Clinical trial NCT05905939: HER2(Human Epidermal Growth Factor Receptor 2) -Positive Metastatic Breast Cancer in Russia
Official title: A Multicenter Observational Retrospective Study of Therapeutic Approaches and Clinical Outcomes in Real Clinical Practice in Russian Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-06-15
Enrollment: 774
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This non-interventional multicenter observational study will include 1,000 adult patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan).

Patients will be included in about 50 oncological centers (in each center it is expected to recruit about 20 patients) in various regions of Russian Federation

Brief summary: Planned study population consists of approximately 1,000 adult patients with HER2-positive mBC receiving anti-HER2 therapy in about 50 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.

Detailed description: Planned study population consists of approximately 1,000 adult patients with HER2-positive mBC receiving anti-HER2 therapy in about 50 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.

Only patients who were diagnosed between the 1st July 2021 and 1st July 2022 will be included. Patients should have at least 12 months of follow-up data. In case patient died within the first 12 months of diagnosis, these data from date of mBC diagnosis until patient's death should also be included. It will be multicenter study

Eligibility criteria: 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 July 2021 and the 1st July 2022;
* Patients with the availability of at least 12 months of follow-up data (from the index data) in the medical records at the participating site, unless patient died within the first 12 months of diagnosis;
* Age ≥ 18 years at the time of inclusion.

Exclusion Criteria:

* Presence of other malignancies within period since diagnosis until the timepoint of data collection;
* Patients receiving trastuzumab deruxtecan currently or in the anamnesis;
* The participation in any randomized controlled trial within period since diagnosis until end of study.

Primary outcomes:
measure: To describe the clinical and demographic profiles of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in the Russian Federation
timeFrame: up to 6 month
measure: To describe the clinical and demographic profiles of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in the Russian Federation
timeFrame: up to 6 month
measure: To describe the clinical and demographic profiles of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in the Russian Federation
timeFrame: up to 6 month
measure: To describe the clinical and demographic profiles of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in the Russian Federation
timeFrame: up to 6 month
measure: To describe the clinical and demographic profiles of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in the Russian Federation
timeFrame: up to 6 month
measure: To describe the clinical and demographic profiles of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in the Russian Federation
timeFrame: up to 6 month
measure: To describe the clinical and demographic profiles of patients with HER2-positive mBC receiving anti-HER2 therapy (except for trastuzumab deruxtecan) in the Russian Federation
timeFrame: up to 6 month
Secondary outcomes:
measure: To describe data on the diagnostic algorithms and therapeutic tactics in patients with HER2-positive mBC in routine practice in the Russian Federation
timeFrame: up to 6 month
measure: To describe data on the treatment approach in patients with HER2-positive mBC in routine practice in the Russian Federation
timeFrame: up to 6 month
measure: To assess the treatment outcomes of patients with HER2-positive mBC in routine practice in the Russian Federation
timeFrame: up to 6 month
measure: To describe data on the diagnostic algorithms and therapeutic tactics in patients with HER2-positive mBC in routine practice in the Russian Federation
timeFrame: up to 6 month
measure: To assess the treatment outcomes of patients with HER2-positive mBC in routine practice in the Russian Federation
timeFrame: up to 6 month
measure: To assess the treatment outcomes of patients with HER2-positive mBC in routine practice in the Russian Federation
timeFrame: up to 6 month
Other outcomes:
Locations:
city: Arkhangelsk
country: Russian Federation
facility: Research Site
city: Barnaul
country: Russian Federation
facility: Research Site
city: Belgorod
country: Russian Federation
facility: Research Site
city: Chelyabinsk
country: Russian Federation
facility: Research Site
city: Grozniy
country: Russian Federation
facility: Research Site
city: Irkutsk
country: Russian Federation
facility: Research Site
city: Kaluga
country: Russian Federation
facility: Research Site
city: Kchabarovsk
country: Russian Federation
facility: Research Site
city: Khanty-Mansiysk
country: Russian Federation
facility: Research Site
city: Kommunarka
country: Russian Federation
facility: Research Site
city: Kostroma
country: Russian Federation
facility: Research Site
city: Krasnodar
country: Russian Federation
facility: Research Site
city: Krasnoyarsk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Perm
country: Russian Federation
facility: Research Site
city: Pyatigorsk
country: Russian Federation
facility: Research Site
city: Ryazan
country: Russian Federation
facility: Research Site
city: Sakhalin
country: Russian Federation
facility: Research Site
city: Saransk
country: Russian Federation
facility: Research Site
city: Sochi
country: Russian Federation
facility: Research Site
city: St.Petersburg
country: Russian Federation
facility: Research Site
city: Surgut
country: Russian Federation
facility: Research Site
city: Tomsk
country: Russian Federation
facility: Research Site
city: Tver
country: Russian Federation
facility: Research Site
city: Ufa
country: Russian Federation
facility: Research Site
city: Ulan-Ude
country: Russian Federation
facility: Research Site
city: Vladivostok
country: Russian Federation
facility: Research Site
city: Volgograd
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
Study officials:
References: