Breast CancerERANCT05939128
A Non-interventional Prospective Study of Early HER2-negative High-risk Breast Cancer and BRCA1/2 Mutations Prevalence in RussiA
An observational study of Breast Cancer, run by AstraZeneca at 19 sites in Russia.
Trial summary
(Neo)adjuvant treatment approaches and outcomes Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 625 participants
- Where
- 19 sitesRussia
- Study dates
- 30 Jun 2023to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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)
Show all 13Show fewer
- -. 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
Who cannot join
- 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
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Russia19 sites
Research Site
Arkhangelsk
Research Site
Barnaul
Research Site
Belgorod
Research Site
Chelyabinsk
Research Site
Grozny
Research Site
Irkutsk
Research Site
Khanty-Mansiysk
Research Site
Krasnodar
Research Site
Krasnoyarsk
Research Site
Moscow
Research Site
Nal'chik
Research Site
Nyzhny Novgorod
Research Site
Ryazan
Research Site
Saint Petersburg
Research Site
Severodvinsk
Research Site
Sochi
Research Site
Ufa
Research Site
Vladivostok
Research Site
Yaroslavl
About this study
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
(Neo)adjuvant treatment approaches and outcomes
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (7)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 years
To evaluate concordance between P53 expression and BRCAm
Testing the archived tumour specimen and blood
Measured: 3 years
To assess the quality of life in patients with various types of adjuvant systemic therapy
completed WHOQOL-BREF questionnaire will be assessed
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start30 Jun 2023
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 625 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939128
- Sponsor's protocol ID
- D133HR00030
- Acronym
- ERA
- Status last verified
- Sep 2026
- First submitted
- 3 Jul 2023
- Last updated
- 2 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05939128
- Acronym / sponsor ID
- ERA / D133HR00030
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 625 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
(Neo)adjuvant treatment approaches and outcomes
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
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
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
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
To determine the prevalence of HRR mutations in HER2-negative breast cancer
Time frame: 3 years
To determine invasive disease-free survival in the HRRm population (including BRCA1/2)
Time frame: 3 years
To evaluate concordance between P53 expression and BRCAm
Time frame: 3 years
To assess the quality of life in patients with various types of adjuvant systemic therapy
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by AstraZeneca at 19 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.