BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Prospective, One-arm, Phase II Clinical Study of Ivoximab Combined With TROP2 ADC in the Treatment of Brain Metastases in Triple-negative Breast Cancer
Sponsor: Fudan University
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Intracranial objective response rate (CNS ORR)
Time frame: Up to approximately 12 weeks
Secondary Endpoints
Intracranial clinical benefit rate (CNS CBR)
Progression-Free Survival (PFS)
Overall Survival (OS)
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 aft…
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