Evaluating the Efficacy and Safety of PD-L1 Monoclonal Antibody Combined With VEX Metronomic Chemotherapy and Concurrent or Delayed Radiotherapy in Patients With Advanced HER2-Negative Breast Cancer With Brain Metastasis

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

A Prospective, multicenter, randomized controlled phase II study to evaluate the efficacy and safety of PD-L1 monoclonal antibody combined with vinorelbine + cyclophosphamide + capecitabine (VEX) metronomic chemotherapy and concurrent or delayed radiotherapy in patients with advanced HER2-negative breast cancer with brain metastasis

Eligibility criteria

Qualifiers

Males or females who are at least 18 years of age on the day of signing the informed consent form.

Patients with metastatic HER2-negative breast cancer brain metastasis, with clear clinical documentation; specific criteria refer to the guidelines of the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP).

Patients who have received no more than one line of chemotherapy during the metastatic stage of breast cancer.

The patient has not previously received intracranial radiotherapy.

Disqualifiers

The subject has leptomeningeal metastasis.

If the patient has concurrent brain metastasis, the neurological symptoms are too severe to cooperate with radiotherapy.

Malabsorption syndrome, or the disease significantly affects gastrointestinal function; or after subtotal gastrectomy, or after proximal small bowel resection, which may affect the absorption of oral metronomic chemotherapy agents.

The subject has dysphagia or is unable to swallow tablets.

Trial design

Treatments tested in this trial

  • Adebrelimab+VEX Metronomic Chemotherapy+Concurrent Radiotherapy
  • Adebrelimab+VEX Metronomic Chemotherapy+Delayed Radiotherapy

Treatment groups

102 Participants
are divided into 2 treatment groups