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S0812 Højdosis kolecalciferol hos præmenopausale kvinder med høj risiko for brystkræft

21. november 2017 opdateret af: Southwest Oncology Group

Fase IIB Randomiseret kontrolleret biomarkørmodulationsundersøgelse af D-vitamin hos præmenopausale kvinder med høj risiko for brystkræft

RATIONALE: Cholecalciferol kan forebygge brystkræft hos præmenopausale kvinder.

FORMÅL: Dette randomiserede fase II-studie undersøger, hvor godt cholecalciferol virker til at forebygge brystkræft hos præmenopausale kvinder.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

MÅL:

  • At vurdere om mammografisk tæthed er reduceret hos præmenopausale kvinder med høj risiko for brystkræft, der tager højdosis D3-vitamin (oral cholecalciferol 20.000 IE ugentligt) sammenlignet med placebo i 1 år.
  • At vurdere om proliferation målt ved Ki-67-farvning af brystepitelceller er reduceret hos kvinder, der modtager disse behandlinger.
  • At udforske forskellen i ekspressionen af ​​andre biomarkører (inklusive spaltet caspase-3 [apoptosemarkør], ER, vitamin D-receptor [VDR] og 1α-hydroxylase) i brystvæv opnået fra disse kvinder.
  • For at vurdere om parathyreoideahormon, IGF-1, IGFBP-3, 25(OH)D og 1,25(OH)D serumniveauer er ændret hos disse kvinder ved baseline og efter 6 og 12 måneder.
  • At undersøge, om en ændring i mammografisk tæthed korrelerer med polymorfismer i VDR-genet.
  • At vurdere andre kilder til vitamin D (eksponering for sollys, kost) hos disse kvinder ved hjælp af et valideret spørgeskema administreret ved baseline og efter 12 og 24 måneder.
  • At indsamle og banke serum, plasma og brystvæv fra disse kvinder før og efter en 1-årig intervention med D-vitamin til fremtidig biomarkøranalyse.
  • At vurdere toksiciteten af ​​højdosis cholecalciferol sammenlignet med placebo i denne indstilling.

OVERSIGT: Dette er en multicenterundersøgelse. Deltagerne er stratificeret efter baseline serum 25(OH)D niveau (< 20 ng/mL vs 20-32 ng/ml eller < 50 nmol/L vs 50-80 nmol/L), baseline mammografisk tæthed (11-50% vs. > 50 %) og udpeget biopsisted (ja vs nej). Deltagerne randomiseres til 1 ud af 2 behandlingsarme.

  • Arm I: Deltagerne får oral cholecalciferol én gang om ugen og oral D-vitamin én gang dagligt. Behandlingen gentages i 12 måneder i mangel af tegn på cancer eller uacceptabel toksicitet.
  • Arm II: Deltagerne får oral placebo én gang om ugen og oral D-vitamin én gang dagligt. Behandlingen gentages i 12 måneder i mangel af tegn på cancer eller uacceptabel toksicitet.

Blodprøver udtages ved baseline og periodisk derefter for biomarkører og 25(OH)D-niveau. Deltagerne gennemgår en mammografi ved baseline og efter 12 måneder. Deltagerne kan også gennemgå en tilfældig kerne-nål brystbiopsi ved baseline og efter 12 måneder.

Deltagerne udfylder et spørgeskema ved baseline og efter 12 og 24 måneder.

Efter afsluttet studieterapi følges deltagerne op efter 1 og 12 måneder.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

208

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Anniston, Alabama, Forenede Stater, 36202
        • Northeast Alabama Regional Medical Center
      • Mobile, Alabama, Forenede Stater, 36608
        • Providence Hospital
    • Alaska
      • Anchorage, Alaska, Forenede Stater, 99508
        • Alaska Breast Care and Surgery LLC
      • Anchorage, Alaska, Forenede Stater, 99508
        • Alaska Women's Cancer Care
      • Anchorage, Alaska, Forenede Stater, 99508
        • Anchorage Oncology Centre
      • Anchorage, Alaska, Forenede Stater, 99508
        • Katmai Oncology Group
      • Anchorage, Alaska, Forenede Stater, 99508
        • Providence Alaska Medical Center
      • Anchorage, Alaska, Forenede Stater, 99508
        • Alaska Regional Hospital
      • Fairbanks, Alaska, Forenede Stater, 99701
        • Fairbanks Memorial Hospital
    • Arizona
      • Tucson, Arizona, Forenede Stater, 85719
        • University of Arizona Cancer Center-North Campus
      • Tucson, Arizona, Forenede Stater, 85724
        • The University of Arizona Medical Center-University Campus
    • Arkansas
      • Rogers, Arkansas, Forenede Stater, 72758
        • Highlands Oncology Group-Rogers
    • California
      • Castro Valley, California, Forenede Stater, 94546
        • East Bay Radiation Oncology Center
      • Castro Valley, California, Forenede Stater, 94546
        • Valley Medical Oncology Consultants-Castro Valley
      • Concord, California, Forenede Stater, 94520
        • John Muir Medical Center-Concord Campus
      • Costa Mesa, California, Forenede Stater, 92627
        • UC Irvine Health Cancer Center-Newport
      • Duarte, California, Forenede Stater, 91010
        • City of Hope Comprehensive Cancer Center
      • Dublin, California, Forenede Stater, 94568
        • Epic Care-Dublin
      • Emeryville, California, Forenede Stater, 94608
        • Bay Area Breast Surgeons Inc
      • Emeryville, California, Forenede Stater, 94608
        • Epic Care Partners in Cancer Care
      • Fremont, California, Forenede Stater, 94538
        • Valley Medical Oncology Consultants-Fremont
      • Los Angeles, California, Forenede Stater, 90033
        • USC / Norris Comprehensive Cancer Center
      • Los Angeles, California, Forenede Stater, 90033
        • Los Angeles County-USC Medical Center
      • Martinez, California, Forenede Stater, 94553-3156
        • Contra Costa Regional Medical Center
      • Mountain View, California, Forenede Stater, 94040
        • El Camino Hospital
      • Oakland, California, Forenede Stater, 94609
        • Alta Bates Summit Medical Center - Summit Campus
      • Oakland, California, Forenede Stater, 94609
        • Hematology and Oncology Associates-Oakland
      • Oakland, California, Forenede Stater, 94602
        • Highland General Hospital
      • Oakland, California, Forenede Stater, 94609
        • Tom K Lee Inc
      • Oakland, California, Forenede Stater, 94609
        • Bay Area Tumor Institute
      • Orange, California, Forenede Stater, 92868
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
      • Pasadena, California, Forenede Stater, 91105
        • Huntington Memorial Hospital
      • Pleasant Hill, California, Forenede Stater, 94523
        • East Bay Medical Oncology Hematology Medical Associates Inc-Pleasant Hill
      • Pleasanton, California, Forenede Stater, 94588
        • Valley Medical Oncology Consultants
      • San Pablo, California, Forenede Stater, 94806
        • Doctors Medical Center- JC Robinson Regional Cancer Center
      • Santa Ana, California, Forenede Stater, 92705
        • Breastlink Medical Group Inc
      • Walnut Creek, California, Forenede Stater, 94598
        • John Muir Medical Center-Walnut Creek
      • Whittier, California, Forenede Stater, 90602
        • Presbyterian Intercommunity Hospital
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80012
        • The Medical Center of Aurora
      • Boulder, Colorado, Forenede Stater, 80301
        • Boulder Community Hospital
      • Boulder, Colorado, Forenede Stater, 80304
        • Rocky Mountain Cancer Centers-Boulder
      • Colorado Springs, Colorado, Forenede Stater, 80907
        • Penrose-Saint Francis Healthcare
      • Colorado Springs, Colorado, Forenede Stater, 80907
        • Rocky Mountain Cancer Centers-Penrose
      • Denver, Colorado, Forenede Stater, 80210
        • Porter Adventist Hospital
      • Denver, Colorado, Forenede Stater, 80218
        • Presbyterian - Saint Lukes Medical Center - Health One
      • Denver, Colorado, Forenede Stater, 80218
        • SCL Health Saint Joseph Hospital
      • Denver, Colorado, Forenede Stater, 80220
        • Rose Medical Center
      • Denver, Colorado, Forenede Stater, 80218
        • Rocky Mountain Cancer Centers-Midtown
      • Denver, Colorado, Forenede Stater, 80220
        • Rocky Mountain Cancer Centers-Rose
      • Denver, Colorado, Forenede Stater, 80218
        • Colorado Blood Cancer Institute
      • Denver, Colorado, Forenede Stater, 80222
        • Colorado Cancer Research Program NCORP
      • Durango, Colorado, Forenede Stater, 81301
        • Mercy Medical Center
      • Englewood, Colorado, Forenede Stater, 80113
        • Swedish Medical Center
      • Englewood, Colorado, Forenede Stater, 80113
        • Comprehensive Cancer Care and Research Institute of Colorado LLC
      • Fort Collins, Colorado, Forenede Stater, 80524
        • Poudre Valley Hospital
      • Fort Collins, Colorado, Forenede Stater, 80528
        • Front Range Cancer Specialists
      • Golden, Colorado, Forenede Stater, 80401
        • Mountain Blue Cancer Care Center
      • Greeley, Colorado, Forenede Stater, 80631
        • North Colorado Medical Center
      • Greenwood Village, Colorado, Forenede Stater, 80111
        • Rocky Mountain Cancer Centers-Greenwood Village
      • Lakewood, Colorado, Forenede Stater, 80228
        • Saint Anthony Hospital
      • Lakewood, Colorado, Forenede Stater, 80228
        • Rocky Mountain Cancer Centers-Lakewood
      • Littleton, Colorado, Forenede Stater, 80122
        • Littleton Adventist Hospital
      • Lone Tree, Colorado, Forenede Stater, 80124
        • Sky Ridge Medical Center
      • Lone Tree, Colorado, Forenede Stater, 80124
        • Rocky Mountain Cancer Centers-Sky Ridge
      • Longmont, Colorado, Forenede Stater, 80501
        • Longmont United Hospital
      • Longmont, Colorado, Forenede Stater, 80501
        • Rocky Mountain Cancer Centers-Longmont
      • Loveland, Colorado, Forenede Stater, 80539
        • McKee Medical Center
      • Parker, Colorado, Forenede Stater, 80138
        • Parker Adventist Hospital
      • Parker, Colorado, Forenede Stater, 80138
        • Rocky Mountain Cancer Centers-Parker
      • Pueblo, Colorado, Forenede Stater, 81004
        • Saint Mary Corwin Medical Center
      • Pueblo, Colorado, Forenede Stater, 81008
        • Rocky Mountain Cancer Centers - Pueblo
      • Wheat Ridge, Colorado, Forenede Stater, 80033
        • SCL Health Lutheran Medical Center
    • Connecticut
      • Greenwich, Connecticut, Forenede Stater, 06830
        • Greenwich Hospital
      • Hartford, Connecticut, Forenede Stater, 06105
        • Smilow Cancer Hospital Care Center at Saint Francis
      • Middletown, Connecticut, Forenede Stater, 06457
        • Middlesex Hospital
    • Florida
      • Orlando, Florida, Forenede Stater, 32803
        • Florida Hospital Orlando
      • Stuart, Florida, Forenede Stater, 34994
        • Martin Medical Center
      • Stuart, Florida, Forenede Stater, 34994
        • Robert and Carol Weissman Cancer Center at Martin Health
      • Stuart, Florida, Forenede Stater, 34997
        • Martin Hospital South
    • Georgia
      • Decatur, Georgia, Forenede Stater, 30033
        • Dekalb Medical Center
    • Hawaii
      • 'Aiea, Hawaii, Forenede Stater, 96701
        • Pali Momi Medical Center
      • 'Aiea, Hawaii, Forenede Stater, 96701
        • Oncare Hawaii Inc-Pali Momi
      • Honolulu, Hawaii, Forenede Stater, 96813
        • Queen's Medical Center
      • Honolulu, Hawaii, Forenede Stater, 96813
        • Straub Clinic and Hospital
      • Honolulu, Hawaii, Forenede Stater, 96813
        • University of Hawaii Cancer Center
      • Honolulu, Hawaii, Forenede Stater, 96817
        • Hawaii Cancer Care Inc-Liliha
      • Honolulu, Hawaii, Forenede Stater, 96817
        • Kuakini Medical Center
      • Honolulu, Hawaii, Forenede Stater, 96826
        • Kapiolani Medical Center for Women and Children
      • Honolulu, Hawaii, Forenede Stater, 96813
        • Hawaii Cancer Care Inc-POB II
      • Honolulu, Hawaii, Forenede Stater, 96817
        • Hawaii Oncology Inc-Kuakini
      • Kailua, Hawaii, Forenede Stater, 96734
        • Castle Medical Center
      • Lihue, Hawaii, Forenede Stater, 96766
        • Wilcox Memorial Hospital and Kauai Medical Clinic
    • Idaho
      • Boise, Idaho, Forenede Stater, 83706
        • Saint Alphonsus Cancer Care Center-Boise
      • Boise, Idaho, Forenede Stater, 83712
        • Saint Luke's Mountain States Tumor Institute
      • Meridian, Idaho, Forenede Stater, 83642
        • Saint Luke's Mountain States Tumor Institute - Meridian
      • Post Falls, Idaho, Forenede Stater, 83854
        • Kootenai Cancer Center
      • Twin Falls, Idaho, Forenede Stater, 83301
        • Saint Luke's Mountain States Tumor Institute-Twin Falls
    • Illinois
      • Alton, Illinois, Forenede Stater, 62002
        • Saint Anthony's Health
      • Bloomington, Illinois, Forenede Stater, 61704
        • Illinois CancerCare-Bloomington
      • Bloomington, Illinois, Forenede Stater, 61701
        • Saint Joseph Medical Center
      • Canton, Illinois, Forenede Stater, 61520
        • Illinois CancerCare-Canton
      • Carbondale, Illinois, Forenede Stater, 62902
        • Memorial Hospital of Carbondale
      • Carthage, Illinois, Forenede Stater, 62321
        • Illinois CancerCare-Carthage
      • Centralia, Illinois, Forenede Stater, 62801
        • Centralia Oncology Clinic
      • Decatur, Illinois, Forenede Stater, 62526
        • Decatur Memorial Hospital
      • Decatur, Illinois, Forenede Stater, 62526
        • Heartland Cancer Research NCORP
      • Decatur, Illinois, Forenede Stater, 62526
        • Cancer Care Center of Decatur
      • Effingham, Illinois, Forenede Stater, 62401
        • Crossroads Cancer Center
      • Eureka, Illinois, Forenede Stater, 61530
        • Illinois CancerCare-Eureka
      • Galesburg, Illinois, Forenede Stater, 61401
        • Illinois CancerCare-Galesburg
      • Galesburg, Illinois, Forenede Stater, 61401
        • Illinois CancerCare-Galesburg Cottage Plaza Office
      • Geneva, Illinois, Forenede Stater, 60134
        • Northwestern Medicine Cancer Center Delnor
      • Kewanee, Illinois, Forenede Stater, 61443
        • Illinois CancerCare-Kewanee Clinic
      • Macomb, Illinois, Forenede Stater, 61455
        • Illinois CancerCare-Macomb
      • Monmouth, Illinois, Forenede Stater, 61462
        • Illinois CancerCare-Monmouth
      • Monmouth, Illinois, Forenede Stater, 61462
        • Holy Family Medical Center
      • Mount Vernon, Illinois, Forenede Stater, 62864
        • Good Samaritan Regional Health Center
      • Normal, Illinois, Forenede Stater, 61761
        • Community Cancer Center Foundation
      • Normal, Illinois, Forenede Stater, 61761
        • Mid-Illinois Hematology Oncology Associates Limited
      • Ottawa, Illinois, Forenede Stater, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Ottawa, Illinois, Forenede Stater, 61350
        • Ottawa Regional Hospital and Healthcare Center
      • Pekin, Illinois, Forenede Stater, 61554
        • Illinois CancerCare-Pekin
      • Pekin, Illinois, Forenede Stater, 61554
        • OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
      • Peoria, Illinois, Forenede Stater, 61637
        • OSF Saint Francis Medical Center
      • Peoria, Illinois, Forenede Stater, 61615
        • Illinois CancerCare-Peoria
      • Peoria, Illinois, Forenede Stater, 61614
        • Proctor Hospital
      • Peoria, Illinois, Forenede Stater, 61603
        • Methodist Medical Center of Illinois
      • Peru, Illinois, Forenede Stater, 61354
        • Illinois CancerCare-Peru
      • Princeton, Illinois, Forenede Stater, 61356
        • Illinois CancerCare-Princeton
      • Springfield, Illinois, Forenede Stater, 62781
        • Memorial Medical Center
      • Warrenville, Illinois, Forenede Stater, 60555
        • Northwestern Medicine Cancer Center Warrenville
    • Indiana
      • Elkhart, Indiana, Forenede Stater, 46515
        • Elkhart General Hospital
      • Elkhart, Indiana, Forenede Stater, 46514
        • Michiana Hematology Oncology PC-Elkhart
      • Elkhart, Indiana, Forenede Stater, 46514-2098
        • Elkhart Clinic
      • Kokomo, Indiana, Forenede Stater, 46904
        • Community Howard Regional Health
      • La Porte, Indiana, Forenede Stater, 46350
        • IU Health La Porte Hospital
      • Mishawaka, Indiana, Forenede Stater, 46545
        • Michiana Hematology Oncology PC-Mishawaka
      • Mishawaka, Indiana, Forenede Stater, 46545
        • Cancer Care Partners LLC
      • Mishawaka, Indiana, Forenede Stater, 46545
        • Saint Joseph Regional Medical Center-Mishawaka
      • Plymouth, Indiana, Forenede Stater, 46563
        • Michiana Hematology Oncology PC-Plymouth
      • South Bend, Indiana, Forenede Stater, 46601
        • Memorial Hospital of South Bend
      • South Bend, Indiana, Forenede Stater, 46601
        • Michiana Hematology Oncology PC-South Bend
      • South Bend, Indiana, Forenede Stater, 46628
        • Northern Indiana Cancer Research Consortium
      • South Bend, Indiana, Forenede Stater, 46617
        • South Bend Clinic
      • Westville, Indiana, Forenede Stater, 46391
        • Michiana Hematology Oncology PC-Westville
    • Iowa
      • Sioux City, Iowa, Forenede Stater, 51101
        • Siouxland Regional Cancer Center
      • Sioux City, Iowa, Forenede Stater, 51104
        • Saint Luke's Regional Medical Center
      • Sioux City, Iowa, Forenede Stater, 51104
        • Mercy Medical Center-Sioux City
    • Kansas
      • Chanute, Kansas, Forenede Stater, 66720
        • Cancer Center of Kansas - Chanute
      • Dodge City, Kansas, Forenede Stater, 67801
        • Cancer Center of Kansas - Dodge City
      • El Dorado, Kansas, Forenede Stater, 67042
        • Cancer Center of Kansas - El Dorado
      • Fort Scott, Kansas, Forenede Stater, 66701
        • Cancer Center of Kansas - Fort Scott
      • Independence, Kansas, Forenede Stater, 67301
        • Cancer Center of Kansas-Independence
      • Kansas City, Kansas, Forenede Stater, 66112
        • Providence Medical Center
      • Kingman, Kansas, Forenede Stater, 67068
        • Cancer Center of Kansas-Kingman
      • Lawrence, Kansas, Forenede Stater, 66044
        • Lawrence Memorial Hospital
      • Liberal, Kansas, Forenede Stater, 67905
        • Cancer Center of Kansas-Liberal
      • Manhattan, Kansas, Forenede Stater, 66502
        • Cancer Center of Kansas-Manhattan
      • McPherson, Kansas, Forenede Stater, 67460
        • Cancer Center of Kansas - McPherson
      • Newton, Kansas, Forenede Stater, 67114
        • Cancer Center of Kansas - Newton
      • Overland Park, Kansas, Forenede Stater, 66209
        • Menorah Medical Center
      • Overland Park, Kansas, Forenede Stater, 66213
        • Saint Luke's South Hospital
      • Parsons, Kansas, Forenede Stater, 67357
        • Cancer Center of Kansas - Parsons
      • Prairie Village, Kansas, Forenede Stater, 66208
        • Kansas City NCI Community Oncology Research Program
      • Pratt, Kansas, Forenede Stater, 67124
        • Cancer Center of Kansas - Pratt
      • Salina, Kansas, Forenede Stater, 67401
        • Cancer Center of Kansas - Salina
      • Wellington, Kansas, Forenede Stater, 67152
        • Cancer Center of Kansas - Wellington
      • Wichita, Kansas, Forenede Stater, 67208
        • Cancer Center of Kansas-Wichita Medical Arts Tower
      • Wichita, Kansas, Forenede Stater, 67214
        • Cancer Center of Kansas - Wichita
      • Wichita, Kansas, Forenede Stater, 67208
        • Associates In Womens Health
      • Wichita, Kansas, Forenede Stater, 67214
        • Wichita NCI Community Oncology Research Program
      • Wichita, Kansas, Forenede Stater, 67214
        • Via Christi Regional Medical Center
      • Winfield, Kansas, Forenede Stater, 67156
        • Cancer Center of Kansas - Winfield
    • Kentucky
      • Corbin, Kentucky, Forenede Stater, 40701
        • Baptist Health Corbin
      • Lexington, Kentucky, Forenede Stater, 40503
        • Baptist Health Lexington
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70809
        • Hematology/Oncology Clinic LLP
      • New Orleans, Louisiana, Forenede Stater, 70121
        • Ochsner Medical Center Jefferson
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Tulane University Health Sciences Center
    • Massachusetts
      • Brighton, Massachusetts, Forenede Stater, 02135
        • Steward Saint Elizabeth's Medical Center
      • Burlington, Massachusetts, Forenede Stater, 01805
        • Lahey Hospital and Medical Center
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48106-0995
        • Saint Joseph Mercy Hospital
      • Ann Arbor, Michigan, Forenede Stater, 48106
        • Michigan Cancer Research Consortium NCORP
      • Dearborn, Michigan, Forenede Stater, 48124
        • Beaumont Hospital-Dearborn
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, Forenede Stater, 48236
        • Saint John Hospital and Medical Center
      • Detroit, Michigan, Forenede Stater, 48201
        • Wayne State University/Karmanos Cancer Institute
      • Farmington, Michigan, Forenede Stater, 48334
        • Botsford General Hospital
      • Flint, Michigan, Forenede Stater, 48502
        • Hurley Medical Center
      • Flint, Michigan, Forenede Stater, 48503
        • Genesys Hurley Cancer Institute
      • Grand Blanc, Michigan, Forenede Stater, 48439
        • Genesys Regional Medical Center
      • Jackson, Michigan, Forenede Stater, 49201
        • Allegiance Health
      • Kalamazoo, Michigan, Forenede Stater, 49007
        • West Michigan Cancer Center
      • Kalamazoo, Michigan, Forenede Stater, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, Forenede Stater, 49001
        • Borgess Medical Center
      • Lansing, Michigan, Forenede Stater, 48912
        • Sparrow Hospital
      • Livonia, Michigan, Forenede Stater, 48154
        • Saint Mary Mercy Hospital
      • Midland, Michigan, Forenede Stater, 48670
        • Mid-Michigan Medical Center - Midland
      • Niles, Michigan, Forenede Stater, 49120
        • Lakeland Community Hospital
      • Pontiac, Michigan, Forenede Stater, 48341
        • Saint Joseph Mercy Oakland
      • Port Huron, Michigan, Forenede Stater, 48060
        • Saint Joseph Mercy Port Huron
      • Royal Oak, Michigan, Forenede Stater, 48073
        • William Beaumont Hospital-Royal Oak
      • Saginaw, Michigan, Forenede Stater, 48601
        • Saint Mary's of Michigan
      • Saint Joseph, Michigan, Forenede Stater, 49085
        • Marie Yeager Cancer Center
      • Saint Joseph, Michigan, Forenede Stater, 49085
        • Lakeland Hospital
      • Troy, Michigan, Forenede Stater, 48098
        • William Beaumont Hospital - Troy
      • Warren, Michigan, Forenede Stater, 48093
        • Saint John Macomb-Oakland Hospital
    • Minnesota
      • Burnsville, Minnesota, Forenede Stater, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, Forenede Stater, 55433
        • Mercy Hospital
      • Edina, Minnesota, Forenede Stater, 55435
        • Fairview-Southdale Hospital
      • Fridley, Minnesota, Forenede Stater, 55432
        • Unity Hospital
      • Hutchinson, Minnesota, Forenede Stater, 55350
        • Hutchinson Area Health Care
      • Maplewood, Minnesota, Forenede Stater, 55109
        • Saint John's Hospital - Healtheast
      • Maplewood, Minnesota, Forenede Stater, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, Forenede Stater, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, Forenede Stater, 55407
        • Abbott-Northwestern Hospital
      • New Ulm, Minnesota, Forenede Stater, 56073
        • New Ulm Medical Center
      • Robbinsdale, Minnesota, Forenede Stater, 55422
        • North Memorial Medical Health Center
      • Saint Louis Park, Minnesota, Forenede Stater, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Louis Park, Minnesota, Forenede Stater, 55416
        • Metro Minnesota Community Oncology Research Consortium
      • Saint Paul, Minnesota, Forenede Stater, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, Forenede Stater, 55102
        • United Hospital
      • Shakopee, Minnesota, Forenede Stater, 55379
        • Saint Francis Regional Medical Center
      • Stillwater, Minnesota, Forenede Stater, 55082
        • Lakeview Hospital
      • Waconia, Minnesota, Forenede Stater, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, Forenede Stater, 56201
        • Rice Memorial Hospital
      • Woodbury, Minnesota, Forenede Stater, 55125
        • Minnesota Oncology and Hematology PA-Woodbury
    • Mississippi
      • Pascagoula, Mississippi, Forenede Stater, 39581
        • Singing River Hospital
    • Missouri
      • Bolivar, Missouri, Forenede Stater, 65613
        • Central Care Cancer Center-Carrie J Babb Cancer Center
      • Cape Girardeau, Missouri, Forenede Stater, 63703
        • Saint Francis Medical Center
      • Independence, Missouri, Forenede Stater, 64057
        • Centerpoint Medical Center LLC
      • Joplin, Missouri, Forenede Stater, 64804
        • Mercy Hospital-Joplin
      • Kansas City, Missouri, Forenede Stater, 64116
        • North Kansas City Hospital
      • Kansas City, Missouri, Forenede Stater, 64111
        • Saint Luke's Hospital of Kansas City
      • Kansas City, Missouri, Forenede Stater, 64132
        • Research Medical Center
      • Kansas City, Missouri, Forenede Stater, 64118
        • Heartland Hematology and Oncology Associates Incorporated
      • Lee's Summit, Missouri, Forenede Stater, 64086
        • Saint Luke's East - Lee's Summit
      • Liberty, Missouri, Forenede Stater, 64068
        • Liberty Radiation Oncology Center
      • Rolla, Missouri, Forenede Stater, 65401
        • Phelps County Regional Medical Center
      • Rolla, Missouri, Forenede Stater, 65401
        • Saint John's Clinic-Rolla-Cancer and Hematology
      • Saint Joseph, Missouri, Forenede Stater, 64506
        • Heartland Regional Medical Center
      • Saint Joseph, Missouri, Forenede Stater, 64507
        • Saint Joseph Oncology Inc
      • Saint Louis, Missouri, Forenede Stater, 63141
        • Mercy Hospital Saint Louis
      • Saint Louis, Missouri, Forenede Stater, 63109
        • Saint Louis Cancer and Breast Institute-South City
      • Saint Louis, Missouri, Forenede Stater, 63141
        • Saint Louis-Cape Girardeau CCOP
      • Springfield, Missouri, Forenede Stater, 65804
        • Cancer Research for the Ozarks NCORP
      • Springfield, Missouri, Forenede Stater, 65807
        • CoxHealth South Hospital
      • Springfield, Missouri, Forenede Stater, 65804
        • Mercy Hospital Springfield
    • Montana
      • Billings, Montana, Forenede Stater, 59101
        • Billings Clinic Cancer Center
      • Billings, Montana, Forenede Stater, 59101
        • Saint Vincent Healthcare
      • Billings, Montana, Forenede Stater, 59102
        • Frontier Cancer Center and Blood Institute-Billings
      • Billings, Montana, Forenede Stater, 59101
        • Montana Cancer Consortium NCORP
      • Bozeman, Montana, Forenede Stater, 59715
        • Bozeman Deaconess Hospital
      • Butte, Montana, Forenede Stater, 59701
        • Saint James Community Hospital and Cancer Treatment Center
      • Great Falls, Montana, Forenede Stater, 59405
        • Great Falls Clinic
      • Great Falls, Montana, Forenede Stater, 59405
        • Benefis Healthcare- Sletten Cancer Institute
      • Helena, Montana, Forenede Stater, 59601
        • Saint Peter's Community Hospital
      • Kalispell, Montana, Forenede Stater, 59901
        • Kalispell Regional Medical Center
      • Kalispell, Montana, Forenede Stater, 59901
        • Glacier Oncology PLLC
      • Missoula, Montana, Forenede Stater, 59802
        • Saint Patrick Hospital - Community Hospital
      • Missoula, Montana, Forenede Stater, 59802
        • Montana Cancer Specialists
    • Nebraska
      • Kearney, Nebraska, Forenede Stater, 68847
        • CHI Health Good Samaritan
      • Lincoln, Nebraska, Forenede Stater, 68510
        • Nebraska Cancer Research Center
      • Omaha, Nebraska, Forenede Stater, 68124
        • Alegent Health Bergan Mercy Medical Center
      • Omaha, Nebraska, Forenede Stater, 68122
        • Alegent Health Immanuel Medical Center
      • Omaha, Nebraska, Forenede Stater, 68130
        • Alegent Health Lakeside Hospital
      • Omaha, Nebraska, Forenede Stater, 68131
        • Creighton University Medical Center
      • Omaha, Nebraska, Forenede Stater, 68106
        • Missouri Valley Cancer Consortium
    • New Jersey
      • Vineland, New Jersey, Forenede Stater, 08360
        • Inspira Medical Center Vineland
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87110
        • Presbyterian Kaseman Hospital
    • New York
      • Auburn, New York, Forenede Stater, 13021
        • Hematology Oncology Associates of Central New York-Auburn
      • East Syracuse, New York, Forenede Stater, 13057
        • Hematology Oncology Associates of Central New York-East Syracuse
      • Mineola, New York, Forenede Stater, 11501
        • Winthrop University Hospital
      • New York, New York, Forenede Stater, 10032
        • Columbia University/Herbert Irving Cancer Center
      • Rochester, New York, Forenede Stater, 14642
        • University of Rochester
      • Rochester, New York, Forenede Stater, 14620
        • Highland Hospital
      • Rome, New York, Forenede Stater, 13440
        • Hematology Oncology Associates of Central New York-Rome
      • Syracuse, New York, Forenede Stater, 13210
        • State University of New York Upstate Medical University
      • Syracuse, New York, Forenede Stater, 13215
        • Hematology Oncology Associates of Central New York-Onondaga Hill
    • North Carolina
      • Asheboro, North Carolina, Forenede Stater, 27203
        • Randolph Hospital
      • Charlotte, North Carolina, Forenede Stater, 28204
        • Novant Health Presbyterian Medical Center
      • Charlotte, North Carolina, Forenede Stater, 28262
        • Southern Oncology Specialists-Charlotte
      • Greensboro, North Carolina, Forenede Stater, 27403
        • Cone Health Cancer Center
      • Hendersonville, North Carolina, Forenede Stater, 28791
        • Hendersonville Hematology and Oncology at Pardee
      • Hendersonville, North Carolina, Forenede Stater, 28791
        • Margaret R Pardee Memorial Hospital
      • Hendersonville, North Carolina, Forenede Stater, 28792
        • Park Ridge Hospital Breast Health Center
      • Huntersville, North Carolina, Forenede Stater, 28078
        • Southern Oncology Specialists-Huntersville
      • Matthews, North Carolina, Forenede Stater, 28105
        • Novant Health Cancer Specialists-Matthews
      • Mooresville, North Carolina, Forenede Stater, 28117
        • Lake Norman Hematology Oncology Specialists-Mooresville
      • Reidsville, North Carolina, Forenede Stater, 27320
        • Annie Penn Memorial Hospital
      • Winston-Salem, North Carolina, Forenede Stater, 27104
        • Southeast Clinical Oncology Research (SCOR) Consortium NCORP
    • North Dakota
      • Minot, North Dakota, Forenede Stater, 58701
        • Trinity Cancer Care Center
    • Ohio
      • Belpre, Ohio, Forenede Stater, 45714
        • Strecker Cancer Center-Belpre
      • Chillicothe, Ohio, Forenede Stater, 45601
        • Adena Regional Medical Center
      • Columbus, Ohio, Forenede Stater, 43214
        • Riverside Methodist Hospital
      • Columbus, Ohio, Forenede Stater, 43219
        • The Mark H Zangmeister Center
      • Columbus, Ohio, Forenede Stater, 43214
        • Columbus Oncology and Hematology Associates Inc
      • Columbus, Ohio, Forenede Stater, 43228
        • Doctors Hospital
      • Columbus, Ohio, Forenede Stater, 43215
        • Grant Medical Center
      • Columbus, Ohio, Forenede Stater, 43222
        • Mount Carmel Health Center West
      • Columbus, Ohio, Forenede Stater, 43215
        • Columbus NCI Community Oncology Research Program
      • Delaware, Ohio, Forenede Stater, 43015
        • Delaware Health Center-Grady Cancer Center
      • Delaware, Ohio, Forenede Stater, 43015
        • Delaware Radiation Oncology
      • Delaware, Ohio, Forenede Stater, 43015
        • Grady Memorial Hospital
      • Lancaster, Ohio, Forenede Stater, 43130
        • Fairfield Medical Center
      • Lancaster, Ohio, Forenede Stater, 43130
        • Lancaster Radiation Oncology
      • Marietta, Ohio, Forenede Stater, 45750
        • Marietta Memorial Hospital
      • Mount Vernon, Ohio, Forenede Stater, 43050
        • Knox Community Hospital
      • Newark, Ohio, Forenede Stater, 43055
        • Licking Memorial Hospital
      • Newark, Ohio, Forenede Stater, 43055
        • Newark Radiation Oncology
      • Portsmouth, Ohio, Forenede Stater, 45662
        • Southern Ohio Medical Center
      • Springfield, Ohio, Forenede Stater, 45505
        • Springfield Regional Medical Center
      • Westerville, Ohio, Forenede Stater, 43081
        • Saint Ann's Hospital
      • Zanesville, Ohio, Forenede Stater, 43701
        • Genesis Healthcare System Cancer Care Center
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • University of Oklahoma Health Sciences Center
    • Oregon
      • Clackamas, Oregon, Forenede Stater, 97015
        • Clackamas Radiation Oncology Center
      • Gresham, Oregon, Forenede Stater, 97030
        • Legacy Mount Hood Medical Center
      • Milwaukie, Oregon, Forenede Stater, 97222
        • Providence Milwaukie Hospital
      • Newberg, Oregon, Forenede Stater, 97132
        • Providence Newberg Medical Center
      • Oregon City, Oregon, Forenede Stater, 97045
        • Providence Willamette Falls Medical Center
      • Portland, Oregon, Forenede Stater, 97210
        • Legacy Good Samaritan Hospital and Medical Center
      • Portland, Oregon, Forenede Stater, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, Forenede Stater, 97225
        • Providence Saint Vincent Medical Center
      • Portland, Oregon, Forenede Stater, 97227
        • Legacy Emanuel Hospital and Health Center
      • Portland, Oregon, Forenede Stater, 97213
        • Western Oncology Research Consortium
      • Tualatin, Oregon, Forenede Stater, 97062
        • Legacy Meridian Park Hospital
    • Pennsylvania
      • Phoenixville, Pennsylvania, Forenede Stater, 19460
        • Phoenixville Hospital
    • South Carolina
      • Anderson, South Carolina, Forenede Stater, 29621
        • AnMed Health Cancer Center
      • Anderson, South Carolina, Forenede Stater, 29621
        • AnMed Health Hospital
      • Easley, South Carolina, Forenede Stater, 29640
        • Greenville Health System Cancer Institute-Easley
      • Florence, South Carolina, Forenede Stater, 29506
        • McLeod Regional Medical Center
      • Greenville, South Carolina, Forenede Stater, 29601
        • Saint Francis Hospital
      • Greenville, South Carolina, Forenede Stater, 29605
        • Greenville Health System Cancer Institute-Andrews
      • Greenville, South Carolina, Forenede Stater, 29605
        • Greenville Health System Cancer Institute-Faris
      • Greenville, South Carolina, Forenede Stater, 29605
        • Greenville Memorial Hospital
      • Greenville, South Carolina, Forenede Stater, 29615
        • Greenville Health System Cancer Institute-Eastside
      • Greenville, South Carolina, Forenede Stater, 29605
        • Greenville Health System Cancer Institute-Butternut
      • Greer, South Carolina, Forenede Stater, 29651
        • Gibbs Cancer Center-Pelham
      • Greer, South Carolina, Forenede Stater, 29650
        • Greenville Health System Cancer Institute-Greer
      • Lancaster, South Carolina, Forenede Stater, 29720
        • Carolina Blood and Cancer Care Associates PA-Lancaster
      • Rock Hill, South Carolina, Forenede Stater, 29732
        • Carolina Blood and Cancer Care Associates PA
      • Seneca, South Carolina, Forenede Stater, 29672
        • Greenville Health System Cancer Institute-Seneca
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • Spartanburg Medical Center
      • Spartanburg, South Carolina, Forenede Stater, 29307
        • Greenville Health System Cancer Institute-Spartanburg
    • Texas
      • Amarillo, Texas, Forenede Stater, 79106
        • Texas Tech University Health Science Center-Amarillo
      • Dallas, Texas, Forenede Stater, 75246
        • Baylor University Medical Center
      • Houston, Texas, Forenede Stater, 77030
        • M D Anderson Cancer Center
      • Houston, Texas, Forenede Stater, 77030
        • The Methodist Hospital System
      • Laredo, Texas, Forenede Stater, 78041
        • Doctor's Hospital of Laredo
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84112
        • Huntsman Cancer Institute/University of Utah
    • Washington
      • Kirkland, Washington, Forenede Stater, 98033
        • EvergreenHealth Medical Center
      • Seattle, Washington, Forenede Stater, 98104
        • Pacific Medical Center-First Hill
      • Seattle, Washington, Forenede Stater, 98101
        • Virginia Mason CCOP
      • Spokane, Washington, Forenede Stater, 99220
        • Rockwood Clinic
      • Vancouver, Washington, Forenede Stater, 98686
        • Legacy Salmon Creek Hospital
      • Vancouver, Washington, Forenede Stater, 98664
        • PeaceHealth Southwest Medical Center
      • Vancouver, Washington, Forenede Stater, 98684
        • Compass Oncology Vancouver
    • West Virginia
      • Princeton, West Virginia, Forenede Stater, 24740
        • Princeton Community Hospital
    • Wisconsin
      • New Richmond, Wisconsin, Forenede Stater, 54017
        • Cancer Center of Western Wisconsin
    • Wyoming
      • Casper, Wyoming, Forenede Stater, 82609
        • Rocky Mountain Oncology
      • Sheridan, Wyoming, Forenede Stater, 82801
        • Welch Cancer Center

Deltagelseskriterier

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

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 50 år (VOKSEN)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

SYGDOMS KARAKTERISTIKA:

  • Ved en forhøjet risiko for brystkræft efter mindst et af følgende kriterier:

    • Diagnose af ADH, ALH, lobulært karcinom in situ (LCIS) eller resekteret duktalt karcinom in situ (DCIS) eller små invasive brystkræftformer (pTmi eller pT1a N0), hvis ingen førstegangs RT, tamoxifen eller systemisk brystkræftbehandling inden for 28 dage før registrering ELLER diagnosticering af resekeret trin I (T1b-c N0-N1mi) til trin II brystkræft, hvor deltageren har været sygdomsfri i mindst 5 år og har gennemført al adjuverende behandling ELLER
    • En kendt* skadelig mutation i BRCA1, BRCA2, PTEN eller TP53 BEMÆRK: *Deltageren skal være en dokumenteret bærer for at opfylde dette kriterium. Hvis der er en kendt mutation i et arvelig brystkræftmodtagelighedsgen hos en deltagers familiemedlem, skal deltageren selv have gennemgået genetisk testning i henhold til NCCNs kliniske retningslinjer for at være berettiget i henhold til dette kriterium.
    • Modificeret Gail-model/CARE-model** risiko ved 5 år ≥ 1,67 % eller livstidsrisiko ≥ 20 % af Claus-, BRCAPro-, Tyrer-Cuzick- eller IBIS-modeller ELLER
    • Mammografisk tæthed ≥ 50 % (heterogen tæt) BEMÆRK: **Risikomodeller må kun anvendes, hvis der ikke er nogen kendt tidligere diagnose af resekeret DCIS eller LCIS, og der ikke er nogen kendt skadelig mutation i BRCA1, BRCA2, PTEN eller TP53.
  • Mindst et bryst tilgængeligt til billeddannelse og biopsi (et tidligere bestrålet bryst [dvs. for resekeret DCIS] kan ikke evalueres til brystbilleddannelse eller biopsi)

  • Baseline mammografi (udført inden for 10 dage efter start af deres sidste menstruation på en digital mammografimaskine), der viser enten normale eller godartede fund

    • Baseline mammografisk tæthed > 10 % baseret på klassifikationssystemet (2 = 11-50 %, "spredte fibroglandulære tætheder"; 3 = 51-75 %, "heterogent tæt"; 4 = >75, "ekstremt tæt". Kvinder med en baseline mammografisk tæthed på ≤ 10 % (1 = ≤ 10 % bryster er næsten udelukkende fede) vil ikke være berettigede.

PATIENT KARAKTERISTIKA:

  • Præmenopausal, defineret som ≥ 1 af følgende kriterier:

    • Mindre end 6 måneder siden sidste menstruation, ingen forudgående bilateral ooforektomi og ingen brug af hormonbehandling
    • Har gennemgået en tidligere hysterektomi, men ingen tidligere bilateral ooforektomi OG follikelstimulerende hormonværdier målt inden for de seneste 28 dage stemmer overens med de normale værdier for den præmenopausale tilstand
  • Zubrod præstationsstatus 0-1
  • Serumkreatinin ≤ øvre normalgrænse (ULN)
  • Serumcalcium eller korrigeret calcium ≤ ULN
  • Pleturin calcium:kreatinin-forhold < 0,37 mg/dL
  • INR ≤ 1,5 gange ULN+
  • PT og PTT ≤ ULN*
  • Baseline serum 25(OH)D niveau ≤ 32 ng/ml (eller 80 nmol/L)
  • Ikke gravid eller ammende
  • Negativ graviditetstest
  • Fertile patienter skal bruge effektiv prævention

  • Ingen anden tidligere malignitet bortset fra følgende:

    • Tilstrækkeligt behandlet basalcelle- eller pladecellehudkræft
    • In situ livmoderhalskræft
    • Tilstrækkeligt behandlet trin I eller II (herunder resekeret trin I, T1b-c N0-N1mi til trin II brystkræft), hvorfra deltageren i øjeblikket er i fuldstændig remission
    • Enhver anden kræftsygdom (inklusive kontralateralt bryst), for hvilken deltageren har været sygdomsfri i ≥ 5 år
  • Ingen historie med nyresten
  • Ingen medicinske tilstande, der kræver calcium- eller D-vitamintilskud (dvs. osteoporose)
  • Ingen kendt overfølsomhed over for D-vitamin
  • Ingen kendt allergi over for soja BEMÆRK: +For patienter, der gennemgår brystbiopsi.

FORUDSÆTNING SAMTYDLIG TERAPI:

  • Forudgående brystreduktion tilladt

    • Ingen bilaterale brystimplantater
  • Mere end 1 måned siden tidligere operation eller strålebehandling af brystet for resekeret DCIS
  • Mindst 28 dage siden tidligere tamoxifen
  • Forudgående antikoagulantbehandling tilladt, forudsat at den seponeres ≥ 7 dage før brystbiopsi

  • Ingen samtidige calcium- eller yderligere D-vitamintilskud

    • Samtidige multivitaminer tilladt, forudsat at dosis af vitamin D i multivitaminet ikke overstiger 400 IE dagligt
  • Ingen samtidig deltagelse i andre kliniske forsøg til behandling eller forebyggelse af kræft, medmindre deltageren ikke længere modtager interventionen og kun er i opfølgningsfasen (deltagere må ikke deltage i et sådant forsøg, mens de deltager i denne undersøgelse)

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: FOREBYGGELSE
  • Tildeling: TILFÆLDIGT
  • Interventionel model: PARALLEL
  • Maskning: DOBBELT

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
EKSPERIMENTEL: Arm I
Deltagerne får oral cholecalciferol én gang om ugen og oral D-vitamin én gang dagligt. Behandlingen gentages i 12 måneder i mangel af tegn på cancer eller uacceptabel toksicitet.
Kosttilskud: cholecalciferol
Gives oralt
ACTIVE_COMPARATOR: Arm II
Deltagerne får oral placebo én gang om ugen og oral D-vitamin én gang dagligt. Behandlingen gentages i 12 måneder i mangel af tegn på cancer eller uacceptabel toksicitet.
Andet: placebo
Gives oralt
Kosttilskud: cholecalciferol
Gives oralt

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Ændring i mammografisk tæthed efter 12 måneder sammenlignet med baseline
Tidsramme: 12 måneder
12 måneder

Sekundære resultatmål

Resultatmål
Tidsramme
Ki-67 som vurderet i væv opnået i brystbiopsier ved baseline og efter 12 måneder
Tidsramme: 12 måneder
12 måneder

Samarbejdspartnere og efterforskere

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

Sponsor

Southwest Oncology Group

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Katherine D. Crew, MD, MS, Columbia University

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. november 2011

Primær færdiggørelse (FAKTISKE)

1. august 2017

Studieafslutning (FAKTISKE)

1. september 2017

Datoer for studieregistrering

Først indsendt

31. marts 2010

Først indsendt, der opfyldte QC-kriterier

31. marts 2010

Først opslået (SKØN)

1. april 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (FAKTISKE)

24. november 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. november 2017

Sidst verificeret

1. november 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • S0812 (ANDET: SWOG)
  • U10CA037429 (U.S. NIH-bevilling/kontrakt)
  • NCI-2011-02032 (ANDET: NCI)

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

Kliniske forsøg med placebo

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Bulgaria

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner