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TROPION-Breast06: Dato-DXd in HR-positive, HER2 IHC 0 Advanced Breast Cancer
NCT07205822Phase 3
Key facts
- Status
- Recruiting
- Start
- Oct 2025
- Primary completion
- Feb 2028
- Countries
- 6
- Sponsor
- AstraZeneca
- Modality
- Monoclonal Antibodies, Antibody-Drug Conjugates (ADCs), Small Molecules
- Conditions
- breast cancer
01
Overview
Phase 3, open-label, single-arm trial of datopotamab deruxtecan in breast cancer, sponsored by AstraZeneca. Primary endpoint: Progression-Free Survival at 24 months. Started Oct 2025; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
single arm group
All participants will receive Dato-DXd (6 mg/kg IV on Day 1, Q3W; up to a maximum of 540 mg Q3W for participants >= 90 kg) until investigator-defined disease progression according to RECIST 1.1 or until unacceptable toxicity.
03
Who it enrols
Adults with HR-positive, HER2 IHC 0, locally advanced inoperable or metastatic breast cancer who have progressed on endocrine therapy and have not received prior chemotherapy in the metastatic setting.
04
Endpoints
Primary
Progression-Free Survival
Secondary
Proportion of participants with oral mucositis/stomatitis
Proportion of participants with ocular events
Proportion of participants with Grade 3 or higher Adverse Events
Clinical Benefit Rate
Objective Response Rate
Duration of Response
Overall Survival
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