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Russian breast cancer study maps Real-World care for HER2-Low patients

NCT ID NCT05913440

Knowledge-focused Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked back at medical records of over 1,600 adults in Russia with HER2-low breast cancer that had spread or could not be removed by surgery. Researchers wanted to understand how common this type is, what patient characteristics are, and how doctors actually diagnose and treat it in everyday practice. The goal was to gather information, not to test a new treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

1,669 people

The number who actually took part.

Started

May 2023

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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 ).

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • 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

  • Research Site

    Kemerovo, Russia

  • Research Site

    Khanty-Mansiysk, Russia

  • Research Site

    Kirov, Russia

  • Research Site

    Kostroma, Russia

  • Research Site

    Krasnodar, Russia

  • Research Site

    Krasnoyarsk, Russia

  • Research Site

    Maykop, Russia

  • Research Site

    Moscow, Russia

  • Research Site

    Nal'chik, Russia

  • Research Site

    Nizhny Novgorod, Russia

  • Research Site

    Novosibirsk, Russia

  • Research Site

    Omsk, Russia

  • Research Site

    Orenburg, Russia

  • Research Site

    Perm, Russia

  • Research Site

    Pyatigorsk, Russia

  • Research Site

    Ryazan, Russia

  • Research Site

    Saint Petersburg, Russia

  • Research Site

    Saransk, Russia

  • Research Site

    Sevedorvinsk, Russia

  • Research Site

    Smolensk, 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

  • Research Site

    Yuzhno-Sakhalinsk, Russia

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