breast cancer brain metastases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women, voluntarily sign informed consent; 2. ECOG score: 0-2; 3. Patients with brain metastasis of breast cancer diagnosed by histopathology or imaging; 4. According to RECIST 1.1, CT or MRI indicates that there is at least one intracranial focus that can be measured or evaluated by imaging; 5. Estimated survival time >= 3 months.
Exclusion criteria
Exclusion criteria: 1. Allergic to test drug; 2. Within 4 weeks before enrollment, patients with any bleeding or bleeding events >= CTCAE Level 3 or have undergone major surgery or severe traumatic injury, fracture or ulcer; 3. Previous cardiac or thromboembolic events, central nervous system bleeding, uncontrolled hypertension or fistula.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| intracranial progress free survival, iPFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| intracranial objective response rate, iORR;intracranial disease control rate ,iDCR;objective response rate,ORR;disease control rate,DCR;progress free survival,PFS;overall survival, OS;Occurrence of neurological symptoms;Glucocorticoid use;safety; | — |
Countries
China