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A Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects With HER2 Negative Metastatic Breast Cancer

12. september 2013 opdateret af: Astellas Pharma Inc

A Phase II, Multicenter, Open-Label, Randomized Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects With HER2 Negative Metastatic Breast Cancer

The purpose of this study is to evaluate survival, response rate, safety and tolerability of YM155 given in combination with docetaxel as first-line treatment in subjects with human epidermal growth factor 2 non-overexpressing (HER2 negative) metastatic breast cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is an outpatient study. All subjects enrolled in this study will receive a combined regimen of YM155 and docetaxel or docetaxel alone given during 21 day cycles. Each subject will be assessed at the end of each cycle to determine if the subject can continue to the next cycle. Each subject assigned to receive YM155 in combination with docetaxel will be eligible to continue receiving the combination regimen in this study until one of the discontinuation criteria is met.

If a subject discontinues treatment with at least stable disease (SD) that subject will complete follow-up visits every 12 weeks for 2 years or until initiating another systemic anti-breast cancer treatment, exhibiting progressive disease (PD), or death.

Each subject will be contacted by the study site every 12 weeks for survival following the End of Treatment Visit. The contacts will continue until death or for no more than 2 years.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

101

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Belgien
      • Brussels, Belgien, 1000
        • Institut Jules Bordet - Medical Oncology and Translational Research
      • Charleroi, Belgien, 6000
        • Grand Hopital de Charleroi - Site Notre Dame
      • Wilrijk, Belgien, 2610
        • Sint-Augustinus GZA Ziekenhuizen
  • Den Russiske Føderation
      • Chelyabinsk, Den Russiske Føderation, 454076
        • State Therapeutic and Prophylactic Institution Chelyabinsk Regional Clinical Oncology Dispensary
      • Kursk, Den Russiske Føderation, 305035
        • State Healthcare institution "Kursk Regional Oncology Dispensary" of Kursk Region Healthcare committee GUZ "KOOD"
      • Moscow, Den Russiske Føderation, 115478
        • Institution of Russian Academy of Medical Sciences Russian Oncology Research Centre
      • Pyatigorsk, Den Russiske Føderation, 357500
        • Pyatigorsk Oncology Dispensary
      • Saint Petersburg, Den Russiske Føderation, 189646
        • Scientific-Research Institute of Oncology named after Petrov
      • Saint Petersburg, Den Russiske Føderation, 197022
        • Saint-Petersburg State Medical University named after Pavlov
      • Samara, Den Russiske Føderation, 443031
        • State Healthcare Institution "Samara Regional Clinical Oncology Dispensary"
      • Tula, Den Russiske Føderation, 300053
        • Tula Regional Dispensary
  • Det Forenede Kongerige
      • Nottingham, Det Forenede Kongerige, NG5 1PB
        • Nottingham University Hospital
  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90057
        • Kenmar Research Institute
      • Pleasant Hill, California, Forenede Stater, 94523
        • Bay Area Cancer Research Group
    • Florida
      • Lakeland, Florida, Forenede Stater, 33805
        • Lakeland Regional Cancer Center
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48201
        • Karmanos Cancer Institute
    • Montana
      • Missoula, Montana, Forenede Stater, 59802
        • Montana Cancer Institute Foundation c/o Montana Cancer Specialists
    • North Carolina
      • Hickory, North Carolina, Forenede Stater, 28602
        • Carolina Oncology Specialists, PA
    • Ohio
      • Canton, Ohio, Forenede Stater, 44718
        • Gabrail Cancer Center
  • Irland
      • Dublin, Irland, 8
        • St. James Hospital
      • Dublin, Irland, 4
        • St. Vincent's University Hospital
      • Dublin, Irland, 9
        • Department of Medical Oncology
  • Polen
      • Warsaw, Polen, 02-781
        • Centrum Onkologii-Instytut im.
      • Wroclaw, Polen, 51-124
        • Wojewodzki Szpital
  • Tjekkiet
      • Prague, Tjekkiet, 180 81
        • Faculty hospital Na Bulovce
      • Prague 10, Tjekkiet, 100 34
        • FN Kralovske Vinohrady
  • Tyskland
      • Augsburg, Tyskland, 86150
        • Hämatologisch-onkologische Praxis
      • Erlangen, Tyskland, 91054
        • Frauenklinik des Universitätsklinikums Erlangen
      • Kiel, Tyskland, 24105
        • Universitätsklinikum Schleswig
      • Trier, Tyskland, 54290
        • Klinikum Mutterhaus der Borromaeerinnen

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

Inclusion Criteria:

  • Histologically- or cytologically-proven adenocarcinoma of the breast that is HER2 negative. Subjects with hormone receptor positive or negative status are eligible. Additionally, subjects with triple negative status (meaning estrogen receptor negative, progesterone receptor negative and HER2 negative) are eligible
  • No prior chemotherapy regimen for metastatic breast cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 at the Baseline Visit
  • The subject's life expectancy is estimated to be > 12 weeks at the Baseline Visit
  • The subject must be non-pregnant and non-lactating. All sexually active subjects of childbearing potential must agree to use an adequate method of contraception throughout the study period

Exclusion Criteria:

  • Hypersensitivity to docetaxel or polysorbate 80
  • Neuropathy ≥ Grade 2 at the Baseline Visit
  • Known brain or leptomeningeal metastasis as assessed through medical history review and physical examination
  • The subject has known Human Immunodeficiency Virus (HIV), Hepatitis B surface Antigen or hepatitis C antibody

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: A. YM155 plus docetaxel
Medicin: YM155
intravenøs infusion
Medicin: Docetaxel
intravenøs infusion
Andre navne:
  • Taxotere
Aktiv komparator: B. docetaxel alone
Medicin: Docetaxel
intravenøs infusion
Andre navne:
  • Taxotere

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Progression free survival (PFS)
Tidsramme: At the time of progression or death or at 2 year follow up
At the time of progression or death or at 2 year follow up

Sekundære resultatmål

Resultatmål
Tidsramme
Objective response rate (proportion of subjects with complete response or partial response)
Tidsramme: At the time of progression or death or at 2 year follow up
At the time of progression or death or at 2 year follow up
Overall survival
Tidsramme: At the time of death or at 2 year follow up
At the time of death or at 2 year follow up
Duration of response
Tidsramme: At the time of progression or at 2 year follow up
At the time of progression or at 2 year follow up
Clinical benefit rate
Tidsramme: At the time of progression or death or at 2 year follow up
At the time of progression or death or at 2 year follow up
Time to response
Tidsramme: At the time of response or at 2 year follow up
At the time of response or at 2 year follow up
Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)
Tidsramme: Up to 30 days after last subject discontinues treatment
Up to 30 days after last subject discontinues treatment

Samarbejdspartnere og efterforskere

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

Sponsor

Astellas Pharma Inc

Efterforskere

  • Studieleder: Sr. Medical Director, Astellas Pharma Global Development
  • Ledende efterforsker: United Kingdom Principal Investigator, Royal Bournemouth Hospital
  • Ledende efterforsker: Poland Principal Investigator, Centrum Onkologii-Instytut im.
  • Ledende efterforsker: Ireland Principal Investigator, St. Vincent's University Hospital
  • Ledende efterforsker: Germany Principal Investigator, Luisenkrankenhaus Duesseldorf
  • Ledende efterforsker: Czech Republic Principal Investigator, Thomayer Faculty Hosptial L.G.
  • Ledende efterforsker: Belgium Principal Investigator, Institut Jules Bordet - Medical Oncology and Translational Research

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. december 2009

Primær færdiggørelse (Faktiske)

1. juni 2012

Studieafslutning (Faktiske)

1. juni 2013

Datoer for studieregistrering

Først indsendt

22. december 2009

Først indsendt, der opfyldte QC-kriterier

22. december 2009

Først opslået (Skøn)

24. december 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

18. september 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. september 2013

Sidst verificeret

1. september 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 155-CL-036
  • 2009-012439-14 (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 .

Kliniske forsøg med Brystkræft

Kliniske forsøg med YM155

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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