A Study to Assess the Efficiency of Trastuzumab Deruxtecan in Russian Breast Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: T-DXd 5.4 mg/kg, IVD, 1 cycle every 21 days..
- Who it may be relevant to
- Registry conditions: HER2-positive Breast Cancer, Trastuzumab Deruxtecan. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
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
Interventions
- 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
Primary outcome measures
- PFS [Time frame: 6 weeks]
Secondary outcome measures (4)
- ORR [Time frame: 6 weeks]
- CBR [Time frame: 6 weeks]
- OS [Time frame: 6 weeks]
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Time frame: 6 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Russia · 1 center
- Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Onco — Moscow
Identifiers
NCT: NCT07281001 · 29.11.2025