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Planned study population consists of approximately 1,000 adult patients with HER2-positive mBC receiving anti-HER2 therapy in about 50 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.
Planned study population consists of approximately 1,000 adult patients with HER2-positive mBC receiving anti-HER2 therapy in about 50 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.
Only patients who were diagnosed between the 1st July 2021 and 1st July 2022 will be included. Patients should have at least 12 months of follow-up data. In case patient died within the first 12 months of diagnosis, these data from date of mBC diagnosis until patient's death should also be included. It will be multicenter study
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| Measure | Description | Time Frame |
|---|---|---|
| To describe the clinical and demographic profiles of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in the Russian Federation | Demographics characteristics : age(years) | up to 6 month |
| To describe the clinical and demographic profiles of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in the Russian Federation | - Demographics characteristics : gender | up to 6 month |
| To describe the clinical and demographic profiles of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in the Russian Federation | - Demographics characteristics : body mass index [BMI]); | up to 6 month |
| To describe the clinical and demographic profiles of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in the Russian Federation | Clinical characteristics, including BC history, family and personal oncology history | up to 6 month |
| To describe the clinical and demographic profiles of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in the Russian Federation | Clinical characteristics: ECOG status | up to 6 month |
| To describe the clinical and demographic profiles of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in the Russian Federation | Clinical characteristics: HER2, estrogen receptor (ER), progesterone receptor (PR) expression status, Ki67 expression status (in %) |
| Measure | Description | Time Frame |
|---|---|---|
| To describe data on the diagnostic algorithms and therapeutic tactics in patients with HER2-positive mBC in routine practice in the Russian Federation | - Proportion of patients with different diagnostic method(s) used for the diagnosis; | up to 6 month |
| To describe data on the treatment approach in patients with HER2-positive mBC in routine practice in the Russian Federation |
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Inclusion Criteria:
Exclusion Criteria:
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This non-interventional multicenter observational study will include 1,000 adult patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan).
Patients will be included in about 50 oncological centers (in each center it is expected to recruit about 20 patients) in various regions of Russian Federation
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Arkhangelsk | Russia | ||||
| Research Site |
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| Label | URL |
|---|---|
| Redacted CSR Synopsis | View source |
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| up to 6 month |
| To describe the clinical and demographic profiles of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in the Russian Federation | Clinical characteristics: number of metastatic sites and localization | up to 6 month |
|
| up to 6 month |
| To assess the treatment outcomes of patients with HER2-positive mBC in routine practice in the Russian Federation | -Number of therapy lines, schemes and duration; | up to 6 month |
| To describe data on the diagnostic algorithms and therapeutic tactics in patients with HER2-positive mBC in routine practice in the Russian Federation | - Proportion of patients treated for early BC (if conducted). | up to 6 month |
| To assess the treatment outcomes of patients with HER2-positive mBC in routine practice in the Russian Federation | -Reasons for anticancer therapy discontinuation, if applicable; | up to 6 month |
| To assess the treatment outcomes of patients with HER2-positive mBC in routine practice in the Russian Federation | -Time to treatment discontinuation (TTD), defined as the median time from the starting first line therapy to the treatment discontinuation from any cause; | up to 6 month |
| Barnaul |
| Russia |
| Research Site | Belgorod | Russia |
| Research Site | Chelyabinsk | Russia |
| Research Site | Grozny | Russia |
| Research Site | Irkutsk | Russia |
| Research Site | Kaluga | Russia |
| Research Site | Kchabarovsk | Russia |
| Research Site | Khanty-Mansiysk | Russia |
| Research Site | Kommunarka | Russia |
| Research Site | Kostroma | Russia |
| Research Site | Krasnodar | Russia |
| Research Site | Krasnoyarsk | Russia |
| Research Site | Moscow | Russia |
| Research Site | Perm | Russia |
| Research Site | Pyatigorsk | Russia |
| Research Site | Ryazan | Russia |
| Research Site | Saint Petersburg | Russia |
| Research Site | Sakhalin | Russia |
| Research Site | Saransk | Russia |
| Research Site | Sochi | Russia |
| Research Site | Surgut | Russia |
| Research Site | Tomsk | Russia |
| Research Site | Tver' | Russia |
| Research Site | Ufa | Russia |
| Research Site | Ulan-Ude | Russia |
| Research Site | Vladivostok | Russia |
| Research Site | Volgograd | Russia |
| Research Site | Yaroslavl | Russia |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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