Metastatic Breast CancerNCT07593196
HER2-positive Metastatic Breast Cancer in Kazakhstan
An observational study of Metastatic Breast Cancer, run by AstraZeneca at 12 sites in Kazakhstan.
Trial summary
Planned study population consists of approximately 240 adult patients with HER2-positive mBC receiving anti-HER2 therapy in 12 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 to 99 years
- Conditions the study is for
- Metastatic Breast Cancer
- How many people
- 240 participants
- Where
- 12 sitesKazakhstan
- Study dates
- 12 Jun 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This non-interventional multicenter observational study will include 240 adult patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan). Patients will be included in about 12 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 January 2022 to 31st December 2023
- Patients with the availability of at least 24 months of follow-up data (from the date of mBC diagnosis) in the medical records at the participating site, unless patient died/moved or refused the therapy within the first 24 months of diagnosis
- Age ≥18 years at the time of inclusion
Who cannot join
- Presence of other malignancies within the period from mBC diagnosis until the timepoint of data collection
- Patients received trastuzumab deruxtecan
- The participation in any interventional trial within period since diagnosis until the end of study
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
12 sites in 1 country
Kazakhstan12 sites, 12 recruiting
- Not yet recruiting
Research Site
Aktobe, 30017
- Recruiting
Research Site
Almaty, 50022
- Recruiting
Research Site
Almaty, 50054
- Recruiting
Research Site
Astana, 10000
- Recruiting
Research Site
Astana, 10017
- Recruiting
Research Site
Karaganda, 100019
- Recruiting
Research Site
Oral, Kazakhstan, 90005
- Recruiting
Research Site
Petropavl, 150000
- Recruiting
Research Site
Semey, 71407
- Not yet recruiting
Research Site
Shymkent, 160000
- Recruiting
Research Site
Shymkent, 160011
- Recruiting
Research Site
Taraz, 80000
About this study
Official title: A Multicenter Observational Retrospective Study of Therapeutic Approaches and Clinical Outcomes in Real Clinical Practice in Kazakhstan Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer
Planned study population consists of approximately 240 adult patients with HER2-positive mBC receiving anti-HER2 therapy in 12 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.
- Conditions
- Metastatic Breast Cancer
- Keywords
- Breast cancer, HER2+
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
(1) To assess median PFS and PFS rate in patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in routine practice in Kazakhstan
Measured: up to 2 years
Secondary outcomes (6)
To describe the clinical and demographic characteristics of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in routine practice in Kazakhstan
Measured: up to 2 years
(2) To describe the diagnostic algorithms and therapeutic tactics in patients with HER2-positive mBC in routine practice in Kazakhstan
Measured: up to 2 years
(3) To describe the treatment approach in patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in routine practice in Kazakhstan
Measured: up to 2 years
(4) To assess the efficacy of anticancer treatment in patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in routine practice in Kazakhstan
Measured: up to 2 years
(5) To describe the reasons for anticancer therapy discontinuation in patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in routine practice in Kazakhstan
Measured: up to 2 years
(6) To assess the number of therapy lines of anticancer treatment in patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in routine practice in Kazakhstan
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start12 Jun 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593196
- Sponsor's protocol ID
- D133FR00252
- Status last verified
- Oct 2026
- First submitted
- 12 May 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Written informed consent is not needed for this study due to its retrospective nature. The protocol will be reviewed by Central Ethics Committee (CEC). CEC approval will be obtained before the start of patients' data collection.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. 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 Kazakhstan Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT07593196
- Acronym / sponsor ID
- D133FR00252
- Conditions
- Metastatic Breast Cancer
- Keywords
- Breast cancer, HER2+
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 May 2026 (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 240 adult patients with HER2-positive mBC receiving anti-HER2 therapy in 12 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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This non-interventional multicenter observational study will include 240 adult patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan). Patients will be included in about 12 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 January 2022 to 31st December 2023
- Patients with the availability of at least 24 months of follow-up data (from the date of mBC diagnosis) in the medical records at the participating site, unless patient died/moved or refused the therapy within the first 24 months of diagnosis
- Age ≥18 years at the time of inclusion
Key exclusion criteria (3 listed)
- Presence of other malignancies within the period from mBC diagnosis until the timepoint of data collection
- Patients received trastuzumab deruxtecan
- The participation in any interventional trial within period since diagnosis until the 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
(1) To assess median PFS and PFS rate in patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in routine practice in Kazakhstan
Time frame: up to 2 years
6 secondary outcomes
To describe the clinical and demographic characteristics of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in routine practice in Kazakhstan
Time frame: up to 2 years
(2) To describe the diagnostic algorithms and therapeutic tactics in patients with HER2-positive mBC in routine practice in Kazakhstan
Time frame: up to 2 years
(3) To describe the treatment approach in patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in routine practice in Kazakhstan
Time frame: up to 2 years
(4) To assess the efficacy of anticancer treatment in patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in routine practice in Kazakhstan
Time frame: up to 2 years
(5) To describe the reasons for anticancer therapy discontinuation in patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in routine practice in Kazakhstan
Time frame: up to 2 years
(6) To assess the number of therapy lines of anticancer treatment in patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in routine practice in Kazakhstan
Time frame: up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No. Written informed consent is not needed for this study due to its retrospective nature. The protocol will be reviewed by Central Ethics Committee (CEC). CEC approval will be obtained before the start of patients' data collection.
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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.
AstraZeneca Clinical Study Information Center contact
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer, run by AstraZeneca at 12 sites in Kazakhstan.
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: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Kazakhstan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(1) To assess median PFS and PFS rate in patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in routine practice in Kazakhstan (time frame: up to 2 years). 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 8 Oct 2026.