HER2-positive Metastatic Breast Cancer in Kazakhstan

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Metastatic Breast Cancer

• Study Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• Kazakhstan
  • Aktobe, Kazakhstan, 30017
    • Medical Centre of the Marat Ospanov West Kazakhstan Medical University, Aktobe
  • Almaty, Kazakhstan, 50022
    • 'Kazakh Research Institute of Oncology and Radiology (KAZNIOR)'
  • Almaty, Kazakhstan, 50054
    • Almaty Cancer Centre
  • Astana, Kazakhstan, 10000
    • 'Multidisciplinary Medical Centre' of the Astana City Administration
  • Astana, Kazakhstan, 10017
    • National Cancer Research Centre, Astana
  • Karaganda, Kazakhstan, 100019
    • 'Karaganda General Hospital No. 3' of the Karaganda Region Health Department
  • Petropavl, Kazakhstan, 150000
    • 'General Regional Hospital' of the municipal state institution 'Health Department of the Akimat of North Kazakhstan Region' Petropavlovsk
  • Semey, Kazakhstan, 71407
    • 'Centre for Nuclear Medicine and Oncology' Abai Regional Health Authority Semey
  • Shymkent, Kazakhstan, 160000
    • 'Shymkent City General Hospital with Oncology Centre' under the Shymkent City Health Department
  • Shymkent, Kazakhstan, 160011
    • 'Regional Clinical Hospital' of the Health Department of the Turkestan Region
  • Taraz, Kazakhstan, 80000
    • 'The Zhambyl Regional Multidisciplinary Centre for Oncology and Surgery' of the Health Department of the Zhambyl Regional Administration, Taraz
  • Kazakhstan
    • Oral, Kazakhstan, Kazakhstan, 90005
      • 'Regional Cancer Centre' Uralsk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
(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	up to 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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	up to 2 years
(2) To describe the diagnostic algorithms and therapeutic tactics in patients with HER2-positive mBC in routine practice in Kazakhstan	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	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	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	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	up to 2 years

Other Outcome Measures

Outcome Measure	Time Frame
To assess change in HER2 status in patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in Kazakhstan	up to 2 years

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Estimated): May 19, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): January 30, 2027

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Breast cancer; HER2+
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: D133FR00252

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No