Breast cancer with brain metastases
Conditions
Interventions
Group1:Standard treatment + XG0201
Sponsors
The Third Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients who voluntarily signed the informed consent form, demonstrated good compliance, and were willing to cooperate with follow-up; 2. Female patients aged =18 years; 3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2; 4. Patients with histologically confirmed HER2-positive metastatic breast cancer, with laboratory-confirmed HER2 overexpression (defined as IHC 3+ or IHC 2+ with FISH amplification). Participants must be able to provide tumor specimens (paraffin-embedded blocks, sections, or fresh tissue sections) from primary or metastatic sites for HER2 testing; 5. Newly diagnosed brain metastases by MRI/contrast-enhanced CT, with at least one measurable intracranial lesion according to RECIST 1.1 criteria; 6. Expected survival >=3 months; 7. Adequate hepatic, renal, and cardiac function to tolerate treatment (as assessed by complete blood count, liver and kidney function tests, cardiac ultrasound, and electrocardiogram).
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation; 2. Patients previously subjected to anti-HER-2 therapy; 3. Patients with extensive leptomeningeal metastases and suboptimal response to corticosteroid-induced removal of hydration therapy for brain metastases; 4. Individuals with a history of hypersensitivity or known allergy to any component of the study regimen; immunodeficiency disorders, including HIV-positive status, or other acquired/congenital innate immunity deficiencies; or a history of organ transplantation; 5. Patients with severe uncontrolled systemic diseases; 6. Other participants deemed ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival;Lesion size; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progress free of survival; | — |
Countries
China
Contacts
Public ContactXinjun Wang
The Third Affiliated Hospital of Zhengzhou University
Outcome results
None listed