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Sammenligning af kombinationskemoterapibehandlinger til behandling af ældre kvinder, der har gennemgået kirurgi for brystkræft

12. juli 2016 opdateret af: Alliance for Clinical Trials in Oncology

Et randomiseret forsøg med adjuverende kemoterapi med standardregimer, cyclophosphamid, methotrexat og fluorouracil - (CMF) eller doxorubicin og cyclophosphamid - (AC), versus capecitabin hos kvinder 65 år og ældre med nodepositiv eller nodenegativ brystkræft

RATIONALE: Lægemidler, der bruges i kemoterapi, bruger forskellige måder til at forhindre tumorceller i at dele sig, så de holder op med at vokse eller dør. At kombinere mere end et lægemiddel og give dem på forskellige måder efter operationen kan dræbe flere tumorceller. Det vides endnu ikke, hvilken kemoterapikur, der er mere effektiv til behandling af ældre kvinder med brystkræft.

FORMÅL: Dette randomiserede fase III-forsøg studerer forskellige kombinationskemoterapiregimer for at se, hvor godt de virker i behandlingen af ældre kvinder, der er blevet opereret for brystkræft.

Studieoversigt

Status

Afsluttet

Betingelser

Brystkræft

Intervention / Behandling

Detaljeret beskrivelse

MÅL:

Sammenlign effektiviteten af adjuverende kemoterapi omfattende standard cyclophosphamid, methotrexat og fluorouracil (CMF) eller doxorubicin og cyclophosphamid (AC) vs oral capecitabin, hvad angår sygdomsfri og samlet overlevelse, hos ældre kvinder med operabelt adenocarcinom i brystet.
Sammenlign livskvaliteten og den fysiske funktion hos patienter behandlet med disse regimer.
Sammenlign toksiciteten af disse regimer hos disse patienter.
Evaluer ældre patienters overholdelse af et oralt kemoterapiregime.

OVERSIGT: Dette er en randomiseret, multicenter undersøgelse. Patienterne er stratificeret efter alder (65 til 69 vs. 70 til 80 vs. over 80), præstationsstatus (0-1 vs 2) og HER2-status (positiv vs. negativ vs. ukendt). Patienterne randomiseres til 1 ud af 2 behandlingsarme.

Arm I: Patienter med utilstrækkelig venstre ventrikulær ejektionsfraktion (LVEF) tildeles gruppe A. Patienter med normal LVEF tildeles gruppe A eller B baseret på lægens/patientens valg.
- Gruppe A (CMF): Patienterne modtager oral cyclophosphamid (CTX) dagligt på dag 1-14 og methotrexat IV og fluorouracil IV på dag 1 og 8. Behandlingen gentages hver 4. uge i 6 forløb i fravær af sygdomsprogression eller uacceptabel toksicitet.
- Gruppe B (AC): Patienter får doxorubicin IV og CTX IV på dag 1. Behandlingen gentages hver 3. uge i 4 forløb i fravær af sygdomsprogression eller uacceptabel toksicitet.
Arm II: Patienterne får oral capecitabin to gange dagligt på dag 1-14. Behandlingen gentages hver 3. uge i 6 forløb i fravær af sygdomsprogression eller uacceptabel toksicitet.

Begyndende inden for 12 uger efter behandling i arm I eller II, modtager patienter med østrogen- eller progesteronreceptor-positiv sygdom oral tamoxifen eller en aromatasehæmmer dagligt i 5 år.

Begyndende 4-6 uger efter behandling i arm I eller II, får kvalificerede patienter, som tidligere har gennemgået brystkonserveringskirurgi, strålebehandling.

Livskvalitet vurderes ved baseline; efter 6 uger (gruppe B), 9 uger (arm II) eller 12 uger (gruppe A); og derefter 1, 12, 18 og 24 måneder efter studiet.

Lægemiddeladhærens vurderes efter 9 uger under undersøgelsen (arm II).

Patienterne følges efter 1 måned, hver 6. måned i 2 år og derefter årligt i 15 år.

PROJEKTERET TILSLUTNING: I alt 600-1.800 patienter (300-900 pr. behandlingsarm) vil blive akkumuleret til denne undersøgelse inden for 2-6 år.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

633

Fase

Fase 3

Kontakter og lokationer

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

Studiesteder

Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 4N2
    - Tom Baker Cancer Centre - Calgary
  - Edmonton, Alberta, Canada, T6G 1Z2
    - Cross Cancer Institute at University of Alberta
- Manitoba
  - Winnipeg, Manitoba, Canada, R3E 0V9
    - CancerCare Manitoba
- Ontario
  - Toronto, Ontario, Canada, M5G 1X5
    - Mount Sinai Hospital - Toronto
  - 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
- Saskatchewan
  - Regina, Saskatchewan, Canada, S4T 7T1
    - Allan Blair Cancer Centre at Pasqua Hospital
Forenede Stater
- Alabama
  - Birmingham, Alabama, Forenede Stater, 35294
    - University of Alabama at Birmingham Comprehensive Cancer Center
  - Mobile, Alabama, Forenede Stater, 36652-2144
    - Mobile Infirmary Medical Center
- Arizona
  - Scottsdale, Arizona, Forenede Stater, 85259-5499
    - Mayo Clinic Scottsdale
  - Tucson, Arizona, Forenede Stater, 85724-5024
    - Arizona Cancer Center at University of Arizona Health Sciences Center
- Arkansas
  - Hot Springs, Arkansas, Forenede Stater, 71913
    - St. Joseph's Mercy Cancer Center
- California
  - Glendale, California, Forenede Stater, 91204
    - Glendale Memorial Hospital Comprehensive Cancer Center
  - Hayward, California, Forenede Stater, 94545
    - Saint Rose Hospital
  - La Jolla, California, Forenede Stater, 92093-0658
    - Moores UCSD Cancer Center
  - Los Angeles, California, Forenede Stater, 90089-9181
    - USC/Norris Comprehensive Cancer Center and Hospital
  - Northridge, California, Forenede Stater, 91328
    - Leavey Cancer Center at Northridge Hospital Medical Center
  - Oakland, California, Forenede Stater, 94609
    - Alta Bates Summit Medical Center - Summit Campus
  - Oakland, California, Forenede Stater, 94609
    - CCOP - Bay Area Tumor Institute
  - Oakland, California, Forenede Stater, 94602
    - Highland General Hospital at St. George's University School of Medicine
  - Pleasanton, California, Forenede Stater, 94588
    - Valley Care Medical Center
  - Salinas, California, Forenede Stater, 93901
    - Salinas Valley Memorial Hospital
  - San Diego, California, Forenede Stater, 92120
    - Kaiser Permanente Medical Office -Vandever Medical Office
  - San Pablo, California, Forenede Stater, 94806
    - Doctors Medical Center - San Pablo Campus
- Colorado
  - Colorado Springs, Colorado, Forenede Stater, 80909
    - Memorial Hospital
- Connecticut
  - Norwich, Connecticut, Forenede Stater, 06360
    - Eastern Connecticut Hematology and Oncology Associates
- Delaware
  - Dover, Delaware, Forenede Stater, 19901
    - Kent General Hospital at Bayhealth Medical Center
  - Newark, Delaware, Forenede Stater, 19713
    - CCOP - Christiana Care Health Services
- District of Columbia
  - Washington, District of Columbia, Forenede Stater, 20016
    - Sibley Memorial Hospital
  - Washington, District of Columbia, Forenede Stater, 20307-5001
    - Walter Reed Army Medical Center
- Florida
  - Daytona Beach, Florida, Forenede Stater, 32115
    - Halifax Medical Center - Daytona Beach
  - Fort Lauderdale, Florida, Forenede Stater, 33308
    - Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
  - Jacksonville, Florida, Forenede Stater, 32224
    - Mayo Clinic - Jacksonville
  - Jupiter, Florida, Forenede Stater, 33458
    - Ella Milbank Foshay Cancer Center at Jupiter Medical Center
  - 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 Beach, Florida, Forenede Stater, 33140
    - CCOP - Mount Sinai Medical Center
  - West Palm Beach, Florida, Forenede Stater, 33401
    - Palm Beach Cancer Institute - West Palm Beach
- Georgia
  - Atlanta, Georgia, Forenede Stater, 30342
    - CCOP - Atlanta Regional
  - Augusta, Georgia, Forenede Stater, 30901
    - Augusta Oncology Associates - Walton Way
  - Lawrenceville, Georgia, Forenede Stater, 30045
    - Gwinnett Medical Center
  - Savannah, Georgia, Forenede Stater, 31405
    - Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
- Hawaii
  - Aiea, Hawaii, Forenede Stater, 96701
    - Kapiolani Medical Center at Pali Momi
  - Honolula, Hawaii, Forenede Stater, 96813
    - Cancer Research Center of Hawaii
  - Honolulu, Hawaii, Forenede Stater, 96826
    - Kapiolani Medical Center for Women and Children
  - Honolulu, Hawaii, Forenede Stater, 96813
    - OnCare Hawaii, Incorporated - Lusitana
  - Honolulu, Hawaii, Forenede Stater, 96813
    - Queen's Cancer Institute at Queen's Medical Center
  - Honolulu, Hawaii, Forenede Stater, 96813
    - Straub Clinic and Hospital, Incorporated
  - Honolulu, Hawaii, Forenede Stater, 96817
    - OnCare Hawaii, Incorporated - Kuakini
  - Honolulu, Hawaii, Forenede Stater, 96817
    - St. Francis Medical Center
  - Wailuku, Maui, Hawaii, Forenede Stater, 96793
    - Pacific Cancer Institute - Maui
- Idaho
  - Idaho Falls, Idaho, Forenede Stater, 83404
    - Hematology Oncology Associates of Eastern Idaho
- Illinois
  - Aurora, Illinois, Forenede Stater, 60507
    - Rush-Copley Cancer Care Center
  - Bloomington, Illinois, Forenede Stater, 61701
    - St. Joseph Medical Center
  - Canton, Illinois, Forenede Stater, 61520
    - Graham Hospital
  - Carthage, Illinois, Forenede Stater, 62321
    - Memorial Hospital
  - Chicago, Illinois, Forenede Stater, 60637-1470
    - University of Chicago Cancer Research Center
  - Chicago, Illinois, Forenede Stater, 60611-3013
    - Robert H. Lurie Comprehensive Cancer Center at Northwestern University
  - Chicago, Illinois, Forenede Stater, 60612-7243
    - University of Illinois Cancer Center
  - Chicago, Illinois, Forenede Stater, 60625
    - Swedish Covenant Hospital
  - Chicago, Illinois, Forenede Stater, 60611
    - Hematology and Oncology Associates
  - Chicago, Illinois, Forenede Stater, 60612
    - Veterans Affairs Medical Center - Chicago Westside Hospital
  - Chicago, Illinois, Forenede Stater, 60616
    - Mercy Hospital and Medical Center
  - Decatur, Illinois, Forenede Stater, 62526
    - Decatur Memorial Hospital Cancer Care Institute
  - Eureka, Illinois, Forenede Stater, 61530
    - Eureka Community Hospital
  - Evanston, Illinois, Forenede Stater, 60201-1781
    - Evanston Northwestern Healthcare - Evanston Hospital
  - Evanston, Illinois, Forenede Stater, 60202
    - St. Francis Hospital
  - Galesburg, Illinois, Forenede Stater, 61401
    - Galesburg Cottage Hospital
  - Galesburg, Illinois, Forenede Stater, 61401
    - Galesburg Clinic
  - Havana, Illinois, Forenede Stater, 62644
    - Mason District Hospital
  - Hopedale, Illinois, Forenede Stater, 61747
    - Hopedale Medical Complex
  - Joliet, Illinois, Forenede Stater, 60435
    - Joliet Oncology-Hematology Associates, Limited - West
  - Joliet, Illinois, Forenede Stater, 60432
    - Midwest Center for Hematology/Oncology
  - Kankakee, Illinois, Forenede Stater, 60901
    - Provena St. Mary's Wasser Regional Cancer Center - Kankakee
  - Libertyville, Illinois, Forenede Stater, 60048
    - North Shore Oncology and Hematology Associates, Limited - Libertyville
  - Macomb, Illinois, Forenede Stater, 61455
    - Mcdonough District Hospital
  - Niles, Illinois, Forenede Stater, 60714
    - Cancer Care and Hematology Specialists of Chicagoland - Niles
  - Normal, Illinois, Forenede Stater, 61761
    - Bromenn Regional Medical Center
  - Normal, Illinois, Forenede Stater, 61761
    - Community Cancer Center
  - Olympia Fields, Illinois, Forenede Stater, 60461
    - Saint James Hospital and Health Centers Comprehensive Cancer Institute - Olympia Fields
  - Ottawa, Illinois, Forenede Stater, 61350
    - Community Hospital of Ottawa
  - Pekin, Illinois, Forenede Stater, 61554
    - Cancer Treatment Center at Pekin Hospital
  - Peoria, Illinois, Forenede Stater, 61636
    - Methodist Medical Center of Illinois
  - Peoria, Illinois, Forenede Stater, 61614
    - Proctor Hospital
  - Peoria, Illinois, Forenede Stater, 61637
    - OSF St. Francis Medical Center
  - Peoria, Illinois, Forenede Stater, 61615
    - CCOP - Illinois Oncology Research Association
  - Peoria, Illinois, Forenede Stater, 61615
    - Oncology Hematology Associates of Central Illinois, PC - Peoria
  - Peru, Illinois, Forenede Stater, 61354
    - Illinois Valley Community Hospital
  - Princeton, Illinois, Forenede Stater, 61356
    - Perry Memorial Hospital
  - Rockford, Illinois, Forenede Stater, 61104-2315
    - Swedish-American Regional Cancer Center
  - Rockford, Illinois, Forenede Stater, 61108
    - Center for Cancer Care at OSF Saint Anthony Medical Center
  - Skokie, Illinois, Forenede Stater, 60076
    - Hematology Oncology Associates - Skokie
  - Skokie, Illinois, Forenede Stater, 60076
    - Hematology/Oncology of the North Shore at Gross Point Medical Center
  - Spring Valley, Illinois, Forenede Stater, 61362
    - St. Margaret's Hospital
  - Springfield, Illinois, Forenede Stater, 62781-0001
    - Regional Cancer Center at Memorial Medical Center
  - Urbana, Illinois, Forenede Stater, 61801
    - Carle Cancer Center at Carle Foundation Hospital
  - Urbana, Illinois, Forenede Stater, 61801
    - CCOP - Carle Cancer Center
- Indiana
  - Beech Grove, Indiana, Forenede Stater, 46107
    - St. Francis Hospital and Health Centers - Beech Grove Campus
  - Bloomington, Indiana, Forenede Stater, 47403
    - Regional Cancer Institute at Bloomington Hospital
  - Fort Wayne, Indiana, Forenede Stater, 46815
    - Fort Wayne Medical Oncology and Hematology
  - Michigan City, Indiana, Forenede Stater, 46360
    - Saint Anthony Memorial Health Centers
  - Munster, Indiana, Forenede Stater, 46321
    - Community Hospital
  - South Bend, Indiana, Forenede Stater, 46601
    - CCOP - Northern Indiana CR Consortium
- Iowa
  - Ames, Iowa, Forenede Stater, 50010
    - McFarland Clinic, PC
  - Bettendorf, Iowa, Forenede Stater, 52722
    - Hematology Oncology Associates of the Quad Cities
  - 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
  - Council Bluffs, Iowa, Forenede Stater, 51503
    - Heartland Oncology & Hematology
  - Davenport, Iowa, Forenede Stater, 52803
    - Genesis Regional Cancer Center at Genesis Medical Center
  - Ottumwa, Iowa, Forenede Stater, 52501
    - McCreery Cancer Center at Ottumwa Regional
  - Waterloo, Iowa, Forenede Stater, 50702
    - Cedar Valley Medical Specialists, PC - West Ridgeway Avenue
- Kansas
  - Topeka, Kansas, Forenede Stater, 66606
    - St. Francis Comprehensive Cancer Center
  - Topeka, Kansas, Forenede Stater, 66604
    - Stormont-Vail Cancer Center
- Louisiana
  - New Orleans, Louisiana, Forenede Stater, 70112
    - MBCCOP - LSU Health Sciences Center
  - Shreveport, Louisiana, Forenede Stater, 71101
    - Christus Schumpert Cancer Treatment Center
- Maine
  - Lewiston, Maine, Forenede Stater, 04240
    - Central Maine Medical Center
  - Portland, Maine, Forenede Stater, 04101
    - Mercy Hospital of Portland
  - Scarborough, Maine, Forenede Stater, 04074
    - Maine Center for Cancer Medicine and Blood Disorders - Scarborough
  - Waterville, Maine, Forenede Stater, 04901
    - MaineGeneral Medical Center - Waterville Campus
- Maryland
  - Baltimore, Maryland, Forenede Stater, 21231-2410
    - Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  - Baltimore, Maryland, Forenede Stater, 21201
    - Greenebaum Cancer Center at University of Maryland Medical Center
  - Frederick, Maryland, Forenede Stater, 21701
    - Frederick Memorial Hospital Regional Cancer Therapy Center
- Massachusetts
  - Boston, Massachusetts, Forenede Stater, 02115
    - Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  - Boston, Massachusetts, Forenede Stater, 02118
    - Cancer Research Center at Boston Medical Center
  - Boston, Massachusetts, Forenede Stater, 02111
    - Tufts-NEMC Cancer Center
  - Boston, Massachusetts, Forenede Stater, 02130
    - Faulkner Hospital
  - Concord, Massachusetts, Forenede Stater, 01742
    - Bethke Cancer Center at Emerson Hospital
  - Hyannis, Massachusetts, Forenede Stater, 02601
    - Cape Cod Hospital
  - Lowell, Massachusetts, Forenede Stater, 01852
    - Saints Memorial Cancer Center at Saints Memorial Medical Center
  - Medford, Massachusetts, Forenede Stater, 02155
    - Lawrence Memorial Hospital of Medford
  - Norwood, Massachusetts, Forenede Stater, 02062
    - Caritas Norwood Hospital
  - South Weymouth, Massachusetts, Forenede Stater, 02190
    - South Shore Hospital
- Michigan
  - Adrian, Michigan, Forenede Stater, 49221
    - Hickman Cancer Center at Bixby Medical Center
  - Detroit, Michigan, Forenede Stater, 48202
    - Josephine Ford Cancer Center at Henry Ford Hospital
  - Grand Rapids, Michigan, Forenede Stater, 49503
    - CCOP - Grand Rapids
  - Kalamazoo, Michigan, Forenede Stater, 49007-3731
    - West Michigan Cancer Center
  - Lambertville, Michigan, Forenede Stater, 48144
    - Haematology-Oncology Associates of Ohio and Michigan, PC
  - Monroe, Michigan, Forenede Stater, 48162
    - Community Cancer Center of Monroe
  - Monroe, Michigan, Forenede Stater, 48162
    - Mercy Memorial Hospital System
  - Petoskey, Michigan, Forenede Stater, 49770
    - Northern Michigan Hospital
  - Royal Oak, Michigan, Forenede Stater, 48073
    - William Beaumont Hospital - Royal Oak Campus
  - Southfield, Michigan, Forenede Stater, 48075
    - Providence Cancer Institute at Providence Hospital - Southfield Campus
  - St. Joseph, Michigan, Forenede Stater, 49085
    - Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
- Minnesota
  - Albert Lea, Minnesota, Forenede Stater, 56007
    - Albert Lea Cancer Center at Albert Lea Medical Center
  - Bemidji, Minnesota, Forenede Stater, 56601
    - MeritCare Clinic - Bemidji
  - 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
    - CCOP - Duluth
  - Duluth, Minnesota, Forenede Stater, 55805
    - Cancer Care Center at St. Luke's Hospital
  - Edina, Minnesota, Forenede Stater, 55435
    - Fairview Southdale Hospital
  - Fridley, Minnesota, Forenede Stater, 55432
    - Mercy and Unity Cancer Center at Unity Hospital
  - Hutchinson, Minnesota, Forenede Stater, 55350
    - Hutchinson Area Health Care
  - Lichfield, Minnesota, Forenede Stater, 55355
    - Meeker County Memorial Hospital
  - Mankato, Minnesota, Forenede Stater, 56002
    - Immanuel St. Joseph's Clinic
  - Maplewood, Minnesota, Forenede Stater, 55109
    - HealthEast Cancer Care at St. John's Hospital
  - Maplewood, Minnesota, Forenede Stater, 55109
    - Minnesota Oncology Hematology, PA at Maplewood Cancer Center
  - Minneapolis, Minnesota, Forenede Stater, 55455
    - University of Minnesota Medical Center & Children's Hospital - Fairview
  - Minneapolis, Minnesota, Forenede Stater, 55415
    - Hennepin County Medical Center - Minneapolis
  - Minneapolis, Minnesota, Forenede Stater, 55407
    - Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
  - Montevideo, Minnesota, Forenede Stater, 56265
    - Chippewa County - Montevideo 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 Louis Park, Minnesota, Forenede Stater, 55416
    - CCOP - Metro-Minnesota
  - Shakopee, Minnesota, Forenede Stater, 55379
    - Saint Francis Cancer Center
  - St Paul, Minnesota, Forenede Stater, 55102
    - St. Joseph's Hospital
  - St. Cloud, Minnesota, Forenede Stater, 56303
    - CentraCare Clinic - River Campus
  - St. Louis Park, Minnesota, Forenede Stater, 55416
    - Park Nicollet Health Services
  - St. Paul, Minnesota, Forenede Stater, 55102
    - United Hospital
  - St. Paul, Minnesota, Forenede Stater, 55101
    - Regions Hospital Cancer Care Center
  - Waconia, Minnesota, Forenede Stater, 55387
    - Ridgeview Medical Center
  - Willmar, Minnesota, Forenede Stater, 56201
    - Willmar Cancer Center at Rice Memorial Hospital
  - Woodbury, Minnesota, Forenede Stater, 55125
    - Woodwinds Health Campus
  - Woodbury, Minnesota, Forenede Stater, 55125
    - Minnesota Oncology Hematology, PA - Woodbury
- Mississippi
  - Pascagoula, Mississippi, Forenede Stater, 39581
    - Regional Cancer Center at Singing River Hospital
- Missouri
  - Columbia, Missouri, Forenede Stater, 65203
    - Ellis Fischel Cancer Center at University of Missouri - Columbia
  - Springfield, Missouri, Forenede Stater, 65804
    - St. John's Regional Health Center
  - Springfield, Missouri, Forenede Stater, 65807
    - Hulston Cancer Center at Cox Medical Center South
  - St Louis, Missouri, Forenede Stater, 63110
    - Siteman Cancer Center at Barnes-Jewish Hospital
  - St. Louis, Missouri, Forenede Stater, 63131
    - Missouri Baptist Cancer Center
- Montana
  - Billings, Montana, Forenede Stater, 59101
    - CCOP - Montana Cancer Consortium
  - Great Falls, Montana, Forenede Stater, 59405
    - Great Falls Clinic
  - Great Falls, Montana, Forenede Stater, 59405
    - Sletten Regional Cancer Institute at Benefis Healthcare
- Nebraska
  - Grand Island, Nebraska, Forenede Stater, 68803
    - Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
  - Kearney, Nebraska, Forenede Stater, 68848-1990
    - Good Samaritan Cancer Center at Good Samaritan Hospital
  - Omaha, Nebraska, Forenede Stater, 68198-6805
    - UNMC Eppley Cancer Center at the University of Nebraska Medical Center
  - Omaha, Nebraska, Forenede Stater, 68106
    - CCOP - Missouri Valley Cancer Consortium
  - Omaha, Nebraska, Forenede Stater, 68122
    - Immanuel Medical Center
  - Omaha, Nebraska, Forenede Stater, 68124
    - Alegant Health Cancer Center at Bergan Mercy Medical Center
  - Omaha, Nebraska, Forenede Stater, 68131-2197
    - Creighton University Medical Center
- Nevada
  - Carson City, Nevada, Forenede Stater, 89703
    - Carson-Tahoe Cancer Services at Carson Tahoe Regional Healthcare
  - Las Vegas, Nevada, Forenede Stater, 89102
    - University Medical Center of Southern Nevada
  - Las Vegas, Nevada, Forenede Stater, 89106
    - CCOP - Nevada Cancer Research Foundation
- New Hampshire
  - Derry, New Hampshire, Forenede Stater, 03038
    - Parkland Oncology-Hematology Clinic at Parkland Medical Center
  - Hooksett, New Hampshire, Forenede Stater, 03106
    - New Hampshire Oncology-Hematology, PA - Hooksett
  - Laconia, New Hampshire, Forenede Stater, 03246
    - Lakes Region General Hospital
  - Manchester, New Hampshire, Forenede Stater, 03103
    - Elliot Regional Cancer Center at Elliot Hospital
- New Jersey
  - Brick, New Jersey, Forenede Stater, 08724
    - Ocean Medical Center at Meridian Health
  - Marlton, New Jersey, Forenede Stater, 08053
    - Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
  - Morristown, New Jersey, Forenede Stater, 07962
    - Carol G. Simon Cancer Center at Morristown Memorial Hospital
  - Red Bank, New Jersey, Forenede Stater, 07701
    - Booker Cancer Center at Riverview Medical Center
  - Summit, New Jersey, Forenede Stater, 07902
    - Overlook Hospital
  - Toms River, New Jersey, Forenede Stater, 08755
    - J. Phillip Citta Regional Cancer Center at Community Medical Center
  - Voorhees, New Jersey, Forenede Stater, 08043
    - Fox Chase Virtua Health Cancer Program at Virtua West Jersey
- New York
  - Bronx, New York, Forenede Stater, 10456
    - Bronx-Lebanon Hospital Center & BronxCare Adult Medical Practice
  - Buffalo, New York, Forenede Stater, 14263-0001
    - Roswell Park Cancer Institute
  - Glens Falls, New York, Forenede Stater, 12801
    - Adirondack Cancer Care - Glens Falls
  - Glens Falls, New York, Forenede Stater, 12801
    - Charles R. Wood Cancer Center at Glens Falls Hospital
  - Mineola, New York, Forenede Stater, 11501
    - Winthrop University Hospital
  - New York, New York, Forenede Stater, 10021
    - Memorial Sloan-Kettering Cancer Center
  - Rochester, New York, Forenede Stater, 14642
    - James P. Wilmot Cancer Center at University of Rochester Medical Center
  - Rochester, New York, Forenede Stater, 14620
    - Highland Hospital of Rochester
  - Stony Brook, New York, Forenede Stater, 11794-8174
    - Stony Brook University Cancer Center
  - Syracuse, New York, Forenede Stater, 13210
    - SUNY Upstate Medical University Hospital
  - Syracuse, New York, Forenede Stater, 13057
    - CCOP - Hematology-Oncology Associates of Central New York
- North Carolina
  - Asheboro, North Carolina, Forenede Stater, 27203-5400
    - Randolph Hospital
  - Asheville, North Carolina, Forenede Stater, 28801
    - Mission Hospitals - Memorial Campus
  - Durham, North Carolina, Forenede Stater, 27710
    - Duke Comprehensive Cancer Center
  - Gastonia, North Carolina, Forenede Stater, 28053
    - CaroMont Cancer Center at Gaston Memorial Hospital
  - Goldsboro, North Carolina, Forenede Stater, 27534
    - Wayne Memorial Hospital, Incorporated
  - Greensboro, North Carolina, Forenede Stater, 27403-1198
    - Moses Cone Regional Cancer Center at Wesley Long Community Hospital
  - Pinehurst, North Carolina, Forenede Stater, 28374
    - FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
  - Reidsville, North Carolina, Forenede Stater, 27320
    - Annie Penn Cancer Center
  - Rutherfordton, North Carolina, Forenede Stater, 28139
    - Rutherford Hospital
  - Wilmington, North Carolina, Forenede Stater, 28401
    - Zimmer Cancer Center at New Hanover Regional Medical Center
- North Dakota
  - Bismarck, North Dakota, Forenede Stater, 58501
    - Mid Dakota Clinic, PC
  - Bismarck, North Dakota, Forenede Stater, 58501
    - Cancer Care Center at Medcenter One Hospital
  - Fargo, North Dakota, Forenede Stater, 58122
    - CCOP - MeritCare Hospital
  - Fargo, North Dakota, Forenede Stater, 58122
    - MeritCare Medical Group
  - Grand Forks, North Dakota, Forenede Stater, 58201
    - Altru Cancer Center at Altru Hospital
  - Minot, North Dakota, Forenede Stater, 58701
    - Trinity Cancer Care Center
- Ohio
  - Akron, Ohio, Forenede Stater, 44309-2090
    - Akron City Hospital
  - Bowling Green, Ohio, Forenede Stater, 43402
    - Wood County Oncology Center
  - Canton, Ohio, Forenede Stater, 44710-1799
    - Aultman Hospital Cancer Center at Aultman Health Foundation
  - Cincinnati, Ohio, Forenede Stater, 45267
    - Charles M. Barrett Cancer Center at University Hospital
  - Cleveland, Ohio, Forenede Stater, 44109
    - MetroHealth's Cancer Care Center at MetroHealth Medical Center
  - Cleveland, Ohio, Forenede Stater, 44106
    - Case Comprehensive Cancer Center
  - Dayton, Ohio, Forenede Stater, 45428
    - Veterans Affairs Medical Center - Dayton
  - Dayton, Ohio, Forenede Stater, 45405
    - Grandview Hospital
  - Dayton, Ohio, Forenede Stater, 45406
    - Good Samaritan Hospital
  - Dayton, Ohio, Forenede Stater, 45409
    - David L. Rike Cancer Center at Miami Valley Hospital
  - Dayton, Ohio, Forenede Stater, 45415
    - Samaritan North Cancer Care Center
  - Fremont, Ohio, Forenede Stater, 43420
    - Fremont Memorial Hospital
  - Kettering, Ohio, Forenede Stater, 45429
    - Charles F. Kettering Memorial Hospital
  - Lima, Ohio, Forenede Stater, 45804
    - Lima Memorial Hospital
  - Lima, Ohio, Forenede Stater, 45801
    - St. Rita's Medical Center
  - Maumee, Ohio, Forenede Stater, 43537
    - Northwest Ohio Oncology Center
  - Maumee, Ohio, Forenede Stater, 43537
    - St. Luke's Hospital
  - Middletown, Ohio, Forenede Stater, 45044
    - Middletown Regional Hospital
  - Oregon, Ohio, Forenede Stater, 43616
    - St. Charles Mercy Hospital
  - Oregon, Ohio, Forenede Stater, 43616
    - Toledo Clinic - Oregon
  - Sandusky, Ohio, Forenede Stater, 44870
    - Firelands Regional Medical Center
  - Sandusky, Ohio, Forenede Stater, 44870
    - North Coast Cancer Care, Incorporated
  - Sylvania, Ohio, Forenede Stater, 43560
    - Flower Hospital Cancer Center
  - Toledo, Ohio, Forenede Stater, 43608
    - St. Vincent Mercy Medical Center
  - Toledo, Ohio, Forenede Stater, 43606
    - Toledo Hospital
  - Toledo, Ohio, Forenede Stater, 43614
    - Medical University of Ohio Cancer Center
  - Toledo, Ohio, Forenede Stater, 43617
    - CCOP - Toledo Community Hospital
  - Toledo, Ohio, Forenede Stater, 43623
    - Toledo Clinic, Incorporated - Main Clinic
  - Troy, Ohio, Forenede Stater, 45373-1300
    - UVMC Cancer Care Center at Upper Valley Medical Center
  - Wauseon, Ohio, Forenede Stater, 43567
    - Fulton County Health Center
  - Xenia, Ohio, Forenede Stater, 45385
    - Ruth G. McMillan Cancer Center at Greene Memorial Hospital
- Oklahoma
  - Lawton, Oklahoma, Forenede Stater, 73505
    - Cleo Craig Cancer Research Clinic
  - Oklahoma City, Oklahoma, Forenede Stater, 73104
    - Oklahoma University Medical Center
  - Oklahoma City, Oklahoma, Forenede Stater, 73120
    - Cancer Care Associates - Mercy Campus
  - Tulsa, Oklahoma, Forenede Stater, 74104
    - LaFortune Cancer Center at St. John Medical Center
- Pennsylvania
  - 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
  - East Stroudsburg, Pennsylvania, Forenede Stater, 18301
    - Dale and Frances Hughes Cancer Center at Pocono Medical Center
  - Hershey, Pennsylvania, Forenede Stater, 17033-0850
    - Penn State Cancer Institute at Milton S. Hershey Medical Center
  - Lewistown, Pennsylvania, Forenede Stater, 17044
    - Lewistown Hospital
  - Meadville, Pennsylvania, Forenede Stater, 16335
    - Meadville Medical Center
  - Paoli, Pennsylvania, Forenede Stater, 19301-1792
    - Cancer Center of Paoli Memorial Hospital
  - Philadelphia, Pennsylvania, Forenede Stater, 19107-5541
    - Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
  - Pittsburgh, Pennsylvania, Forenede Stater, 15224-1791
    - Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
  - Reading, Pennsylvania, Forenede Stater, 19612-6052
    - Reading Hospital and Medical Center
  - Reading, Pennsylvania, Forenede Stater, 19604
    - St. Joseph Medical Center
  - Scranton, Pennsylvania, Forenede Stater, 18510
    - Hematology and Oncology Associates
  - State College, Pennsylvania, Forenede Stater, 16803
    - Mount Nittany Medical Center
  - State College, Pennsylvania, Forenede Stater, 16801
    - Geisinger Medical Group - Scenery Park
  - Upland, Pennsylvania, Forenede Stater, 19013
    - Associates in Hematology-Oncology, PC at Crozer Regional Cancer Center
  - West Grove, Pennsylvania, Forenede Stater, 19390-9499
    - Jennersville Regional Hospital
  - 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
- Rhode Island
  - Pawtucket, Rhode Island, Forenede Stater, 02860
    - Memorial Hospital of Rhode Island
  - Warwick, Rhode Island, Forenede Stater, 02886
    - Kent County Memorial Hospital
- South Carolina
  - Anderson, South Carolina, Forenede Stater, 29621
    - AnMed Health Cancer Center
  - Charleston, South Carolina, Forenede Stater, 29425
    - Hollings Cancer Center at Medical University of South Carolina
  - 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
  - Aberdeen, South Dakota, Forenede Stater, 57401
    - Oncology Services of Aberdeen
  - Sioux Falls, South Dakota, Forenede Stater, 57105
    - Avera Cancer Institute
  - 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
- Tennessee
  - Johnson City, Tennessee, Forenede Stater, 37604
    - East Tennessee State University Cancer Center at Johnson City Medical Center
  - Knoxville, Tennessee, Forenede Stater, 37916
    - Thompson Cancer Survival Center
  - Nashville, Tennessee, Forenede Stater, 37208-3599
    - MBCCOP - Meharry Medical College - Nashville
  - Nashville, Tennessee, Forenede Stater, 37203
    - Nashville Oncology Associates, P.C.
- Texas
  - Fort Sam Houston, Texas, Forenede Stater, 78234
    - Brooke Army Medical Center
  - Lackland AFB, Texas, Forenede Stater, 78236
    - Wilford Hall Medical Center
- Utah
  - Salt Lake City, Utah, Forenede Stater, 84112
    - Huntsman Cancer Institute at University of Utah
- Vermont
  - Berlin, Vermont, Forenede Stater, 05602
    - Mountainview Medical
  - Burlington, Vermont, Forenede Stater, 05401
    - Fletcher Allen Health Care - University Health Center Campus
- Virginia
  - Charlottesville, Virginia, Forenede Stater, 22901
    - Martha Jefferson Hospital Cancer Care Center
- Washington
  - Auburn, Washington, Forenede Stater, 98002
    - Auburn Regional Center for Cancer Care
  - Bellingham, Washington, Forenede Stater, 98225
    - St. Joseph Cancer Center
  - Federal Way, Washington, Forenede Stater, 98003
    - St. Francis Hospital
  - Olympia, Washington, Forenede Stater, 98507
    - Capital Medical Center
  - Olympia, Washington, Forenede Stater, 98506-5166
    - Providence St. Peter Hospital Regional Cancer Center
  - Puyallup, Washington, Forenede Stater, 98372
    - Good Samaritan Cancer 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
  - Spokane, Washington, Forenede Stater, 99204
    - Providence Cancer Center at Sacred Heart Medical Center
  - Spokane, Washington, Forenede Stater, 99207
    - Providence Cancer Center at Holy Family Hospital
  - Tacoma, Washington, Forenede Stater, 98405
    - CCOP - Northwest
  - Tacoma, Washington, Forenede Stater, 98499
    - St. Clare Hospital
  - Tacoma, Washington, Forenede Stater, 98431
    - Madigan Army Medical Center - Tacoma
  - Tacoma, Washington, Forenede Stater, 98405-3004
    - St. Joseph Medical Center at Franciscan Health System
  - Yakima, Washington, Forenede Stater, 98902
    - North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
- West Virginia
  - Huntington, West Virginia, Forenede Stater, 25701
    - Marshall University Medical Center
- Wisconsin
  - Elkhorn, Wisconsin, Forenede Stater, 53121
    - Vince Lombardi Cancer Center at Aurora Lakeland Medical Center - Elkhorn
  - 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
  - Madison, Wisconsin, Forenede Stater, 53717
    - Dean Medical Center - Madison
  - Manitowoc, Wisconsin, Forenede Stater, 54221-1450
    - Holy Family Memorial Medical Center Cancer Care Center
  - Milwaukee, Wisconsin, Forenede Stater, 53201-0342
    - Aurora Sinai Medical Center
  - Milwaukee, Wisconsin, Forenede Stater, 53215
    - Medical Consultants, Limited
  - Wausau, Wisconsin, Forenede Stater, 54401
    - University of Wisconcin Cancer Center at Aspirus Wausau Hospital
Peru
- - Lima, Peru, Lima 34
    - Instituto Nacional de Enfermedades Neoplásicas

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

65 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Patienter med operabelt, histologisk bekræftet adenokarcinom i det kvindelige bryst.
TNM Stage pr. AJCC Cancer Staging Manual 6. udgave:
- T1-4 (tumorstørrelse > 1 cm), N0, M0 eller T1-4, N1-3, M0
- Patienter med bilateral, synkron brystkræft er berettiget, så længe en primær tumor opfylder ovenstående kriterier.
Patienter med HER2/neu positiv, negativ eller ukendt sygdom er kvalificerede til dette forsøg.
Patienter, hvis tumorer er HER2-positive ved enten immunhistokemi 3+ farvning eller demonstrerer genamplifikation med FISH, vil være berettiget til at modtage trastuzumab som beskrevet i protokollen.
Alder 65 år eller ældre
Ydeevnestatus 0-2 (Common Toxicity Criteria).
Forudgående behandling:
- Kirurgisk resektion -
  - Al tumor skal fjernes ved enten en modificeret radikal mastektomi eller en lumpektomi. Patienter skal registreres ≤ 84 dage fra mastektomi eller inden for 84 dage efter aksillær dissektion, hvis patientens mest omfattende brystoperation var en brystbesparende procedure.
  - Nodedissektion: Akselknudedissektion er ikke påkrævet. Håndtering af aksillen er efter den behandlende læges skøn. Der er ingen begrænsning på berettigelse baseret på antallet af fjernede noder.
  - Mastektomi: Der bør ikke være tegn på grov eller mikroskopisk invasiv tumor ved de kirurgiske resektionsmarginer, der er noteret i de endelige operations- eller patologirapporter for patienter, der har fået foretaget en modificeret radikal mastektomi. Patienter med tætte marginer (tumor < 1 mm fra margin) er kvalificerede.
  - Segmentel mastektomi (lumpektomi): Selvom klare marginer er at foretrække, vil DCIS eller LCIS ved den kirurgiske resektionsmargin ikke gøre en patient, der har gennemgået en segmentel mastektomi, uegnet til denne undersøgelse. Invasiv tumor ved den endelige resektionsmargin vil gøre en patient uegnet.
- Ingen forudgående kemoterapi for denne malignitet.
- Patienter med en anamnese med overfølsomhed over for 5-FU eller kendt dihydropyrimidindehydrogenase-mangel (DPD) er ikke kvalificerede til at deltage.
- Patienter kan modtage op til fire ugers tamoxifen-behandling for denne malignitet og stadig være berettiget til undersøgelse. Patienter, der modtog tamoxifen eller raloxifen med henblik på kemoforebyggelse (f.eks. forsøg med brystkræftforebyggelse) eller til andre indikationer (herunder tidligere brystkræft), er berettigede. Tamoxifen- eller raloxifenbehandling bør seponeres, før patienten optages i denne undersøgelse.
Nødvendige indledende laboratoriedata:
- Granulocytter > 1.500/µl
- Blodpladeantal ≥100.000/µl
- Beregnet kreatininclearance > 30 ml/min
- Total bilirubin ≤ ULN

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)

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
Aktiv komparator: Standard kemoterapi Patient/læge valg af cyclophosphamid + MTX + 5-FU ELLER Cyclophosphamid + doxorubicin	Medicin: Standard behandling Cyclophosphamid 100 mg/sqm PO d 1-14 + MTX 40 mg/sqm IV push d 1 & 8 og 5-FU 600 mg/sqm IV push d 1 & 8 q 28 dage i 6 cyklusser ELLER doxorubicin 60 mg/ sq m IV d 1 + cyclophosphamid 600 mg/sq m IV d 1 q 21 d i 4 cyklusser Andre navne: doxorubicin = adriamycin
Eksperimentel: Capecitabin Behandling med capecitabin	Medicin: capecitabin 2000 mg/sqm PO d 1-14, 7 dages hvile og gentag derefter i i alt 6 cyklusser

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Tilbagefaldsfri overlevelsesrater ved 2,4 år Tidsramme: randomisering indtil datoen for den første hændelse, eller datoen for sidst kendt som hændelsesfri, hvis ingen hændelse blev rapporteret (op til 5 år)	Procentdel af deltagere, der var i live og tilbagefaldsfri på analysetidspunktet, blev talt som "I live uden tilbagefald" ved 2,4 år. Deltagere, der havde et første lokalt tilbagefald, første fjernmetastase eller død af en hvilken som helst årsag, blev talt som "tilbagefald, første forekomst". Disse rater blev estimeret ved hjælp af Kaplan Meier-metoden	randomisering indtil datoen for den første hændelse, eller datoen for sidst kendt som hændelsesfri, hvis ingen hændelse blev rapporteret (op til 5 år)

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Samlet overlevelsesrate på 2,4 år Tidsramme: Tid fra registrering til død (op til 15 år)	Procentdel af patienter, der var i live efter 2,4 år. Denne hastighed blev estimeret ved hjælp af Kaplan Meier-metoden.	Tid fra registrering til død (op til 15 år)
Antal deltagere med grad 3, 4 eller 5 uønskede hændelser i det mindste muligvis relateret til behandling. Tidsramme: Rapporteret under protokolbehandling efter hver cyklus	National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Version 2.0 blev brugt til at evaluere toksicitet. Karakter 1: Mild; Karakter 2: Moderat; Grad 3: Alvorlig; Karakter 4: Livstruende; 5. klasse: Død.	Rapporteret under protokolbehandling efter hver cyklus

Samarbejdspartnere og efterforskere

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

Sponsor

Alliance for Clinical Trials in Oncology

Samarbejdspartnere

National Cancer Institute (NCI)

NCIC Clinical Trials Group

Efterforskere

Studiestol: Hyman B. Muss, MD, University of North Carolina

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

Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.
Pal SK, Mortimer J. Adjuvant chemotherapy for older adults with breast cancer: making the standard a standard. Womens Health (Lond). 2009 Sep;5(5):481-4. doi: 10.2217/whe.09.43.
Partridge AH, Archer L, Kornblith AB, Gralow J, Grenier D, Perez E, Wolff AC, Wang X, Kastrissios H, Berry D, Hudis C, Winer E, Muss H. Adherence and persistence with oral adjuvant chemotherapy in older women with early-stage breast cancer in CALGB 49907: adherence companion study 60104. J Clin Oncol. 2010 May 10;28(14):2418-22. doi: 10.1200/JCO.2009.26.4671. Epub 2010 Apr 5.
Kornblith AB, Archer L, Lan L, et al.: Quality of life of early stage breast cancer patients 65 years old or older randomized to standard chemotherapy or capecitabine: A Cancer and Leukemia Group B Study (CALGB 49907). [Abstract] 32nd Annual San Antonio Breast Cancer Symposium, December 9-13, 2009, San Antonio, Texas. A-5035, 2009.
Muss HB, Berry DA, Cirrincione CT, Theodoulou M, Mauer AM, Kornblith AB, Partridge AH, Dressler LG, Cohen HJ, Becker HP, Kartcheske PA, Wheeler JD, Perez EA, Wolff AC, Gralow JR, Burstein HJ, Mahmood AA, Magrinat G, Parker BA, Hart RD, Grenier D, Norton L, Hudis CA, Winer EP; CALGB Investigators. Adjuvant chemotherapy in older women with early-stage breast cancer. N Engl J Med. 2009 May 14;360(20):2055-65. doi: 10.1056/NEJMoa0810266. Erratum In: N Engl J Med. 2009 Oct 22;361(17):1714. Magrinat, Gutav [corrected to Magrinat, Gustav].
Muss HB, Berry DL, Cirrincione C, et al.: Standard chemotherapy (CMF or AC) versus capecitabine in early-stage breast cancer (BC) patients aged 65 and older: results of CALGB/CTSU 49907. [Abstract] J Clin Oncol 26 (Suppl 15): A-507, 2008.
Partridge AH, Archer LE, Kornblith AB, et al.: CALGB 60104: adherence with adjuvant capecitabine among women age 65 and older with early stage breast cancer treated on CALGB 49907. [Abstract] J Clin Oncol 26 (Suppl 15): A-6542, 2008.
Muss HB, Polley MC, Berry DA, Liu H, Cirrincione CT, Theodoulou M, Mauer AM, Kornblith AB, Partridge AH, Dressler LG, Cohen HJ, Kartcheske PA, Perez EA, Wolff AC, Gralow JR, Burstein HJ, Mahmood AA, Sutton LM, Magrinat G, Parker BA, Hart RD, Grenier D, Hurria A, Jatoi A, Norton L, Hudis CA, Winer EP, Carey L. Randomized Trial of Standard Adjuvant Chemotherapy Regimens Versus Capecitabine in Older Women With Early Breast Cancer: 10-Year Update of the CALGB 49907 Trial. J Clin Oncol. 2019 Sep 10;37(26):2338-2348. doi: 10.1200/JCO.19.00647. Epub 2019 Jul 24.
Magnuson A, Lei L, Gilmore N, Kleckner AS, Lin FV, Ferguson R, Hurria A, Wittink MN, Esparaz BT, Giguere JK, Misleh J, Bautista J, Mohile SG, Janelsins MC. Longitudinal Relationship Between Frailty and Cognition in Patients 50 Years and Older with Breast Cancer. J Am Geriatr Soc. 2019 May;67(5):928-936. doi: 10.1111/jgs.15934.
Gajra A, McCall L, Muss HB, Cohen HJ, Jatoi A, Ballman KV, Partridge AH, Sutton L, Parker BA, Magrinat G, Klepin HD, Lafky JM, Hurria A. The preference to receive chemotherapy and cancer-related outcomes in older adults with breast cancer CALGB 49907 (Alliance). J Geriatr Oncol. 2018 May;9(3):221-227. doi: 10.1016/j.jgo.2018.02.003. Epub 2018 Mar 28.
Morrison VA, McCall L, Muss HB, Jatoi A, Cohen HJ, Cirrincione CT, Ligibel JA, Lafky JM, Hurria A. The impact of actual body weight-based chemotherapy dosing and body size on adverse events and outcome in older patients with breast cancer: Results from Cancer and Leukemia Group B (CALGB) trial 49907 (Alliance A151436). J Geriatr Oncol. 2018 May;9(3):228-234. doi: 10.1016/j.jgo.2017.11.007. Epub 2017 Dec 8.

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

1. september 2001

Primær færdiggørelse (Faktiske)

1. maj 2008

Studieafslutning (Faktiske)

1. november 2012

Datoer for studieregistrering

Først indsendt

13. september 2001

Først indsendt, der opfyldte QC-kriterier

26. januar 2003

Først opslået (Skøn)

27. januar 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

12. august 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juli 2016

Sidst verificeret

1. juli 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

CALGB-49907
U10CA031946 (U.S. NIH-bevilling/kontrakt)
CAN-NCIC-MAC1
CDR0000068891 (Registry Identifier: NCI Physician Data Query)

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 Brystkræft

Cairo University

Ikke rekrutterer endnu

Gyldighed og pålidelighed af arabisk version af brystspørgeskema

BREAST-Q
Abouqir General Hospital
Alexandria University

Rekruttering

Øjeblikkelig brystrekonstruktion med hybrid fedtoverførsel

Breast Udseende Rekonstruktion Disproportion

Egypten
Tianjin Medical University Cancer Institute and...
Guangxi Medical University; Sun Yat-sen University; Chinese PLA General Hospital og andre samarbejdspartnere

Afsluttet

De tekniske operationer og standard klinisk anvendelsesprotokol for CBBCT i diagnostisk proces af brystkræft (CBBCT)

Den kliniske anvendelsesvejledning af Conebeam Breast CT

Kina
ETOP IBCSG Partners Foundation

Afsluttet

Forsøg om den endokrine aktivitet af Neoadjuvant Degarelix (TREND)

Breast Cancer Invasive Nos

Italien
Spanish Breast Cancer Research Group
Hoffmann-La Roche; Roche Farma, S.A

Afsluttet

A Combined GWAS and miRNA for the Identification of Bevacizumab Response Predictors in Metastatic Breast Cancer

Breast Cancer Invasive Nos

Spanien
Ontario Clinical Oncology Group (OCOG)

Afsluttet

Blodiltniveauafhængig magnetisk resonansbilleddannelse (BOLD MRI) og Fluorothymidine Positron Emission Tomography (FLT PET) hos patienter med lokalt avanceret brystkræft, der gennemgår neoadjuverende kemoterapi (IMPACT)

Locally Advanced Breast Cancer (LABC)

Canada
Pomeranian Medical University Szczecin
Maria Sklodowska-Curie National Research Institute of Oncology; Regional...

Ukendt

Cisplatin-monotherapy in the Treatment of BRCA1 Positive Breast Cancer Patients in Poland

BRCA1 mutation | Breast Cancer Invasive Nos

Polen
Aga Khan University

Afsluttet

Resultater af lokale perforatorflapper i onkoplastisk kirurgi

Brystkræft | Perforatorklap | Brysttumor | Oncoplasty | Breast-Q

Pakistan
University Health Network, Toronto

Afsluttet

En prototype Tri-modal billedbehandlingsenhed til brystkræft

Breast Cancer Invasive Nos | Primær invasiv brystkræft

Canada
KU Leuven
Novartis

Ukendt

Undersøgelse af patienttilfredshed med oral anti-cancer-behandling hos patienter med hormon-receptor positiv, HER2-receptor negativ, avanceret brystkræft (IPSOC-mamma)

ER Positive, HER2 Negative Breast Cancer Neoplasma

Belgien

Kliniske forsøg med Standard behandling

Hospital Clinic of Barcelona

Ukendt

Effektiviteten af beredskabsstyring i behandlingen af unge med cannabisbrugsforstyrrelser

Misbrug af marihuana

Spanien
Oklahoma State University
University of Oklahoma; University of Minnesota; Case Western Reserve University og andre samarbejdspartnere

Afsluttet

Kognitive og selvregulerende mekanismer for fedmeundersøgelse (COSMOS)

Fedme
The Miriam Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Rekruttering

Program til fuld forståelse af spisning og livsstilsændring (FUEL) (FUEL)

Fedme

Forenede Stater
Kaiser Permanente

Afsluttet

Forbedring af familiebaseret behandling af fedme blandt børn gennem sociale netværk (CONNECT)

Børns fedme
University of Georgia
Makerere University

Afsluttet

DOT Selfie: En mobil teknologiintervention til at evaluere behandlingsoverholdelse blandt tuberkulosepatienter

Tuberkulose

Uganda
University of Miami

Aktiv, ikke rekrutterende

MR-kortlagt dosis-eskaleret redningsstrålebehandling efter prostatektomi: MAPS-forsøget (MAPS)

Prostatakræft | Prostata Adenocarcinom

Forenede Stater
University of Minnesota
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) og andre samarbejdspartnere

Afsluttet

Vedligeholdelseskræddersyet fedmebehandling (LIFE)

Fedme

Forenede Stater
Stanford University
National Institute on Deafness and Other Communication Disorders (NIDCD)

Rekruttering

Neuroimaging prædiktorer for forbedring af pivotal responsbehandling (PRT) hos små børn med autisme (PRT-I)

Autismespektrumforstyrrelse | Autisme

Forenede Stater
Waikato Hospital
Wellington Hospital

Rekruttering

Metabolisk terapiprogram i forbindelse med standardbehandling for Glioblastom Multiforme

Glioblastom

New Zealand
University of California, San Francisco
National Institute on Drug Abuse (NIDA)

Afsluttet

Tobaksintervention i buprenorphinbehandling (IBIS)

Tobaksafhængighed

Forenede Stater

Sammenligning af kombinationskemoterapibehandlinger til behandling af ældre kvinder, der har gennemgået kirurgi for brystkræft

Et randomiseret forsøg med adjuverende kemoterapi med standardregimer, cyclophosphamid, methotrexat og fluorouracil - (CMF) eller doxorubicin og cyclophosphamid - (AC), versus capecitabin hos kvinder 65 år og ældre med nodepositiv eller nodenegativ brystkræft

Studieoversigt

Status

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Undersøgelsestype

Tilmelding (Faktiske)

Fase

Kontakter og lokationer

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal våben

Våben og indgreb

Deltagergruppe / Arm

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Samarbejdspartnere

Efterforskere

Publikationer og nyttige links

Generelle publikationer

Datoer for undersøgelser

Studer store datoer

Studiestart

Primær færdiggørelse (Faktiske)

Studieafslutning (Faktiske)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Skøn)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Kliniske forsøg med Brystkræft

Kliniske forsøg med Standard behandling

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Ghana

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer