Trastuzumab deruxtecan for Russian patients with HER2-positive unresectable or metastatic breast cancer
A Study to Assess the Efficiency of Trastuzumab Deruxtecan in Russian Breast Cancer Patients
This study will see how well trastuzumab deruxtecan (T-DXd) works in Russian adults with unresectable or metastatic HER2-positive breast cancer who received at least one cycle.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Blokhin's Russian Cancer Research Center Academic / other |
| Drugs / interventions | Trastuzumab |
| Locations | 1 site (Moscow) |
| Trial ID | NCT07281001 on ClinicalTrials.gov |
What this trial studies
This multi-center observational retrospective project will collect real-world clinical data from patients in the Russian Federation with unresectable or metastatic HER2-positive breast cancer who received one or more cycles of trastuzumab deruxtecan (T-DXd). Investigators will extract treatment details including the reported dosing regimen (5.4 mg/kg IV every 21 days), prior therapies, tumor response, progression, survival outcomes, and adverse events from medical records. Analyses will describe real-world effectiveness outcomes and explore clinical and disease-related predictors of response and toxicity in the treated population. Eligible patients are adults with available medical history, while those with incomplete records or who are pregnant or breastfeeding are excluded.
Who should consider this trial
Good fit: Adults (over 18) with unresectable locally advanced or metastatic HER2-positive breast cancer who have received one or more cycles of trastuzumab deruxtecan and have complete medical records are ideal candidates.
Not a fit: Patients without adequate medical records or those who are pregnant or breastfeeding would not be eligible and are unlikely to benefit from inclusion in this analysis.
Why it matters
Potential benefit: If successful, the results could help clinicians in Russia understand real-world benefits and risks of T-DXd and inform treatment choices for HER2-positive metastatic disease.
How similar studies have performed: Other clinical trials and real-world series have shown meaningful activity and survival benefit with T-DXd in HER2-positive metastatic breast cancer, so this effort builds on existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Moscow
- Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" оf the Ministry of Health of the Russian Federation — Moscow, Russia (Recruiting)
Study contacts
- Principal investigator: Elena Artamonova — The Blokhin National Medical Research Center of Oncology of the Russian Ministry of Health
- Study coordinator: Elena Artamonova
- Email: tatiana.titovadoc@gmail.com
- Phone: +7 (499) 444-24-24
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.