Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Post Marketing Surveillance Study To Observe Safety And Efficacy Of Aromasin In The Patients With Early Or Advanced Breast Cancer

6. oktober 2015 opdateret af: Pfizer
This non-interventional study is to monitor use in real practice in Korea including adverse events on Aromasin (Exemestane).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

All cases at the participating institutions.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

206

Kontakter og lokationer

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

Studiesteder

  • Korea, Republikken
      • Busan, Korea, Republikken, 614-735
        • Inje University Busan Paik Hospital
      • Daegu, Korea, Republikken, 705-717
        • Yeung Nam University Hospital
      • Gyeonggi-do, Korea, Republikken, 463-707
        • Seoul National University Bundang Hospital
      • Incheon, Korea, Republikken, 400-711
        • Inha University Hospital
      • Seoul, Korea, Republikken, 110-744
        • Seoul National University Hospital
      • Seoul, Korea, Republikken, 156-707
        • SMG-SNU Boramae Medical Center
      • Seoul, Korea, Republikken, 136-705
        • Korea University Anam Hospital
      • Seoul, Korea, Republikken, 138-736
        • Asan Medical Center, University of Ulsan
      • Seoul, Korea, Republikken, 120-752
        • Severance Hospital, Yonsei University Health System, Yonsei Cancer Center
      • Seoul, Korea, Republikken, 158-710
        • Ewha Womans University Mokdong Hospital
      • Seoul, Korea, Republikken, 135 710
        • Samsung Medical Center
      • Seoul, Korea, Republikken, 110-744
        • Seoul National University Hospital (SNUH)
      • Seoul, Korea, Republikken, 100-380
        • Cheil General Hospital & Women's Healthcare Center
      • Seoul, Korea, Republikken, 152-703
        • Korea University Medical Center (KUMC) - Korea University Guro Hospital
      • Suwon, Korea, Republikken, 443-380
        • Ajou University Hospital
    • Chungcheongnam-do
      • Cheonan, Chungcheongnam-do, Korea, Republikken, 330-721
        • Soon Chun Hyang University Hospital Cheonan
    • Gyeonggi-do
      • Anyang, Gyeonggi-do, Korea, Republikken, 431-070
        • Hallym University Sacred Heart Hospital
      • Bucheon, Gyeonggi-do, Korea, Republikken, 420-767
        • Soon Chun Hyang University Bucheon Hospital
      • Goyang, Gyeonggi-do, Korea, Republikken, 412-270
        • Myongji Hospital, Kwangdong Unversity College of Medicine
    • Jeollabuk-do
      • Iksan -si, Jeollabuk-do, Korea, Republikken, 570-749
        • Wonkwang University School of Medicine and Hospital (WUH)
    • Korea
      • Seoul, Korea, Korea, Republikken, 138-736
        • Asan Medical Center
    • South Jeolla Province
      • Cheonnam, South Jeolla Province, Korea, Republikken, 519-809
        • Hwasun Hospital, Chonnam National University

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

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

- Postmenopausal women diagnosed as estrogen-receptor positive early breast cancer, who have received two to three years of tamoxifen and are switched to AROMASIN for completion of a total of five consecutive years of adjuvant hormonal therapy OR postmenopausal women with breast cancer that has progressed following anti-estrogen therapy.

Beskrivelse

Inclusion Criteria:

  • - Postmenopausal women with breast cancer eligible for hormonal therapy.

Exclusion Criteria:

  • Pregnant breast-feeding premenopausal.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
ajuvant group
adjuvant setting after two to three years of tamoxifen
Medicin: Aromasin
25 mg table QD
Andre navne:
  • exemestan
palliative group
palliative setting after progression of disease with anti-estrogen therapy
Medicin: Aromasin
25 mg table QD
Andre navne:
  • exemestan

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Tidsramme: From the first dose of Aromasin through the end of the study for an average of 5.6 months
All AEs reported after start of administration of Aromasin were considered as TEAEs and summarized.
From the first dose of Aromasin through the end of the study for an average of 5.6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Without Recurrence/Metastasis (Early Breast Cancer)
Tidsramme: At the end of the study, average of 5.6 months.
The antitumor efficacy for early breast cancer was measured by recurrence/metastasis status (Yes or No) of the participant at the end of the study. The investigator recorded the final evaluation date and the information of tumor recurrence or metastasis (Yes or No) in each participant's case report form (CRF).
At the end of the study, average of 5.6 months.
Time-to-Progression (Early Breast Cancer)
Tidsramme: At the end of the study, average of 5.6 months
Time-to-Progression was defined as the duration from the date of first administration of Aromasin to the date of recurrence or contralateral breast cancer.
At the end of the study, average of 5.6 months
Percentage of Participants by Overall Tumor Response Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) (Advanced Breast Cancer)
Tidsramme: At the end of the study, average of 5.6 months
The antitumor efficacy for advanced breast cancer was measured by objective tumor assessments according to the RECIST of uni-dimensional evaluation. Complete response (CR) was defined as disappearance of all target and non-target lesions, and no new lesions. Partial response (PR) was defined as disappearance of all target lesions, a persistence of ≥1 non-target lesions, no new lesions; or a ≥30% decrease in the sum of the longest dimensions of the target lesions, no unequivocal progression of existing non-target lesions, no new lesions. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), no unequivocal progression of existing non-target lesions, and no new lesions. PD was defined as a ≥20% increase in the sum of the longest dimensions of the target lesions; or unequivocal progression of existing non-target lesions, or the appearance of ≥1 new lesions.
At the end of the study, average of 5.6 months

Samarbejdspartnere og efterforskere

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

Sponsor

Pfizer

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.

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

1. juni 2010

Primær færdiggørelse (Faktiske)

1. juni 2014

Studieafslutning (Faktiske)

1. juni 2014

Datoer for studieregistrering

Først indsendt

24. december 2009

Først indsendt, der opfyldte QC-kriterier

8. januar 2010

Først opslået (Skøn)

12. januar 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

8. oktober 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. oktober 2015

Sidst verificeret

1. oktober 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A5991089

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 Aromasin

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Guatemala

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner