RecruitingPhase 2NCT06771609

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.

Evaluate the Efficacy and Safety of PD-L1 Monoclonal Antibody Combined With VEX Metronomic Chemotherapy With or Without Radiotherapy in Advanced Triple-negative Breast Cancer: a Prospective, Multicenter, Randomized Controlled Phase II Clinical Trial.


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

150 participants

Start Date

Sep 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of an immunotherapy drug (a PD-L1 inhibitor) with low-dose metronomic chemotherapy (vinorelbine, cyclophosphamide, and capecitabine, given in small regular doses) with or without radiotherapy for people with advanced triple-negative breast cancer (a type that is harder to treat because it lacks the three most common receptors targeted by breast cancer drugs). **You may be eligible if...** - You are 18 or older (male or female) - You have confirmed metastatic triple-negative breast cancer - Your cancer diagnosis is documented with clinical data - You have measurable disease on imaging **You may NOT be eligible if...** - You have already received certain prior treatments that would interfere with the study - You have active brain metastases - You have severe heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAdebrelimab + VEX metronomic chemotherapy + radiotherapy

1、Adebrelimab: 1200mg on day 1, every 3 weeks; 2、VEX Metronomic Chemotherapy: Vinorelbine 20mg orally, once every other day, Q3W Cyclophosphamide 50mg orally, once daily, Q3W Capecitabine 500mg orally, three times daily, Q3W

DRUGAdebrelimab + VEX metronomic chemotherapy

1、Adebrelimab: 1200mg on day 1, every 3 weeks; 2、VEX Metronomic Chemotherapy: Vinorelbine 20mg orally, once every other day, Q3W Cyclophosphamide 50mg orally, once daily, Q3W Capecitabine 500mg orally, three times daily, Q3W


Locations(2)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06771609


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