Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT06418594

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

Led by Beijing 302 Hospital · Updated on 2024-12-10

30

Participants Needed

1

Research Sites

116 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female, aged 6518 years
  • Expected survival time of at least 3 months
  • Histologically or cytologically confirmed HER2-negative locally recurrent or metastatic disease
  • New brain metastasis or progression of brain metastasis after treatment
  • HR+ advanced breast cancer with prior CDK4/6 inhibitor failure or unsuitable for CDK4/6 inhibitors
  • At least one measurable brain lesion by RECIST V1.1 criteria
  • ECOG performance status of 0-2
  • Ability to swallow oral medications
  • Prior whole brain radiation therapy, stereotactic radiosurgery, or surgical resection allowed
  • Basically normal organ function and investigator's approval for study drug use
  • Willing to sign informed consent, comply with study, and follow-up
Not Eligible

You will not qualify if you...

  • Urgent need for local brain metastasis treatment
  • HER2 positive by immunohistochemistry or ISH amplification
  • Previous treatment with Apatinib, Avelumab, or Etoposide
  • Severe heart, liver, or kidney dysfunction
  • Inability to swallow, chronic diarrhea, or intestinal obstruction affecting drug absorption
  • Diagnosis of other malignant tumors within 5 years except treated non-melanoma skin cancer, cervical carcinoma in situ, or thyroid papillary carcinoma
  • Allergy to study drugs or history of immunodeficiency including HIV, hepatitis B or C, or organ transplantation
  • History of significant cardiac disease including arrhythmia, myocardial infarction, heart failure, or other conditions deemed unsuitable
  • Pregnant or lactating women, or women unwilling to use effective contraception during the study
  • Severe accompanying diseases that endanger safety or study completion such as uncontrolled hypertension, severe diabetes, or active infection

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

The Fifth Medical Center of PLA General Hospital

Beijing, Beijing Municipality, China, 100071

Actively Recruiting

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Research Team

J

Jinmei Zhou, Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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