(Neo)adjuvant treatment approaches and outcomes
Study Type
OBSERVATIONAL
Enrollment
625
Research Site
Arkhangelsk, Russia
Research Site
Barnaul, Russia
Research Site
Belgorod, Russia
The primary objective of this study is to determine the prevalence of germline and somatic BRCA1/2 mutations in high-risk early HER2-negative breast cancer
The prevalence of germline and somatic BRCA1/2 mutations in high-risk early HER2-negative breast cancer will be presented as a number of missing and non-missing records, median, standard deviation, 95% confidence interval for median
Time frame: 3 years
To describe treatment approaches of high-risk early HER2-negative breast cancer in routine practice in the general population, in the BRCAm and non-BRCAm population
Demographics, clinical characteristics, and treatment approaches will be summarized using descriptive statistics.
Time frame: 3 years
To determine invasive disease-free survival for high-risk early HER2-negative breast cancer in the general population, in the BRCAm and non-BRCAm population
The Kaplan-Meier method will be used to estimate the median (95% CI) IDFS and OS for the total sample and all subgroups. Cumulative survival curves will be created using Kaplan-Meier analysis
Time frame: 3 years
To determine 3-year OS for high-risk early HER2-negative breast cancer in the general population, in the BRCAm and non-BRCAm population
The Kaplan-Meier method will be used to estimate the median (95% CI) IDFS and OS for the total sample and all subgroups. Cumulative survival curves will be created using Kaplan-Meier analysis
Time frame: 3 years
To determine the prevalence of HRR mutations in HER2-negative breast cancer
Testing the archived tumour specimen and blood for BRCA1/2m and HRRm status
Time frame: 3 years
To determine invasive disease-free survival in the HRRm population (including BRCA1/2)
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Research Site
Chelyabinsk, Russia
Research Site
Grozny, Russia
Research Site
Irkutsk, Russia
Research Site
Khanty-Mansiysk, Russia
Research Site
Krasnodar, Russia
Research Site
Krasnoyarsk, Russia
Research Site
Moscow, Russia
...and 9 more locations
Testing the archived tumour specimen and blood for BRCA1/2m and HRRm status
Time frame: 3 years
To evaluate concordance between P53 expression and BRCAm
Testing the archived tumour specimen and blood
Time frame: 3 years
To assess the quality of life in patients with various types of adjuvant systemic therapy
completed WHOQOL-BREF questionnaire will be assessed
Time frame: 3 years