Efficacy and Safety of PD-L1 Monoclonal Antibody Combined With Metronomic VEX in Advanced Triple-negative Breast Cancer

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

182

Participants

Timeline

Start Date

January 19, 2024

Primary Completion Date

January 19, 2025

Study Completion Date

January 19, 2027

Conditions
Breast CancerTriple Negative Breast Cancer
Interventions
DRUG

Adebrelimab

Adebrelimab at a dose of 1200 mg via intravenous infusion every three weeks. Adebrelimab will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.

DRUG

Vinorelbine

Metronomic oral vinorelbine 20 mg every other day. Vinorelbine will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.

DRUG

Cyclophosphamide (tablet)

Metronomic oral cyclophosphamide 50 mg daily. Cyclophosphamide will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.

DRUG

Capecitabine

Metronomic oral capecitabine 500 mg three times daily. Capecitabine will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.

All Listed Sponsors
lead

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

NCT06229067 - Efficacy and Safety of PD-L1 Monoclonal Antibody Combined With Metronomic VEX in Advanced Triple-negative Breast Cancer | Biotech Hunter | Biotech Hunter