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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

(Neo)adjuvant treatment approaches  and outcomes

A non-interventional prospective study of Early HER2-negative high-risk breast cancer and BRCA1/2 mutations prevalence in RussiA

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A multicentre, single arm, non-interventional, observational, prospective study to assess the BRCA1/2m prevalence, treatment approaches and outcomes in HER2-negative high-risk early breast cancer patients in Russia

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

Demographics, clinical characteristics, and treatment approaches will be summarized using descriptive statistics.

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

Testing the archived tumour specimen and blood for BRCA1/2m and HRRm status

Testing the archived tumour specimen and blood

completed WHOQOL-BREF questionnaire  will be assessed

A non-interventional prospective study of Early HER2-negative high-risk breast cancer and BRCA1/2 mutations prevalence in RussiA - ERA

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