Viewing Study NCT06418594



Ignite Creation Date: 2024-05-19 @ 5:34 PM
Last Modification Date: 2024-10-26 @ 3:29 PM
Study NCT ID: NCT06418594
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-05-17
First Post: 2024-05-13

Brief Title: Adebrelimab Plus Apatinib and Etoposide for the Treatment of HER2-Negative Breast Cancer Brain Metastasis
Sponsor: Beijing 302 Hospital
Organization: Beijing 302 Hospital

Study Overview

Official Title: Adebrelimab Plus Apatinib and Etoposide for the Treatment of HER2-Negative Breast Cancer Brain Metastasis A Phase II Study
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Some studies have shown that approximately 15 of patients with advanced hormone receptor HR positive breast cancer and 13 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None