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Pyrotinib after Adjuvant Anti-HER2 Therapy in High-risk HER2+ Breast Cancer
NCT05834764Phase 2
Key facts
- Status
- Recruiting
- Start
- Apr 2023
- Primary completion
- Jun 2026
- Countries
- 1
- Sponsor
- Jiangsu Provincial People's Hospital
- Modality
- Fragment-Derived Small Molecules, Allosteric Modulators, Orthosteric Ligands
- Drugs
- pyrotinib
- Conditions
- breast cancer
01
Overview
Phase 2, open-label, single-arm trial of pyrotinib in breast cancer, sponsored by Jiangsu Provincial People's Hospital. Primary endpoint: Invasive Disease-free Survival at 2 years. Started Apr 2023; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Pyrotinib
Pyrotinib 400mg orally daily for one year
03
Who it enrols
HER2-positive early or locally advanced breast cancer (Stage II-IIIC) with node-positive disease, having completed standard adjuvant trastuzumab+pertuzumab or T-DM1, or non-pCR after neoadjuvant therapy.
04
Endpoints
Primary
Invasive Disease-free Survival
Secondary
Disease-free Survival
Overall Survival
Invasive Disease-free Survival
Adverse Events
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