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Sac-TMT followed by carboplatin/paclitaxel versus chemotherapy, both with pembrolizumab, as neoadjuvant therapy for high-risk early-stage TNBC or HR-low/HER2-negative breast cancer
2024-520190-12-00Phase 3Authorised
- Sponsor
- Merck & Co.
- Start
- Nov 2025
- Modality
- Immune Checkpoint Inhibitors → Monoclonal Antibodies → Antibody-Based Therapeutics, Recombinant Proteins and Enzymes, Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics
- Countries
- 41
01
Overview
Phase 3, randomised, open-label trial of sacituzumab tirumotecan and pembrolizumab in triple-negative breast cancer (TNBC) and breast cancer (2 arms), sponsored by Merck & Co. Primary endpoints: Pathological Complete Response (pCR) Rate Using the Definition of ypT0/Tis ypN0 and Event-Free Survival (EFS). Planned start Nov 2025; status: authorised.
02
Drugs
sacituzumab tirumotecanpembrolizumab
03
Conditions
triple-negative breast cancer (TNBC)breast cancer
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