RecruitingPhase IIFemale onlyEN original

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Kobieta w wieku 18 lat lub starszy
  • Spodziewany czas przeżycia co najmniej 3 miesiące
  • Potwierdzony nowotwór piersi bez nadmiernego białka HER2 (test negatywny)
  • Nowe lub postępujące przerzuty do mózgu
  • Zaawansowany rak piersi z wcześniejszym niepowodzeniem leczenia inhibitorami CDK4/6
  • Co najmniej jeden możliwy do zmierzenia guz w mózgu
  • Zdolność do połykania leków w postaci tabletek
  • Zgodę na udział w badaniu i chęć współpracy w obserwacji

✗ Disqualifies

  • Pilna potrzeba lokalnego leczenia przerzutów do mózgu
  • Pozytywny wynik testu na białko HER2
  • Wcześniejsze leczenie apatynibem, awelumanem lub VP-16
  • Poważne uszkodzenie pracy serca, wątroby lub nerek
  • Niezdolność do połykania, chroniczna biegunka lub niedrożność jelit
  • Inne nowotwory w ciągu ostatnich 5 lat (z wyjątkami dotyczącymi niektórych nowotworów skóry)
  • Alergia na składniki leku lub historia niedoboru odporności (HIV, zapalenie wątroby)
  • Ciąża, karmienie piersią lub potencjalna ciąża bez efektywnej antykoncepcji

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
December 10, 2024
Sex
Female only

Therapies / drugs in trial

Locations (1)

The Fifth Medical Center of PLA General Hospital

Beijing, China

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.