Breast Cancer Clinical Trial
— ERAOfficial title:
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
NCT number | NCT05939128 |
Other study ID # | D133HR00030 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 30, 2023 |
Est. completion date | June 30, 2027 |
(Neo)adjuvant treatment approaches and outcomes
Status | Recruiting |
Enrollment | 750 |
Est. completion date | June 30, 2027 |
Est. primary completion date | June 30, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Research Site | Arkhangelsk | |
Russian Federation | Research Site | Barnaul | |
Russian Federation | Research Site | Belgorod | |
Russian Federation | Research Site | Chelyabinsk | |
Russian Federation | Research Site | Ekaterinburg | |
Russian Federation | Research Site | Grozny | |
Russian Federation | Research Site | Irkutsk | |
Russian Federation | Research Site | Kazan | |
Russian Federation | Research Site | Khanty-Mansiysk | |
Russian Federation | Research Site | Krasnodar | |
Russian Federation | Research Site | Krasnoyarsk | |
Russian Federation | Research Site | Moscow | |
Russian Federation | Research Site | Moscow | |
Russian Federation | Research Site | Moscow | |
Russian Federation | Research Site | Nalchik | |
Russian Federation | Research Site | Nyzhny Novgorod | |
Russian Federation | Research Site | Ryazan | |
Russian Federation | Research Site | Saint Petersburg | |
Russian Federation | Research Site | Samara | |
Russian Federation | Research Site | Severodvinsk | |
Russian Federation | Research Site | Sochi | |
Russian Federation | Research Site | Tomsk | |
Russian Federation | Research Site | Ufa | |
Russian Federation | Research Site | Vladivostok | |
Russian Federation | Research Site | Yaroslavl |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 3 years | |
Secondary | 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. | 3 years | |
Secondary | 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 | 3 years | |
Secondary | 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 | 3 years | |
Secondary | 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 | 3 years | |
Secondary | 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 | 3 years | |
Secondary | To evaluate concordance between P53 expression and BRCAm | Testing the archived tumour specimen and blood | 3 years | |
Secondary | To assess the quality of life in patients with various types of adjuvant systemic therapy | completed WHOQOL-BREF questionnaire will be assessed | 3 years |
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