HER2(Human Epidermal Growth Factor Receptor 2) -Positive Metastatic Breast Cancer in Russia
A Multicenter Observational Retrospective Study of Therapeutic Approaches and Clinical Outcomes in Real Clinical Practice in Russian Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer
1 other identifier
observational
774
1 country
29
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2023
Shorter than P25 for all trials
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 31, 2023
CompletedFirst Submitted
Initial submission to the registry
June 1, 2023
CompletedFirst Posted
Study publicly available on registry
June 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 29, 2024
CompletedApril 1, 2025
March 1, 2025
10 months
June 1, 2023
March 26, 2025
Conditions
Outcome Measures
Primary Outcomes (7)
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 %)
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
Secondary Outcomes (6)
To describe data on the diagnostic algorithms and therapeutic tactics in patients with HER2-positive mBC in routine practice in the Russian Federation
up to 6 month
To describe data on the treatment approach in patients with HER2-positive mBC in routine practice in the Russian Federation
up to 6 month
To assess the treatment outcomes of patients with HER2-positive mBC in routine practice in the Russian Federation
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
up to 6 month
To assess the treatment outcomes of patients with HER2-positive mBC in routine practice in the Russian Federation
up to 6 month
- +1 more secondary outcomes
Eligibility Criteria
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
You may qualify if:
- The diagnosis of mBC was established between the 1st July 2021 and the 1st July 2022;
- Patients with the availability of at least 12 months of follow-up data (from the index data) in the medical records at the participating site, unless patient died within the first 12 months of diagnosis;
You may not qualify if:
- Presence of other malignancies within period since diagnosis until the timepoint of data collection;
- Patients receiving trastuzumab deruxtecan currently or in the anamnesis;
- The participation in any randomized controlled trial within period since diagnosis until end of study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (29)
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
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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2023
First Posted
June 15, 2023
Study Start
May 31, 2023
Primary Completion
March 29, 2024
Study Completion
March 29, 2024
Last Updated
April 1, 2025
Record last verified: 2025-03