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HER2-positive Metastatic Breast Cancer in Kazakhstan

12. maj 2026 opdateret af: AstraZeneca

A Multicenter Observational Retrospective Study of Therapeutic Approaches and Clinical Outcomes in Real Clinical Practice in Kazakhstan Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer

Planned study population consists of approximately 240 adult patients with HER2-positive mBC receiving anti-HER2 therapy in 12 oncological centers (in each center it is expected to recruit about 20 patients) in different regions in order to provide representative study sample. Patients will be included consecutively from the least recent diagnosis (within defined time period).

Planned retrospective follow-up period for 1 patient is a period starting from the date of mBC diagnosis until end study or until patient's death, whichever occurs first. End of study will be at least 12 months after the latest date of mBC diagnosis to ensure all patients have the opportunity to contribute at least 12 months of data.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

240

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Kasakhstan
      • Aktobe, Kasakhstan, 30017
        • Medical Centre of the Marat Ospanov West Kazakhstan Medical University, Aktobe
      • Almaty, Kasakhstan, 50022
        • 'Kazakh Research Institute of Oncology and Radiology (KAZNIOR)'
      • Almaty, Kasakhstan, 50054
        • Almaty Cancer Centre
      • Astana, Kasakhstan, 10000
        • 'Multidisciplinary Medical Centre' of the Astana City Administration
      • Astana, Kasakhstan, 10017
        • National Cancer Research Centre, Astana
      • Karaganda, Kasakhstan, 100019
        • 'Karaganda General Hospital No. 3' of the Karaganda Region Health Department
      • Petropavl, Kasakhstan, 150000
        • 'General Regional Hospital' of the municipal state institution 'Health Department of the Akimat of North Kazakhstan Region' Petropavlovsk
      • Semey, Kasakhstan, 71407
        • 'Centre for Nuclear Medicine and Oncology' Abai Regional Health Authority Semey
      • Shymkent, Kasakhstan, 160000
        • 'Shymkent City General Hospital with Oncology Centre' under the Shymkent City Health Department
      • Shymkent, Kasakhstan, 160011
        • 'Regional Clinical Hospital' of the Health Department of the Turkestan Region
      • Taraz, Kasakhstan, 80000
        • 'The Zhambyl Regional Multidisciplinary Centre for Oncology and Surgery' of the Health Department of the Zhambyl Regional Administration, Taraz
    • Kazakhstan
      • Oral, Kazakhstan, Kasakhstan, 90005
        • 'Regional Cancer Centre' Uralsk

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

This non-interventional multicenter observational study will include 240 adult patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan).

Patients will be included in about 12 oncological centers (in each center it is expected to recruit about 20 patients) in various regions of Russian Federation

Beskrivelse

Inclusion Criteria:

  • Patients with HER2-positive mBC who are receiving or have started any anti-HER2 therapy (except for trastuzumab deruxtecan) at the time of inclusion
  • The diagnosis of mBC was established between the 1st January 2022 to 31st December 2023
  • Patients with the availability of at least 24 months of follow-up data (from the date of mBC diagnosis) in the medical records at the participating site, unless patient died/moved or refused the therapy within the first 24 months of diagnosis
  • Age ≥18 years at the time of inclusion

Exclusion Criteria:

  • Presence of other malignancies within the period from mBC diagnosis until the timepoint of data collection
  • Patients received trastuzumab deruxtecan
  • The participation in any interventional trial within period since diagnosis until the end of study

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
Tidsramme
(1) To assess median PFS and PFS rate in patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in routine practice in Kazakhstan
Tidsramme: up to 2 years
up to 2 years

Sekundære resultatmål

Resultatmål
Tidsramme
To describe the clinical and demographic characteristics of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in routine practice in Kazakhstan
Tidsramme: up to 2 years
up to 2 years
(2) To describe the diagnostic algorithms and therapeutic tactics in patients with HER2-positive mBC in routine practice in Kazakhstan
Tidsramme: up to 2 years
up to 2 years
(3) To describe the treatment approach in patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in routine practice in Kazakhstan
Tidsramme: up to 2 years
up to 2 years
(4) To assess the efficacy of anticancer treatment in patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in routine practice in Kazakhstan
Tidsramme: up to 2 years
up to 2 years
(5) To describe the reasons for anticancer therapy discontinuation in patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in routine practice in Kazakhstan
Tidsramme: up to 2 years
up to 2 years
(6) To assess the number of therapy lines of anticancer treatment in patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in routine practice in Kazakhstan
Tidsramme: up to 2 years
up to 2 years

Andre resultatmål

Resultatmål
Tidsramme
To assess change in HER2 status in patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in Kazakhstan
Tidsramme: up to 2 years
up to 2 years

Samarbejdspartnere og efterforskere

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

Sponsor

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 (Anslået)

19. maj 2026

Primær færdiggørelse (Anslået)

30. september 2026

Studieafslutning (Anslået)

30. januar 2027

Datoer for studieregistrering

Først indsendt

12. maj 2026

Først indsendt, der opfyldte QC-kriterier

12. maj 2026

Først opslået (Faktiske)

18. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • D133FR00252

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Written informed consent is not needed for this study due to its retrospective nature. The protocol will be reviewed by Central Ethics Committee (CEC). CEC approval will be obtained before the start of patients' data collection.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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