ClinicalTrials.gg
RecruitingNCT07593196Updated Oct 8, 2026

HER2-positive Metastatic Breast Cancer in Kazakhstan

An observational study in Metastatic Breast Cancer, sponsored by AstraZeneca. Recruiting at 12 sites in Kazakhstan. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by AstraZeneca · Observational

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.
Updated Oct 8, 2026Now RecruitingStart date moved+4 moreGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
240
Ages
18 Years to 99 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Metastatic Breast Cancer

Browse trials for

Keywords

  • Breast cancer
  • HER2+
03

In context

Breast Neoplasms

14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.

This study's planned enrollment of 240 is above the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with -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

Exclusion criteria

Exclusion Criteria:

  • Presence of other 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HER2

HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.

In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
240 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. (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

Secondary outcomes

  1. 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. (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. (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. (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. (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. (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

Other outcomes

  1. To assess change in HER2 status in patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in Kazakhstan

    Time frame: up to 2 years

07

Study locations

10 of 12 sites recruiting
  • Research Site
    Oral, Kazakhstan 90005, Kazakhstan
    Recruiting
  • Research Site
    Aktobe, 30017, Kazakhstan
    Not yet recruiting
  • Research Site
    Almaty, 50022, Kazakhstan
    Recruiting
  • Research Site
    Almaty, 50054, Kazakhstan
    Recruiting
  • Research Site
    Astana, 10000, Kazakhstan
    Recruiting
  • Research Site
    Astana, 10017, Kazakhstan
    Recruiting
  • Research Site
    Karaganda, 100019, Kazakhstan
    Recruiting
  • Research Site
    Petropavl, 150000, Kazakhstan
    Recruiting
  • Research Site
    Semey, 71407, Kazakhstan
    Recruiting
  • Research Site
    Shymkent, 160000, Kazakhstan
    Not yet recruiting
  • Research Site
    Shymkent, 160011, Kazakhstan
    Recruiting
  • Research Site
    Taraz, 80000, Kazakhstan
    Recruiting
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started Jun 2026 (actual). Primary completion is estimated for Dec 2026, 6 months after the start.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 8, 2026: start May 2026 → Jun 2026, primary completion Sep 2026 → Dec 2026 and completion Jan 2027 → Dec 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
May 12, 2026
First posted
May 18, 2026
StartActual
Jun 12, 2026was May 2026
Primary completionEst.
Dec 31, 2026was Sep 2026
CompletionEst.
Dec 31, 2026was Jan 2027
Last update
Oct 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 8, 2026
Sites
12 sites added, 12 sites removed
Show 12 added (12 Kazakhstan)
  • Research Site · Oral, Kazakhstan
  • Research Site · Aktobe, Kazakhstan
  • Research Site · Almaty, Kazakhstan
  • Research Site · Almaty, Kazakhstan
  • Research Site · Astana, Kazakhstan
  • Research Site · Astana, Kazakhstan
  • Research Site · Karaganda, Kazakhstan
  • Research Site · Petropavl, Kazakhstan
  • Research Site · Semey, Kazakhstan
  • Research Site · Shymkent, Kazakhstan
  • Research Site · Shymkent, Kazakhstan
  • Research Site · Taraz, Kazakhstan
Show 12 removed
  • 'Regional Cancer Centre' Uralsk · Oral, Kazakhstan
  • Medical Centre of the Marat Ospanov West Kazakhstan Medical University, Aktobe · Aktobe, Kazakhstan
  • 'Kazakh Research Institute of Oncology and Radiology (KAZNIOR)' · Almaty, Kazakhstan
  • Almaty Cancer Centre · Almaty, Kazakhstan
  • 'Multidisciplinary Medical Centre' of the Astana City Administration · Astana, Kazakhstan
  • National Cancer Research Centre, Astana · Astana, Kazakhstan
  • 'Karaganda General Hospital No. 3' of the Karaganda Region Health Department · Karaganda, Kazakhstan
  • 'General Regional Hospital' of the municipal state institution 'Health Department of the Akimat of North Kazakhstan Region' Petropavlovsk · Petropavl, Kazakhstan
  • 'Centre for Nuclear Medicine and Oncology' Abai Regional Health Authority Semey · Semey, Kazakhstan
  • 'Shymkent City General Hospital with Oncology Centre' under the Shymkent City Health Department · Shymkent, Kazakhstan
  • 'Regional Clinical Hospital' of the Health Department of the Turkestan Region · Shymkent, Kazakhstan
  • 'The Zhambyl Regional Multidisciplinary Centre for Oncology and Surgery' of the Health Department of the Zhambyl Regional Administration, Taraz · Taraz, Kazakhstan
Oct 8, 2026
Start date
May 19, 2026→Jun 12, 2026 (actual)
Oct 8, 2026
Primary completion
Sep 30, 2026→Dec 31, 2026
Oct 8, 2026
Study completion
Jan 30, 2027→Dec 31, 2026
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    Not yet recruiting→Recruiting
    12 sites added, 12 sites removed
    Show 12 added (12 Kazakhstan)
    • Research Site · Oral, Kazakhstan
    • Research Site · Aktobe, Kazakhstan
    • Research Site · Almaty, Kazakhstan
    • Research Site · Almaty, Kazakhstan
    • Research Site · Astana, Kazakhstan
    • Research Site · Astana, Kazakhstan
    • Research Site · Karaganda, Kazakhstan
    • Research Site · Petropavl, Kazakhstan
    • Research Site · Semey, Kazakhstan
    • Research Site · Shymkent, Kazakhstan
    • Research Site · Shymkent, Kazakhstan
    • Research Site · Taraz, Kazakhstan
    Show 12 removed
    • 'Regional Cancer Centre' Uralsk · Oral, Kazakhstan
    • Medical Centre of the Marat Ospanov West Kazakhstan Medical University, Aktobe · Aktobe, Kazakhstan
    • 'Kazakh Research Institute of Oncology and Radiology (KAZNIOR)' · Almaty, Kazakhstan
    • Almaty Cancer Centre · Almaty, Kazakhstan
    • 'Multidisciplinary Medical Centre' of the Astana City Administration · Astana, Kazakhstan
    • National Cancer Research Centre, Astana · Astana, Kazakhstan
    • 'Karaganda General Hospital No. 3' of the Karaganda Region Health Department · Karaganda, Kazakhstan
    • 'General Regional Hospital' of the municipal state institution 'Health Department of the Akimat of North Kazakhstan Region' Petropavlovsk · Petropavl, Kazakhstan
    • 'Centre for Nuclear Medicine and Oncology' Abai Regional Health Authority Semey · Semey, Kazakhstan
    • 'Shymkent City General Hospital with Oncology Centre' under the Shymkent City Health Department · Shymkent, Kazakhstan
    • 'Regional Clinical Hospital' of the Health Department of the Turkestan Region · Shymkent, Kazakhstan
    • 'The Zhambyl Regional Multidisciplinary Centre for Oncology and Surgery' of the Health Department of the Zhambyl Regional Administration, Taraz · Taraz, Kazakhstan
    Start date May 19, 2026→Jun 12, 2026 (now actual)
    Primary completion Sep 30, 2026→Dec 31, 2026
    Study completion Jan 30, 2027→Dec 31, 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07593196
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
May 18, 2026
Start date
Jun 12, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Oct 8, 2026

Study contacts

AstraZeneca Clinical Study Information Center
Contact
information.center@astrazeneca.com
1-877-240-9479

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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