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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer

Detailed Description

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 (Actual): 774

Contacts and Locations

Study Locations

• Russian Federation
  • Arkhangelsk, Russian Federation
    • Research Site
  • Barnaul, Russian Federation
    • Research Site
  • Belgorod, Russian Federation
    • Research Site
  • Chelyabinsk, Russian Federation
    • Research Site
  • Grozniy, Russian Federation
    • Research Site
  • Irkutsk, Russian Federation
    • Research Site
  • Kaluga, Russian Federation
    • Research Site
  • Kchabarovsk, Russian Federation
    • Research Site
  • Khanty-Mansiysk, Russian Federation
    • Research Site
  • Kommunarka, Russian Federation
    • Research Site
  • Kostroma, Russian Federation
    • Research Site
  • Krasnodar, Russian Federation
    • Research Site
  • Krasnoyarsk, Russian Federation
    • Research Site
  • Moscow, Russian Federation
    • Research Site
  • Perm, Russian Federation
    • Research Site
  • Pyatigorsk, Russian Federation
    • Research Site
  • Ryazan, Russian Federation
    • Research Site
  • Sakhalin, Russian Federation
    • Research Site
  • Saransk, Russian Federation
    • Research Site
  • Sochi, Russian Federation
    • Research Site
  • St.Petersburg, Russian Federation
    • Research Site
  • Surgut, Russian Federation
    • Research Site
  • Tomsk, Russian Federation
    • Research Site
  • Tver, Russian Federation
    • Research Site
  • Ufa, Russian Federation
    • Research Site
  • Ulan-Ude, Russian Federation
    • Research Site
  • Vladivostok, Russian Federation
    • Research Site
  • Volgograd, Russian Federation
    • Research Site
  • Yaroslavl, Russian Federation
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 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;
• Age ≥ 18 years at the time of inclusion.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 %)	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 Outcome Measures

Outcome Measure	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	Anticancer therapy;; Concomitant therapy.	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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Oleg Selyutin, Voronezh Regional Oncology Dispensary; Principal Investigator: Yana Chapko, Arkhangelsk Regional Clinical Oncology Dispensary; Principal Investigator: Nadezhda Kovalenko, State Budgetary Healthcare Institution Volgograd Regional Clinical Oncology Dispensary #1; Principal Investigator: Aleksander Sultanbaev, Republican Clinical Oncology Dispensary MoH of the Republic of Bashkortostan; Principal Investigator: Beslan Kertiev, GBUZ Oncological Dispensary of the Ministry of Health of the Kabardino-Balkar Republic; Principal Investigator: Yuliya Makarova, Krasnodar Regional Clinical Oncology Center; Principal Investigator: Ruslan Zukov, Krasnoyarsk Regional Clinical Oncology Clinic named after Kryzhanovsky A.I.; Principal Investigator: Sergey Belonogov, GBUZ Yaroslavl region Regional Clinical Oncology Hospital; Principal Investigator: Irina Shumskaya, Nizhny Novgorod Oblast Clinical Oncology Dispensary; Principal Investigator: Konstantin Shetinin, State Healthcare Institution Orenburg regional clinical onco; Principal Investigator: Marina Shomova, Ryazan Regional clinical oncology dispensary; Principal Investigator: Igor Kudryavtsev, Regional Clinical Oncological Dispensary; Principal Investigator: Yulia Makarycheva, State Healthcare Institution Samara Regional Clinical Oncolo; Principal Investigator: Sergey Startsev, State Budget Healthcare Institution - Sakhalin Regional Oncology Dispensary; Principal Investigator: Rustem Safin, Republican clinical oncological center; Principal Investigator: Lyudmila Dunaeva, Tomsk Regional Clinical Hospital; Principal Investigator: Sergey Panchenko, GUZ Oblastnoy klinicheskiy Onkologicheskiy dispanser; Principal Investigator: Olga Novikova, Regional Clinical Oncology Center; Principal Investigator: Natalia Fadeeva, Chelyabinsk district Oncology and Nuclear Medicine Center; Principal Investigator: Hedi Musaeva, Imed Clinic; Principal Investigator: Elena Matyushina, Oncologic Dispensary of Komi Republic; Principal Investigator: Nina Tyukavina, St.Petersburg City Hospital 40; Principal Investigator: Elena Babich, Khanty-Mansiysk Regional Clinical Hospital; Principal Investigator: Mikhail Khabarov, RSBI of RF "Kostroma Oncology Center"; Principal Investigator: Murat Shakhiev, Adygea Republican Clinical Oncology Dispensary; Principal Investigator: Ivan Karnaukhov, FGBOUVO "Saint-Petersburg State University"; Principal Investigator: Vladislav Petkau, Sverdlovsk Regional Oncology Dispensary; Principal Investigator: Dmitriy Ponomarenko, Irkutsk Regional Clinical Hospital; Principal Investigator: Elena Rossokha, Altai Regional Oncology Dispensary

Publications and helpful links

Helpful Links

• Redacted CSR Synopsis

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2023
• Primary Completion (Actual): March 29, 2024
• Study Completion (Actual): March 29, 2024

Study Registration Dates

• First Submitted: June 1, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: D133HR00027