A Study to Assess the Efficiency of Trastuzumab Deruxtecan in Russian Breast Cancer Patients

NCT ID: NCT07281001

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This multi-center observational retrospective study will collect real-world clinical data from eligible patients with unresectable or metastatic HER2+ breast cancer who have received one or more cycles Trastuzumab Deruxtecan in Russian Federation

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This multi-center observational retrospective study will collect real-world clinical data from eligible patients with unresectable or metastatic HER2+ breast cancer who have received one or more cycles Trastuzumab Deruxtecan in Russian Federation

The aim of this trial is to explore the real-world effectiveness T-Dxd and potential predictors in Russian metastatic breast cancer patients

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HER2-positive Breast Cancer Trastuzumab Deruxtecan

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with unresectable or metastatic HER2+ BC who have received one or more cycles T-DXd

Group Type EXPERIMENTAL

T-DXd 5.4 mg/kg, IVD, 1 cycle every 21 days.

Intervention Type DRUG

T-DXd 5.4 mg/kg, IVD, 1 cycle every 21 days. Intravenous infusion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

T-DXd 5.4 mg/kg, IVD, 1 cycle every 21 days.

T-DXd 5.4 mg/kg, IVD, 1 cycle every 21 days. Intravenous infusion

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients aged over 18 years old.
2. Metastatic breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
3. Patients has received Trastuzumab Deruxtecan
4. Available medical history.

Exclusion Criteria

1. Incomplete medical history.
2. Pregnancy or breast-breeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Blokhin's Russian Cancer Research Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Elena Artamonova

Role: PRINCIPAL_INVESTIGATOR

The Blokhin National Medical Research Center of Oncology of the Russian Ministry of Health

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" оf the Ministry of Health of the Russian Federation

Moscow, , Russia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Russia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Elena Artamonova

Role: CONTACT

+7 (499) 444-24-24

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Elena А Artamonova

Role: primary

4994442424

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

29.11.2025

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.