Actively Recruiting
Study of PD-L1 Antibody Adebry Plus VEX Metronomic Chemotherapy With or Without Radiotherapy for Advanced Triple-negative Breast Cancer A Prospective, Randomized Phase II Trial
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-01-13
150
Participants Needed
2
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combination treatment involving a PD-L1 monoclonal antibody with vinorelbine, cyclophosphamide, and capecitabine (VEX) metronomic chemotherapy, with or without radiotherapy, in patients with advanced triple-negative breast cancer. This phase II clinical trial aims to assess the effectiveness and safety of these treatments for this aggressive form of breast cancer. Participants are assigned to one of two groups: one receiving the PD-L1 antibody (Adebry) plus VEX metronomic chemotherapy along with radiotherapy, and the other receiving the PD-L1 antibody plus VEX chemotherapy without radiotherapy. The PD-L1 antibody is given as 1200 mg on day 1 every three weeks. VEX chemotherapy includes oral vinorelbine 20 mg every other day, oral cyclophosphamide 50 mg daily, and oral capecitabine 500 mg three times daily, all on a three-week cycle. During the study, participants will be monitored for progression-free survival over 24 months. Assessments include clinical data review, measurable tumor lesion evaluation according to standard criteria, and organ function tests conducted within 10 days before treatment start. Safety, treatment response, and overall health status will be closely followed throughout the trial to evaluate the benefits and risks of these treatment combinations.
CONDITIONS
Official Title
Phase II Clinical Trial of PD-L1 in Combination with Vinorelbine + Cyclophosphamide + Capecitabine (VEX) Metronomic Chemotherapy with or Without Radiotherapy for Advanced Triple-negative Breast Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older at signing informed consent
- Diagnosed with metastatic triple-negative breast cancer with clear clinical data per ASCO/CAP guidelines
- Received one or fewer lines of chemotherapy for metastatic breast cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 10 days before treatment
- At least one measurable lesion according to RECIST v1.1 guidelines
- Prior treatment with anthracyclines and/or taxanes allowed under specified conditions
- Female participants are not pregnant or lactating and agree to use contraception
- Ability to provide informed consent
- Appropriate organ function confirmed by laboratory tests within 10 days before treatment start
You will not qualify if you...
- None explicitly stated in the provided eligibility criteria
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Trial Site Locations
Total: 2 locations
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
2
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
F
Fei Ma 马
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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