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

Blokhin's Russian Cancer Research Center

Status: Enrolling

Conditions: HER2-positive Breast Cancer; Trastuzumab Deruxtecan

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07281001

29.11.2025

Details and patient eligibility

About

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

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

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

Experimental group

Treatment:

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