Tumor-Derived FGF19
NCT06068257
Breast Cancer, Breast Diseases
Orlando, Florida, United States
View Trial DetailsNCT Number: NCT05905939
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.
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Notify Me18 year and older
All sexes
Observational
Research Site, Arkhangelsk, Russia
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: up to 6 month
Demographics characteristics : age(years)
Time frame: up to 6 month
Time frame: up to 6 month
Time frame: up to 6 month
Clinical characteristics, including BC history, family and personal oncology history
Time frame: up to 6 month
Clinical characteristics: ECOG status
Time frame: up to 6 month
Clinical characteristics: HER2, estrogen receptor (ER), progesterone receptor (PR) expression status, Ki67 expression status (in %)
Time frame: up to 6 month
Clinical characteristics: number of metastatic sites and localization
Time frame: up to 6 month
Time frame: up to 6 month
Time frame: up to 6 month
-Number of therapy lines, schemes and duration;
Time frame: up to 6 month
Time frame: up to 6 month
-Reasons for anticancer therapy discontinuation, if applicable;
Time frame: up to 6 month
-Time to treatment discontinuation (TTD), defined as the median time from the starting first line therapy to the treatment discontinuation from any cause;
AstraZeneca
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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