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Russian study maps BRCA mutations in early breast cancer

NCT ID NCT05939128

Knowledge-focused Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at 625 people in Russia with high-risk early-stage breast cancer that is HER2-negative. Researchers want to find out how many have BRCA1 or BRCA2 gene mutations and what treatments they receive in real-world practice. Participants provide blood and tumor samples for genetic testing, and their health is followed over time. This is an observational study, meaning no new treatment is being tested.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors better understand how common BRCA1/2 mutations are in this group and how treatment is currently managed, potentially guiding future care decisions.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly improve outcomes for participants. Results may not apply to patients outside Russia.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

625 people

The number who actually took part.

Started

Jun 2023

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Her2-receptor negative breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Research Site

    Arkhangelsk, Russia

  • Research Site

    Barnaul, Russia

  • Research Site

    Belgorod, Russia

  • Research Site

    Chelyabinsk, Russia

  • Research Site

    Grozny, Russia

  • Research Site

    Irkutsk, Russia

  • Research Site

    Khanty-Mansiysk, Russia

  • Research Site

    Krasnodar, Russia

  • Research Site

    Krasnoyarsk, Russia

  • Research Site

    Moscow, Russia

  • Research Site

    Nal'chik, Russia

  • Research Site

    Nyzhny Novgorod, Russia

  • Research Site

    Ryazan, Russia

  • Research Site

    Saint Petersburg, Russia

  • Research Site

    Severodvinsk, Russia

  • Research Site

    Sochi, Russia

  • Research Site

    Ufa, Russia

  • Research Site

    Vladivostok, Russia

  • Research Site

    Yaroslavl, Russia

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