, til behandling af duktalt carcinom in situ.

FORMÅL: Randomiseret fase III-forsøg til at sammenligne effektiviteten af ​​strålebehandling med effektiviteten af ​​observation, med eller uden tamoxifen, til behandling af kvinder, der har duktalt carcinom in situ.

Studieoversigt

Detaljeret beskrivelse

MÅL:

  • Sammenlign effektiviteten af ​​helbryststrålebehandling vs observation med eller uden valgfri tamoxifen til at mindske eller forsinke forekomsten af ​​lokal svigt (både invasiv og in situ) og forhindre behovet for mastektomi hos kvinder med god-risiko duktalt carcinom in situ (DCIS) af brystet.
  • Sammenlign fjern sygdomsfri overlevelse af patienter behandlet med disse regimer.

OVERSIGT: Dette er en randomiseret, multicenter undersøgelse. Patienterne er stratificeret efter alder (under 50 vs 50 og derover), endelige stimargener (negative vs 3-9 mm vs. mindst 10 mm), mammografisk størrelse af primær (ikke større end 1 cm vs. større end 1 cm til 2,5 cm ), kernekvalitet (lav vs mellemliggende) og tamoxifenbrug (ja vs nej). Patienterne randomiseres til 1 ud af 2 behandlingsarme.

  • Arm I: Patienter gennemgår observation og kan få valgfri oral tamoxifen én gang dagligt (efter lægens skøn) i 5 år.
  • Arm II: Begyndende inden for 12 uger efter den sidste operation, modtager patienter strålebehandling af hele brystet én gang dagligt, 5 dage om ugen, i 3,5-5,5 uger. Patienter kan få valgfri tamoxifen som i arm I.

Patienterne følges hver 3. måned i 1 år, hver 6. måned i 2 år og derefter årligt.

PROJEKTERET TILSLUTNING: I alt 1.790 patienter vil blive akkumuleret til denne undersøgelse inden for 6 år.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

636

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

      • Quebec, Canada, G1S 4L8
        • Centre Hospitalier Regional De Rimouski
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute at University of Alberta
      • Lethbridge, Alberta, Canada, T1J 1W5
        • Lethbridge Cancer Centre
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • British Columbia Cancer Agency - Centre for the Southern Interior
      • Nanaimo, British Columbia, Canada, V9S 2B7
        • Nanaimo Cancer Clinic at Nanaimo Regional General Hospital
      • North Vancouver, British Columbia, Canada, V7L 2P9
        • Lions Gate Hospital
      • Surrey, British Columbia, Canada, V3V 1Z2
        • BCCA - Fraser Valley Cancer Centre
      • Vancouver, British Columbia, Canada, V5Z 3J5
        • Prostate Centre at Vancouver General Hospital
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • British Columbia Cancer Agency - Vancouver Cancer Centre
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Providence Health Care - Vancouver
      • Victoria, British Columbia, Canada, V8V 3N1
        • G. Steinhoff Clinical Research
      • Victoria, British Columbia, Canada, V8R 6V5
        • British Columbia Cancer Agency - Vancouver Island Cancer Centre
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6ZB
        • Moncton Hospital
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Saint John Regional Hospital
    • Newfoundland and Labrador
      • St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
        • Newfoundland Cancer Treatment and Research Foundation
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Nova Scotia Cancer Centre
      • Sydney, Nova Scotia, Canada, B1P 1P3
        • Cape Breton Cancer Centre
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Royal Victoria Hospital of Barrie
      • Brampton, Ontario, Canada, L6W 2Z8
        • William Osler Health Centre
      • Hamilton, Ontario, Canada, L8V 5C2
        • Margaret and Charles Juravinski Cancer Centre
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Hospital
      • Kingston, Ontario, Canada, K7L 5P9
        • Cancer Centre of Southeastern Ontario at Kingston General Hospital
      • Kitchner, Ontario, Canada, N2G 1G3
        • Grand River Regional Cancer Centre at Grand River Hospital
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Program at London Health Sciences Centre
      • Markham, Ontario, Canada, L6B IAI
        • Markham Stouffville Hospital
      • Mississauga, Ontario, Canada, L5B 1B8
        • Trillium Health Centre - Mississauga Site
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Southlake Regional Health Centre
      • North York, Ontario, Canada, M2K 1E1
        • North York General Hospital - Ontario
      • Oakville, Ontario, Canada, L6H 3PI
        • Male Health Centre - Oakville
      • Oshawa, Ontario, Canada, L1G 2B9
        • R. S. McLaughlin Durham Regional Cancer Centre at Lakeridge Health Oshawa
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital Regional Cancer Centre - General Campus
      • Peterborough, Ontario, Canada, K9H 7B6
        • Peterborough Oncology Clinic
      • Sault Sainte Marie, Ontario, Canada, P6A 2C4
        • Algoma Regional Cancer Program at Sault Area Hospital
      • Scarborough, Ontario, Canada, M1P 2V5
        • Scarborough Hospital - General Campus
      • St. Catharines, Ontario, Canada, L2R 5K3
        • St. Catharines General Hospital at Niagara Health System
      • Sudbury, Ontario, Canada, P3E 5J1
        • Northeastern Ontario Regional Cancer Centre
      • Thunder Bay, Ontario, Canada, P7B 6V4
        • Northwestern Ontario Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
      • Toronto, Ontario, Canada, M4C 3E7
        • Toronto East General Hospital
      • Toronto, Ontario, Canada, M5B 1W8
        • St. Michael's Hospital - Toronto
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital - Toronto
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
      • Toronto, Ontario, Canada, M6R 1B5
        • St. Joseph's Health Centre - Toronto
      • Toronto, Ontario, Canada, M6A 3B5
        • Male Health Centre - North York
      • Toronto, Ontario, Canada, M4N 3M5
        • Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre
      • Weston, Ontario, Canada, M9N 1N8
        • Humber River Regional Hospital - Weston
      • Windsor, Ontario, Canada, N8W 2X3
        • Windsor Regional Cancer Centre at Windsor Regional Hospital
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada, C1A 8T5
        • Prince Edward Island Cancer Centre at Queen Elizabeth Hospital
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Centre De Sante Et De Services Sociaux De Chicoutimi
      • Fleurimont, Quebec, Canada, J1H 5N4
        • CHUS-Hopital Fleurimont
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Hôpital Charles LeMoyne
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Doctor Leon Richard Oncology Centre
      • Joliette, Quebec, Canada, J6E 6J2
        • Centre hospitalier régional de Lanaudière
      • Levis, Quebec, Canada, G6V 3Z1
        • Hotel-Dieu de Levis
      • Montreal, Quebec, Canada, H1T 2M4
        • Maisonneuve-Rosemont Hospital
      • Montreal, Quebec, Canada, H2W 1T8
        • Hotel Dieu de Montreal
      • Montreal, Quebec, Canada, H4J 1C5
        • Hôpital du Sacré-Cœur de Montréal
      • Montreal, Quebec, Canada, H3T 1C5
        • Hôpital Sainte Justine
      • Montreal, Quebec, Canada, (P.Q.) H2X 3J4
        • Centre Hospitalier de l'Université de Montréal
      • Quebec City, Quebec, Canada, G1R 2J6
        • Centre Hospitalier Universitaire de Quebec
      • Quebec City, Quebec, Canada, G1S 4L8
        • Hopital du Saint-Sacrement - Quebec
      • Ste-Foy, Quebec, Canada, G1V 4G5
        • L'Hopital Laval
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 7T1
        • Allan Blair Cancer Centre at Pasqua Hospital
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatoon Cancer Centre at the University of Saskatchewan
    • Alabama
      • Mobile, Alabama, Forenede Stater, 36652-2144
        • Mobile Infirmary Medical Center
    • Alaska
      • Fairbanks, Alaska, Forenede Stater, 99701
        • Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
    • Arizona
      • Phoenix, Arizona, Forenede Stater, 85013
        • Arizona Oncology Services Foundation
    • Arkansas
      • Hot Springs, Arkansas, Forenede Stater, 71913
        • Saint Joseph's Mercy Cancer Center
    • California
      • Burbank, California, Forenede Stater, 91505
        • Providence Saint Joseph Medical Center - Burbank
      • Chico, California, Forenede Stater, 95926
        • Enloe Cancer Center at Enloe Medical Center
      • Concord, California, Forenede Stater, 94524-4110
        • Mount Diablo Regional Cancer Center
      • Fairfield, California, Forenede Stater, 94533
        • North Bay Cancer Center
      • Fremont, California, Forenede Stater, 94538
        • Washington Township Hospital
      • Fresno, California, Forenede Stater, 93720-3397
        • Saint Agnes Medical Center
      • Inglewood, California, Forenede Stater, 90301
        • Cancer Care Consultants Medical Associates at Daniel Freeman Memorial Hospital
      • Los Angeles, California, Forenede Stater, 90089-9181
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Mission Hills, California, Forenede Stater, 91346-9600
        • Providence Holy Cross Cancer Center
      • Modesto, California, Forenede Stater, 95355
        • Memorial Medical Center Cancer Services
      • Oakland, California, Forenede Stater, 94609
        • CCOP - Bay Area Tumor Institute
      • Pomona, California, Forenede Stater, 91767
        • Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
      • Sacramento, California, Forenede Stater, 95815
        • Radiological Associates of Sacramento Medical Group, Incorporated
      • Sacramento, California, Forenede Stater, 95817
        • University of California Davis Cancer Center
      • Santa Rosa, California, Forenede Stater, 95405
        • CCOP - Santa Rosa Memorial Hospital
      • Torrance, California, Forenede Stater, 90509
        • Torrance Memorial Medical Center
      • Walnut Creek, California, Forenede Stater, 94598
        • John Muir/Mt. Diablo Comprehensive Cancer Center
      • Whittier, California, Forenede Stater, 90602
        • Ruby L. Golleher Cancer Program at Presbyterian Intercommunity Hospital
    • Connecticut
      • Bridgeport, Connecticut, Forenede Stater, 06606
        • St. Vincent's Medical Center
      • New Haven, Connecticut, Forenede Stater, 06511
        • Hospital of Saint Raphael
      • Norwich, Connecticut, Forenede Stater, 06360
        • Eastern Connecticut Hematology and Oncology Associates
    • Delaware
      • Newark, Delaware, Forenede Stater, 19713
        • CCOP - Christiana Care Health Services
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20007
        • Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
    • Florida
      • Gainesville, Florida, Forenede Stater, 32610-0232
        • University of Florida Shands Cancer Center
      • Jacksonville, Florida, Forenede Stater, 32224
        • Mayo Clinic - Jacksonville
      • Lakeland, Florida, Forenede Stater, 33805
        • Lakeland Regional Cancer Center at Lakeland Regional Medical Center
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami Sylvester Comprehensive Cancer Center
      • Miami, Florida, Forenede Stater, 33176
        • Baptist-South Miami Regional Cancer Program
    • Georgia
      • Gainesville, Georgia, Forenede Stater, 30501
        • Northeast Georgia Medical Center
      • Savannah, Georgia, Forenede Stater, 31405
        • Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
    • Hawaii
      • 'Ewa Beach, Hawaii, Forenede Stater, 96706
        • Leeward Radiation Oncology Center
      • Honolulu, Hawaii, Forenede Stater, 96813
        • Cancer Research Center of Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96813
        • Queen's Cancer Institute at Queen's Medical Center
      • Honolulu, Hawaii, Forenede Stater, 96859
        • Tripler Army Medical Center
      • Honolulu, Hawaii, Forenede Stater, 96817
        • St. Francis Medical Center
    • Idaho
      • Boise, Idaho, Forenede Stater, 83712
        • St. Luke's Mountain States Tumor Institute - Boise
      • Idaho Falls, Idaho, Forenede Stater, 83404
        • Hematology Oncology Associates of Eastern Idaho
    • Illinois
      • Arlington Heights, Illinois, Forenede Stater, 60005
        • Northwest Community Hospital
      • Aurora, Illinois, Forenede Stater, 60507
        • Rush-Copley Cancer Care Center
      • Barrington, Illinois, Forenede Stater, 60010
        • Good Shepherd Hospital
      • Bloomington, Illinois, Forenede Stater, 61701
        • St. Joseph Medical Center
      • Chicago, Illinois, Forenede Stater, 60611-3013
        • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
      • Chicago, Illinois, Forenede Stater, 60657
        • Creticos Cancer Center at Advocate Illinois Masonic Medical Center
      • Chicago, Illinois, Forenede Stater, 60612-3785
        • John H. Stroger, Jr. Hospital of Cook County
      • Downers Grove, Illinois, Forenede Stater, 60515
        • Advocate Good Samaritan Hospital
      • Galesburg, Illinois, Forenede Stater, 61401
        • InterCommunity Cancer Center of Western Illinois
      • Joliet, Illinois, Forenede Stater, 60435
        • Joliet Oncology-Hematology Associates, Limited - West
      • Maywood, Illinois, Forenede Stater, 60153
        • Cardinal Bernardin Cancer Center at Loyola University Medical Center
      • Normal, Illinois, Forenede Stater, 61761
        • Bromenn Regional Medical Center
      • Normal, Illinois, Forenede Stater, 61761
        • Community Cancer Center
      • Park Ridge, Illinois, Forenede Stater, 60068
        • Lutheran General Cancer Care Center
      • 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, 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
      • Spring Valley, Illinois, Forenede Stater, 61362
        • Valley Cancer Center
      • Urbana, Illinois, Forenede Stater, 61801
        • Carle Cancer Center at Carle Foundation Hospital
      • Urbana, Illinois, Forenede Stater, 61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Anderson, Indiana, Forenede Stater, 46016
        • St. John's Cancer Center at St. John's Medical Center
      • Bloomington, Indiana, Forenede Stater, 47403
        • Regional Cancer Institute at Bloomington Hospital
      • Elkhart, Indiana, Forenede Stater, 46515
        • Elkhart General Hospital
      • Fort Wayne, Indiana, Forenede Stater, 46805
        • Parkview Regional Cancer Center at Parkview Health
      • Indianapolis, Indiana, Forenede Stater, 46202-5289
        • Indiana University Cancer Center
      • Kokomo, Indiana, Forenede Stater, 46904
        • Howard Community Hospital at Howard Regional Health System
      • La Porte, Indiana, Forenede Stater, 46350
        • Center for Cancer Therapy at LaPorte Hospital and Health Services
      • Michigan City, Indiana, Forenede Stater, 46360
        • Saint Anthony Memorial Health Centers
      • South Bend, Indiana, Forenede Stater, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, Forenede Stater, 46601
        • CCOP - Northern Indiana CR Consortium
    • Iowa
      • Cedar Rapids, Iowa, Forenede Stater, 52402
        • St. Luke's Hospital
      • Cedar Rapids, Iowa, Forenede Stater, 52403
        • Cedar Rapids Oncology Associates
      • Cedar Rapids, Iowa, Forenede Stater, 52403
        • Mercy Regional Cancer Center at Mercy Medical Center
    • Kansas
      • Topeka, Kansas, Forenede Stater, 66606
        • St. Francis Comprehensive Cancer Center
      • Topeka, Kansas, Forenede Stater, 66604
        • Stormont-Vail Cancer Center
    • Kentucky
      • Bowling Green, Kentucky, Forenede Stater, 42101
        • Cancer Treatment Center for Southern Kentucky
      • Lexington, Kentucky, Forenede Stater, 40503-9985
        • Central Baptist Hospital
      • Madisonville, Kentucky, Forenede Stater, 42431
        • Merle M. Mahr Cancer Center at Regional Medical Center of Hopkins County
    • Maine
      • Lewiston, Maine, Forenede Stater, 04240
        • Central Maine Medical Center
      • Portland, Maine, Forenede Stater, 04102
        • Maine Medical Center - Bramhall Campus
    • Maryland
      • Annapolis, Maryland, Forenede Stater, 21401
        • DeCesaris Cancer Institute at Anne Arundel Medical Center
      • Baltimore, Maryland, Forenede Stater, 21204
        • Greater Baltimore Medical Center
      • Bethesda, Maryland, Forenede Stater, 20814
        • Suburban Hospital
      • Salisbury, Maryland, Forenede Stater, 21801
        • Peninsula Regional Medical Center
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, Forenede Stater, 02115
        • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital Cancer Center
      • Boston, Massachusetts, Forenede Stater, 02118
        • Cancer Research Center at Boston Medical Center
      • Burlington, Massachusetts, Forenede Stater, 01805
        • Lahey Clinic Medical Center - Burlington
      • Concord, Massachusetts, Forenede Stater, 01742
        • Bethke Cancer Center at Emerson Hospital
      • Fall River, Massachusetts, Forenede Stater, 02721
        • Hudner Oncology Center at Saint Anne's Hospital
      • Framingham, Massachusetts, Forenede Stater, 01702
        • Metrowest Medical Center - Framingham Union Hospital
      • Hyannis, Massachusetts, Forenede Stater, 02601
        • Cape Cod Hospital
      • Lowell, Massachusetts, Forenede Stater, 01854
        • Lowell General Hospital
      • Milford, Massachusetts, Forenede Stater, 01757
        • Community Cancer Care at Milford Regional Medical Center
      • Norwood, Massachusetts, Forenede Stater, 02062
        • Caritas Norwood Hospital
      • Springfield, Massachusetts, Forenede Stater, 01199
        • Baystate Regional Cancer Program at D'Amour Center for Cancer Care
    • Michigan
      • Adrian, Michigan, Forenede Stater, 49221
        • Hickman Cancer Center at Bixby Medical Center
      • Ann Arbor, Michigan, Forenede Stater, 48109-0942
        • University Of Michigan Comprehensive Cancer Center
      • Ann Arbor, Michigan, Forenede Stater, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Ann Arbor, Michigan, Forenede Stater, 48106-0995
        • St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
      • Detroit, Michigan, Forenede Stater, 48202
        • Josephine Ford Cancer Center at Henry Ford Hospital
      • 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
        • Genesys Hurley Cancer Institute
      • Flint, Michigan, Forenede Stater, 48532
        • Great Lakes Cancer Institute at McLaren Regional Medical Center
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • CCOP - Grand Rapids
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Lacks Cancer Center at Saint Mary's Mercy Medical Center
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Spectrum Health Cancer Care - Butterworth Campus
      • Grosse Pointe Woods, Michigan, Forenede Stater, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Iron Mountain, Michigan, Forenede Stater, 49801
        • Green Bay Oncology, Limited - Iron Mountain
      • Jackson, Michigan, Forenede Stater, 49201
        • Foote 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, 48910
        • Breslin Cancer Center at Ingham Regional Medical Center
      • Marquette, Michigan, Forenede Stater, 49855
        • Upper Michigan Cancer Center at Marquette General Hospital
      • Midland, Michigan, Forenede Stater, 48670
        • MidMichigan Medical Center - Midland
      • Petoskey, Michigan, Forenede Stater, 49770
        • Northern Michigan Hospital
      • Royal Oak, Michigan, Forenede Stater, 48073
        • William Beaumont Hospital - Royal Oak Campus
      • Saginaw, Michigan, Forenede Stater, 48601
        • Seton Cancer Institute - Saginaw
      • Saint Joseph, Michigan, Forenede Stater, 49085
        • Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
      • 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
      • Duluth, Minnesota, Forenede Stater, 55805
        • St. Mary's - Duluth Clinic Cancer Center
      • Edina, Minnesota, Forenede Stater, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, Forenede Stater, 55432
        • Mercy and Unity Cancer Center at Unity Hospital
      • Mankato, Minnesota, Forenede Stater, 56002
        • Immanuel St. Joseph's Clinic
      • Minneapolis, Minnesota, Forenede Stater, 55407
        • Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
      • Robbinsdale, Minnesota, Forenede Stater, 55422-2900
        • Hubert H. Humphrey Cancer Center at North Memorial Medical Center
      • Rochester, Minnesota, Forenede Stater, 55905
        • Mayo Clinic Cancer Center
      • Saint Cloud, Minnesota, Forenede Stater, 56303
        • CentraCare Clinic - River Campus
      • Saint Cloud, Minnesota, Forenede Stater, 56303
        • Coborn Cancer Center
      • Saint Louis Park, Minnesota, Forenede Stater, 55416
        • CCOP - Metro-Minnesota
      • Saint Louis Park, Minnesota, Forenede Stater, 55416
        • Park Nicollet Health Services
      • Saint Paul, Minnesota, Forenede Stater, 55102
        • United Hospital
      • Saint Paul, Minnesota, Forenede Stater, 55101
        • Regions Hospital Cancer Care Center
      • Waconia, Minnesota, Forenede Stater, 55387
        • Ridgeview Medical Center
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39216
        • University of Mississippi Medical Center
    • Missouri
      • Columbia, Missouri, Forenede Stater, 65203
        • Ellis Fischel Cancer Center at University of Missouri - Columbia
      • Kansas City, Missouri, Forenede Stater, 64131
        • CCOP - Kansas City
    • Montana
      • Billings, Montana, Forenede Stater, 59101
        • CCOP - Montana Cancer Consortium
      • Billings, Montana, Forenede Stater, 59101
        • Northern Rockies Radiation Oncology Center
      • Billings, Montana, Forenede Stater, 59107-7000
        • Deaconess Billings Clinic - Downtown
      • Great Falls, Montana, Forenede Stater, 59405
        • Great Falls Clinic
    • Nebraska
      • Kearney, Nebraska, Forenede Stater, 68848-1990
        • Good Samaritan Cancer Center at Good Samaritan Hospital
      • Omaha, Nebraska, Forenede Stater, 68114
        • Methodist Cancer Center at Methodist Hospital - Omaha
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89106
        • CCOP - Nevada Cancer Research Foundation
    • New Hampshire
      • Concord, New Hampshire, Forenede Stater, 03301
        • Dartmouth - Hitchcock Concord
      • Dover, New Hampshire, Forenede Stater, 03820
        • Seacoast Cancer Center at Wentworth-Douglass Hospital
      • Lebanon, New Hampshire, Forenede Stater, 03756-0002
        • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
      • Manchester, New Hampshire, Forenede Stater, 03103
        • Elliot Regional Cancer Center at Elliot Hospital
    • New Jersey
      • East Orange, New Jersey, Forenede Stater, 07018-1095
        • Veterans Affairs Medical Center - East Orange
      • Edison, New Jersey, Forenede Stater, 08818
        • John F. Kennedy Medical Center
      • Englewood, New Jersey, Forenede Stater, 07631
        • Dizzy Gillespie Cancer Institute at Englewood Hospital and Medical Center
      • Long Branch, New Jersey, Forenede Stater, 07740-6395
        • Monmouth Medical Center
      • Marlton, New Jersey, Forenede Stater, 08053
        • Fox Chase Virtua Health Cancer Program - Marlton
      • New Brunswick, New Jersey, Forenede Stater, 08903
        • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
      • New Brunswick, New Jersey, Forenede Stater, 08903
        • Saint Peter's University Hospital
      • Newark, New Jersey, Forenede Stater, 07112
        • Newark Beth Israel Medical Center
      • Pomona, New Jersey, Forenede Stater, 08240
        • AtlantiCare Regional Medical Center
      • Red Bank, New Jersey, Forenede Stater, 07701
        • Booker Cancer Center at Riverview Medical Center
      • Trenton, New Jersey, Forenede Stater, 08629
        • Fox Chase Cancer Center at St. Francis Medical Center
      • Voorhees, New Jersey, Forenede Stater, 08043
        • Cancer Institute of New Jersey at Cooper - Voorhees
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87131-5636
        • University of New Mexico Cancer Research and Treatment Center
      • Albuquerque, New Mexico, Forenede Stater, 87102
        • Albuquerque Regional Medical Center at Lovelace Sandia Health System
    • New York
      • Brooklyn, New York, Forenede Stater, 11201
        • Long Island College Hospital
      • Buffalo, New York, Forenede Stater, 14263-0001
        • Roswell Park Cancer Institute
      • Manhasset, New York, Forenede Stater, 11030
        • CCOP - North Shore University Hospital
      • Manhasset, New York, Forenede Stater, 11030
        • North Shore University Hospital
      • Middletown, New York, Forenede Stater, 10940-4199
        • Tucker Center for Cancer Care at Orange Regional Medical Center
      • New Hyde Park, New York, Forenede Stater, 11042
        • Long Island Jewish Medical Center
      • New York, New York, Forenede Stater, 10021
        • Memorial Sloan-Kettering Cancer Center
      • Syracuse, New York, Forenede Stater, 13057
        • CCOP - Hematology-Oncology Associates of Central New York
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599-7295
        • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
      • 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
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke Comprehensive Cancer Center
      • Goldsboro, North Carolina, Forenede Stater, 27534
        • Wayne Radiation Oncology
      • Goldsboro, North Carolina, Forenede Stater, 27534
        • Wayne Memorial Hospital, Incorporated
      • Greenville, North Carolina, Forenede Stater, 27835-6028
        • Leo W. Jenkins Cancer Center at Pitt County Memorial Hospital
      • Hendersonville, North Carolina, Forenede Stater, 28791
        • Pardee Memorial Hospital
      • Kinston, North Carolina, Forenede Stater, 28501
        • Lenoir Memorial Cancer Center
      • Pinehurst, North Carolina, Forenede Stater, 28374
        • Moore Regional Community Hospital Comprehensive Cancer Center
      • Raleigh, North Carolina, Forenede Stater, 27607
        • Rex Cancer Center at Rex Hospital
      • Rutherfordton, North Carolina, Forenede Stater, 28139
        • Rutherford Hospital
      • Wilmington, North Carolina, Forenede Stater, 28401
        • Zimmer Cancer Center at New Hanover Regional Medical Center
      • Wilson, North Carolina, Forenede Stater, 27893
        • Wilmed Radiation Oncology Services
    • North Dakota
      • Minot, North Dakota, Forenede Stater, 58701
        • Trinity Cancer Care Center
    • Ohio
      • Akron, Ohio, Forenede Stater, 44307
        • McDowell Cancer Center at Akron General Medical Center
      • Canton, Ohio, Forenede Stater, 44708
        • Mercy Cancer Center at Mercy Medical Center
      • Chillicothe, Ohio, Forenede Stater, 45601
        • Adena Regional Medical Center
      • Cincinnati, Ohio, Forenede Stater, 45242
        • Bethesda North Hospital
      • Cincinnati, Ohio, Forenede Stater, 45220
        • Cancer Treatment Center at Good Samaritan Hospital
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland, Ohio, Forenede Stater, 44109
        • MetroHealth's Cancer Care Center at MetroHealth Medical Center
      • Cleveland, Ohio, Forenede Stater, 44106
        • Case Comprehensive Cancer Center
      • Columbus, Ohio, Forenede Stater, 43210-1240
        • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
      • 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
      • Delaware, Ohio, Forenede Stater, 43015
        • Grady Memorial Hospital
      • Findlay, Ohio, Forenede Stater, 45840
        • Blanchard Valley Medical Associates
      • Lima, Ohio, Forenede Stater, 45804
        • Lima Memorial Hospital
      • Lima, Ohio, Forenede Stater, 45801
        • St. Rita's Medical Center
      • Marietta, Ohio, Forenede Stater, 45750
        • Strecker Cancer Center at Marietta Memorial Hospital
      • Maumee, Ohio, Forenede Stater, 43623
        • Northwest Ohio Oncology Center
      • Mayfield Heights, Ohio, Forenede Stater, 44124
        • Hillcrest Cancer Center at Hillcrest Hospital
      • Newark, Ohio, Forenede Stater, 43055
        • Licking Memorial Cancer Care Program at Licking Memorial Hospital
      • Oregon, Ohio, Forenede Stater, 43616
        • St. Charles Mercy Hospital
      • Sandusky, Ohio, Forenede Stater, 44870
        • Firelands Regional Medical Center
      • Springfield, Ohio, Forenede Stater, 45504
        • Mercy Medical Center
      • Sylvania, Ohio, Forenede Stater, 43560
        • Promedica Cancer Center at Flower Hospital
      • Toledo, Ohio, Forenede Stater, 43608
        • St. Vincent Mercy Medical Center
      • Toledo, Ohio, Forenede Stater, 43614
        • Medical University of Ohio Cancer Center
      • Toledo, Ohio, Forenede Stater, 43623
        • Toledo Clinic, Incorporated - Main Clinic
      • Toledo, Ohio, Forenede Stater, 43623
        • CCOP - Toledo Community Hospital
      • Warren, Ohio, Forenede Stater, 44484
        • St. Joseph Cancer Center at St. Joseph Health Center
      • Westerville, Ohio, Forenede Stater, 43081
        • Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
    • Oklahoma
      • Tulsa, Oklahoma, Forenede Stater, 74136
        • Natalie Warren Bryant Cancer Center at St. Francis Hospital
    • Oregon
      • Grants Pass, Oregon, Forenede Stater, 97527
        • Three Rivers Community Hospital
      • Gresham, Oregon, Forenede Stater, 97030
        • Legacy Mount Hood Medical Center
      • Medford, Oregon, Forenede Stater, 97504
        • Providence Medford Medical Center
      • Medford, Oregon, Forenede Stater, 97504
        • Dubs Cancer Center at Rogue Valley Medical Center
      • Milwaukie, Oregon, Forenede Stater, 97222
        • Providence Milwaukie Hospital
      • Portland, Oregon, Forenede Stater, 97213-2967
        • Providence Cancer Center at Providence Portland Medical Center
      • Portland, Oregon, Forenede Stater, 97225
        • CCOP - Columbia River Oncology Program
      • Portland, Oregon, Forenede Stater, 97225
        • Providence St. Vincent Medical Center
      • Portland, Oregon, Forenede Stater, 97210
        • Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
      • Portland, Oregon, Forenede Stater, 97227
        • Legacy Emanuel Hospital and Health Center & Children's Hospital
      • Portland, Oregon, Forenede Stater, 97239-3098
        • Cancer Institute at Oregon Health and Science University
      • Tualatin, Oregon, Forenede Stater, 97062
        • Legacy Meridian Park Hospital
    • Pennsylvania
      • Abington, Pennsylvania, Forenede Stater, 19001
        • Rosenfeld Cancer Center at Abington Memorial Hospital
      • Bethlehem, Pennsylvania, Forenede Stater, 18015
        • St. Luke's Hospital Cancer Center
      • Bryn Mawr, Pennsylvania, Forenede Stater, 19010
        • Bryn Mawr Hospital
      • Danville, Pennsylvania, Forenede Stater, 17822-0001
        • Geisinger Medical Center
      • Darby, Pennsylvania, Forenede Stater, 19023
        • Mercy Fitzgerald Hospital
      • Easton, Pennsylvania, Forenede Stater, 18042
        • Easton Regional Cancer Center at Easton Hospital
      • Langhorne, Pennsylvania, Forenede Stater, 19047
        • St. Mary Regional Cancer Center
      • Paoli, Pennsylvania, Forenede Stater, 19301-1792
        • Paoli Memorial Hospital
      • Philadelphia, Pennsylvania, Forenede Stater, 19107-5541
        • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
      • Philadelphia, Pennsylvania, Forenede Stater, 19140
        • Fox Chase-Temple Cancer Center CCOP Research Base
      • Pittsburgh, Pennsylvania, Forenede Stater, 15232
        • Hillman Cancer Center at University of Pittsburgh Cancer Institute
      • Pittsburgh, Pennsylvania, Forenede Stater, 15219
        • Mercy Cancer Institute at Mercy Hospital
      • Reading, Pennsylvania, Forenede Stater, 19612-6052
        • Reading Hospital and Medical Center
      • Scranton, Pennsylvania, Forenede Stater, 18501
        • Mercy Hospital Cancer Center - Scranton
      • State College, Pennsylvania, Forenede Stater, 16803
        • Mount Nittany Medical Center
      • Wilkes-Barre, Pennsylvania, Forenede Stater, 18711
        • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
      • Wynnewood, Pennsylvania, Forenede Stater, 19096
        • CCOP - MainLine Health
      • Wynnewood, Pennsylvania, Forenede Stater, 19096
        • Lankenau Cancer Center at Lankenau Hospital
      • York, Pennsylvania, Forenede Stater, 17403
        • York Cancer Center at Wellspan Health
    • South Carolina
      • Anderson, South Carolina, Forenede Stater, 29621
        • AnMed Health Cancer Center
      • Columbia, South Carolina, Forenede Stater, 29203
        • Palmetto Health South Carolina Cancer Center
      • Greenville, South Carolina, Forenede Stater, 29615
        • CCOP - Greenville
      • Greenville, South Carolina, Forenede Stater, 29601
        • Bon Secours St. Francis Health System
      • 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
      • Rapid City, South Dakota, Forenede Stater, 57701
        • Rapid City Regional Hospital
      • Sioux Falls, South Dakota, Forenede Stater, 57117-5039
        • Sioux Valley Hospital and University of South Dakota Medical Center
      • Sioux Falls, South Dakota, Forenede Stater, 57105
        • Medical X-Ray Center, PC
    • Texas
      • Galveston, Texas, Forenede Stater, 77555-0209
        • University of Texas Medical Branch
      • Houston, Texas, Forenede Stater, 77030-4009
        • M.D. Anderson Cancer Center at University of Texas
      • Laredo, Texas, Forenede Stater, 78041
        • Doctor's Hospital of Laredo
      • Lubbock, Texas, Forenede Stater, 79410-1894
        • Joe Arrington Cancer Research and Treatment Center
    • Utah
      • Murray, Utah, Forenede Stater, 84107
        • Cottonwood Hospital Medical Center
      • Ogden, Utah, Forenede Stater, 84403
        • McKay-Dee Hospital Center
      • Provo, Utah, Forenede Stater, 84604
        • Utah Valley Regional Medical Center - Provo
      • Saint George, Utah, Forenede Stater, 84770
        • Dixie Regional Medical Center - East Campus
      • Salt Lake City, Utah, Forenede Stater, 84143
        • LDS Hospital
      • Salt Lake City, Utah, Forenede Stater, 84106
        • Utah Cancer Specialists at UCS Cancer Center
    • Vermont
      • Burlington, Vermont, Forenede Stater, 05401
        • Fletcher Allen Health Care - University Health Center Campus
      • Rutland, Vermont, Forenede Stater, 05701
        • Community Cancer Center at Rutland Regional Medical Center
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22901
        • Martha Jefferson Hospital Cancer Care Center
      • Portsmouth, Virginia, Forenede Stater, 23708-2197
        • Naval Medical Center - Portsmouth
    • Washington
      • Federal Way, Washington, Forenede Stater, 98003
        • St. Francis Hospital
      • Kirkland, Washington, Forenede Stater, 98033
        • Cascade Cancer Center at Evergreen Hospital Medical Center
      • Seattle, Washington, Forenede Stater, 98101
        • CCOP - Virginia Mason Research Center
      • Seattle, Washington, Forenede Stater, 98112
        • Group Health Central Hospital
      • Seattle, Washington, Forenede Stater, 98122-4307
        • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
      • Seattle, Washington, Forenede Stater, 98195-6043
        • University Cancer Center at University of Washington Medical Center
      • Spokane, Washington, Forenede Stater, 99202
        • Cancer Care Northwest - Spokane South
      • Tacoma, Washington, Forenede Stater, 98431
        • Madigan Army Medical Center - Tacoma
      • Vancouver, Washington, Forenede Stater, 98668
        • Southwest Washington Medical Center Cancer Center
    • Wisconsin
      • Appleton, Wisconsin, Forenede Stater, 54911
        • Theda Care Cancer Institute
      • Green Bay, Wisconsin, Forenede Stater, 54307-3508
        • 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, 54301-3526
        • Green Bay Oncology, Limited at St. Vincent Hospital
      • Green Bay, Wisconsin, Forenede Stater, 54311
        • Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
      • La Crosse, Wisconsin, Forenede Stater, 54601
        • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
      • Madison, Wisconsin, Forenede Stater, 53792-6164
        • University of Wisconsin Comprehensive Cancer Center
      • Marinette, Wisconsin, Forenede Stater, 54143
        • Bay Area Cancer Care Center at Bay Area Medical Center
      • Menomonee Falls, Wisconsin, Forenede Stater, 53051
        • Community Memorial Hospital Cancer Care Center
      • Milwaukee, Wisconsin, Forenede Stater, 53215
        • Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
      • Milwaukee, Wisconsin, Forenede Stater, 53211
        • Columbia St. Mary's Cancer Care 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
      • Sturgeon Bay, Wisconsin, Forenede Stater, 54235
        • Green Bay Oncology, Limited - Sturgeon Bay
      • Waukesha, Wisconsin, Forenede Stater, 53188
        • Waukesha Memorial Hospital Regional Cancer Center
      • West Milwaukee, Wisconsin, Forenede Stater, 53227
        • West Allis Memorial 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

22 år til 116 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

SYGDOMS KARAKTERISTIKA:

  • Ductal carcinoma in situ (DCIS) i brystet påvist ved mammografi på diagnosetidspunktet

    • Unicentrisk
    • Læsioner ≤ 2,5 cm
    • Lav nuclei grade (NG1) eller intermediate nuclei grade (NG2) med nekrose i < en tredjedel af de involverede kanaler
    • Farvede marginer ≥ 3 mm
    • Klinisk node negativ
    • Ikke-håndgribelig
  • Ingen mistænkelige områder på postoperativ mammografi taget inden for 12 uger efter den sidste operation
  • Intet blodigt udflåd fra brystvorten
  • Ikke mere end 12 uger siden sidste sidste operation (kun arm II)
  • Hormonreceptorstatus:

    • Ikke specificeret

PATIENT KARAKTERISTIKA:

Alder:

  • 26 og derover

Køn:

  • Kvinde

Menopausal status:

  • Ikke specificeret

Ydeevnestatus:

  • Ikke specificeret

Forventede levealder:

  • Ikke specificeret

Hæmatopoietisk:

  • Ikke specificeret

Hepatisk:

  • Ikke specificeret

Nyre:

  • Ikke specificeret

Andet:

  • Ikke gravid eller ammende
  • Ingen aktive bindevævssygdomme (f.eks. lupus eller sklerodermi)
  • Ingen tidligere malignitet inden for de seneste 5 år undtagen tilstrækkeligt behandlet basalcelle- eller pladecellehudkræft eller carcinom in situ i livmoderhalsen

FORUDSÆTNING SAMTYDLIG TERAPI:

Biologisk terapi:

  • Ikke specificeret

Kemoterapi:

  • Ingen forudgående kemoterapi

Endokrin terapi:

  • Ingen anden samtidig hormonbehandling (f.eks. raloxifen, hormonbehandling eller p-piller)

Strålebehandling:

  • Ingen forudgående strålebehandling

Kirurgi:

  • Se Sygdomskarakteristika

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: Observation +/- tamoxifen i 5 år
Observation +/- tamoxifen 20 mg dagligt i 5 år
Eksperimentel: Strålebehandling +/- tamoxifen i 5 år
Strålebehandling til hele brystet +/- tamoxifen 20 mg dagligt i 5 år

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Lokalt tilbagefald (f.eks. invasivt eller ikke-invasivt tilbagefald)
Tidsramme: Fra randomisering til dato for lokal svigt i det behandlede bryst eller sidste opfølgning. Analyse sker efter, at alle patienter potentielt er blevet fulgt i 5 år.
Fra randomisering til dato for lokal svigt i det behandlede bryst eller sidste opfølgning. Analyse sker efter, at alle patienter potentielt er blevet fulgt i 5 år.

Sekundære resultatmål

Resultatmål
Tidsramme
Samlet overlevelse
Tidsramme: Fra randomisering til dødsdato eller sidste opfølgning. Analyse sker efter, at alle patienter potentielt er blevet fulgt i 5 år.
Fra randomisering til dødsdato eller sidste opfølgning. Analyse sker efter, at alle patienter potentielt er blevet fulgt i 5 år.
Tid til fjernmetastaser
Tidsramme: Fra randomisering til dato for fjernmetastase eller sidste opfølgning. Analyse sker efter, at alle patienter potentielt er blevet fulgt i 5 år.
Fra randomisering til dato for fjernmetastase eller sidste opfølgning. Analyse sker efter, at alle patienter potentielt er blevet fulgt i 5 år.
Invasiv lokal gentagelse
Tidsramme: Fra randomisering til dato for invasiv lokal svigt i det behandlede bryst eller sidste opfølgning. Analyse sker efter, at alle patienter potentielt er blevet fulgt i 5 år.
Fra randomisering til dato for invasiv lokal svigt i det behandlede bryst eller sidste opfølgning. Analyse sker efter, at alle patienter potentielt er blevet fulgt i 5 år.
Salvage mastektomi rate
Tidsramme: Analyse sker efter, at alle patienter potentielt er blevet fulgt i 5 år.
Analyse sker efter, at alle patienter potentielt er blevet fulgt i 5 år.

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Studiestol: Barbara L. Smith, MD, PhD, Massachusetts General Hospital
  • Studiestol: Beryl McCormick, MD, Memorial Sloan Kettering Cancer Center
  • Clifford A. Hudis, MD, Memorial Sloan Kettering Cancer Center
  • Studiestol: Timothy J. Whelan, MD, Margaret and Charles Juravinski Cancer Centre
  • Eileen Rakovitch, MD, Toronto Sunnybrook Regional Cancer Centre

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.

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)

1. december 1999

Primær færdiggørelse (Faktiske)

1. februar 2004

Studieafslutning (Faktiske)

20. maj 2022

Datoer for studieregistrering

Først indsendt

1. november 1999

Først indsendt, der opfyldte QC-kriterier

26. januar 2003

Først opslået (Skøn)

27. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. maj 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. maj 2022

Sidst verificeret

1. maj 2022

Mere information

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 .

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