HER2-positive Metastatic Breast Cancer in Kazakhstan
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Metastatic Breast Cancer. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Kazakhstan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Primary outcome measures
- (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 [Time frame: up to 2 years]
Secondary outcome measures (6)
- 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 [Time frame: up to 2 years]
- (2) To describe the diagnostic algorithms and therapeutic tactics in patients with HER2-positive mBC in routine practice in Kazakhstan [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: up to 2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Kazakhstan · 12 centers
- 'Regional Cancer Centre' Uralsk — Oral
- Medical Centre of the Marat Ospanov West Kazakhstan Medical University, Aktobe — Aktobe
- 'Kazakh Research Institute of Oncology and Radiology (KAZNIOR)' — Almaty
- Almaty Cancer Centre — Almaty
- 'Multidisciplinary Medical Centre' of the Astana City Administration — Astana
- National Cancer Research Centre, Astana — Astana
- 'Karaganda General Hospital No. 3' of the Karaganda Region Health Department — Karaganda
- 'General Regional Hospital' of the municipal state institution 'Health Department of the A — Petropavl
- … and 4 more centers
Identifiers
NCT: NCT07593196 · D133FR00252