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 ).
Study Type
OBSERVATIONAL
Enrollment
1,669
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
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
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).
Time frame: 12 months
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
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
Time frame: 12 months
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).
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
Time frame: 12 months
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
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Research Site
Arkhangelsk, Russia
Research Site
Barnaul, Russia
Research Site
Belgorod, Russia
Research Site
Chelyabinsk, Russia
Research Site
Chita, Russia
Research Site
Grozny, Russia
Research Site
Irkutsk, Russia
Research Site
Istra, Russia
Research Site
Izhevsk, Russia
Research Site
Kaluga, Russia
...and 30 more locations
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
Time frame: 12 months
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
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.
Time frame: 12 months
To describe the concordance of HER2 status evaluations performed in a reference laboratory by a pathologist manually and by an artificial intelligence (AI) program.
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.
Time frame: 12 months