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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with unresectable or metastatic HER2+ BC who have received one or more cycles T-DXd | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T-DXd 5.4 mg/kg, IVD, 1 cycle every 21 days. | Drug | T-DXd 5.4 mg/kg, IVD, 1 cycle every 21 days. Intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS | progression-free survival | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Overall Response Rate | 6 weeks |
| CBR | Clinical benefit Rates | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elena Artamonova | Contact | +7 (499) 444-24-24 | tatiana.titovadoc@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Elena Artamonova | The Blokhin National Medical Research Center of Oncology of the Russian Ministry of Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" оf the Ministry of Health of the Russian Federation | Recruiting | Moscow | 115522 | Russia |
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| ID | Term |
|---|---|
| D050769 | Isovaleryl-CoA Dehydrogenase |
| ID | Term |
|---|---|
| D044925 | Oxidoreductases Acting on CH-CH Group Donors |
| D010088 | Oxidoreductases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
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| OS |
Overall Survival |
| 6 weeks |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Safety | 6 weeks |
|