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S0800, Nab-Paclitaxel, Doxorubicin, Cyclophosphamid og Pegfilgrastim med eller uden Bevacizumab til behandling af kvinder med inflammatorisk eller lokalt fremskreden brystkræft

23. maj 2017 opdateret af: Southwest Oncology Group

Et randomiseret fase II-forsøg med ugentlig nanopartikelalbuminbundet paclitaxel (Nab-Paclitaxel) (NSC-736631) med eller uden bevacizumab, enten forud for eller efterfulgt af 2 ugers doxorubicin (A) og cyclophosphamid (C) plus pegfilgrastim (PEG-Gastim) ) som neoadjuverende terapi til inflammatorisk og lokalt avanceret HER-2/NEU negativ brystkræft

RATIONALE: Lægemidler brugt i kemoterapi, såsom paclitaxel albumin-stabiliseret nanopartikelformulering, doxorubicin og cyclophosphamid, virker på forskellige måder for at stoppe væksten af ​​tumorceller, enten ved at dræbe cellerne eller ved at stoppe dem i at dele sig. Kolonistimulerende faktorer, såsom pegfilgrastim, kan øge antallet af immunceller, der findes i knoglemarv eller perifert blod, og kan hjælpe immunsystemet med at komme sig efter bivirkningerne af kemoterapi. Monoklonale antistoffer, såsom bevacizumab, kan blokere tumorvækst på forskellige måder. Nogle finder tumorceller og dræber dem eller bærer tumordræbende stoffer til dem. Andre forstyrrer tumorcellernes evne til at vokse og sprede sig. Bevacizumab kan også stoppe væksten af ​​tumorceller ved at blokere blodtilførslen til tumoren. At give disse behandlinger før operationen kan gøre tumoren mindre og reducere mængden af ​​normalt væv, der skal fjernes. Det vides endnu ikke, hvilket behandlingsregime der er mere effektivt til behandling af kvinder med brystkræft.

FORMÅL: Dette randomiserede fase II-studie studerer paclitaxelalbumin-stabiliseret nanopartikelformulering, doxorubicin, cyclophosphamid og pegfilgrastim for at sammenligne, hvor godt de virker, når de gives med eller uden bevacizumab til behandling af kvinder med inflammatorisk eller lokalt fremskreden brystkræft.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

MÅL:

  • At sammenligne de patologiske fuldstændige responsrater hos kvinder med HER2/neu-negativ inflammatorisk eller lokalt fremskreden brystkræft behandlet med paclitaxel albumin-stabiliseret nanopartikelformulering, doxorubicin hydrochlorid, cyclophosphamid og pegfilgrastim med vs uden bevacizumab.
  • At sammenligne den samlede overlevelse af patienter behandlet med disse regimer.
  • At vurdere om der er en sammenhæng mellem bevacizumab og stratifikationsfaktorer (sygdomstype og hormonreceptorstatus).
  • For at sammenligne toksiciteten af ​​disse regimer.
  • At udforske de molekylære biomarkører relateret til biologien og resultatet af inflammatorisk brystkræft.
  • At udforske potentielle molekylære biomarkører, der forudsiger respons på terapi og lægemiddelfølsomhed.
  • At evaluere biomarkører med hensyn til sekvensen af ​​paclitaxelalbuminstabiliseret nanopartikelformulering og administration af doxorubicinhydrochlorid/cyclophosphamid/pegfilgrastim hos patienter, der ikke får bevacizumab.
  • At udforske den resterende kræftbyrde og korrelere den med resultatet.
  • For at evaluere tiden til behandlingsfejl før operation.
  • At evaluere sygdomsfri overlevelse fra operationstidspunktet hos patienter, der gennemgår endelig operation.

OVERSIGT: Dette er en multicenterundersøgelse. Patienterne er stratificeret efter sygdomstype (inflammatorisk vs lokalt fremskreden brystkræft) og hormonreceptorstatus (positiv [østrogenreceptor (ER)+ og/eller progesteronreceptor (PgR)+] vs negativ [ER- og PgR-]). Patienterne randomiseres til 1 ud af 3 behandlingsarme.

  • Arm I: Patienterne modtager paclitaxel albumin-stabiliseret nanopartikelformulering IV over 30 minutter på dag 1 og bevacizumab IV over 30- til 90 minutter på dag 1 i uge 1-12. Patienterne får derefter doxorubicinhydrochlorid IV og cyclophosphamid IV på dag 1 og pegfilgrastim SC på dag 2 i uge 14, 16, 18, 20, 22 og 24.
  • Arm II: Patienter modtager paclitaxel albumin-stabiliseret nanopartikelformulering IV over 30 minutter på dag 1 i uge 1-12. Patienterne får derefter doxorubicinhydrochlorid IV og cyclophosphamid IV på dag 1 og pegfilgrastim SC på dag 2 i uge 14, 16, 18, 20, 22 og 24.
  • Arm III: Patienterne får doxorubicinhydrochlorid IV og cyclophosphamid IV på dag 1 og pegfilgrastim SC på dag 2 i uge 1, 3, 5, 7, 9 og 11. Patienterne modtager derefter paclitaxel albumin-stabiliseret nanopartikelformulering IV over 30 minutter på dag 1 i uge 14-25.

I alle arme bliver patienter med stabil eller responderende sygdom opereret 3-6 uger efter afslutning af kemoterapi. Patienter kan derefter gennemgå strålebehandling 5 dage om ugen i 6 uger.

Serum-, fuldblods- og vævsprøver indsamles periodisk til henholdsvis biomarkøranalyse, cirkulerende endotelcelleanalyse og farmakogenomiske undersøgelser.

Efter afsluttet undersøgelsesbehandling følges patienterne hver 6. måned i 1 år og derefter årligt i 4 år.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

215

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Mobile, Alabama, Forenede Stater, 36608
        • Providence Cancer Center at Providence Hospital
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
    • California
      • Berkeley, California, Forenede Stater, 94704
        • Alta Bates Summit Comprehensive Cancer Center
      • Burbank, California, Forenede Stater, 91505
        • Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
      • Burlingame, California, Forenede Stater, 94010
        • Peninsula Medical Center
      • Castro Valley, California, Forenede Stater, 94546
        • East Bay Radiation Oncology Center
      • Castro Valley, California, Forenede Stater, 94546
        • Valley Medical Oncology Consultants - Castro Valley
      • Fremont, California, Forenede Stater, 94538
        • Valley Medical Oncology
      • Loma Linda, California, Forenede Stater, 92354
        • Loma Linda University Cancer Institute at Loma Linda University Medical Center
      • Long Beach, California, Forenede Stater, 90806
        • Breastlink Medical Group, Incorporated at Long Beach Memorial Medical Center
      • Los Angeles, California, Forenede Stater, 90089-9181
        • USC/Norris Comprehensive Cancer Center and Hospital
      • Los Angeles, California, Forenede Stater, 90048
        • Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
      • Martinez, California, Forenede Stater, 94553-3156
        • Contra Costa Regional Medical Center
      • Marysville, California, Forenede Stater, 95901
        • Tibotec Therapeutics - Division of Ortho Biotech Products, LP
      • Mountain View, California, Forenede Stater, 94040
        • El Camino Hospital Cancer Center
      • Novato, California, Forenede Stater, 94945
        • Sutter Health - Western Division Cancer Research Group
      • Oakland, California, Forenede Stater, 94609
        • Alta Bates Summit Medical Center - Summit Campus
      • Oakland, California, Forenede Stater, 94602
        • Highland General Hospital
      • Oakland, California, Forenede Stater, 94609
        • Larry G Strieff MD Medical Corporation
      • Oakland, California, Forenede Stater, 94609
        • CCOP - Bay Area Tumor Institute
      • Oakland, California, Forenede Stater, 94609
        • Bay Area Breast Surgeons, Incorporated
      • Oakland, California, Forenede Stater, 94609
        • Tom K Lee, Incorporated
      • Oakland, California, Forenede Stater, 94612
        • Epic Care - Oakland
      • Orange, California, Forenede Stater, 92868
        • St. Joseph Hospital Regional Cancer Center - Orange
      • Palm Springs, California, Forenede Stater, 92262
        • Desert Regional Medical Center Comprehensive Cancer Center
      • Pleasanton, California, Forenede Stater, 94588
        • Valley Medical Oncology Consultants - Pleasanton
      • Sacramento, California, Forenede Stater, 95817
        • University of California Davis Cancer Center
      • San Francisco, California, Forenede Stater, 94118
        • California Pacific Medical Center - California Campus
      • San Pablo, California, Forenede Stater, 94806
        • Doctors Medical Center - San Pablo Campus
      • Santa Rosa, California, Forenede Stater, 95403
        • Sutter Pacific Medical Foundation
      • Truckee, California, Forenede Stater, 96161
        • Tahoe Forest Cancer Center
      • Vallejo, California, Forenede Stater, 94589
        • Sutter Solano Medical Center
    • Colorado
      • Alamosa, Colorado, Forenede Stater, 81101
        • San Luis Valley Regional Medical Center
      • Aurora, Colorado, Forenede Stater, 80045
        • University of Colorado Cancer Center at UC Health Sciences Center
      • Colorado Springs, Colorado, Forenede Stater, 80909
        • Memorial Hospital Cancer Center - Colorado Springs
      • Edwards, Colorado, Forenede Stater, 81632
        • Shaw Regional Cancer Center
      • Glenwood Springs, Colorado, Forenede Stater, 81601
        • Valley View Hospital Cancer Center
      • Grand Junction, Colorado, Forenede Stater, 81502
        • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
      • Montrose, Colorado, Forenede Stater, 81401
        • Montrose Memorial Hospital Cancer Center
    • Connecticut
      • Hartford, Connecticut, Forenede Stater, 06105
        • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
    • Delaware
      • Lewes, Delaware, Forenede Stater, 19958
        • Tunnell Cancer Center at Beebe Medical Center
      • Newark, Delaware, Forenede Stater, 19713
        • CCOP - Christiana Care Health Services
    • Florida
      • Fort Lauderdale, Florida, Forenede Stater, 33308
        • Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
      • Jupiter, Florida, Forenede Stater, 33458
        • Ella Milbank Foshay Cancer Center at Jupiter Medical Center
      • Miami Beach, Florida, Forenede Stater, 33140
        • CCOP - Mount Sinai Medical Center
    • Georgia
      • Albany, Georgia, Forenede Stater, 31701
        • Phoebe Cancer Center at Phoebe Putney Memorial Hospital
      • Athens, Georgia, Forenede Stater, 30607
        • Northeast Georgia Cancer Care, LLC - Medical Oncology
      • Atlanta, Georgia, Forenede Stater, 30309
        • Piedmont Hospital
      • Atlanta, Georgia, Forenede Stater, 30342-1611
        • Northside Hospital Cancer Center
      • Atlanta, Georgia, Forenede Stater, 30342-1701
        • Saint Joseph's Hospital of Atlanta
      • Atlanta, Georgia, Forenede Stater, 30342
        • CCOP - Atlanta Regional
      • Augusta, Georgia, Forenede Stater, 30912
        • MBCCOP - Medical College of Georgia Cancer Center
      • Austell, Georgia, Forenede Stater, 30106
        • WellStar Cobb Hospital
      • Columbus, Georgia, Forenede Stater, 31904
        • John B. Amos Cancer Center
      • Decatur, Georgia, Forenede Stater, 30033
        • Charles B. Eberhart Cancer Center at DeKalb Medical Center
      • Fayetteville, Georgia, Forenede Stater, 30214
        • Piedmont Fayette Hospital
      • Gainesville, Georgia, Forenede Stater, 30501
        • Northeast Georgia Medical Center
      • Lawrenceville, Georgia, Forenede Stater, 30045
        • Gwinnett Medical Center
      • Marietta, Georgia, Forenede Stater, 30060
        • Kennestone Cancer Center at Wellstar Kennestone Hospital
      • Riverdale, Georgia, Forenede Stater, 30274-2600
        • Southern Regional Medical Center
      • Rome, Georgia, Forenede Stater, 30165
        • Harbin Clinic Cancer Center - Medical Oncology
      • 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
      • Honolulu, 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
        • Hawaii Medical Center - East
      • Honolulu, Hawaii, Forenede Stater, 96817
        • OnCare Hawaii, Incorporated - Kuakini
      • Kailua, Hawaii, Forenede Stater, 96734
        • Castle Medical Center
      • Lihue, Hawaii, Forenede Stater, 96766
        • Kauai Medical Clinic
      • Wailuku, Hawaii, Forenede Stater, 96793
        • Maui Memorial Medical Center
      • Wailuku, Hawaii, Forenede Stater, 96793
        • Pacific Cancer Institute - Maui
    • Idaho
      • Boise, Idaho, Forenede Stater, 83706
        • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
      • Lewiston, Idaho, Forenede Stater, 83501
        • St. Joseph Regional Medical Center
    • Illinois
      • Bloomington, Illinois, Forenede Stater, 61701
        • Illinois CancerCare - Bloomington
      • Bloomington, Illinois, Forenede Stater, 61701
        • St. Joseph Medical Center
      • Canton, Illinois, Forenede Stater, 61520
        • Illinois CancerCare - Canton
      • Canton, Illinois, Forenede Stater, 61520
        • Graham Hospital
      • Carthage, Illinois, Forenede Stater, 62321
        • Memorial Hospital
      • Carthage, Illinois, Forenede Stater, 62321
        • Illinois CancerCare - Carthage
      • Chicago, Illinois, Forenede Stater, 60637-1470
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, Forenede Stater, 60631
        • Resurrection Medical Center
      • Decatur, Illinois, Forenede Stater, 62526
        • Decatur Memorial Hospital Cancer Care Institute
      • Eureka, Illinois, Forenede Stater, 61530
        • Illinois CancerCare - Eureka
      • Eureka, Illinois, Forenede Stater, 61530
        • Eureka Community Hospital
      • Galesburg, Illinois, Forenede Stater, 61401
        • Illinois CancerCare - Galesburg
      • Galesburg, Illinois, Forenede Stater, 61401
        • Galesburg Clinic, PC
      • Havana, Illinois, Forenede Stater, 62644
        • Mason District Hospital
      • Havana, Illinois, Forenede Stater, 62644
        • Illinois CancerCare - Havana
      • Kewanee, Illinois, Forenede Stater, 61443
        • Illinois CancerCare - Kewanee Clinic
      • Macomb, Illinois, Forenede Stater, 61455
        • Illinois CancerCare - Macomb
      • Macomb, Illinois, Forenede Stater, 61455
        • Mcdonough District Hospital
      • Maywood, Illinois, Forenede Stater, 60153
        • Cardinal Bernardin Cancer Center at Loyola University Medical Center
      • Monmouth, Illinois, Forenede Stater, 61462
        • Illinois CancerCare - Monmouth
      • Monmouth, Illinois, Forenede Stater, 61462
        • OSF Holy Family Medical Center
      • Normal, Illinois, Forenede Stater, 61761
        • Bromenn Regional Medical Center
      • Normal, Illinois, Forenede Stater, 61761
        • Community Cancer Center
      • Normal, Illinois, Forenede Stater, 61761
        • Illinois CancerCare - Community Cancer Center
      • Ottawa, Illinois, Forenede Stater, 61350
        • Community Hospital of Ottawa
      • Ottawa, Illinois, Forenede Stater, 61350
        • Oncology Hematology Associates of Central Illinois, PC - Ottawa
      • Pekin, Illinois, Forenede Stater, 61554
        • Cancer Treatment Center at Pekin Hospital
      • Pekin, Illinois, Forenede Stater, 61603
        • Illinois CancerCare - Pekin
      • 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 CancerCare - Peru
      • Peru, Illinois, Forenede Stater, 61354
        • Illinois Valley Community Hospital
      • Princeton, Illinois, Forenede Stater, 61356
        • Perry Memorial Hospital
      • Princeton, Illinois, Forenede Stater, 61356
        • Illinois CancerCare - Princeton
      • Spring Valley, Illinois, Forenede Stater, 61362
        • Illinois CancerCare - Spring Valley
      • Springfield, Illinois, Forenede Stater, 62781-0001
        • Regional Cancer Center at Memorial Medical Center
    • Indiana
      • Beech Grove, Indiana, Forenede Stater, 46107
        • St. Francis Hospital and Health Centers - Beech Grove Campus
      • Fort Wayne, Indiana, Forenede Stater, 46845
        • Fort Wayne Medical Oncology and Hematology
      • Richmond, Indiana, Forenede Stater, 47374
        • Reid Hospital & Health Care Services
    • Iowa
      • Ames, Iowa, Forenede Stater, 50010
        • McFarland Clinic, PC
      • Sioux City, Iowa, Forenede Stater, 51101
        • Siouxland Hematology-Oncology Associates, LLP
      • Sioux City, Iowa, Forenede Stater, 51102
        • Mercy Medical Center - Sioux City
      • Sioux City, Iowa, Forenede Stater, 51104
        • St. Luke's Regional Medical Center
    • Kansas
      • Chanute, Kansas, Forenede Stater, 66720
        • Cancer Center of Kansas, PA - Chanute
      • Dodge City, Kansas, Forenede Stater, 67801
        • Cancer Center of Kansas, PA - Dodge City
      • El Dorado, Kansas, Forenede Stater, 67042
        • Cancer Center of Kansas, PA - El Dorado
      • Fort Scott, Kansas, Forenede Stater, 66701
        • Cancer Center of Kansas - Fort Scott
      • Independence, Kansas, Forenede Stater, 67301
        • Cancer Center of Kansas-Independence
      • Kingman, Kansas, Forenede Stater, 67068
        • Cancer Center of Kansas, PA - Kingman
      • Lawrence, Kansas, Forenede Stater, 66044
        • Lawrence Memorial Hospital
      • Liberal, Kansas, Forenede Stater, 67901
        • Cancer Center of Kansas, PA - Liberal
      • McPherson, Kansas, Forenede Stater, 67460
        • Cancer Center of Kansas, PA - McPherson
      • Newton, Kansas, Forenede Stater, 67114
        • Cancer Center of Kansas, PA - Newton
      • Overland Park, Kansas, Forenede Stater, 66209
        • Menorah Medical Center
      • Overland Park, Kansas, Forenede Stater, 66213
        • Saint Luke's Hospital - South
      • Parsons, Kansas, Forenede Stater, 67357
        • Cancer Center of Kansas, PA - Parsons
      • Prairie Village, Kansas, Forenede Stater, 66208
        • CCOP - Kansas City
      • Pratt, Kansas, Forenede Stater, 67124
        • Cancer Center of Kansas, PA - Pratt
      • Salina, Kansas, Forenede Stater, 67401
        • Cancer Center of Kansas, PA - Salina
      • Wellington, Kansas, Forenede Stater, 67152
        • Cancer Center of Kansas, PA - Wellington
      • Wichita, Kansas, Forenede Stater, 67208
        • Cancer Center of Kansas, PA - Medical Arts Tower
      • Wichita, Kansas, Forenede Stater, 67214
        • Cancer Center of Kansas, PA - Wichita
      • Wichita, Kansas, Forenede Stater, 67214
        • CCOP - Wichita
      • Wichita, Kansas, Forenede Stater, 67214
        • Via Christi Cancer Center at Via Christi Regional Medical Center
      • Wichita, Kansas, Forenede Stater, 67208
        • Associates in Womens Health, PA - North Review
      • Winfield, Kansas, Forenede Stater, 67156
        • Cancer Center of Kansas, PA - Winfield
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70809
        • Mary Bird Perkins Cancer Center - Baton Rouge
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21215
        • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
      • Baltimore, Maryland, Forenede Stater, 21204
        • Greater Baltimore Medical Center Cancer Center
      • Elkton, Maryland, Forenede Stater, 21921
        • Union Hospital of Cecil County
      • Salisbury, Maryland, Forenede Stater, 21801
        • Peninsula Regional Medical Center
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02118
        • Boston University Cancer Research Center
    • Michigan
      • Adrian, Michigan, Forenede Stater, 49221
        • Hickman Cancer Center at Bixby Medical Center
      • Ann Arbor, Michigan, Forenede Stater, 48109-0942
        • University of Michigan Comprehensive Cancer Center
      • Ann Arbor, Michigan, Forenede Stater, 48106-0995
        • Saint Joseph Mercy Cancer Center
      • Ann Arbor, Michigan, Forenede Stater, 48106
        • CCOP - Michigan Cancer Research Consortium
      • Bay City, Michigan, Forenede Stater, 48708
        • Bay Regional Medical Center
      • Dearborn, Michigan, Forenede Stater, 48123-2500
        • Oakwood Cancer Center at Oakwood Hospital and Medical Center
      • Detroit, Michigan, Forenede Stater, 48202
        • Josephine Ford Cancer Center at Henry Ford Hospital
      • Detroit, Michigan, Forenede Stater, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
      • Escanaba, Michigan, Forenede Stater, 49431
        • Green Bay Oncology, Limited - Escanaba
      • Flint, Michigan, Forenede Stater, 48503
        • Hurley Medical Center
      • Flint, Michigan, Forenede Stater, 48503
        • Genesys Hurley Cancer Institute
      • Flint, Michigan, Forenede Stater, 48532
        • McLaren Cancer Institute
      • Flint, Michigan, Forenede Stater, 48532
        • Singh and Arora Hematology Oncology, PC
      • Grand Blanc, Michigan, Forenede Stater, 48439
        • Genesys Regional Medical Center
      • Grosse Pointe Woods, Michigan, Forenede Stater, 48236
        • Van Elslander Cancer Center at St. John Hospital and Medical Center
      • Iron Mountain, Michigan, Forenede Stater, 49801
        • Dickinson County Healthcare System
      • Jackson, Michigan, Forenede Stater, 49201
        • Foote Memorial Hospital
      • Lansing, Michigan, Forenede Stater, 48912-1811
        • Sparrow Regional Cancer Center
      • Lapeer, Michigan, Forenede Stater, 48446
        • Great Lakes Cancer Institute - Lapeer Campus
      • Livonia, Michigan, Forenede Stater, 48154
        • St. Mary Mercy Hospital
      • Midland, Michigan, Forenede Stater, 48670
        • MidMichigan Medical Center - Midland
      • Monroe, Michigan, Forenede Stater, 48162
        • Mercy Memorial Hospital - Monroe
      • Mount Clemens, Michigan, Forenede Stater, 48043
        • Clemens Regional Medical Center
      • Petoskey, Michigan, Forenede Stater, 49770
        • Northern Michigan Hospital
      • Pontiac, Michigan, Forenede Stater, 48341-2985
        • St. Joseph Mercy Oakland
      • Port Huron, Michigan, Forenede Stater, 48060
        • Mercy Regional Cancer Center at Mercy Hospital
      • Saginaw, Michigan, Forenede Stater, 48601
        • Seton Cancer Institute at Saint Mary's - Saginaw
      • Southfield, Michigan, Forenede Stater, 48075
        • Providence Cancer Institute at Providence Hospital - Southfield Campus
      • Warren, Michigan, Forenede Stater, 48093
        • St. John Macomb Hospital
    • Minnesota
      • Burnsville, Minnesota, Forenede Stater, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, Forenede Stater, 55433
        • Mercy and Unity Cancer Center at Mercy Hospital
      • Edina, Minnesota, Forenede Stater, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, Forenede Stater, 55432
        • Mercy and Unity Cancer Center at Unity Hospital
      • Hutchinson, Minnesota, Forenede Stater, 55350
        • Hutchinson Area Health Care
      • Maplewood, Minnesota, Forenede Stater, 55109
        • HealthEast Cancer Care at St. John's Hospital
      • Maplewood, Minnesota, Forenede Stater, 55109
        • Minnesota Oncology - Maplewood
      • Minneapolis, Minnesota, Forenede Stater, 55407
        • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
      • Minneapolis, Minnesota, Forenede Stater, 55415
        • Hennepin County Medical Center - Minneapolis
      • New Ulm, Minnesota, Forenede Stater, 56073
        • New Ulm Medical Center
      • Robbinsdale, Minnesota, Forenede Stater, 55422-2900
        • Humphrey Cancer Center at North Memorial Outpatient Center
      • Saint Louis Park, Minnesota, Forenede Stater, 55416
        • CCOP - Metro-Minnesota
      • Saint Louis Park, Minnesota, Forenede Stater, 55416
        • Park Nicollet Cancer Center
      • Saint Paul, Minnesota, Forenede Stater, 55102
        • United Hospital
      • Saint Paul, Minnesota, Forenede Stater, 55101
        • Regions Hospital Cancer Care Center
      • Shakopee, Minnesota, Forenede Stater, 55379
        • St. Francis Cancer Center at St. Francis Medical Center
      • Stillwater, Minnesota, Forenede Stater, 55082
        • Lakeview Hospital
      • Waconia, Minnesota, Forenede Stater, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, Forenede Stater, 56201
        • Willmar Cancer Center at Rice Memorial Hospital
      • Woodbury, Minnesota, Forenede Stater, 55125
        • Minnesota Oncology - Woodbury
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39216
        • University of Mississippi Cancer Clinic
      • Pascagoula, Mississippi, Forenede Stater, 39581
        • Regional Cancer Center at Singing River Hospital
    • Missouri
      • Columbia, Missouri, Forenede Stater, 65203
        • Ellis Fischel Cancer Center at University of Missouri - Columbia
      • Joplin, Missouri, Forenede Stater, 64804
        • St. John's Regional Medical Center
      • Kansas City, Missouri, Forenede Stater, 64116
        • North Kansas City Hospital
      • Kansas City, Missouri, Forenede Stater, 64132
        • Research Medical Center
      • Kansas City, Missouri, Forenede Stater, 64111
        • Saint Luke's Cancer Institute at Saint Luke's Hospital
      • Kansas City, Missouri, Forenede Stater, 64118
        • Heartland Hematology Oncology Associates, Incorporated
      • Lee's Summit, Missouri, Forenede Stater, 64086
        • Saint Luke's East - Lee's Summit
      • Liberty, Missouri, Forenede Stater, 64068
        • Parvin Radiation Oncology
      • Rolla, Missouri, Forenede Stater, 65401
        • Phelps County Regional Medical Center
      • Saint Joseph, Missouri, Forenede Stater, 64506
        • Heartland Regional Medical Center
      • Saint Joseph, Missouri, Forenede Stater, 64507
        • Saint Joseph Oncology, Incorporated
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
      • Springfield, Missouri, Forenede Stater, 65802
        • CCOP - Cancer Research for the Ozarks
      • Springfield, Missouri, Forenede Stater, 65804
        • St. John's Regional Health Center
      • Springfield, Missouri, Forenede Stater, 65807
        • Hulston Cancer Center at Cox Medical Center South
    • Montana
      • Billings, Montana, Forenede Stater, 59101
        • CCOP - Montana Cancer Consortium
      • Billings, Montana, Forenede Stater, 59101
        • St. Vincent Healthcare Cancer Care Services
      • Billings, Montana, Forenede Stater, 59107-7000
        • Billings Clinic - Downtown
      • Billings, Montana, Forenede Stater, 59102
        • Hematology-Oncology Centers of the Northern Rockies - Billings
      • Bozeman, Montana, Forenede Stater, 59715
        • Bozeman Deaconess Cancer Center
      • Butte, Montana, Forenede Stater, 59701
        • St. James Healthcare Cancer Care
      • Great Falls, Montana, Forenede Stater, 59405
        • Great Falls Clinic - Main Facility
      • Great Falls, Montana, Forenede Stater, 59405-5309
        • Big Sky Oncology
      • Great Falls, Montana, Forenede Stater, 59405
        • Sletten Cancer Institute at Benefis Healthcare
      • Helena, Montana, Forenede Stater, 59601
        • St. Peter's Hospital
      • Kalispell, Montana, Forenede Stater, 59901
        • Kalispell Regional Medical Center
      • Kalispell, Montana, Forenede Stater, 59901
        • Glacier Oncology, PLLC
      • Kalispell, Montana, Forenede Stater, 59901
        • Kalispell Medical Oncology at KRMC
      • Missoula, Montana, Forenede Stater, 59807-7877
        • Montana Cancer Specialists at Montana Cancer Center
      • Missoula, Montana, Forenede Stater, 59807
        • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
    • New Jersey
      • Flemington, New Jersey, Forenede Stater, 08822
        • Hunterdon Regional Cancer Center at Hunterdon Medical Center
      • Voorhees, New Jersey, Forenede Stater, 08043
        • Cancer Institute of New Jersey at Cooper - Voorhees
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87131-5636
        • University of New Mexico Cancer Center
      • Albuquerque, New Mexico, Forenede Stater, 87110
        • Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital
      • Las Cruces, New Mexico, Forenede Stater, 88011
        • University of New Mexico Cancer Center - South
    • New York
      • Glens Falls, New York, Forenede Stater, 12801
        • Charles R. Wood Cancer Center at Glens Falls Hospital
      • Staten Island, New York, Forenede Stater, 10305
        • Nalitt Cancer Institute at Staten Island University Hospital
    • North Carolina
      • Goldsboro, North Carolina, Forenede Stater, 27534
        • Wayne Memorial Hospital, Incorporated
      • Kinston, North Carolina, Forenede Stater, 28501
        • Kinston Medical Specialists
      • Rutherfordton, North Carolina, Forenede Stater, 28139
        • Rutherford Hospital
      • Statesville, North Carolina, Forenede Stater, 28677
        • Iredell Memorial Hospital
    • Ohio
      • Akron, Ohio, Forenede Stater, 44309-2090
        • Summa Center for Cancer Care at Akron City Hospital
      • Barberton, Ohio, Forenede Stater, 44203
        • Barberton Citizens Hospital
      • Beachwood, Ohio, Forenede Stater, 44122
        • Cleveland Clinic Beachwood Family Health and Surgery Center
      • Chillicothe, Ohio, Forenede Stater, 45601
        • Adena Regional Medical Center
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland, Ohio, Forenede Stater, 44111
        • Cleveland Clinic Cancer Center at Fairview Hospital
      • Columbus, Ohio, Forenede Stater, 43214-3998
        • Riverside Methodist Hospital Cancer Care
      • Columbus, Ohio, Forenede Stater, 43222
        • Mount Carmel Health - West Hospital
      • Columbus, Ohio, Forenede Stater, 43215
        • CCOP - Columbus
      • Columbus, Ohio, Forenede Stater, 43215
        • Grant Medical Center Cancer Care
      • Columbus, Ohio, Forenede Stater, 43228
        • Doctors Hospital at Ohio Health
      • Dayton, Ohio, Forenede Stater, 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
      • Dayton, Ohio, Forenede Stater, 45420
        • CCOP - Dayton
      • Delaware, Ohio, Forenede Stater, 43015
        • Grady Memorial Hospital
      • Elyria, Ohio, Forenede Stater, 44035
        • Community Cancer Center
      • Elyria, Ohio, Forenede Stater, 44035
        • Hematology Oncology Center
      • Findlay, Ohio, Forenede Stater, 45840
        • Blanchard Valley Medical Associates
      • Franklin, Ohio, Forenede Stater, 45005-1066
        • Middletown Regional Hospital
      • Greenville, Ohio, Forenede Stater, 45331
        • Wayne Hospital
      • Independence, Ohio, Forenede Stater, 44131
        • Cleveland Clinic Cancer Center
      • Kettering, Ohio, Forenede Stater, 45429
        • Charles F. Kettering Memorial Hospital
      • Lancaster, Ohio, Forenede Stater, 43130
        • Fairfield Medical Center
      • Lima, Ohio, Forenede Stater, 45804
        • Lima Memorial Hospital
      • Marietta, Ohio, Forenede Stater, 45750
        • Strecker Cancer Center at Marietta Memorial Hospital
      • Maumee, Ohio, Forenede Stater, 43537-1839
        • Northwest Ohio Oncology Center
      • Mayfield Heights, Ohio, Forenede Stater, 44124
        • Hillcrest Cancer Center at Hillcrest Hospital
      • Mount Vernon, Ohio, Forenede Stater, 43050
        • Knox Community Hospital
      • Newark, Ohio, Forenede Stater, 43055
        • Licking Memorial Cancer Care Program at Licking Memorial Hospital
      • Oregon, Ohio, Forenede Stater, 43616
        • St. Charles Mercy Hospital
      • Parma, Ohio, Forenede Stater, 44129
        • Parma Community General Hospital
      • Portsmouth, Ohio, Forenede Stater, 45662
        • Southern Ohio Medical Center Cancer Center
      • Sandusky, Ohio, Forenede Stater, 44870
        • North Coast Cancer Care, Incorporated
      • Springfield, Ohio, Forenede Stater, 45505
        • Community Hospital of Springfield and Clark County
      • Strongsville, Ohio, Forenede Stater, 44136
        • Cleveland Clinic Foundation - Strongsville
      • Sylvania, Ohio, Forenede Stater, 43560
        • Flower Hospital Cancer Center
      • Tiffin, Ohio, Forenede Stater, 44883
        • Mercy Hospital of Tiffin
      • Toledo, Ohio, Forenede Stater, 43608
        • St. Vincent Mercy Medical Center
      • Toledo, Ohio, Forenede Stater, 43606
        • Toledo Hospital
      • Toledo, Ohio, Forenede Stater, 43614
        • Medical University of Ohio Cancer Center
      • Toledo, Ohio, Forenede Stater, 43617
        • CCOP - Toledo Community Hospital
      • Toledo, Ohio, Forenede Stater, 43623
        • Toledo Clinic, Incorporated - Main Clinic
      • Toledo, Ohio, Forenede Stater, 43623
        • St. Anne Mercy Hospital
      • Troy, Ohio, Forenede Stater, 45373-1300
        • UVMC Cancer Care Center at Upper Valley Medical Center
      • Wauseon, Ohio, Forenede Stater, 43567
        • Fulton County Health Center
      • Westerville, Ohio, Forenede Stater, 43081
        • Mount Carmel St. Ann's Cancer Center
      • Wooster, Ohio, Forenede Stater, 44691
        • Cleveland Clinic - Wooster
      • Xenia, Ohio, Forenede Stater, 45385
        • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
      • Zanesville, Ohio, Forenede Stater, 43701
        • Genesis - Good Samaritan Hospital
    • Oregon
      • Gresham, Oregon, Forenede Stater, 97030
        • Legacy Mount Hood Medical Center
      • Portland, Oregon, Forenede Stater, 97210
        • Legacy Good Samaritan Hospital & Comprehensive Cancer Center
      • Portland, Oregon, Forenede Stater, 97227
        • Legacy Emanuel Hospital and Health Center and Children's Hospital
      • Tualatin, Oregon, Forenede Stater, 97062
        • Legacy Meridian Park Hospital
    • Pennsylvania
      • Hershey, Pennsylvania, Forenede Stater, 17033-0850
        • Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
      • Lewistown, Pennsylvania, Forenede Stater, 17044
        • Lewistown Hospital
      • Pottstown, Pennsylvania, Forenede Stater, 19464
        • Pottstown Memorial Regional Cancer Center
      • State College, Pennsylvania, Forenede Stater, 16803
        • Mount Nittany Medical Center
    • South Carolina
      • Anderson, South Carolina, Forenede Stater, 29621
        • AnMed Cancer Center
      • Florence, South Carolina, Forenede Stater, 29501
        • McLeod Regional Medical Center
      • Greenville, South Carolina, Forenede Stater, 29601
        • Bon Secours St. Francis Health System
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • CCOP - Upstate Carolina
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
    • South Dakota
      • Rapid City, South Dakota, Forenede Stater, 57701
        • Rapid City Regional Hospital
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37403
        • Erlanger Cancer Center at Erlanger Hospital - Baroness
      • Kingsport, Tennessee, Forenede Stater, 37662
        • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
    • Texas
      • Laredo, Texas, Forenede Stater, 78045
        • Doctor's Hospital of Laredo
      • Temple, Texas, Forenede Stater, 76508
        • CCOP - Scott and White Hospital
    • Utah
      • American Fork, Utah, Forenede Stater, 84003
        • American Fork Hospital
      • Cedar City, Utah, Forenede Stater, 84720
        • Sandra L. Maxwell Cancer Center
      • Logan, Utah, Forenede Stater, 84321
        • Logan Regional Hospital
      • Murray, Utah, Forenede Stater, 84157
        • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
      • Ogden, Utah, Forenede Stater, 84403
        • Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
      • Provo, Utah, Forenede Stater, 84604
        • Utah Valley Regional Medical Center - Provo
      • Saint George, Utah, Forenede Stater, 84770
        • Dixie Regional Medical Center - East Campus
      • Salt Lake City, Utah, Forenede Stater, 84143
        • LDS Hospital
      • Salt Lake City, Utah, Forenede Stater, 84106
        • Utah Cancer Specialists at UCS Cancer Center
    • Virginia
      • Fredericksburg, Virginia, Forenede Stater, 22401
        • Fredericksburg Oncology, Incorporated
      • Norton, Virginia, Forenede Stater, 24273
        • Southwest Virginia Regional Cancer Center at Wellmonth Health
    • Washington
      • Anacortes, Washington, Forenede Stater, 98221
        • Island Hospital Cancer Care Center at Island Hospital
      • Bellevue, Washington, Forenede Stater, 98004
        • Overlake Cancer Center at Overlake Hospital Medical Center
      • Bellingham, Washington, Forenede Stater, 98225
        • St. Joseph Cancer Center
      • Bremerton, Washington, Forenede Stater, 98310
        • Olympic Hematology and Oncology
      • Burien, Washington, Forenede Stater, 98166
        • Highline Medical Center Cancer Center
      • Centralia, Washington, Forenede Stater, 98531-9027
        • Providence Centralia Hospital
      • Everett, Washington, Forenede Stater, 98201
        • Providence Regional Cancer Partnership
      • Federal Way, Washington, Forenede Stater, 98003
        • St. Francis Hospital
      • Issaquah, Washington, Forenede Stater, 98029
        • Swedish Medical Center - Issaquah Campus
      • Kennewick, Washington, Forenede Stater, 99336
        • Columbia Basin Hematology
      • Mount Vernon, Washington, Forenede Stater, 98274
        • Skagit Valley Hospital Cancer Care Center
      • Olympia, Washington, Forenede Stater, 98506-5166
        • Providence St. Peter Hospital Regional Cancer Center
      • Poulsbo, Washington, Forenede Stater, 98370
        • Harrison Poulsbo Hematology and Onocology
      • Puyallup, Washington, Forenede Stater, 98372
        • Good Samaritan Cancer Center
      • Seattle, Washington, Forenede Stater, 98109
        • Fred Hutchinson Cancer Research Center
      • Seattle, Washington, Forenede Stater, 98104
        • Harborview Medical 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, 98122
        • Polyclinic First Hill
      • Seattle, Washington, Forenede Stater, 98195
        • University Cancer Center at University of Washington Medical Center
      • Sedro-Woolley, Washington, Forenede Stater, 98284
        • North Puget Oncology at United General Hospital
      • Spokane, Washington, Forenede Stater, 99202
        • Cancer Care Northwest - Spokane South
      • Spokane, Washington, Forenede Stater, 99218
        • Evergreen Hematology and Oncology, PS
      • Spokane, Washington, Forenede Stater, 99204
        • Providence Cancer Center at Sacred Heart Medical Center
      • Tacoma, Washington, Forenede Stater, 98405-3004
        • Franciscan Cancer Center at St. Joseph Medical Center
      • Tacoma, Washington, Forenede Stater, 98405
        • Allenmore Hospital
      • Tacoma, Washington, Forenede Stater, 98405
        • CCOP - Northwest
      • Tacoma, Washington, Forenede Stater, 98405
        • MultiCare Regional Cancer Center at Tacoma General Hospital
      • Tacoma, Washington, Forenede Stater, 98499
        • St. Clare Hospital
      • Vancouver, Washington, Forenede Stater, 98686
        • Legacy Salmon Creek Medical Center
      • Wenatchee, Washington, Forenede Stater, 98801-2028
        • Wenatchee Valley Medical Center
    • Wisconsin
      • Green Bay, Wisconsin, Forenede Stater, 54307-3508
        • St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, Forenede Stater, 54301-3526
        • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, Forenede Stater, 54303
        • Green Bay Oncology, Limited at St. Mary's Hospital
      • Green Bay, Wisconsin, Forenede Stater, 54303
        • St. Mary's Hospital Medical Center - Green Bay
      • La Crosse, Wisconsin, Forenede Stater, 54601
        • Gundersen Lutheran Center for Cancer and Blood
      • Manitowoc, Wisconsin, Forenede Stater, 54221-1450
        • Holy Family Memorial Medical Center Cancer Care Center
      • Marinette, Wisconsin, Forenede Stater, 54143
        • Bay Area Cancer Care Center at Bay Area Medical Center
      • Oconto Falls, Wisconsin, Forenede Stater, 54154
        • Green Bay Oncology, Limited - Oconto Falls
      • Sheboygan, Wisconsin, Forenede Stater, 53081
        • St. Nicholas Hospital
      • Sturgeon Bay, Wisconsin, Forenede Stater, 54235
        • Green Bay Oncology, Limited - Sturgeon Bay
    • Wyoming
      • Casper, Wyoming, Forenede Stater, 82609
        • Rocky Mountain Oncology
  • Puerto Rico
      • San Juan, Puerto Rico, 00936
        • San Juan City Hospital

Deltagelseskriterier

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

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

SYGDOMS KARAKTERISTIKA:

  • Histologisk eller patologisk bekræftet brystkræft, der opfylder et af følgende kriterier:

    • Lokalt fremskreden sygdom (stadie IIIB sygdom, stadium IIB/IIIA eller stadium IIIC sygdom)

    • Inflammatorisk sygdom, der opfylder følgende to klinikopatologiske kriterier:

      • Diffust erytem OG ødem (peau d'orange) i brystet, der involverer størstedelen af ​​brystets hud, dvs. mere end 50 %
      • En biopsi, der viser kræft enten i den dermale lymfe ELLER i selve brystparenkymet

  • HER2/neu-negativ tumor som vist ved 0 eller 1+ (svag eller ingen farvning) ved DAKO, IHC eller tilsvarende test ELLER ingen genamplifikation med FISH*

    • 2+ af DAKO eller IHC tilladt forudsat FISH* negativ
  • BEMÆRK: *Et negativt FISH-testforhold er < 1,8 eller FISH HER2-genkopi < 4,0; hvis kun et positivt eller negativt resultat er tilgængeligt fra FISH-testen, er et negativt resultat acceptabelt for studieoptagelse
  • Hormonreceptorstatus kendt

PATIENT KARAKTERISTIKA:

  • Menopausal status ikke specificeret
  • Zubrod præstationsstatus 0-2
  • Granulocyttal > 1.500/mm^3
  • ANC ≥ 1.500/mm^3
  • Blodpladetal > 100.000/mm^3
  • Hæmoglobin 9,0 g/dL
  • Serumkreatinin ≤ 1,5 gange øvre normalgrænse (ULN)
  • Bilirubin ≤ 1,5 mg/dL
  • ALT og ASAT ≤ 3 gange ULN
  • Alkalisk fosfatase ≤ 2,5 ULN (medmindre knoglemetastaser er til stede i fravær af levermetastaser)
  • Urinprotein:kreatininforhold ≤ 0,5 ELLER urinprotein < 1.000 mg ved 24-timers urinopsamling
  • Ikke gravid eller ammende
  • Negativ graviditetstest
  • Fertile patienter skal bruge effektiv prævention
  • I stand til at tage oral medicin (fx ingen ukontrolleret kvalme, opkastning eller diarré, manglende fysisk integritet af den øvre mave-tarmkanal eller malabsorptionssyndrom)
  • QTc < 500 msek ved EKG
  • LVEF normal ved MUGA eller ECHO (til patienter med hypertension eller til patienter > 60 år)
  • NYHA klasse II hjertefunktion ved baseline ECHO/MUGA (til patienter, der har modtaget central thorax-strålebehandling, der inkluderede hjertet i strålebehandlingsporten, eller for patienter, der har en historie med klasse II-hjertesvigt, men er asymptomatiske under behandling, er berettigede)

  • Ingen anamnese med slagtilfælde (cerebrovaskulær ulykke), forbigående iskæmisk anfald eller hjertehændelse inden for de seneste 12 måneder, inklusive nogen af ​​følgende:

    • Myokardieinfarkt (inklusive svær/ustabil angina)
    • Koronar/perifer arterie bypass graft
    • Symptomatisk kongestiv hjertesvigt
    • Lungeemboli
  • Ingen dårligt kontrolleret hypertension, defineret som tilbagevendende eller vedvarende (≥ 24 timer) forhøjet blodtryk (dvs. systolisk blodtryk ≥ 140 mm Hg og/eller diastolisk blodtryk ≥ 90 mm Hg)
  • Ingen anden malignitet inden for de seneste 5 år bortset fra tilstrækkeligt behandlet basalcelle- eller pladecellehudkræft eller in situ livmoderhalskræft
  • Perifer neuropati < grad 2

FORUDSÆTNING SAMTYDLIG TERAPI:

  • Ingen tidligere tyrosinkinasehæmmere
  • Mere end 5 år siden tidligere kemoterapi, strålebehandling eller biologisk behandling (f.eks. trastuzumab eller bevacizumab) for invasiv brystkræft
  • Mindst 7 dage siden forudgående hormonbehandling
  • Mindst 7 dage siden tidligere og ingen samtidige stærke CYP3A4-hæmmere (f.eks. ketoconazol, itraconazol, clarithromycin, atazanavir, indinavir, nefazodon, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazol) eller grapefrugtjuice
  • Ingen samtidige CYP3A4-inducere (f.eks. dexamethason, phenytoin, carbamazepin, rifampin, rifabutin, rifapentin, phenobarbital, perikon)
  • Ingen anden samtidig behandling til behandling af brystkræft undtagen bisfosfonater
  • Ingen samtidig brachyterapi

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm 1
Patienter modtager paclitaxel albumin-stabiliseret nanopartikelformulering IV over 30 minutter på dag 1 og bevacizumab IV over 30- til 90 minutter på dag 1 i uge 1-12. Patienterne får derefter doxorubicinhydrochlorid IV og cyclophosphamid IV på dag 1 og pegfilgrastim SC på dag 2 i uge 14, 16, 18, 20, 22 og 24.
Biologisk: bevacizumab
Givet IV
Medicin: cyclophosphamid
Givet IV
Medicin: doxorubicin hydrochlorid
Givet IV
Medicin: paclitaxel albumin-stabiliseret nanopartikelformulering
Givet IV
Biologisk: pegfilgrastim
Gives subkutant
Aktiv komparator: Arm 2
Patienterne modtager paclitaxel albumin-stabiliseret nanopartikelformulering IV over 30 minutter på dag 1 i uge 1-12 og får derefter doxorubicin hydrochlorid IV og cyclophosphamid IV på dag 1 og pegfilgrastim SC på dag 2 i uge 14, 16, 18, 20, 22 og 24.
Medicin: cyclophosphamid
Givet IV
Medicin: doxorubicin hydrochlorid
Givet IV
Medicin: paclitaxel albumin-stabiliseret nanopartikelformulering
Givet IV
Biologisk: pegfilgrastim
Gives subkutant
Aktiv komparator: Arm 3
Patienterne får doxorubicin hydrochlorid IV og cyclophosphamid IV på dag 1 og pegfilgrastim SC på dag 2 i uge 1, 3, 5, 7, 9 og 11 og modtager derefter paclitaxel albumin-stabiliseret nanopartikelformulering IV over 30 minutter på dag 1 i ugen. 14-25.
Medicin: cyclophosphamid
Givet IV
Medicin: doxorubicin hydrochlorid
Givet IV
Medicin: paclitaxel albumin-stabiliseret nanopartikelformulering
Givet IV
Biologisk: pegfilgrastim
Gives subkutant

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Antal patienter med patologisk fuldstændig responsrate
Tidsramme: forundersøgelsespatologi vs. post-kemokirurgisk patologi (ca. 39-42 uger efter randomisering)
Patologisk komplet respons (pCR), almindeligvis defineret som fraværet af resterende invasiv cancer i både bryst- og aksillære lymfeknuder, er dukket op som et surrogat-endepunkt for sygdomsfri og samlet overlevelse, da opnåelse af en pCR er forbundet med en gunstig langsigtet prognose for alle undertyper af brystkræft.
forundersøgelsespatologi vs. post-kemokirurgisk patologi (ca. 39-42 uger efter randomisering)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Samlet overlevelse
Tidsramme: Sygdom vurderet hver 4. uge under behandling, derefter hver 6. måned i et år og derefter årligt i fire år fra registrering.
Tid fra registrering til død på grund af enhver årsag
Sygdom vurderet hver 4. uge under behandling, derefter hver 6. måned i et år og derefter årligt i fire år fra registrering.
Begivenhedsfri overlevelse
Tidsramme: Sygdom vurderet hver 4. uge under behandling, derefter hver 6. måned i et år derefter årligt i fire år fra registrering eller indtil tilbagevenden
Tid fra registrering til første tilfælde af en af ​​følgende hændelser: progression før operationen, recidiv efter operationen eller død af enhver årsag.
Sygdom vurderet hver 4. uge under behandling, derefter hver 6. måned i et år derefter årligt i fire år fra registrering eller indtil tilbagevenden
Antal uønskede hændelser, der er muligvis, sandsynligt eller bestemt relateret til undersøgelsesmedicin
Tidsramme: Op til 28 uger
Kun uønskede hændelser, der muligvis, sandsynligvis eller helt sikkert er relateret til undersøgelseslægemidlet, er rapporteret.
Op til 28 uger

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: Zeina Nahleh, MD, Barbara Ann Karmanos Cancer Institute

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. april 2010

Primær færdiggørelse (Faktiske)

1. oktober 2015

Studieafslutning (Faktiske)

1. december 2015

Datoer for studieregistrering

Først indsendt

4. marts 2009

Først indsendt, der opfyldte QC-kriterier

4. marts 2009

Først opslået (Skøn)

5. marts 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. juni 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. maj 2017

Sidst verificeret

1. maj 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CDR0000636131
  • U10CA032102 (U.S. NIH-bevilling/kontrakt)
  • S0800 (Anden identifikator: SWOG)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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 bevacizumab

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Ghana

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner