HER2-positive Metastatic Breast Cancer in Kazakhstan

NCT07593196 | Not Yet Recruiting

• 1 other identifier: D133FR00252
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Metastatic Breast Cancer

Keywords

Breast cancer; HER2+

Outcome Measures

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

  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

  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

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

  up to 2 years

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (12)

'Regional Cancer Centre' Uralsk

Oral, Kazakhstan, 90005, Kazakhstan

Location

Medical Centre of the Marat Ospanov West Kazakhstan Medical University, Aktobe

Aktobe, 30017, Kazakhstan

Location

'Kazakh Research Institute of Oncology and Radiology (KAZNIOR)'

Almaty, 50022, Kazakhstan

Location

Almaty Cancer Centre

Almaty, 50054, Kazakhstan

Location

'Multidisciplinary Medical Centre' of the Astana City Administration

Astana, 10000, Kazakhstan

Location

National Cancer Research Centre, Astana

Astana, 10017, Kazakhstan

Location

'Karaganda General Hospital No. 3' of the Karaganda Region Health Department

Karaganda, 100019, Kazakhstan

Location

'General Regional Hospital' of the municipal state institution 'Health Department of the Akimat of North Kazakhstan Region' Petropavlovsk

Petropavl, 150000, Kazakhstan

Location

'Centre for Nuclear Medicine and Oncology' Abai Regional Health Authority Semey

Semey, 71407, Kazakhstan

Location

'Shymkent City General Hospital with Oncology Centre' under the Shymkent City Health Department

Shymkent, 160000, Kazakhstan

Location

'Regional Clinical Hospital' of the Health Department of the Turkestan Region

Shymkent, 160011, Kazakhstan

Location

'The Zhambyl Regional Multidisciplinary Centre for Oncology and Surgery' of the Health Department of the Zhambyl Regional Administration, Taraz

Taraz, 80000, Kazakhstan

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 18, 2026
• Study Start: May 19, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KA (12)