HER2-positive breast cancer brain metastases
Conditions
Interventions
HER2-low group:N/A
HER2-positive group:N/A
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed HER2-positive or HER2-low (IHC 1+, or IHC 2+ with FISH-negative) breast cancer. 2. Age > 18 years. 3. Brain metastases confirmed by contrast-enhanced brain magnetic resonance imaging (MRI), with fewer than 15 metastatic lesions. 4. KPS = 70, or KPS = 60 with neurological symptoms caused by brain metastases. 5. Life expectancy > 6 months. 6. Prior oral dexamethasone treatment not exceeding 16 mg/day. 7. At least 2 weeks since prior treatment, with all adverse events resolved to Grade = 1. 8. Stable extracranial disease with no evidence of progression. 9. Laboratory tests must meet the following criteria: 1. Absolute neutrophil count (ANC) = 1.5 × 10?/L, platelet count = 90 × 10?/L, hemoglobin = 90 g/L; 2. Aspartate aminotransferase/alanine aminotransferase (AST/ALT) = 2.5 × upper limit of normal (ULN) in patients without liver metastases, or = 5 × ULN in patients with liver metastases; 3. Blood urea nitrogen (BUN) and creatinine = 1.5 × ULN; 4. Left ventricular ejection fraction (LVEF) = 50%; 5. QTcF interval < 480 ms; 6. International normalized ratio (INR) = 1.5 × ULN, activated partial thromboplastin time (APTT) = 1.5 × ULN. 10. Patients should sign informed consent forms.
Exclusion criteria
Exclusion criteria: 1. Leptomeningeal metastasis or hemorrhagic lesions. 2. Concomitant uncontrolled seizures. 3. Presence of severe or uncontrolled systemic diseases, including but not limited to: severe cardiovascular disease, end-stage renal disease, severe liver disease, history of immunodeficiency (including HIV positivity, active HBV/HCV infection, other acquired or congenital immunodeficiency disorders), history of organ transplantation, or active infection. 4. History of hypersensitivity to the planned treatment regimen. 5. Pregnancy or breastfeeding, or unwillingness to use contraceptive measures in women of childbearing potential. 6. Inability to undergo contrast-enhanced MRI. 7. Any other condition deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intracranial Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;intracranial CNS progression-free survival; | — |
Countries
China
Contacts
Public ContactJin Yiting
Huashan Hospital, Fudan University
Outcome results
None listed