HER2-positive Metastatic Breast Cancer in Kazakhstan
12 maj 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Studietyp
Observationell
Inskrivning (Beräknad)
240
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: AstraZeneca Clinical Study Information Center
- Telefonnummer: 1-877-240-9479
- E-post: information.center@astrazeneca.com
Studieorter
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-
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Aktobe, Kazakstan, 30017
- Medical Centre of the Marat Ospanov West Kazakhstan Medical University, Aktobe
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Almaty, Kazakstan, 50022
- 'Kazakh Research Institute of Oncology and Radiology (KAZNIOR)'
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Almaty, Kazakstan, 50054
- Almaty Cancer Centre
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Astana, Kazakstan, 10000
- 'Multidisciplinary Medical Centre' of the Astana City Administration
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Astana, Kazakstan, 10017
- National Cancer Research Centre, Astana
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Karaganda, Kazakstan, 100019
- 'Karaganda General Hospital No. 3' of the Karaganda Region Health Department
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Petropavl, Kazakstan, 150000
- 'General Regional Hospital' of the municipal state institution 'Health Department of the Akimat of North Kazakhstan Region' Petropavlovsk
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Semey, Kazakstan, 71407
- 'Centre for Nuclear Medicine and Oncology' Abai Regional Health Authority Semey
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Shymkent, Kazakstan, 160000
- 'Shymkent City General Hospital with Oncology Centre' under the Shymkent City Health Department
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Shymkent, Kazakstan, 160011
- 'Regional Clinical Hospital' of the Health Department of the Turkestan Region
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Taraz, Kazakstan, 80000
- 'The Zhambyl Regional Multidisciplinary Centre for Oncology and Surgery' of the Health Department of the Zhambyl Regional Administration, Taraz
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Kazakhstan
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Oral, Kazakhstan, Kazakstan, 90005
- 'Regional Cancer Centre' Uralsk
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
(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
Tidsram: up to 2 years
|
up to 2 years
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: up to 2 years
|
up to 2 years
|
Andra resultatmått
Resultatmått |
Tidsram |
|---|---|
|
To assess change in HER2 status in patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in Kazakhstan
Tidsram: up to 2 years
|
up to 2 years
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
19 maj 2026
Primärt slutförande (Beräknad)
30 september 2026
Avslutad studie (Beräknad)
30 januari 2027
Studieregistreringsdatum
Först inskickad
12 maj 2026
Först inskickad som uppfyllde QC-kriterierna
12 maj 2026
Första postat (Faktisk)
18 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 maj 2026
Senast verifierad
1 april 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- D133FR00252
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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