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A Trial Comparing the Efficacy and Tolerability of Faslodex With Nolvadex in Postmenopausal Women With Advanced Breast Cancer

5. juni 2012 opdateret af: AstraZeneca

A Double-blind, Randomized, Multicentre Trial Comparing the Efficacy and Tolerability of 250mg of Faslodex (Long Acting ICI 182,780) With 20mg of Nolvadex (Tamoxifen) in Postmenopausal Women With Advanced Breast Cancer

The purpose of this study is to compare the efficacy of Faslodex (fulvestrant) to Nolvadex (tamoxifen) as first-line treatment for postmenopausal women with advanced breast cancer. Patients will be treated until disease progression or until the investigator has determined that treatment is not in the best interest of the patient, whichever occurs first.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

51

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Argentina
      • Buenos Aires, Argentina
        • Research Site
      • Rosario, Argentina
        • Research Site
  • Australien
      • Camperdown, Australien
        • Research Site
      • Concord, Australien
        • Research Site
      • Heidelburg, Australien
        • Research Site
      • Melbourne, Australien
        • Research Site
  • Belgien
      • Antwerpen, Belgien
        • Research Site
      • Haine-Saint Paul, Belgien
        • Research Site
      • Hasselt, Belgien
        • Research Site
      • Leuven, Belgien
        • Research Site
  • Brasilien
      • Belo Horizonte, Brasilien
        • Research Site
      • Goiania, Brasilien
        • Research Site
      • Sao Paulo, Brasilien
        • Research Site
  • Canada
      • Chicoutimi, Canada
        • Research Site
      • Montreal, Canada
        • Research Site
    • Alberta
      • Edmonton, Alberta, Canada
        • Research Site
    • British Columbia
      • Penticton, British Columbia, Canada
        • Research Site
    • New Brunswick
      • Saint John, New Brunswick, Canada
        • Research Site
    • Ontario
      • Newmarket, Ontario, Canada
        • Research Site
      • Ottawa, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
      • Weston, Ontario, Canada
        • Research Site
      • York, Ontario, Canada
        • Research Site
  • Den Russiske Føderation
      • Moscow, Den Russiske Føderation
        • Research Site
  • Det Forenede Kongerige
      • Belfast, Det Forenede Kongerige
        • Research Site
      • Birmingham, Det Forenede Kongerige
        • Research Site
      • Chelmsford, Det Forenede Kongerige
        • Research Site
      • Chorley, Det Forenede Kongerige
        • Research Site
      • Coventry, Det Forenede Kongerige
        • Research Site
      • Huddersfield, Det Forenede Kongerige
        • Research Site
      • Leeds, Det Forenede Kongerige
        • Research Site
      • London, Det Forenede Kongerige
        • Research Site
      • Luton, Det Forenede Kongerige
        • Research Site
      • Manchester, Det Forenede Kongerige
        • Research Site
      • Newcastle Upon Tyne, Det Forenede Kongerige
        • Research Site
      • Northampton, Det Forenede Kongerige
        • Research Site
      • Nottingham, Det Forenede Kongerige
        • Research Site
      • Prescot, Det Forenede Kongerige
        • Research Site
      • Telford, Det Forenede Kongerige
        • Research Site
      • Whitehaven, Det Forenede Kongerige
        • Research Site
      • Worthing, Det Forenede Kongerige
        • Research Site
      • York, Det Forenede Kongerige
        • Research Site
  • Finland
      • Kotka, Finland
        • Research Site
      • Kuopio, Finland
        • Research Site
      • Rovaniemi, Finland
        • Research Site
  • Forenede Stater
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater
        • Research Site
    • California
      • Fountain Valley, California, Forenede Stater
        • Research Site
      • La Jolla, California, Forenede Stater
        • Research Site
      • Orange, California, Forenede Stater
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater
        • Research Site
    • Florida
      • Venice, Florida, Forenede Stater
        • Research Site
    • Georgia
      • Decatur, Georgia, Forenede Stater
        • Research Site
    • Illinois
      • Chicago, Illinois, Forenede Stater
        • Research Site
    • Iowa
      • Mason City, Iowa, Forenede Stater
        • Research Site
    • Louisiana
      • Shreveport, Louisiana, Forenede Stater
        • Research Site
    • Massachusetts
      • Gloucester, Massachusetts, Forenede Stater
        • Research Site
    • Michigan
      • Detroit, Michigan, Forenede Stater
        • Research Site
    • New Jersey
      • Voorhees, New Jersey, Forenede Stater
        • Research Site
    • Ohio
      • Columbus, Ohio, Forenede Stater
        • Research Site
    • Pennsylvania
      • Meadowbrook, Pennsylvania, Forenede Stater
        • Research Site
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater
        • Research Site
    • Texas
      • Austin, Texas, Forenede Stater
        • Research Site
      • Galveston, Texas, Forenede Stater
        • Research Site
      • Houston, Texas, Forenede Stater
        • Research Site
      • San Antonio, Texas, Forenede Stater
        • Research Site
      • Temple, Texas, Forenede Stater
        • Research Site
    • Virginia
      • Richmond, Virginia, Forenede Stater
        • Research Site
    • Washington
      • Lacey, Washington, Forenede Stater
        • Research Site
      • Seattle, Washington, Forenede Stater
        • Research Site
  • Frankrig
      • Clermont Ferrand, Frankrig
        • Research Site
      • Evreux, Frankrig
        • Research Site
      • Lyon, Frankrig
        • Research Site
      • Montpellier, Frankrig
        • Research Site
      • Pierre-Benite, Frankrig
        • Research Site
      • Rodez, Frankrig
        • Research Site
      • Rouen, Frankrig
        • Research Site
      • Tours, Frankrig
        • Research Site
  • Holland
      • Den Haag, Holland
        • Research Site
  • Irland
      • Dublin, Irland
        • Research Site
  • Israel
      • Ashkelon, Israel
        • Research Site
      • Haifa, Israel
        • Research Site
  • Italien
      • Bologna, Italien
        • Research Site
      • Brescia, Italien
        • Research Site
      • Forli, Italien
        • Research Site
      • Genova, Italien
        • Research Site
      • Milano, Italien
        • Research Site
      • Napoli, Italien
        • Research Site
      • Palermo, Italien
        • Research Site
      • Perugia, Italien
        • Research Site
      • Pisa, Italien
        • Research Site
      • Reggio Calabria, Italien
        • Research Site
      • Reggio Emilia, Italien
        • Research Site
      • Rozzano, Italien
        • Research Site
      • Sassari, Italien
        • Research Site
      • Trieste, Italien
        • Research Site
  • Japan
      • Amagasaki, Japan
        • Research Site
      • Fukuoka, Japan
        • Research Site
      • Kitakyusyu, Japan
        • Research Site
      • Kumamoto, Japan
        • Research Site
      • Matsuyama, Japan
        • Research Site
      • Nagoya, Japan
        • Research Site
      • Niigata, Japan
        • Research Site
      • Oita, Japan
        • Research Site
      • Osaka, Japan
        • Research Site
      • Saitama, Japan
        • Research Site
      • Sapporo, Japan
        • Research Site
      • Suita, Japan
        • Research Site
      • Tokyo, Japan
        • Research Site
  • Kalkun
      • Istanbul, Kalkun
        • Research Site
  • Mexico
      • Guadalajara, Mexico
        • Research Site
      • Mexico, D.F., Mexico
        • Research Site
  • New Zealand
      • Christchurch, New Zealand
        • Research Site
      • Palmerston North, New Zealand
        • Research Site
  • Polen
      • Bydgoszcz, Polen
        • Research Site
      • Krakow, Polen
        • Research Site
      • Szczecin, Polen
        • Research Site
      • Warszawa, Polen
        • Research Site
  • Portugal
      • Coimbra, Portugal
        • Research Site
  • Spanien
      • Badalona, Spanien
        • Research Site
      • Guadalajara, Spanien
        • Research Site
      • Madrid, Spanien
        • Research Site
      • Málaga, Spanien
        • Research Site
  • Sydafrika
      • Cape Town, Sydafrika
        • Research Site
      • Johannesburg, Sydafrika
        • Research Site
      • Lyttelton Manor, Sydafrika
        • Research Site
  • Taiwan
      • Kaohsiung, Taiwan
        • Research Site
      • Taichung, Taiwan
        • Research Site
      • Tainan, Taiwan
        • Research Site
      • Taipei, Taiwan
        • Research Site
      • Tao-Yuan, Taiwan
        • Research Site
  • Tyskland
      • Frankfurt, Tyskland
        • Research Site
      • Gottingen, Tyskland
        • Research Site
      • Rostock, Tyskland
        • Research Site
  • Ungarn
      • Budapest, Ungarn
        • Research Site
      • Pécs, Ungarn
        • Research Site
      • Szolnok, Ungarn
        • Research Site
      • Székesfehérvár, Ungarn
        • Research Site
  • Østrig
      • Salzburg, Østrig
        • Research Site
      • Wien, Østrig
        • Research Site

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Biopsy confirmation of breast cancer. Evidence of breast cancer that is not considered amenable to curative treatment.

Postmenopausal women. Written informed consent to participate in the study.

Exclusion Criteria:

  • Previous treatment with hormonal therapy unless that therapy was tamoxifen for adjuvant breast cancer. The use of tamoxifen must have ceased at least one year before this study.

Previous treatment with Faslodex. Any existing serious disease, illness, or condition that will prevent participation or compliance with the study procedures.

Treatment with an investigational or non-approved drug within one month of then start of the study.

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: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 1
Tamoxifen
Medicin: Tamoxifen
20 mg oral tablet
Andre navne:
  • Nolvadex
Eksperimentel: 2
Fulvestrant
Medicin: Fulvestrant
intramuscular injection 250 mg
Andre navne:
  • Faslodex
  • ZD9238

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to disease progression (TTP)
Tidsramme: At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.
It is considered that these results indicate that adequate data were available for obtaining clinically meaningful information for the primary efficacy endpoint of time to disease progression
At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective response rate (ORR)
Tidsramme: At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.
It is considered that these results indicate that adequate data were available for obtaining clinically meaningful information for the primary efficacy endpoint of time to disease progression
At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.
Duration of response (DoR)
Tidsramme: At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.
At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.
Time to treatment failure (TTF)
Tidsramme: At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.
At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.
Overall survival (OS)
Tidsramme: At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.
At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.
Quality of Life (QOL) and Tolerability.
Tidsramme: At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.
At the time of data cut-off for this trial, the median overall duration of follow-up was 441 days, with a total of 434 (73.9%) randomised patients, including 47 patients from Japanese centres having progressed.

Samarbejdspartnere og efterforskere

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

Sponsor

AstraZeneca

Efterforskere

  • Studieleder: AstraZeneca Oncology Medical Science Director, MD, AstraZeneca

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. november 1998

Primær færdiggørelse (Faktiske)

1. marts 2007

Studieafslutning (Faktiske)

1. januar 2012

Datoer for studieregistrering

Først indsendt

17. oktober 2005

Først indsendt, der opfyldte QC-kriterier

17. oktober 2005

Først opslået (Skøn)

19. oktober 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. juni 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. juni 2012

Sidst verificeret

1. juni 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 9238IL/0025

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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