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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorBeijing 302 Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Urgent need for local treatment of brain metastasis

Immunohistochemistry HER2 positive (IHC 3 or IHC 2 ISH amplification)

Previously treated with Apatinib, Avelumab, or VP-16;

Severe dysfunction of important organs such as the heart, liver, or kidneys;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Adebrelimab+Apatinib+EtoposideExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

CNS-ORR

Central nervous system objective response rate (CNS-ORR), as assessed according to the RANO-BM criteria

Time frame
2 months

Secondary outcomes

1

CNS-PFS

CNS progression-free survival

Time frame
1 Year
2

Extracranial objective response rate

According to recist1.1 standard, the proportion of patients whose extracranial best remission was CR or PR accounted for the total number of evaluable patients

Time frame
2 Years
3

Extracranial progression-free survival

The time to the date of first documented progression or date of death from any cause, whichever came first

Time frame
2 Years
4

OS

The time from the beginning of treatment to the time of death caused by any cause

Time frame
3 Years

Other outcomes

Sponsors and contacts

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