Adebrelimab Plus Apatinib and Etoposide for the Treatment of HER2-Negative Breast Cancer Brain Metastasis

Sponsor
Beijing 302 Hospital
Study ID
NCT06418594
Phase
PHASE2
Status
Recruiting
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Conditions

  • HER2-negative Breast Cancer Brain Metastases

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adebrelimab — DRUG
    Adebrelimab: 1200mg, ivgtt, administered on the first day of each cycle, with a cycle of 21 days
  • Apatinib — DRUG
    Apatinib: 250 mg, oral, once daily, continuous use, with a cycle of 21 days
  • Etoposide — DRUG
    Etoposide: 50mg/day, oral, administered on days 1-14 of each cycle, with a cycle of 21 days

Study Details

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.

Key Dates

Start date
Oct 10, 2024
Status verified
Dec 2024
Primary completion
Nov 30, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adebrelimab+Apatinib+Etoposide
    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.

Primary Outcome Measure

CNS-ORR [ Time Frame: 2 months ]

Central Contacts