BrAin Metastasis in TripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Trial Parameters
Brief Summary
This study is a single-center, prospective, single-arm clinical trial, which intends to enroll patients with triple-negative breast cancer with brain metastases to receive ivonescimab combined with TROP2 ADC (such as sacituzumab govitecan) treatment until disease progression, intolerable toxicity, withdrawal of informed consent, or the investigator deems it necessary to discontinue the medication, and to collect data on the drug's efficacy and safety.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years and ≤ 70 years, with no gender restrictions; 2. ECOG performance score of 0 to 2; 3. Expected survival ≥ 3 months; 4. Patients with unresectable locally advanced, recurrent or metastatic triple-negative breast cancer who have failed treatment with taxane drugs are included. 5. Ten tissue pathology slides of the primary lesion and/or metastatic lesion (preferably metastatic lesion) can be obtained before the start of treatment for exploratory analysis of molecular indicators related to therapeutic efficacy. 6. Patients must have brain metastases confirmed by MRI, with at least one brain metastasis lesion that previously has not received radiotherapy and has a longest diameter of ≥ 1.0 cm; for brain metastasis lesions that have received local treatment, progression must be confirmed by imaging examination; 7. Cohort A: Patients with brain metastases who have not received central nervous system radiotherapy before. Patients with new brain lesions afte