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Completed

NCT Number: NCT05905939

HER2(Human Epidermal Growth Factor Receptor 2) -Positive Metastatic Breast Cancer in Russia

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Arkhangelsk, Russia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

    Time frame: up to 6 month

    Demographics characteristics : age(years)

  2. 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

    Time frame: up to 6 month

    • Demographics characteristics : gender
  3. 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

    Time frame: up to 6 month

    • Demographics characteristics : body mass index [BMI]);
  4. 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

    Time frame: up to 6 month

    Clinical characteristics, including BC history, family and personal oncology history

  5. 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

    Time frame: up to 6 month

    Clinical characteristics: ECOG status

  6. 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

    Time frame: up to 6 month

    Clinical characteristics: HER2, estrogen receptor (ER), progesterone receptor (PR) expression status, Ki67 expression status (in %)

  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

    Time frame: up to 6 month

    Clinical characteristics: number of metastatic sites and localization

Secondary outcomes

  1. To describe data on the diagnostic algorithms and therapeutic tactics in patients with HER2-positive mBC in routine practice in the Russian Federation

    Time frame: up to 6 month

    • Proportion of patients with different diagnostic method(s) used for the diagnosis;
  2. To describe data on the treatment approach in patients with HER2-positive mBC in routine practice in the Russian Federation

    Time frame: up to 6 month

    • Anticancer therapy;
    • Concomitant therapy.
  3. To assess the treatment outcomes of patients with HER2-positive mBC in routine practice in the Russian Federation

    Time frame: up to 6 month

    -Number of therapy lines, schemes and duration;

  4. To describe data on the diagnostic algorithms and therapeutic tactics in patients with HER2-positive mBC in routine practice in the Russian Federation

    Time frame: up to 6 month

    • Proportion of patients treated for early BC (if conducted).
  5. To assess the treatment outcomes of patients with HER2-positive mBC in routine practice in the Russian Federation

    Time frame: up to 6 month

    -Reasons for anticancer therapy discontinuation, if applicable;

  6. To assess the treatment outcomes of patients with HER2-positive mBC in routine practice in the Russian Federation

    Time frame: up to 6 month

    -Time to treatment discontinuation (TTD), defined as the median time from the starting first line therapy to the treatment discontinuation from any cause;

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 15, 2023
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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