Trastuzumab deruxtecan for Russian patients with HER2-positive unresectable or metastatic breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.