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

5 giugno 2012 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

51

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Argentina
      • Buenos Aires, Argentina
        • Research Site
      • Rosario, Argentina
        • Research Site
  • Australia
      • Camperdown, Australia
        • Research Site
      • Concord, Australia
        • Research Site
      • Heidelburg, Australia
        • Research Site
      • Melbourne, Australia
        • Research Site
  • Austria
      • Salzburg, Austria
        • Research Site
      • Wien, Austria
        • Research Site
  • Belgio
      • Antwerpen, Belgio
        • Research Site
      • Haine-Saint Paul, Belgio
        • Research Site
      • Hasselt, Belgio
        • Research Site
      • Leuven, Belgio
        • Research Site
  • Brasile
      • Belo Horizonte, Brasile
        • Research Site
      • Goiania, Brasile
        • Research Site
      • Sao Paulo, Brasile
        • 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
  • Federazione Russa
      • Moscow, Federazione Russa
        • Research Site
  • Finlandia
      • Kotka, Finlandia
        • Research Site
      • Kuopio, Finlandia
        • Research Site
      • Rovaniemi, Finlandia
        • Research Site
  • Francia
      • Clermont Ferrand, Francia
        • Research Site
      • Evreux, Francia
        • Research Site
      • Lyon, Francia
        • Research Site
      • Montpellier, Francia
        • Research Site
      • Pierre-Benite, Francia
        • Research Site
      • Rodez, Francia
        • Research Site
      • Rouen, Francia
        • Research Site
      • Tours, Francia
        • Research Site
  • Germania
      • Frankfurt, Germania
        • Research Site
      • Gottingen, Germania
        • Research Site
      • Rostock, Germania
        • Research Site
  • Giappone
      • Amagasaki, Giappone
        • Research Site
      • Fukuoka, Giappone
        • Research Site
      • Kitakyusyu, Giappone
        • Research Site
      • Kumamoto, Giappone
        • Research Site
      • Matsuyama, Giappone
        • Research Site
      • Nagoya, Giappone
        • Research Site
      • Niigata, Giappone
        • Research Site
      • Oita, Giappone
        • Research Site
      • Osaka, Giappone
        • Research Site
      • Saitama, Giappone
        • Research Site
      • Sapporo, Giappone
        • Research Site
      • Suita, Giappone
        • Research Site
      • Tokyo, Giappone
        • Research Site
  • Irlanda
      • Dublin, Irlanda
        • Research Site
  • Israele
      • Ashkelon, Israele
        • Research Site
      • Haifa, Israele
        • Research Site
  • Italia
      • Bologna, Italia
        • Research Site
      • Brescia, Italia
        • Research Site
      • Forli, Italia
        • Research Site
      • Genova, Italia
        • Research Site
      • Milano, Italia
        • Research Site
      • Napoli, Italia
        • Research Site
      • Palermo, Italia
        • Research Site
      • Perugia, Italia
        • Research Site
      • Pisa, Italia
        • Research Site
      • Reggio Calabria, Italia
        • Research Site
      • Reggio Emilia, Italia
        • Research Site
      • Rozzano, Italia
        • Research Site
      • Sassari, Italia
        • Research Site
      • Trieste, Italia
        • Research Site
  • Messico
      • Guadalajara, Messico
        • Research Site
      • Mexico, D.F., Messico
        • Research Site
  • Nuova Zelanda
      • Christchurch, Nuova Zelanda
        • Research Site
      • Palmerston North, Nuova Zelanda
        • Research Site
  • Olanda
      • Den Haag, Olanda
        • Research Site
  • Polonia
      • Bydgoszcz, Polonia
        • Research Site
      • Krakow, Polonia
        • Research Site
      • Szczecin, Polonia
        • Research Site
      • Warszawa, Polonia
        • Research Site
  • Portogallo
      • Coimbra, Portogallo
        • Research Site
  • Regno Unito
      • Belfast, Regno Unito
        • Research Site
      • Birmingham, Regno Unito
        • Research Site
      • Chelmsford, Regno Unito
        • Research Site
      • Chorley, Regno Unito
        • Research Site
      • Coventry, Regno Unito
        • Research Site
      • Huddersfield, Regno Unito
        • Research Site
      • Leeds, Regno Unito
        • Research Site
      • London, Regno Unito
        • Research Site
      • Luton, Regno Unito
        • Research Site
      • Manchester, Regno Unito
        • Research Site
      • Newcastle Upon Tyne, Regno Unito
        • Research Site
      • Northampton, Regno Unito
        • Research Site
      • Nottingham, Regno Unito
        • Research Site
      • Prescot, Regno Unito
        • Research Site
      • Telford, Regno Unito
        • Research Site
      • Whitehaven, Regno Unito
        • Research Site
      • Worthing, Regno Unito
        • Research Site
      • York, Regno Unito
        • Research Site
  • Spagna
      • Badalona, Spagna
        • Research Site
      • Guadalajara, Spagna
        • Research Site
      • Madrid, Spagna
        • Research Site
      • Málaga, Spagna
        • Research Site
  • Stati Uniti
    • Arkansas
      • Little Rock, Arkansas, Stati Uniti
        • Research Site
    • California
      • Fountain Valley, California, Stati Uniti
        • Research Site
      • La Jolla, California, Stati Uniti
        • Research Site
      • Orange, California, Stati Uniti
        • Research Site
    • District of Columbia
      • Washington, District of Columbia, Stati Uniti
        • Research Site
    • Florida
      • Venice, Florida, Stati Uniti
        • Research Site
    • Georgia
      • Decatur, Georgia, Stati Uniti
        • Research Site
    • Illinois
      • Chicago, Illinois, Stati Uniti
        • Research Site
    • Iowa
      • Mason City, Iowa, Stati Uniti
        • Research Site
    • Louisiana
      • Shreveport, Louisiana, Stati Uniti
        • Research Site
    • Massachusetts
      • Gloucester, Massachusetts, Stati Uniti
        • Research Site
    • Michigan
      • Detroit, Michigan, Stati Uniti
        • Research Site
    • New Jersey
      • Voorhees, New Jersey, Stati Uniti
        • Research Site
    • Ohio
      • Columbus, Ohio, Stati Uniti
        • Research Site
    • Pennsylvania
      • Meadowbrook, Pennsylvania, Stati Uniti
        • Research Site
    • Rhode Island
      • Providence, Rhode Island, Stati Uniti
        • Research Site
    • Texas
      • Austin, Texas, Stati Uniti
        • Research Site
      • Galveston, Texas, Stati Uniti
        • Research Site
      • Houston, Texas, Stati Uniti
        • Research Site
      • San Antonio, Texas, Stati Uniti
        • Research Site
      • Temple, Texas, Stati Uniti
        • Research Site
    • Virginia
      • Richmond, Virginia, Stati Uniti
        • Research Site
    • Washington
      • Lacey, Washington, Stati Uniti
        • Research Site
      • Seattle, Washington, Stati Uniti
        • Research Site
  • Sud Africa
      • Cape Town, Sud Africa
        • Research Site
      • Johannesburg, Sud Africa
        • Research Site
      • Lyttelton Manor, Sud Africa
        • Research Site
  • Tacchino
      • Istanbul, Tacchino
        • Research Site
  • Taiwan
      • Kaohsiung, Taiwan
        • Research Site
      • Taichung, Taiwan
        • Research Site
      • Tainan, Taiwan
        • Research Site
      • Taipei, Taiwan
        • Research Site
      • Tao-Yuan, Taiwan
        • Research Site
  • Ungheria
      • Budapest, Ungheria
        • Research Site
      • Pécs, Ungheria
        • Research Site
      • Szolnok, Ungheria
        • Research Site
      • Székesfehérvár, Ungheria
        • Research Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 1
Tamoxifene
Droga: Tamoxifen
20 mg oral tablet
Altri nomi:
  • Novadex
Sperimentale: 2
Fulvestrant
Droga: Fulvestrant
intramuscular injection 250 mg
Altri nomi:
  • Faslodex
  • ZD9238

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to disease progression (TTP)
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Objective response rate (ORR)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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.
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

AstraZeneca

Investigatori

  • Direttore dello studio: AstraZeneca Oncology Medical Science Director, MD, AstraZeneca

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 novembre 1998

Completamento primario (Effettivo)

1 marzo 2007

Completamento dello studio (Effettivo)

1 gennaio 2012

Date di iscrizione allo studio

Primo inviato

17 ottobre 2005

Primo inviato che soddisfa i criteri di controllo qualità

17 ottobre 2005

Primo Inserito (Stima)

19 ottobre 2005

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

6 giugno 2012

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 giugno 2012

Ultimo verificato

1 giugno 2012

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 9238IL/0025

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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