NCT05905939Completed
HER2(Human Epidermal Growth Factor Receptor 2) -Positive Metastatic Breast Cancer in Russia
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
Source: ClinicalTrials.gov · Last updated 1 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 774 (actual)
- First submitted
- 1 Jun 2023
- Start date
- 31 May 2023
- Primary completion date
- 29 Mar 2024
- Lead sponsor
- AstraZeneca
- Diseases
- Metastatic breast cancer
- NCT number
- NCT05905939
What you commit to
- Study type: Observational
- Participants enrolled: 774
- From 31 May 2023 to the primary completion date, 29 Mar 2024
- 29 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients receiving trastuzumab deruxtecan currently or in the anamnesis;
Other illness
- Presence of other malignancies within period since diagnosis until the timepoint of data collection;
Other
- The participation in any randomized controlled trial within period since diagnosis until end of study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (29)
Sites in registry order. Save your city in your profile to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.