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
Study Type
OBSERVATIONAL
Enrollment
774
Research Site
Arkhangelsk, Russia
Research Site
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
...and 19 more locations
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)
Time frame: 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
Time frame: 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 \[BMI\]);
Time frame: 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
Time frame: 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
Time frame: 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 %)
Time frame: 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
Time frame: 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 with different diagnostic method(s) used for the diagnosis;
Time frame: up to 6 month
To describe data on the treatment approach in patients with HER2-positive mBC in routine practice in the Russian Federation
* Anticancer therapy; * Concomitant therapy.
Time frame: 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;
Time frame: 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).
Time frame: 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;
Time frame: 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;
Time frame: up to 6 month
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