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Collection of Efficacy and Safety Data of Chinese Patients Who Have Received Faslodex 250mg Treatment

4. december 2017 opdateret af: AstraZeneca

A Multicenter, Non-interventional, Prospective Study to Collect Efficacy and Safety Data in Chinese Patients Who Have Received Faslodex 250mg Treatment Under the Condition of Actual Usage in Clinical Practice

This study is a post-authorisation study, committed to Center for Drug Evaluation (CDE) and China Food and Drug Administration (CFDA), in order to provide more effectiveness and safety data about Faslodex in real world clinical practice in China. The primary objective of this study was to evaluate the effectiveness of Faslodex 250mg monthly to treat post-menopausal women with oestrogen receptor-positive locally advanced or metastatic breast cancer, for disease relapse on or after adjuvant anti-oestrogen therapy or disease progression on therapy with an anti-oestrogen, in terms of progression-free survival (PFS), by collecting real world data according to Chinese physicians' clinical practice.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

A Multicenter, non-interventional, prospective study to collect effectiveness and safety data in Chinese patients who have received Faslodex treatment under the condition of actual usage in clinical practice

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

231

Kontakter og lokationer

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

Studiesteder

  • Kina
    • Beijing
      • Beijing, Beijing, Kina
        • Research Site
    • Fujian
      • Fuzhou, Fujian, Kina
        • Research Site
    • Guangdong
      • Guangzhou, Guangdong, Kina
        • Research Site
    • Guizhou
      • Guiyang, Guizhou, Kina
        • Research Site
    • Hebei
      • Tangshan, Hebei, Kina
        • Research Site
    • Heilongjiang
      • Ha'erbin, Heilongjiang, Kina
        • Research Site
    • Hubei
      • Wuhan, Hubei, Kina
        • Research Site
    • Hunan
      • Changsha, Hunan, Kina
        • Research Site
    • Inner Mongolia
      • Huhehaote, Inner Mongolia, Kina
        • Research Site
    • Jiangsu
      • Kunshan, Jiangsu, Kina
        • Research Site
      • Nanjing, Jiangsu, Kina
        • Research Site
      • Nantong, Jiangsu, Kina
        • Research Site
      • Xuzhou, Jiangsu, Kina
        • Research Site
    • Jilin
      • Changchun, Jilin, Kina
        • Research Site
    • Shandong
      • Qingdao, Shandong, Kina
        • Research Site
      • Weifang, Shandong, Kina
        • Research Site
    • Shanghai
      • Shanghai, Shanghai, Kina
        • Research Site
    • Sichuan
      • Chengdu, Sichuan, Kina
        • Research Site
    • Tianjin
      • Tianjin, Tianjin, Kina
        • Research Site
    • Yunnan
      • Kunming, Yunnan, Kina
        • Research Site
    • Zhejiang
      • Hanghzou, Zhejiang, Kina
        • Research Site
      • Hangzhou, Zhejiang, Kina
        • Research Site
      • Zhoushan, Zhejiang, Kina
        • 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

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Medical units

Beskrivelse

Inclusion Criteria:

  • Chinese postmenopausal women with estrogen receptor positive, locally advanced or metastatic breast cancer Failure to previous anti-estrogen therapy, already received Faslodex 250mg treatment as determined by treating physician.
  • The prescription of the Faslodex is clearly separated from the decision to include the subject in the NIS, and is part of normal medical practice. The recruitment of the patient to the study should be within 1 month of the first Faslodex injection.
  • Provision of subject informed consent.

Exclusion Criteria:

  • If participating in any controlled clinical trial, the subject cannot take part in this study.
  • Hypersensitivity to the active substance, or to any of the other excipients.
  • Pregnancy and lactation, or severe hepatic impairment.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
To evaluate the effectiveness of Faslodex 250mg monthly to treat post-menopausal women with ER+ locally advanced or MBC in terms of progression-free survival (PFS), by collecting real world data according to Chinese physicians' clinical practice.
Tidsramme: Follow-up will be taken every 3 months after commencement of the protocol, through study completion, an average of 12 months.
The primary objective of this study was to evaluate the effectiveness of Faslodex 250mg monthly to treat post-menopausal women with oestrogen receptor-positive locally advanced or metastatic breast cancer, for disease relapse on or after adjuvant anti-oestrogen therapy or disease progression on therapy with an anti-oestrogen, in terms of progression-free survival (PFS), by collecting real world data according to Chinese physicians' clinical practice.
Follow-up will be taken every 3 months after commencement of the protocol, through study completion, an average of 12 months.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective response rate (ORR)
Tidsramme: Follow-up will be taken every 3 months after commencement of the protocol, through the study completion, an average of 12 months.
ORR was defined as the percentage of patients who had a best objective tumour response of either complete response (CR) or partial response (PR) among the evaluable patients with measurable disease at baseline. The best overall response was the best response recorded from the start of the treatment until disease progression. The RECIST1.1 criteria were used to assess objective tumour response. ORR was summarized and expressed as the percentage together with the corresponding 95% confidence intervals (CI).
Follow-up will be taken every 3 months after commencement of the protocol, through the study completion, an average of 12 months.
Frequency of Adverse Events
Tidsramme: Follow-up will be taken every 3 months after commencement of the protocol, through study completion, an average of 12 months.
Adverse events (AEs) data were coded using Medical dictionary for Regulatory Activities (MedDRA) version 14.0 and summarized by preferred term (PT) and system organ class (SOC).
Follow-up will be taken every 3 months after commencement of the protocol, through study completion, an average of 12 months.
Severity of Adverse Events
Tidsramme: Follow-up will be taken every 3 months after commencement of the protocol, through study completion, an average of 12 months.
SAEs causally related to study drug, AEs leading to discontinuation, AEs leading to death, respectively. Separate listings were provided for AEs causally related to study drug, AEs leading to death, respectively. The severity of all adverse events was analyzed according to CTCAE grading.
Follow-up will be taken every 3 months after commencement of the protocol, through study completion, an average of 12 months.

Samarbejdspartnere og efterforskere

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

Sponsor

AstraZeneca

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

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 (Faktiske)

1. august 2011

Primær færdiggørelse (Faktiske)

30. januar 2016

Studieafslutning (Faktiske)

30. januar 2016

Datoer for studieregistrering

Først indsendt

19. august 2011

Først indsendt, der opfyldte QC-kriterier

26. august 2011

Først opslået (Skøn)

30. august 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. december 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. december 2017

Sidst verificeret

1. december 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NIS-OCN-FAS-2011/1

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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