NCT06839560

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

A Prospective, Multicenter, Randomized Controlled Phase II Study to Evaluate 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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Brain Metastasis from Advanced HER2-negative Breast Cancer

Interventions

Type	Name	Description
DRUG	Adelumab+VEX Metronomic Chemotherapy+Concurrent Radiotherapy	1. Adelumab: 1200 mg on Day 1, every 3 weeks (q3w). 2. VEX Metronomic Chemotherapy: Vinorelbine: 20 mg orally, every other day, every 3 weeks (q3w). Cyclophosphamide: 50 mg orally, once daily, every 3 weeks (q3w). Capecitabine: 500 mg orally, three times daily, every 3 weeks (q3w). 3. Radiotherapy: The interval between radiotherapy and immunotherapy should be within 3 weeks, with no specific order required. Different radiotherapy techniques will be selected based on the size and location of the metastatic lesions: Stereotactic Body Radiation Therapy (SBRT), Spatially Fractionated Radiation Therapy (SFRT), Low-dose Radiotherapy (LDRT).
DRUG	Adelumab+VEX Metronomic Chemotherapy+Delayed Radiotherapy	1. Adelumab: 1200 mg on Day 1, every 3 weeks (q3w). 2. VEX Metronomic Chemotherapy: Vinorelbine: 20 mg orally, every other day, every 3 weeks (q3w). Cyclophosphamide: 50 mg orally, once daily, every 3 weeks (q3w). Capecitabine: 500 mg orally, three times daily, every 3 weeks (q3w). 3. Radiotherapy: If there is intracranial disease progression but extracranial disease remains stable, the systemic treatment regimen of Adelumab + VEX metronomic chemotherapy will be continued, with the addition of intracranial radiotherapy. If there is intracranial disease progression and extracranial disease progression, the systemic treatment regimen will be modified, with the addition of intracranial radiotherapy. The radiotherapy positioning and techniques will be the same as those used in the experimental group.

Timeline

• Start date: 2025-03-01
• Primary completion: 2028-09-10
• Completion: 2028-09-10
• First posted: 2025-02-21
• Last updated: 2025-02-21

Locations

1 site across 1 country: China