An observational study in Breast Cancer, sponsored by AstraZeneca. Active, not recruiting at 19 sites in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by AstraZeneca · Observational
(Neo)adjuvant treatment approaches and outcomes
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 625 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Study population will consist of early breast cancer HER2-negative patients with high risk of recurrence with available medical history, surgery or biopsy FFPE from primary tumor. It is estimated that approximately 750 patients will be enrolled in approximately 25 sites
Patients aged ≥ 18 years old
-. Signed ICF, including patient's consent for genetic testing specimens from primary tumor and blood samples
Performed surgical treatment (not more than 7 months before inclusion)
-. High risk of recurrence according to one or more criteria:
Exclusion Criteria:
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)
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
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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AstraZeneca