NCT05939128

Brief Summary

(Neo)adjuvant treatment approaches and outcomes

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
625

participants targeted

Target at P75+ for all trials

Timeline
14mo left

Started Jun 2023

Longer than P75 for all trials

Geographic Reach
1 country

19 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Jun 2023Sep 2027

Study Start

First participant enrolled

June 30, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 11, 2023

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

4.3 years

First QC Date

July 3, 2023

Last Update Submit

May 14, 2026

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 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

    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

    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

    3 years

  • To determine the prevalence of HRR mutations in HER2-negative breast cancer

    3 years

  • To determine invasive disease-free survival in the HRRm population (including BRCA1/2)

    3 years

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Research Site

Arkhangelsk, Russia

Location

Research Site

Barnaul, Russia

Location

Research Site

Belgorod, Russia

Location

Research Site

Chelyabinsk, Russia

Location

Research Site

Grozny, Russia

Location

Research Site

Irkutsk, Russia

Location

Research Site

Khanty-Mansiysk, Russia

Location

Research Site

Krasnodar, Russia

Location

Research Site

Krasnoyarsk, Russia

Location

Research Site

Moscow, Russia

Location

Research Site

Nal'chik, Russia

Location

Research Site

Nyzhny Novgorod, Russia

Location

Research Site

Ryazan, Russia

Location

Research Site

Saint Petersburg, Russia

Location

Research Site

Severodvinsk, Russia

Location

Research Site

Sochi, Russia

Location

Research Site

Ufa, Russia

Location

Research Site

Vladivostok, Russia

Location

Research Site

Yaroslavl, Russia

Location

Biospecimen

Retention: SAMPLES WITH DNA

tumor and blood samples

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2023

First Posted

July 11, 2023

Study Start

June 30, 2023

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

May 15, 2026

Record last verified: 2026-05

Locations

RU(19)