RecruitingPhase 2NCT06418594

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

Adebrelimab Plus Apatinib and Etoposide for the Treatment of HER2-Negative Breast Cancer Brain Metastasis: A Phase II Study


Sponsor

Beijing 302 Hospital

Enrollment

30 participants

Start Date

Oct 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three drugs — adebrelimab (immunotherapy), apatinib (a drug that cuts off blood supply to tumors), and etoposide (chemotherapy) — for women with HER2-negative breast cancer that has spread to the brain. **You may be eligible if...** - You are a woman aged 18 or older - You have HER2-negative breast cancer that has spread to the brain (brain metastases), either newly discovered or progressing after prior brain treatment - If your cancer is hormone receptor-positive, you have already tried CDK4/6 inhibitor therapy or your doctor determines it is not appropriate for you - You have at least one measurable brain tumor on scans - Your general health is acceptable (ECOG 0–2) - You can swallow oral medication - Your organ function is within acceptable levels **You may NOT be eligible if...** - You need urgent treatment for brain metastasis (e.g., life-threatening symptoms) - Your cancer is HER2-positive - You have previously received apatinib, avelumab, or VP-16 (etoposide) - You have severe dysfunction of the heart, liver, or kidneys - You have been diagnosed with another cancer in the past 5 years (with some exceptions) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAdebrelimab

Adebrelimab: 1200mg, ivgtt, administered on the first day of each cycle, with a cycle of 21 days

DRUGApatinib

Apatinib: 250 mg, oral, once daily, continuous use, with a cycle of 21 days

DRUGEtoposide

Etoposide: 50mg/day, oral, administered on days 1-14 of each cycle, with a cycle of 21 days


Locations(1)

The Fifth Medical Center of PLA General Hospital

Beijing, Beijing Municipality, China

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NCT06418594