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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ClinicalTrials.gov Identifier: NCT05939128 |
Recruitment Status :
Recruiting
First Posted : July 11, 2023
Last Update Posted : May 10, 2024
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Condition or disease |
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Breast Cancer |
Study Type : | Observational |
Estimated Enrollment : | 750 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official 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 |
Actual Study Start Date : | June 30, 2023 |
Estimated Primary Completion Date : | June 30, 2027 |
Estimated Study Completion Date : | June 30, 2027 |
- 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 [ Time Frame: 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
- 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 3 years ]Testing the archived tumour specimen and blood for BRCA1/2m and HRRm status
- To evaluate concordance between P53 expression and BRCAm [ Time Frame: 3 years ]Testing the archived tumour specimen and blood
- To assess the quality of life in patients with various types of adjuvant systemic therapy [ Time Frame: 3 years ]completed WHOQOL-BREF questionnaire will be assessed
Biospecimen Retention: Samples With DNA
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
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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
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Performed surgical treatment (not more than 7 months before inclusion)
-. High risk of recurrence according to one or more criteria:
- incomplete pathomorphological response (in case of neoadjuvant therapy)
- CPS-EG 3 scale score 3 and more (in case of neoadjuvant therapy)
- presence of ≥ 4 metastatic lymph nodes in HR+ pts (in case of only adjuvant therapy)
- ≥pT2 or ≥pN1 in TNBC pts (in case of only adjuvant therapy)
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05939128
Contact: AstraZeneca Clinical Study Information Center | 1-877-240-9479 | information.center@astrazeneca.com |
Russian Federation | |
Research Site | Recruiting |
Arkhangelsk, Russian Federation | |
Research Site | Recruiting |
Barnaul, Russian Federation | |
Research Site | Recruiting |
Belgorod, Russian Federation | |
Research Site | Recruiting |
Chelyabinsk, Russian Federation | |
Research Site | Withdrawn |
Ekaterinburg, Russian Federation | |
Research Site | Recruiting |
Grozny, Russian Federation | |
Research Site | Recruiting |
Irkutsk, Russian Federation | |
Research Site | Withdrawn |
Kazan, Russian Federation | |
Research Site | Recruiting |
Khanty-Mansiysk, Russian Federation | |
Research Site | Recruiting |
Krasnodar, Russian Federation | |
Research Site | Recruiting |
Krasnoyarsk, Russian Federation | |
Research Site | Recruiting |
Moscow, Russian Federation | |
Research Site | Withdrawn |
Moscow, Russian Federation | |
Research Site | Not yet recruiting |
Moscow, Russian Federation | |
Research Site | Recruiting |
Nalchik, Russian Federation | |
Research Site | Recruiting |
Nyzhny Novgorod, Russian Federation | |
Research Site | Recruiting |
Ryazan, Russian Federation | |
Research Site | Recruiting |
Saint Petersburg, Russian Federation | |
Research Site | Withdrawn |
Samara, Russian Federation | |
Research Site | Recruiting |
Severodvinsk, Russian Federation | |
Research Site | Recruiting |
Sochi, Russian Federation | |
Research Site | Withdrawn |
Tomsk, Russian Federation | |
Research Site | Recruiting |
Ufa, Russian Federation | |
Research Site | Recruiting |
Vladivostok, Russian Federation | |
Research Site | Recruiting |
Yaroslavl, Russian Federation |
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT05939128 |
Other Study ID Numbers: |
D133HR00030 |
First Posted: | July 11, 2023 Key Record Dates |
Last Update Posted: | May 10, 2024 |
Last Verified: | May 2024 |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |