NCT05913440

Brief Summary

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 ).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,669

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Geographic Reach
1 country

40 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

May 30, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2025

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

May 30, 2023

Last Update Submit

March 11, 2026

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • 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

    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).

    12 months

Secondary Outcomes (5)

  • 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

    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).

    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

    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

    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.

    12 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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 ).

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (40)

Research Site

Arkhangelsk, Russia

Location

Research Site

Barnaul, Russia

Location

Research Site

Belgorod, Russia

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Research Site

Chelyabinsk, Russia

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Research Site

Chita, Russia

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Grozny, Russia

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Irkutsk, Russia

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Istra, Russia

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Research Site

Izhevsk, Russia

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Kaluga, Russia

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Kemerovo, Russia

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Research Site

Khanty-Mansiysk, Russia

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Kirov, Russia

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Kostroma, Russia

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Research Site

Krasnodar, Russia

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Research Site

Krasnoyarsk, Russia

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Research Site

Maykop, Russia

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Research Site

Moscow, Russia

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Research Site

Nal'chik, Russia

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Nizhny Novgorod, Russia

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Novosibirsk, Russia

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Research Site

Omsk, Russia

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Orenburg, Russia

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Perm, Russia

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Pyatigorsk, Russia

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Ryazan, Russia

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Saint Petersburg, Russia

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Research Site

Saransk, Russia

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Sevedorvinsk, Russia

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Smolensk, Russia

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Sochi, Russia

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Surgut, Russia

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Tomsk, Russia

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Research Site

Tver', Russia

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Ufa, Russia

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Research Site

Ulan-Ude, Russia

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Research Site

Vladivostok, Russia

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Volgograd, Russia

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Research Site

Yaroslavl, Russia

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Research Site

Yuzhno-Sakhalinsk, Russia

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2023

First Posted

June 22, 2023

Study Start

May 30, 2023

Primary Completion

March 14, 2025

Study Completion

March 14, 2025

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
More information

Locations

RU(40)