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
Recruiting
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
Interested in participating?
Request InfoKey information
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
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.
DrugT-DXd 5.4 mg/kg, IVD, 1 cycle every 21 days. Intravenous infusion
Primary outcomes
-
PFS
Time frame: 6 weeks
progression-free survival
Secondary outcomes
-
ORR
Time frame: 6 weeks
Overall Response Rate
-
CBR
Time frame: 6 weeks
Clinical benefit Rates
-
OS
Time frame: 6 weeks
Overall Survival
-
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.
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.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Recruiting
HER2 Vaccine for Locally Advanced Breast Cancer
NCT06949410
Breast Cancer, Breast Diseases
Indianapolis, Indiana, United States
View Trial Details
Recruiting
HER-2 B Cell Peptide Vaccine
NCT06414733
Breast Diseases, Breast Neoplasms
Indianpolis, Indiana, United States
View Trial Details
Recruiting
A Study of BL-M07D1 With or Without Pertuzumab Versus Docetaxel + Carboplatin + Trastuzumab + Pertuzumab in Neoadjuvant Therapy for HER2-Positive Breast Cancer
NCT06891833
HER2-positive Breast Cancer
Bengbu, Anhui, China
View Trial Details
Recruiting
Prolonged Overnight Fasting and/or Exercise on Fatigue and Other Patient Reported Outcomes in Women With Hormone Receptor Positive Advanced Breast Cancer
NCT06123988
Advanced Breast Cancer, HER2-positive Breast Cancer
Phoenix, Arizona, United States
View Trial Details