Breast CancerNCT05905939
HER2(Human Epidermal Growth Factor Receptor 2) -Positive Metastatic Breast Cancer in Russia
An observational study of Breast Cancer, run by AstraZeneca at 29 sites in Russia.
Trial summary
Planned study population consists of approximately 1,000 adult patients with HER2-positive mBC receiving anti-HER2 therapy in about 50 oncological centers (in each center it is expected to recruit about 20 patients) in different regions in order to provide representative study sample. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 774 participants
- Where
- 29 sitesRussia
- Study dates
- 31 May 2023to 29 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This non-interventional multicenter observational study will include 1,000 adult patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan). Patients will be included in about 50 oncological centers (in each center it is expected to recruit about 20 patients) in various regions of Russian Federation
Who may be able to join
- Patients with HER2-positive mBC who are receiving or have started any anti-HER2 therapy (except for trastuzumab deruxtecan) at the time of inclusion;
- The diagnosis of mBC was established between the 1st July 2021 and the 1st July 2022;
- Patients with the availability of at least 12 months of follow-up data (from the index data) in the medical records at the participating site, unless patient died within the first 12 months of diagnosis;
- Age ≥ 18 years at the time of inclusion.
Who cannot join
- Presence of other malignancies within period since diagnosis until the timepoint of data collection;
- Patients receiving trastuzumab deruxtecan currently or in the anamnesis;
- The participation in any randomized controlled trial within period since diagnosis until end of study.
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
Russia29 sites
Research Site
Arkhangelsk
Research Site
Barnaul
Research Site
Belgorod
Research Site
Chelyabinsk
Research Site
Grozny
Research Site
Irkutsk
Research Site
Kaluga
Research Site
Kchabarovsk
Research Site
Khanty-Mansiysk
Research Site
Kommunarka
Research Site
Kostroma
Research Site
Krasnodar
Research Site
Krasnoyarsk
Research Site
Moscow
Research Site
Perm
Research Site
Pyatigorsk
Research Site
Ryazan
Research Site
Saint Petersburg
Research Site
Sakhalin
Research Site
Saransk
Research Site
Sochi
Research Site
Surgut
Research Site
Tomsk
Research Site
Tver'
Research Site
Ufa
Research Site
Ulan-Ude
Research Site
Vladivostok
Research Site
Volgograd
Research Site
Yaroslavl
About this study
Official 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)-Positive Metastatic Breast Cancer
Planned study population consists of approximately 1,000 adult patients with HER2-positive mBC receiving anti-HER2 therapy in about 50 oncological centers (in each center it is expected to recruit about 20 patients) in different regions in order to provide representative study sample. Patients will be included consecutively from the least recent diagnosis (within defined time period).
Planned retrospective follow-up period for 1 patient is a period starting from the date of mBC diagnosis until end study or until patient's death, whichever occurs first. End of study will be at least 12 months after the latest date of mBC diagnosis to ensure all patients have the opportunity to contribute at least 12 months of data.
Read the detailed description
Planned study population consists of approximately 1,000 adult patients with HER2-positive mBC receiving anti-HER2 therapy in about 50 oncological centers (in each center it is expected to recruit about 20 patients) in different regions in order to provide representative study sample. Patients will be included consecutively from the least recent diagnosis (within defined time period).
Planned retrospective follow-up period for 1 patient is a period starting from the date of mBC diagnosis until end study or until patient's death, whichever occurs first. End of study will be at least 12 months after the latest date of mBC diagnosis to ensure all patients have the opportunity to contribute at least 12 months of data.
Only patients who were diagnosed between the 1st July 2021 and 1st July 2022 will be included. Patients should have at least 12 months of follow-up data. In case patient died within the first 12 months of diagnosis, these data from date of mBC diagnosis until patient's death should also be included. It will be multicenter study
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe the clinical and demographic profiles of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in the Russian Federation
Demographics characteristics : age(years)
Measured: up to 6 month
To describe the clinical and demographic profiles of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in the Russian Federation
- Demographics characteristics : gender
Measured: up to 6 month
To describe the clinical and demographic profiles of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in the Russian Federation
- Demographics characteristics : body mass index [BMI]);
Measured: up to 6 month
To describe the clinical and demographic profiles of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in the Russian Federation
Clinical characteristics, including BC history, family and personal oncology history
Measured: up to 6 month
To describe the clinical and demographic profiles of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in the Russian Federation
Clinical characteristics: ECOG status
Measured: up to 6 month
To describe the clinical and demographic profiles of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in the Russian Federation
Clinical characteristics: HER2, estrogen receptor (ER), progesterone receptor (PR) expression status, Ki67 expression status (in %)
Measured: up to 6 month
To describe the clinical and demographic profiles of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in the Russian Federation
Clinical characteristics: number of metastatic sites and localization
Measured: up to 6 month
Secondary outcomes (6)
To describe data on the diagnostic algorithms and therapeutic tactics in patients with HER2-positive mBC in routine practice in the Russian Federation
- Proportion of patients with different diagnostic method(s) used for the diagnosis;
Measured: up to 6 month
To describe data on the treatment approach in patients with HER2-positive mBC in routine practice in the Russian Federation
- Anticancer therapy;
- Concomitant therapy.
Measured: up to 6 month
To assess the treatment outcomes of patients with HER2-positive mBC in routine practice in the Russian Federation
-Number of therapy lines, schemes and duration;
Measured: up to 6 month
To describe data on the diagnostic algorithms and therapeutic tactics in patients with HER2-positive mBC in routine practice in the Russian Federation
- Proportion of patients treated for early BC (if conducted).
Measured: up to 6 month
To assess the treatment outcomes of patients with HER2-positive mBC in routine practice in the Russian Federation
-Reasons for anticancer therapy discontinuation, if applicable;
Measured: up to 6 month
To assess the treatment outcomes of patients with HER2-positive mBC in routine practice in the Russian Federation
-Time to treatment discontinuation (TTD), defined as the median time from the starting first line therapy to the treatment discontinuation from any cause;
Measured: up to 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start31 May 2023
- Primary completion29 Mar 2024
- Study completion29 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 774 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905939
- Sponsor's protocol ID
- D133HR00027
- Status last verified
- Mar 2025
- First submitted
- 1 Jun 2023
- Last updated
- 1 Apr 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)-Positive Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT05905939
- Acronym / sponsor ID
- D133HR00027
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 774 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 31 May 2023 (actual)
- Primary completion
- 29 Mar 2024 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Planned study population consists of approximately 1,000 adult patients with HER2-positive mBC receiving anti-HER2 therapy in about 50 oncological centers (in each center it is expected to recruit about 20 patients) in different regions in order to provide representative study sample. Patients will be included consecutively from the least recent diagnosis (within defined time period).
Planned retrospective follow-up period for 1 patient is a period starting from the date of mBC diagnosis until end study or until patient's death, whichever occurs first. End of study will be at least 12 months after the latest date of mBC diagnosis to ensure all patients have the opportunity to contribute at least 12 months of data.
Detailed description
Planned study population consists of approximately 1,000 adult patients with HER2-positive mBC receiving anti-HER2 therapy in about 50 oncological centers (in each center it is expected to recruit about 20 patients) in different regions in order to provide representative study sample. Patients will be included consecutively from the least recent diagnosis (within defined time period).
Planned retrospective follow-up period for 1 patient is a period starting from the date of mBC diagnosis until end study or until patient's death, whichever occurs first. End of study will be at least 12 months after the latest date of mBC diagnosis to ensure all patients have the opportunity to contribute at least 12 months of data.
Only patients who were diagnosed between the 1st July 2021 and 1st July 2022 will be included. Patients should have at least 12 months of follow-up data. In case patient died within the first 12 months of diagnosis, these data from date of mBC diagnosis until patient's death should also be included. It will be multicenter study
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This non-interventional multicenter observational study will include 1,000 adult patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan). Patients will be included in about 50 oncological centers (in each center it is expected to recruit about 20 patients) in various regions of Russian Federation
Key inclusion criteria (4 listed)
- Patients with HER2-positive mBC who are receiving or have started any anti-HER2 therapy (except for trastuzumab deruxtecan) at the time of inclusion;
- The diagnosis of mBC was established between the 1st July 2021 and the 1st July 2022;
- Patients with the availability of at least 12 months of follow-up data (from the index data) in the medical records at the participating site, unless patient died within the first 12 months of diagnosis;
- Age ≥ 18 years at the time of inclusion.
Key exclusion criteria (3 listed)
- Presence of other malignancies within period since diagnosis until the timepoint of data collection;
- Patients receiving trastuzumab deruxtecan currently or in the anamnesis;
- The participation in any randomized controlled trial within period since diagnosis until end of study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To describe the clinical and demographic profiles of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in the Russian Federation
Time frame: up to 6 month
Demographics characteristics : age(years)
To describe the clinical and demographic profiles of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in the Russian Federation
Time frame: up to 6 month
- Demographics characteristics : gender
To describe the clinical and demographic profiles of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in the Russian Federation
Time frame: up to 6 month
- Demographics characteristics : body mass index [BMI]);
To describe the clinical and demographic profiles of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in the Russian Federation
Time frame: up to 6 month
Clinical characteristics, including BC history, family and personal oncology history
To describe the clinical and demographic profiles of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in the Russian Federation
Time frame: up to 6 month
Clinical characteristics: ECOG status
To describe the clinical and demographic profiles of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in the Russian Federation
Time frame: up to 6 month
Clinical characteristics: HER2, estrogen receptor (ER), progesterone receptor (PR) expression status, Ki67 expression status (in %)
To describe the clinical and demographic profiles of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in the Russian Federation
Time frame: up to 6 month
Clinical characteristics: number of metastatic sites and localization
6 secondary outcomes
To describe data on the diagnostic algorithms and therapeutic tactics in patients with HER2-positive mBC in routine practice in the Russian Federation
Time frame: up to 6 month
To describe data on the treatment approach in patients with HER2-positive mBC in routine practice in the Russian Federation
Time frame: up to 6 month
To assess the treatment outcomes of patients with HER2-positive mBC in routine practice in the Russian Federation
Time frame: up to 6 month
To describe data on the diagnostic algorithms and therapeutic tactics in patients with HER2-positive mBC in routine practice in the Russian Federation
Time frame: up to 6 month
To assess the treatment outcomes of patients with HER2-positive mBC in routine practice in the Russian Federation
Time frame: up to 6 month
To assess the treatment outcomes of patients with HER2-positive mBC in routine practice in the Russian Federation
Time frame: up to 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Redacted CSR SynopsisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by AstraZeneca at 29 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To describe the clinical and demographic profiles of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in the Russian Federation (time frame: up to 6 month). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.