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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Female, aged ≥18 years

• Expected survival time ≥3 months.

• Histologically or cytologically confirmed HER2-negative (IHC 0 or 1+; or IHC 2+ ISH negative) locally recurrent or metastatic disease

• New brain metastasis or brain metastasis progression after treatment

• HR+ advanced breast cancer with prior CDK4/6 inhibitor treatment failure or the investigator deems unsuitable for CDK4/6 inhibitors

• At least one intracranial measurable lesion as defined by RECIST V1.1 criteria;

• ECOG PS 0-2;

• Patients must have the ability to swallow oral medication;

• Prior WBRT, stereotactic radiosurgery, and surgical resection are allowed;

• Organ function levels are basically normal, and the investigator believes that the study drug can be applied:

• Voluntarily join this study, sign the informed consent, have good compliance, and are willing to cooperate with follow-up

Locations
Other Locations
China
The Fifth Medical Center of PLA General Hospital
RECRUITING
Beijing
Contact Information
Primary
Jinmei Zhou, Doctor
jinzhu2714@sina.com
+86-010-66947250
Time Frame
Start Date: 2024-10-10
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 30
Treatments
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.
Sponsors
Leads: Beijing 302 Hospital

This content was sourced from clinicaltrials.gov

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