HER2-positive Breast Cancer, Trastuzumab Deruxtecan
Conditions
Keywords
Trastuzumab Deruxtecan, HER2-positive Breast Cancer
Brief summary
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
DRUGT-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
Sponsors
Blokhin's Russian Cancer Research Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 6 weeks | progression-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR | 6 weeks | Overall Response Rate |
| CBR | 6 weeks | Clinical benefit Rates |
| OS | 6 weeks | Overall Survival |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 6 weeks | Safety |
Countries
Russia
Contacts
Primary ContactElena Artamonova
Outcome results
None listed