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

December 11, 2025 updated by: Blokhin's Russian Cancer Research Center
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russia
      • Moscow, Russia, 115522
        • Recruiting
        • Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" оf the Ministry of Health of the Russian Federation
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with unresectable or metastatic HER2+ BC who have received one or more cycles T-DXd
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 6 weeks
progression-free survival
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: 6 weeks
Overall Response Rate
6 weeks
CBR
Time Frame: 6 weeks
Clinical benefit Rates
6 weeks
OS
Time Frame: 6 weeks
Overall Survival
6 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: 6 weeks
Safety
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Blokhin's Russian Cancer Research Center

Investigators

  • Principal Investigator: Elena Artamonova, The Blokhin National Medical Research Center of Oncology of the Russian Ministry of Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

November 29, 2025

First Submitted That Met QC Criteria

December 11, 2025

First Posted (Actual)

December 15, 2025

Study Record Updates

Last Update Posted (Actual)

December 15, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29.11.2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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