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Tobemstomig + Nab-Paclitaxel vs Pembrolizumab + Nab-Paclitaxel in Advanced Triple-Negative Breast Cancer
NCT05852691Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2023
- Primary completion
- Oct 2026
- Countries
- 16
- Sponsor
- Roche
- Modality
- Bispecific Antibodies, Monoclonal Antibodies
- Drugs
- tobemstomig
- Conditions
- triple-negative breast cancer (TNBC)
01
Overview
Phase 2, randomised, double-blind trial of tobemstomig in triple-negative breast cancer (TNBC) (2 arms), sponsored by Roche. Primary endpoint: Progression-Free Survival. Started Jul 2023; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Arm A
Tobemstomig Q3W + Nab-Paclitaxel (3 weeks on, 1 week off)
Arm B
Pembrolizumab Q3W + Nab-Paclitaxel (3 weeks on, 1 week off)
03
Who it enrols
Patients with previously untreated, PD-L1-positive, HER2-low, locally advanced unresectable or metastatic triple-negative breast cancer with ECOG 0-1 and adequate organ function.
04
Endpoints
Primary
Progression-Free Survival
Secondary
Objective Response Rate
Duration of Response
Overall Survival
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