HER2-positive Metastatic Breast Cancer in Kazakhstan
ConditionMetastatic Breast Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorAstraZeneca
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 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
Trial design
Design model
Other
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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 yearsSecondary 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 years2
(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 years3
(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 years4
(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 yearsOther 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 yearsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: