Et fase II-studie af neoadjuverende Trastuzumab+Docetaxel+NPLD+/-Bevacizumab i Her2-pos. Tidlig brystkræft (ABCSG 32)
12. maj 2014 opdateret af: Austrian Breast & Colorectal Cancer Study Group
Multicenter randomiseret fase II undersøgelse af neoadjuverende trastuzumab plus docetaxel med og uden bevacizumab og trastuzumab plus docetaxel plus ikke-pegyleret liposom-indkapslet doxorubicin (NPLD) med og uden bevacizumab i HER2-positiv tidlig brystkræft
Multicenter randomiseret fase II undersøgelse af neoadjuverende terapi i HER2 positiv tidlig brystkræft.
Det primære formål er at evaluere hjertetoksiciteten af den kombinerede behandling (trastuzumab, docetaxel, bevacizumab, NPLD) sammenlignet med standardbehandlingen.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
Målundersøgelsespopulationen består af mandlige og kvindelige præ- og postmenopausale patienter med HER2-positivt adenokarcinom i brystet (undtagen inflammatorisk brystkræft, T4d), der er planlagt til at modtage neoadjuverende cytotoksisk behandling.
Patienter skal have patologisk bekræftet brystkræft med histologisk bekræftet HER2-overekspression. Ved screening skal patienter have en tilstrækkelig venstre ventrikel ejektionsfraktion (LVEF); en ECOG-ydelsesstatus på 0 eller 1; tilstrækkelig lever-, nyre- og knoglemarvsfunktion; og være fri for andre alvorlige sygdomme, der kan påvirke protokoloverholdelse eller fortolkning af resultater.
Patienter bør ikke have øget risiko for GI-perforation, hypertension, proteinuri, sårhelingskomplikationer, tromboemboli eller blødning. Patienter må ikke have haft en anden primær malignitet, der kunne påvirke overholdelse af protokollen eller fortolkning af resultater. Patienter med metastaser i centralnervesystemet (CNS) er udelukket. Drægtige eller ammende kvinder er udelukket. Patienter med hypertension (>150 mmHG systolisk eller >100 mmHG diastolisk) og patienter med en anamnese med GI-perforation, abdominal fistel eller intraabdominal absces inden for 6 måneder efter undersøgelsens start er udelukket.
Fuld antikoagulationsbehandling ved studiestart er tilladt, så længe patienten har været på et stabilt niveau af antikoagulantia i mindst 2 uger på tidspunktet for studiebehandlingens start.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
100
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Salzburg, Østrig, 5020
- Paracelsus Medical University Salzburg-Oncology, Coop. Group
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Vienna, Østrig, 1090
- Medical University Vienna, General Hospital
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Vienna, Østrig, 1130
- State Hospital Vienna-Hietzing
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Vienna, Østrig, 1090
- Med. Univ. Vienna; General Hospital Vienna
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Styria
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Graz, Styria, Østrig, 8036
- Medical University of Graz-Oncology; Coop. Group
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Leoben, Styria, Østrig, 8700
- State Hospital Leoben
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Tyrol
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Innsbruck, Tyrol, Østrig, 6020
- Gynaegological Medical University Innsbruck
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Kufstein, Tyrol, Østrig, 6330
- District Hospital Kufstein
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Upper Austria
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Linz, Upper Austria, Østrig, 4010
- Hospital BHS Linz, Coop. Study Group
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Linz, Upper Austria, Østrig, 4020
- AKH Linz
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Vorarlberg
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Feldkirch, Vorarlberg, Østrig, 6807
- State Hospital Feldkirch, Coop. Group
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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
Alle
Beskrivelse
Inklusionskriterier:
- Kvinde eller mand, alder ≥ 18 år
- Patologisk bekræftet invasivt primært brystadenokarcinom (undtagen inflammatorisk brystkræft, T4d) planlagt til taxanholdig neoadjuverende systemisk behandling med/uden palpable lymfeknuder.
- Dokumenteret HER2-proteinoverekspression som bestemt ved immunhistokemi (IHC) 3+ eller ved demonstreret HER2/c-erbB2-genamplifikation af den primære tumor af et lokalt laboratorium.
- LVEF ≥ 55 % målt ved ekkokardiografi eller MUGA inden for 4 uger før randomisering
- ECOG Performance Status ≤ 1
- Kan og er villig til at overholde planlagte besøg, behandlingsplaner, laboratorietests og andre undersøgelsesprocedurer.
- Skriftligt informeret samtykke
Ekskluderingskriterier:
Nuværende behandling
- Krav om samtidig brug af det antivirale middel sorivudin eller kemisk beslægtede analoger, såsom brivudin.
- Kronisk daglig behandling med kortikosteroider ekskl. inhalerede steroider.
- Kronisk daglig behandling med aspirin og aspirinanaloger eller clopidogrel
- Større kirurgisk indgreb, åben biopsi eller betydelig traumatisk skade inden for 28 dage før randomisering eller forventning om behov for større operation under studiebehandlingsforløbet
- Aktuel eller nylig (inden for 30 dage før randomisering) behandling med et andet forsøgslægemiddel eller deltagelse i et andet forsøgsstudie.
Laboratorium
- Utilstrækkelig knoglemarvsfunktion
- Utilstrækkelig leverfunktion
- Utilstrækkelig nyrefunktion
- Patienter, der ikke får antikoagulerende medicin, og som har aktiveret partiel tromboplastintid (aPTT) inden for 7 dage før dag 1 i cyklus 1.
Samtidige forhold
- Anden malignitet inden for de sidste 5 år før randomisering undtagen kurativt behandlet carcinom in situ i livmoderhalsen eller ikke-melanomatøs hudkræft
- Bevis for fjernmetastaser bedømt klinisk og i det mindste ved røntgen af thorax, lever-sonografi og knoglescanning. Hvis der er klinisk mistanke om hjernemetastaser, skal en CT-scanning eller MR af hjernen udføres inden for 4 uger før randomisering.
Alvorlig samtidig sygdom, som kan påvirke overholdelse af protokollen eller fortolkning af resultater, herunder, men ikke begrænset til:
- Aktiv infektion, der kræver i.v. antibiotika
- Ukontrolleret hypertension
- Klinisk signifikant anamnese med kardiovaskulær sygdom som angivet ved: cerebrovaskulær ulykke eller slagtilfælde; myokardieinfarkt; ustabil angina; NYHA Grade II eller højere CHF; hjertearytmi, der kræver medicin; klinisk signifikant hjerteklapsygdom.
- Dyspnø i hvile nødvendiggør understøttende iltbehandling eller med betydelige pleurale effusioner
- Dårligt kontrolleret diabetes mellitus
- Anamnese eller bevis efter fysisk/neurologisk undersøgelse af CNS-sygdom, der ikke er relateret til kræft (f. ukontrollerede anfald), medmindre de behandles tilstrækkeligt med standard medicinsk behandling
- Anamnese eller tegn på arvelig blødende diatese eller koagulopati med risiko for blødning
- Anamnese med abdominal fistel, GI-perforation eller intraabdominal abscess inden for 6 måneder efter randomisering
- Alvorligt ikke-helende sår, mavesår eller knoglebrud
- Klinisk signifikant malabsorptionssyndrom, colitis ulcerosa, sygdom, der påvirker GI-funktionen, resektion af mave eller tyndtarm eller manglende evne til at tage oral medicin
- Ukorrigeret hypokaliæmi eller hypomagnesæmi
- Organallotransplantater, der kræver immunsuppressiv terapi
- Beviser for enhver anden sygdom, metabolisk eller psykologisk dysfunktion, fysisk undersøgelsesfund eller klinisk laboratoriefund, der giver rimelig mistanke om en sygdom eller tilstand, der kontraindikerer brugen af et forsøgslægemiddel, kan påvirke patientens overholdelse af undersøgelsesrutiner eller placere patienten højt risiko for behandlingsrelaterede komplikationer.
- Kendt overfølsomhed over for nogen af undersøgelsens lægemidler/hjælpestoffer.
- Overfølsomhed over for ovariecelleprodukter fra kinesisk hamster eller andre rekombinante humane eller humaniserede antistoffer.
Andet
- Gravide, ammende kvinder eller kvinder i den fødedygtige alder uden negativ graviditetstest
- Fertile hanner eller hunner i den fødedygtige alder
- Patienter, der ikke er tilgængelige for behandling eller opfølgning
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 |
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Andet: A: Trastuzumab+Docetaxel
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6 cyklusser - Dag1 (Dag22 = Dag1): Trastuzumab: 8 mg/kg ladningsdosis (1. cyklus) i.v.; 6 mg/kg vedligeholdelsesdosis i efterfølgende cyklusser i.v. Docetaxel: 100 mg/m2 ved 60 min i.v. infusion
Andre navne:
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Eksperimentel: B: Trastuzumab+Docetaxel+Bevacizumab
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6 cyklusser - Dag1 (Dag22 = Dag1): Trastuzumab: 8 mg/kg ladningsdosis (1. cyklus) i.v.; 6 mg/kg vedligeholdelsesdosis i efterfølgende cyklusser i.v. Docetaxel: 100 mg/m2 ved 60 min i.v. infusion Bevacizumab 15 mg/kg
Andre navne:
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Eksperimentel: C: Trastuzumab+Docetaxel+NPLD
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6 cyklusser - Dag1 (Dag22=Dag1): Trastuzumab: 8 mg/kg ladningsdosis (1. cyklus) i.v.; 6 mg/kg vedligeholdelsesdosis i efterfølgende cyklusser i.v. Docetaxel: 75 mg/m2 gange 60 min IV infusion NPLD 50 mg/m2 gange 60 min i.v. infusion
Andre navne:
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Eksperimentel: D: Trastuzumab+Docetaxel+NPLD+Bevacizumab
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6 cyklusser - Dag1 (Dag22= Dag1): Trastuzumab: 8 mg/kg ladningsdosis (1. cyklus) i.v.; 6 mg/kg vedligeholdelsesdosis i efterfølgende cyklusser i.v. Docetaxel: 75 mg/m2 ved 60 min i.v. infusion NPLD: 50 mg/m2 ved 60 min i.v. infusion; Bevacizumab 15 mg/kg
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Hjertetoksicitet
Tidsramme: mellem dag 1 i cyklus 1 og dag 28 efter dagen for den sidste operation
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for at evaluere hjertetoksiciteten af kombinationen trastuzumab+docetaxel+bevacizumab og trastuzumab+docetaxel+NPLD +/- bevacizumab sammenlignet med standardbehandlingen, trastuzumab+docetaxel ved brug af et sammensat endepunkt, der fremkommer mellem dag 1 i cyklus 1 og dag 28 efter dagen af den sidste operation.
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mellem dag 1 i cyklus 1 og dag 28 efter dagen for den sidste operation
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Patologisk komplet respons (ypCR)
Tidsramme: op til 22 uger
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ypCR defineret som fravær af invasiv tumor på tidspunktet for den sidste operation
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op til 22 uger
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Total patologisk komplet respons (ytpCR)
Tidsramme: op til 22 uger
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ytpCR defineret som fravær af invasive tumor- og tumorceller i brystet og de aksillære lymfeknuder (ypT0 eller yDCIS og ypN=0)
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op til 22 uger
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Samlet klinisk responsrate (cORR)
Tidsramme: op til 22 uger
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cORR defineret som procentdelen af patienter med enten et komplet klinisk respons (cCR) eller et partielt klinisk respons (cPR), men ingen ypCR
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op til 22 uger
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Sikkerhedsevaluering i henhold til patientantallet af AE'er, SAE'er, abnormiteter i laboratorietest, hjertevurdering, klinisk evaluering
Tidsramme: op til 22 uger
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Sikkerhed (AE'er, SAE'er, abnormiteter i laboratorietest, hjertevurdering, klinisk evaluering) af kombinationen trastuzumab og docetaxel med bevacizumab og trastuzumab, docetaxel og NPLD plus/minus bevacizumab på tidspunktet for den sidste operation
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op til 22 uger
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Guenther Steger, MD, Austrian Breast & Colorectal Cancer Study Group
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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Hjælpsomme links
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. juni 2011
Primær færdiggørelse (Faktiske)
1. april 2014
Studieafslutning (Faktiske)
1. april 2014
Datoer for studieregistrering
Først indsendt
31. maj 2011
Først indsendt, der opfyldte QC-kriterier
3. juni 2011
Først opslået (Skøn)
6. juni 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
13. maj 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. maj 2014
Sidst verificeret
1. maj 2014
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Hudsygdomme
- Neoplasmer
- Neoplasmer efter sted
- Brystsygdomme
- Brystneoplasmer
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antineoplastiske midler, immunologiske
- Angiogenese-hæmmere
- Angiogenesemodulerende midler
- Vækststoffer
- Væksthæmmere
- Docetaxel
- Trastuzumab
- Bevacizumab
Andre undersøgelses-id-numre
- ABCSG 32
- 2010-023324-25 (EudraCT nummer)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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