breast cancer brain metastasis
Conditions
Interventions
Case series:NA
Sponsors
Affiliated Hospital of Guangdong Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. age >= 18 years; 2. ECOG score <= 3; 3. Pathologically confirmed HER2-positive or HER2 low-expression breast cancer: HER2-positive status is defined as primary and/or metastatic foci with HER2 3+ or 2+ by immunohistochemistry (IHC) and HER2 amplification by fluorescence in situ hybridization (FISH); HER2 low-expression is defined as IHC 1+ or IHC 1+; HER2 low-expression is defined as IHC 1+ or IHC 1+. HER2 amplification was reported by immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH); low expression of HER2 was defined as IHC 1+ or IHC 2+ and negative FISH; 4. At least 1 measurable lesion as defined by the criteria in Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1); 5. patients diagnosed with breast cancer brain metastasis (BCBM); 6. have been treated with at least 2 courses of T-DXd after diagnosis of BCBM and have had at least one efficacy assessment; 7. cranial MRI within 4 weeks before and 4 months after treatment; 8. brain metastases that can be outlined or depicted on baseline MRI images;
Exclusion criteria
Exclusion criteria: 1. poor quality of cranial MRI images, difficult to observe or outline the region of interest (ROI); 2. lesions are not visible on cranial MRI images; 3. Other malignant tumors within the past 3 years, except for radically treated basal cell carcinoma of the skin and carcinoma in situ of the cervix; 4. patients with incomplete clinical data and lost to visit;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Central Nervous System-Progress Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intracranial Objective Response Rate, IC-ORR;Intracranial Duration of Overall Response, IC-DOR; | — |
Countries
China
Contacts
Public ContactLi Lixia
Affiliated Hospital of Guangdong Medical University
Outcome results
None listed