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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05905939
Other study ID # D133HR00027
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 31, 2023
Est. completion date June 21, 2024

Study information

Verified date March 2024
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email information.center@astrazeneca.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date June 21, 2024
Est. primary completion date June 21, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Russian Federation Research Site Arkhangelsk
Russian Federation Research Site Barnaul
Russian Federation Research Site Belgorod
Russian Federation Research Site Chelyabinsk
Russian Federation Research Site Grozniy
Russian Federation Research Site Irkutsk
Russian Federation Research Site Kaluga
Russian Federation Research Site Kchabarovsk
Russian Federation Research Site Khanty-Mansiysk
Russian Federation Research Site Kommunarka
Russian Federation Research Site Kostroma
Russian Federation Research Site Krasnodar
Russian Federation Research Site Krasnoyarsk
Russian Federation Research Site Moscow
Russian Federation Research Site Moscow
Russian Federation Research Site N.Novgorod
Russian Federation Research Site Nalchik
Russian Federation Research Site Novosibirsk
Russian Federation Research Site Noyabrsk
Russian Federation Research Site Perm
Russian Federation Research Site Pyatigorsk
Russian Federation Research Site Ryazan
Russian Federation Research Site Sakhalin
Russian Federation Research Site Sochi
Russian Federation Research Site St.Petersburg
Russian Federation Research Site St.Petersburg
Russian Federation Research Site Surgut
Russian Federation Research Site Tomsk
Russian Federation Research Site Tver
Russian Federation Research Site Ufa
Russian Federation Research Site Ulan-Ude
Russian Federation Research Site Vladivostok
Russian Federation Research Site Volgograd
Russian Federation Research Site Yaroslavl

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Demographics characteristics : age(years) up to 6 month
Primary 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 - Demographics characteristics : gender up to 6 month
Primary 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 - Demographics characteristics : body mass index [BMI]); up to 6 month
Primary 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 Clinical characteristics, including BC history, family and personal oncology history up to 6 month
Primary 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 Clinical characteristics: ECOG status up to 6 month
Primary 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 Clinical characteristics: HER2, estrogen receptor (ER), progesterone receptor (PR) expression status, Ki67 expression status (in %) up to 6 month
Primary 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 Clinical characteristics: number of metastatic sites and localization up to 6 month
Secondary To describe data on the diagnostic algorithms and therapeutic tactics in patients with HER2-positive mBC in routine practice in the Russian Federation - Proportion of patients with different diagnostic method(s) used for the diagnosis; up to 6 month
Secondary To describe data on the treatment approach in patients with HER2-positive mBC in routine practice in the Russian Federation Anticancer therapy;
Concomitant therapy.
up to 6 month
Secondary To assess the treatment outcomes of patients with HER2-positive mBC in routine practice in the Russian Federation -Number of therapy lines, schemes and duration; up to 6 month
Secondary To describe data on the diagnostic algorithms and therapeutic tactics in patients with HER2-positive mBC in routine practice in the Russian Federation - Proportion of patients treated for early BC (if conducted). up to 6 month
Secondary To assess the treatment outcomes of patients with HER2-positive mBC in routine practice in the Russian Federation -Reasons for anticancer therapy discontinuation, if applicable; up to 6 month
Secondary To assess the treatment outcomes of patients with HER2-positive mBC in routine practice in the Russian Federation -Time to treatment discontinuation (TTD), defined as the median time from the starting first line therapy to the treatment discontinuation from any cause; up to 6 month
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