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Clinical Trials/EUCTR2008-007951-29-DK
EUCTR2008-007951-29-DK
Active, not recruiting
Not Applicable

Et fase II forsøg af neoadjuverende behandling med pegyleret liposomal doxorubicin (Caelyx®) og cyklofosfamid +/- trastuzumab med efterfølgende docetaxel til patienter med primær inoperabel og lokoregional avanceret cancer mammae (LABC). - Et videnskabeligt forsøg med kombinations kemoterapi før operation til patienter med brystkræft.

Herlev Hospital, Onkologisk Afd. R0 sitesJanuary 22, 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Herlev Hospital, Onkologisk Afd. R
Status
Active, not recruiting
Last Updated
14 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 22, 2009
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
Herlev Hospital, Onkologisk Afd. R

Eligibility Criteria

Inclusion Criteria

  • ?Histologisk/cytologisk verificeret primær cancer mammae hos kvinder.
  • ?Primær tumor \> 50 mm (T3\-4,Nx,M0\) eller inoperabel lokoregional avanceret sygdom (Tx,N2\-3,M0\).
  • ?Alder mellem 18 og 75 år.
  • ?WHO Performance Status \= 2\.
  • ?Forventet levetid mere end 3 måneder.
  • ?Målbar (primærtumor(er) eller lymfeknudemetastaser) eller ikke\-målbar sygdom (inflammatorisk cancer mammae) i henhold til RECIST kriterier
  • ?”Adækvat” knoglemarvsfunktion defineret som:
  • oleukocytter \= 3,0 x 109/L
  • oneutrofile \= 1,5 x 109/L,
  • othrombocytter \= 100 x 109/L

Exclusion Criteria

  • ?Anden malign sygdom i anamnesen (patienter som har været sygdomsfri i mindst 5 år eller patienter med basalcellekarcinom i hud eller karcinoma in situ cervix uteri i anamnesen indenfor de sidste 5 år kan dog indgå).
  • ?Behandling med et ikke\-godkendt lægemiddel eller en forsøgsmedicin inden for 30 dage før opstart af forsøgsbehandling.
  • ?Samtidig behandling med anden forsøgsmedicin.
  • ?Enhver evidens, i henhold til investigators bedømmelse, for svær eller ukontrolleret systemisk sygdom eller et signifikant laboratoriefund der gør det uønskeligt for patienten at deltage i forsøget.
  • ?Psykiske, familiære, sociale eller geografiske tilstande, som hindrer protokolcompliance.
  • ?Gravide eller ammende kvinder. Der skal foreligge negativ graviditetstest umiddelbart inden behandlingsstart for fertile kvinder.

Outcomes

Primary Outcomes

Not specified

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