HER2(Human Epidermal Growth Factor Receptor 2) -Positive Metastatic Breast Cancer in Russia

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05905939
• Other study ID #: D133HR00027
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

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