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NCT Number: NCT07281001

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

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

Recruiting

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Key information

Conditions

HER2-positive Breast Cancer Trastuzumab Deruxtecan

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Moscow, 115522, Russia

Location status: Recruiting

Location contact

Elena А Artamonova

CONTACT

[email protected]

4994442424

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Incomplete medical history.
  • Pregnancy or breast-breeding

Treatment and study plan

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

Drug

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

Primary outcomes

  1. PFS

    Time frame: 6 weeks

    progression-free survival

Secondary outcomes

  1. ORR

    Time frame: 6 weeks

    Overall Response Rate

  2. CBR

    Time frame: 6 weeks

    Clinical benefit Rates

  3. OS

    Time frame: 6 weeks

    Overall Survival

  4. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: 6 weeks

    Safety

Study contacts

Contact information is provided by the study sponsor or research team.

Elena Artamonova

CONTACT

[email protected]

+7 (499) 444-24-24

Sponsors and collaborators

Lead sponsor

Blokhin's Russian Cancer Research Center

Other

Registry information

Acronym: Traderrus

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 15, 2025
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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