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DEMETHER: T-DXd Induction Followed by PHESGO Maintenance in HER2+ Advanced Breast Cancer
NCT06172127Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Jul 2024
- Primary completion
- Apr 2027
- Countries
- 5
- Sponsor
- MEDSIR
- Modality
- Monoclonal Antibodies, Antibody-Drug Conjugates (ADCs), Engineered Antibody Formats
- Conditions
- breast cancer
01
Overview
Phase 2, open-label, single-arm trial of trastuzumab deruxtecan and trastuzumab in breast cancer, sponsored by MEDSIR. Primary endpoints: 1-year Progression-Free Survival rate and 3-year Overall Survival rate. Started Jul 2024; status: active, not recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
T-DXd induction followed by PHESGO maintenance
All patients receive a 6-cycle induction phase with T-DXd followed by a maintenance phase with PHESGO.
03
Who it enrols
Adults with HER2-positive, unresectable locally recurrent or metastatic breast cancer with no prior chemotherapy or HER2-targeted therapy for advanced disease, ECOG 0-1, adequate organ function, and LVEF >= 55%.
04
Endpoints
Primary
1-year Progression-Free Survival rate
3-year Overall Survival rate
Secondary
Global Progression-Free Survival rate
Global Overall Survival rate
Objective Response Rate
Clinical Benefit Rate
Time to Response
Duration of Response
Best percentage of change
Quality of Life
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