DK3055429T3 - Fremgangsmåde til prognose og behandling af metastaserende cancer i knoglerne, som hidrører fra brystcancer - Google Patents

Fremgangsmåde til prognose og behandling af metastaserende cancer i knoglerne, som hidrører fra brystcancer Download PDF

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DK3055429T3
DK3055429T3 DK14824529.3T DK14824529T DK3055429T3 DK 3055429 T3 DK3055429 T3 DK 3055429T3 DK 14824529 T DK14824529 T DK 14824529T DK 3055429 T3 DK3055429 T3 DK 3055429T3
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maf
inhibitor
breast cancer
gene
amplification
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Roger Gomis
Evarist Planet
Milica Pavlovic
Anna Arnal
Maria Tarragona
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Fundacio Inst De Recerca Biomedica Irb Barcelona
Inst Catalana Recerca Estudis Avancats
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Claims (12)

1. In wfro-fremgangsmåde til forudsigelse af risikoen for knoglemetastase af en HER2+ brystcancer og/eller det kliniske resultat af en HER2+ brystcancer hos et individ, der har denne cancer, hvilken fremgangsmåde omfatter i) at bestemme amplifikationen eller kopiantallet af MAF-genet i en HER2+ brystcancerprøve fra individet og ii) at sammenligne amplifikationen eller kopiantallet opnået i trin i) med en referenceværdi, hvor øget kopiantal eller grad af amplifikation af genet med hensyn til referenceværdien indikerer øget risiko for at udvikle knoglemetastaser og/eller et dårligt klinisk resultat.
2. In vitro-fremgangsmåde til udformning af en individuelt tilpasset terapi til et individ, der har HER2+ brystcancer, hvilken fremgangsmåde omfatter: i) at bestemme MAF-genamplifikationen eller kopiantallet i en FIER2+ brystcancerprøve fra individet og ii) at sammenligne amplifikationen eller kopiantallet opnået i trin i) med en referenceværdi, hvor, hvis kopiantallet eller graden af amplifikation øges i forhold til referenceværdien, så er individet modtagelig for en terapi, der har til formål at forebygge eller behandle knoglemetastase, og/eller en terapi, der har til formål at undgå og/eller forebygge knoglenedbrydning, hvor, hvis kopiantallet eller graden af amplifikation ikke øges i forhold til en referenceværdi, så er individet ikke modtagelig for en terapi, der har til formål at forebygge og/eller behandle knoglemetastase og/eller en terapi, der har til formål at undgå og/eller behandle knoglenedbrydning.
3. In wfro-fremgangsmåde til forudsigelse af risikoen for knoglemetastase ifølge krav 1, hvor et kopiantal eller en grad af amplifikation af genet over den gennemsnitlige værdi plus en standardafvigelse indikereren øget risiko for tidlig knoglemetastase.
4. Fremgangsmåde ifølge krav 2, hvor terapien til undgåelse eller forebyggelse af knoglenedbrydning er udvalgt fra gruppen bestående af et biphosphonat, en RANKL-inhibitor, en PTH-inhibitor, en PTHLH-inhibitor, en PRG-analog, stron-tiumranelat, en DKK-1 -inhibitor, en dobbelt-inhibitor af MET og VEGFR2, en østrogenreceptormodulator, calcitonin, radium-223 og en cathepsin K-inhibi-tor, og/eller terapien til forebyggelse eller behandling af metastase er udvalgt fra gruppen bestående af: et c-MAF-hæmmende middel, systemiske behandlinger, herunder, men ikke begrænset til: kemoterapi, hormonbehandling, im-minterapi, stråleterapi, kirurgi, en mTor-inhibitor, en Src-kinase-inhibitor, en CCR5-antagonist, en COX-2-inhibitor og alpharadin.
5. Fremgangsmåde ifølge krav 4, hvor RANKL-inhibitoren er udvalgt fra gruppen bestående af et RANKL-specifikt antistof, et RANKL-specifikt nanobody, osteoprotegerin, bisphosphonat-zoledronsyre og dobbelt-inhibitoren cabozantinib af MET og VEGFR2.
6. Fremgangsmåde ifølge et hvilket som helst af kravene 1 til 5, hvor det at bestemme MAF-amplifikationen eller kopiantallet omfatter at kvantificering af kopiantallet eller amplifikation af protein, der kodes af genet eller af en variant deraf, hvor kopiantallet eller amplifikationen af protein kvantificeres ved hjælp af western blot, ELISA, FISH, immunhistokemi eller protein-array eller kvantificering af messenger-RNA'en (mRNA) af genet eller et fragment af mRNA'en, den komplementære DNA (cDNA) af genet eller et fragment af cDNA'en.
7. In wtro-fremgangsmåde til forudsigelse af risikoen for knoglemetastase og/eller forudsigelse af det kliniske resultat af en HER2+ brystcancer ifølge krav 1, omfattende at bestemme, om MAF-genet er amplificeret i HER2+ brystcancerprøven fra individet i forhold til et reference-gen kopiantal, hvor en amplifikation af MAF-genet i forhold til reference-genkopiantallet indikerer en øget risiko for at udvikle knoglemetastase og/eller et dårligt klinisk resultat.
8. Middel, der er i stand til at forhindre eller forebygge knoglenedbrydning, til anvendelse til forebyggelse, inhibering eller behandling af knoglemetastase fra HER2+ brystcancer eller forhindre eller forebygge knoglenedbrydning ved HER2+ brystcancer hos et individ, der er blevet identificeret som havende en amplifikation af MAF-genet eller et øget kopiantal i forhold til en referenceværdi, hvor midlet, der er i stand til at forhindre eller forebygge knoglenedbryd ning, er udvalgt fra gruppen bestående af et bisphosphonat, en RANKL-inhibi-tor, en PTH- eller PTHLH-inhibitor, herunder blokerende antistoffer eller re-kombinante former deraf, en PRG-analog, strontiumranelat, en DKK-1-inhibitor, en dobbelt-inhibitor af MET og VEGFR2, en østrogenreceptormodulator, calcitonin, en cathepsin K-inhibitorog alpharadin.
9. Middel, der er i stand til at forhindre eller forebygge knoglenedbrydning, til anvendelse til behandling, inhibering eller forebyggelse af knoglemetastase fra HER2+ brystcancer eller knoglenedbrydning ifølge krav 8, hvor midlet er udvalgt fra gruppen bestående af et bisphosphonat, en RANKL-inhibitor, en PTH-inhibitor en PTHLH-inhibitor eller en PRG-analog, strontiumranelat, en DKK- 1-inhibitor, en dobbelt-inhibitor af MET og VEGFR2, en østrogenreceptormodulator, calcitonin, radium-223 og en cathepsin K-inhibitor.
10. Middel, der er i stand til at forhindre eller forebygge knoglenedbrydning til anvendelse til behandling, inhibering eller forebyggelse af knoglemetastase fra HER2+ brystcancer eller knoglenedbrydning ifølge krav 9, hvor RANKL-inhibi-toren er udvalgt fra gruppen af et RANKL-specifikt antistof, et RANKL-specifikt nanobody, osteoprotegerin, bisphosphonat-zoledronsyre og dobbelt-inhibito-ren cabozantinib af MET og VEGFR2.
11. In vitro-fremgangsmåde til typebestemmelse af en prøve fra et individ, der lider af HER2+ brystcancer, hvilken fremgangsmåde omfatter: (a) at tilvejebringe en HER2+ brystcancerprøve fra individet; (b) at kvantificere amplifikationen eller kopiantallet af MAF i prøven; (c) at typebestemme prøven ved at sammenligne den kvantificerede amplifi-kation eller kopiantallet af MAF med et forudbestemt referenceniveau af MAF; hvor typebestemmelsen tilvejebringer prognostisk information i relation til risikoen for knoglemetastase hos individet.
12. Fremgangsmåde til klassificering af et individ, der har HER2+ brystcancer, i en kohorte, omfattende: a) at bestemme amplifikationen eller kopiantallet af MAF i en HER2+ brystcancerprøve fra individet; b) at sammenligne amplifikationen eller kopiantallet af MAF i prøven med et forudbestemt referenceniveau af MAF; og c) at klassificere individet i en kohorte på basis af amplifikationen eller kopiantallet af MAF i prøven.
DK14824529.3T 2013-10-09 2014-10-07 Fremgangsmåde til prognose og behandling af metastaserende cancer i knoglerne, som hidrører fra brystcancer DK3055429T3 (da)

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EP3055429B1 (en) 2019-03-27
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MX2016004557A (es) 2016-07-22
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CN105980576A (zh) 2016-09-28
BR112016007864A2 (pt) 2017-12-05
KR20160061424A (ko) 2016-05-31
AU2014333513A1 (en) 2016-04-28
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