Breast Cancer
Conditions
Brief summary
(Neo)adjuvant treatment approaches and outcomes
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged ≥ 18 years old -. Signed ICF, including patient's consent for genetic testing specimens from primary tumor and blood samples * Early HER2-negative BC (stages 2 and 3) * Compliance with at least 1 of the criteria for BRCA1/2 testing in accordance with the clinical guidelines of the Ministry of Health of the Russian Federation * Unknown BRCAm status or negative BRCAm PCR test * Performed surgical treatment (not more than 7 months before inclusion) -. High risk of recurrence according to one or more criteria: 1. incomplete pathomorphological response (in case of neoadjuvant therapy) 2. CPS-EG 3 scale score 3 and more (in case of neoadjuvant therapy) 3. presence of ≥ 4 metastatic lymph nodes in HR+ pts (in case of only adjuvant therapy) 4. ≥pT2 or ≥pN1 in TNBC pts (in case of only adjuvant therapy) 5. Any other high risk criterion according to investigators opinion * The presence of postoperative or biopsy FFPE
Exclusion criteria
* Participation in another clinical study with an investigational product during the last 3 months * Confirmation that the subject was already included in this study before * Absence of a written informed consent form; Data erroneously collected from subjects for which written consent is not available, will not be included in or will be deleted from the study database
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 3 years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 3 years | Demographics, clinical characteristics, and treatment approaches will be summarized using descriptive statistics. |
| 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 | 3 years | 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 |
| To determine 3-year OS for high-risk early HER2-negative breast cancer in the general population, in the BRCAm and non-BRCAm population | 3 years | 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 |
| To determine the prevalence of HRR mutations in HER2-negative breast cancer | 3 years | Testing the archived tumour specimen and blood for BRCA1/2m and HRRm status |
| To determine invasive disease-free survival in the HRRm population (including BRCA1/2) | 3 years | Testing the archived tumour specimen and blood for BRCA1/2m and HRRm status |
| To evaluate concordance between P53 expression and BRCAm | 3 years | Testing the archived tumour specimen and blood |
| To assess the quality of life in patients with various types of adjuvant systemic therapy | 3 years | completed WHOQOL-BREF questionnaire will be assessed |
Countries
Russia
Outcome results
None listed