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Toripalimab + Metronomic Vinorelbine in HER2- Metastatic Breast Cancer
NCT04389073Phase 2
Key facts
- Status
- Unknown
- Start
- Apr 2020
- Primary completion
- Dec 2022
- Countries
- 1
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Modality
- Immune Checkpoint Inhibitors, Recombinant Proteins and Enzymes
- Drugs
- toripalimab
01
Overview
Phase 2, randomised, open-label trial of toripalimab (5 arms), sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Primary endpoint: Clinical Benefit Rate at 6 weeks. Status: unknown.
02
Design
5 arms- Study design
- RandomizedOpen-label
PD-1+NVB
Toripalimab + Vinorelbine
PD-1+NVB+Bev
Toripalimab + Vinorelbine + Bevacizumab
PD-1+NVB+DDP
Toripalimab + Vinorelbine + Cisplatin
PD-1+VEX
Toripalimab + Vinorelbine + Cyclophosphamide + Capecitabine
NVB
Vinorelbine alone
03
Who it enrols
Female patients >= 18 years with HER2-negative metastatic breast cancer, ECOG <= 1, and no more than one prior line of standard chemotherapy.
04
Endpoints
Primary
Clinical Benefit Rate
Secondary
Overall Response Rate
Progression-Free Survival
Overall Survival
Adverse events reporting
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