HER2-low Unresectable and/or Metastatic Breast Cancer in Russia
NCT ID: NCT05913440
Last Updated: 2025-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1669 participants
OBSERVATIONAL
2023-05-30
2025-03-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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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
Research Site
Kemerovo, , Russia
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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
Countries
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Other Identifiers
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D133HR00029
Identifier Type: -
Identifier Source: org_study_id
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