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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.
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| Measure | Description | Time Frame |
|---|---|---|
| (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 | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 2 years | |
| (2) To describe the diagnostic algorithms and therapeutic tactics in patients with HER2-positive mBC in routine practice in Kazakhstan |
| Measure | Description | Time Frame |
|---|---|---|
| To assess change in HER2 status in patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in Kazakhstan | up to 2 years |
Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 'Regional Cancer Centre' Uralsk | Oral | Kazakhstan | 90005 | Kazakhstan | ||
| Medical Centre of the Marat Ospanov West Kazakhstan Medical University, Aktobe |
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.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 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 | 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 | 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 | 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 | up to 2 years |
| Aktobe |
| 30017 |
| Kazakhstan |
| 'Kazakh Research Institute of Oncology and Radiology (KAZNIOR)' | Almaty | 50022 | Kazakhstan |
| Almaty Cancer Centre | Almaty | 50054 | Kazakhstan |
| 'Multidisciplinary Medical Centre' of the Astana City Administration | Astana | 10000 | Kazakhstan |
| National Cancer Research Centre, Astana | Astana | 10017 | Kazakhstan |
| 'Karaganda General Hospital No. 3' of the Karaganda Region Health Department | Karaganda | 100019 | Kazakhstan |
| 'General Regional Hospital' of the municipal state institution 'Health Department of the Akimat of North Kazakhstan Region' Petropavlovsk | Petropavl | 150000 | Kazakhstan |
| 'Centre for Nuclear Medicine and Oncology' Abai Regional Health Authority Semey | Semey | 71407 | Kazakhstan |
| 'Shymkent City General Hospital with Oncology Centre' under the Shymkent City Health Department | Shymkent | 160000 | Kazakhstan |
| 'Regional Clinical Hospital' of the Health Department of the Turkestan Region | Shymkent | 160011 | Kazakhstan |
| 'The Zhambyl Regional Multidisciplinary Centre for Oncology and Surgery' of the Health Department of the Zhambyl Regional Administration, Taraz | Taraz | 80000 | Kazakhstan |
| D017437 |
| Skin and Connective Tissue Diseases |