Some studies have shown that approximately 15% of patients with advanced hormone receptor (HR) positive breast cancer and 1/3 of triple negative breast cancer will develop brain metastasis. At present, there is no unified drug treatment standard for HER2-negative breast cancer brain metastasis (BCBM). The evidence of single traditional chemotherapy drug as the main treatment of brain metastasis is not sufficient. Some exploratory studies on HER2-negative BCBM have shown that the central nervous system objective response rate (CNS-ORR) of anti-angiogenic drugs combined with chemotherapy is around 55%-80%。 Adebrelimab (a humanized PD-L1 monoclonal antibody) specifically blocks the binding of PD-1 and PD-L1, terminates the immunosuppressive signal produced by T cells, and makes T cells re-recognize tumor cells and kill them, thereby inhibiting tumor growth. In China, Adebelizumab has been approved for using in combination with chemotherapy as a first-line treatment for extensive stage small cell lung cancer. Apatinib (a small molecule VEGFR tyrosine kinase inhibitor) mainly plays an anti-angiogenic effect in the treatment of malignant tumors by inhibiting VEGFR. Apatinib has been approved monotherapy for advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma that has progressed or relapsed after at least two systematic chemotherapies, advanced liver cancer that has failed or is intolerable after at least first-line systematic treatment, and first-line treatment in patients with unresectable or metastatic hepatocellular carcinoma combined with camrelizumab. Due to the lack of effective drug therapy for HER2-negative BCBM, a variety of treatment combinations are still being explored. We hypothesized that adebrelimab plus apatinib and etoposide is an explorable and effective treatment for HER2- negative BCBM.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Adebrelimab: 1200mg, ivgtt, administered on the first day of each cycle, with a cycle of 21 days
Apatinib: 250 mg, oral, once daily, continuous use, with a cycle of 21 days
Etoposide: 50mg/day, oral, administered on days 1-14 of each cycle, with a cycle of 21 days
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGCNS-ORR
Central nervous system objective response rate (CNS-ORR), as assessed according to the RANO-BM criteria
Time frame: 2 months
CNS-PFS
CNS progression-free survival
Time frame: 1 Year
Extracranial objective response rate
According to recist1.1 standard, the proportion of patients whose extracranial best remission was CR or PR accounted for the total number of evaluable patients
Time frame: 2 Years
Extracranial progression-free survival
The time to the date of first documented progression or date of death from any cause, whichever came first
Time frame: 2 Years
OS
The time from the beginning of treatment to the time of death caused by any cause
Time frame: 3 Years
CBR
Clinical benefit rate: CR+PR+SD≥6 months
Time frame: 2 Years
DoR
The time from the beginning of CR or PR to the time when the tumor was first evaluated as PD or any cause of death.
Time frame: 2 Years
Safety
Adverse events (AE), serious adverse events (SAE), and immune-related adverse events (irAE), in accordance with the NCI-CTC AE version 5.0 criteria. AE recorded from infromed consent to 28 days after treatment completion.
Time frame: AE recorded from infromed consent to 28 days after treatment completion
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