Advanced breast cancer with low HER-2 expression and brain metastasis
Conditions
Interventions
Experimental group:T-DXd, 5.4mg/kg IV
Sponsors
The Affiliated Hospital of Inner Mongolia Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Age >= 18 years; (2) Pathologically confirmed diagnosis of breast cancer; (3) Most recent pathological confirmation of HER2-low expression (IHC 1+ or IHC 2+ with negative ISH); (4) Presence of stable or active brain metastases (untreated or progressive) prior to T-DXd treatment, with no indication for immediate local therapy; (5) Measurable brain lesions according to the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria; (6) Patients who have previously received at least one line of systemic therapy for metastatic disease, or those who relapsed during or within 6 months after completing adjuvant chemotherapy; (7) Received at least one cycle of T-DXd treatment; (8) Life expectancy of at least three months.
Exclusion criteria
Exclusion criteria: (1) Missing information on treatment efficacy or adverse reactions; (2) Coexisting primary malignancy that affects patient survival time; (3) Imaging findings suggestive of interstitial lung disease prior to T-DXd treatment; (4) Concomitant other antitumor therapies during T-DXd treatment; (5) Presence of leptomeningeal disease; (6) Clinically significant cardiac, hepatic/biliary, or renal diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intracranial objective response rate of T-DXd in patients with HER2-low advanced breast cancer and brain metastases; | — |
Countries
China
Contacts
Public ContactShaojun Wang
The Affiliated Hospital of Inner Mongolia Medical University
Outcome results
None listed