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Boserolimab in early-stage triple-negative breast cancer
NCT06829199Phase 2
Key facts
- Status
- Withdrawn
- Start
- Mar 2025
- Primary completion
- Jan 2029
- Countries
- 2
- Sponsor
- Merck & Co.
- Modality
- Monoclonal Antibodies
- Drugs
- boserolimab
- Conditions
- triple-negative breast cancer (TNBC)
01
Overview
Phase 2, randomised trial of boserolimab in triple-negative breast cancer (TNBC), sponsored by Merck & Co. Primary endpoints: Number of participants with one or more adverse events at 34 months, Number of participants who discontinue study intervention due to an AE at 27 months and 1 more. Planned start Mar 2025; status: withdrawn.
02
Design
- Study design
- Randomized
03
Who it enrols
Patients with previously untreated high-risk, early-stage, non-metastatic triple-negative breast cancer (T1c N1-2 or T2-4 N0-2) with ECOG 0-1 and LVEF >= 50%.
04
Endpoints
Primary
Number of participants with one or more adverse events
Number of participants who discontinue study intervention due to an AE
Pathological complete response rate
Secondary
Pathological complete response - no ductal carcinoma in situ rate
Event-Free Survival
Overall Survival
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