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NCT Number: NCT05913440

HER2-low Unresectable and/or Metastatic Breast Cancer in Russia

Planned study population consists of approximately 3,150 adult patients with HER2-negative (IHC 0, + or IHC2+/ISH-) unresectable or metastatic BC enrolled to the study in order to obtain approximately 2,000 patients with confirmed HER2 low status (IHC1+ or IHC2+/ISH ).

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Arkhangelsk, Russia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with confirmed diagnosis of unresectable and/or metastatic BC established between the 1st July 2021 and the 1st July 2022.
  • Patients have HER2-negative status (IHC0, IHC1+, IHC2+/ISH-) obtained in the local laboratory.

-. Patients have an adequate archival tumor sample and slides suitable for reassessment HER2 status* by the reference laboratory.

  • Patients have documented hormonal status (ER, PR) IHC score.
  • Age ≥ 18 years at the time of inclusion.
  • Patients provided written consent allowing for data and samples to be used in the future and this study would be covered by the consent for future use in accordance with ICH GCP, GPP (Good Pharmacoepidemiology Practices) and local law prior to inclusion in the study. If the patient is deceased, a waiver may be accepted

Exclusion criteria

  • Patients with previous HER2 positive status in the anamnesis at the diagnosis or after the diagnosis of breast cancer.
  • Presence of other malignancies within period since diagnosis until the timepoint of data collection.
  • Patients receiving trastuzumab deruxtecan currently or received in anamnesis.
  • The participation in any randomised controlled trial within period since diagnosis until end of study.

Treatment and study plan

Primary outcomes

  1. To study the overall prevalence of HER2-low among patients with HER2-negative mBC, based on reassessment of historical HER2 fixed tissue IHC stained slides assay in the Russian Federation

    Time frame: 12 months

  2. To study the clinical-pathological, histopathological and demographic profiles of patients of HR-positive and HR-negative HER2-low status among unresectable and/or mBC patients identified as HER2-negative HR-positive/negative

    Time frame: 12 months

    Clinical and demographic data, as well as other study variables will be presented as frequencies or percentages, or as the mean value, standard deviation, median, quantiles, minimum and maximum, depending on the type of variable (continuous or categorical) for the total sample and all subgroups (if applicable).

Secondary outcomes

  1. To describe data on the diagnostic algorithms and therapeutic tactics in patients with HR-positive and HR-negative HER2-low unresectable and/or mBC in routine practice in the Russian Federation

    Time frame: 12 months

    Data on methods used for diagnosis will be presented as frequencies or percentages, or as the mean value, standard deviation, median, quartiles, minimum and maximum, depending on the type of variable (categorical or continuous) for the total sample and all subgroups

  2. To describe data on the treatment approach in patients with HR-positive and HR-negative HER2-low unresectable and/or mBC in routine practice in the Russian Federation, and the sequence of therapy administration (HR-positive and HR-negative).

    Time frame: 12 months

    Data on methods used for anticancer and concomitant treatment will be presented as frequencies or percentages, or as the mean value, standard deviation, median, quartiles, minimum and maximum, depending on the type of variable (categorical or continuous) for the total sample and all subgroups

  3. To assess the treatment outcomes of patients with HR-positive and HR-negative HER2-low unresectable and/or mBC in routine practice in the Russian Federation

    Time frame: 12 months

    Data on methods used for anticancer and concomitant treatment will be presented as frequencies or percentages, or as the mean value, standard deviation, median, quartiles, minimum and maximum, depending on the type of variable (categorical or continuous) for the total sample and all subgroups

  4. To characterize the concordance between HER2 IHC scores in local and reference laboratories after reassessment in the reference lab (IHC 0, 1+, 2+/ISH-) using the existing, and refined, criteria of ASCO/CAP definition

    Time frame: 12 months

    The frequency of concordance of IHC HER2 scores and ISH results between local and reference laboratories will be calculated along with exact 95% CIs. Cohen's Kappa statistics will be used to evaluate concordance between HER2 IHC scores in local and reference laboratories.

  5. To describe the concordance of HER2 status evaluations performed in a reference laboratory by a pathologist manually and by an artificial intelligence (AI) program.

    Time frame: 12 months

    Concordance assessed using Cohen's Kappa statistics (positive, negative and overall agreement) between HER2 status evaluations performed in a reference laboratory by a pathologist manually and by an AI program.

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)-Low Unresectable and/or Metastatic Breast Cancer

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 22, 2023
Registry last updated
Mar 12, 2026

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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