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Phase 2 clinical trial to evaluate patritumab deruxtecan pembrolizumab in high-risk triple-negative breast cancer
THE MAIN OBJECTIVE IS TO DETERMINE WHETHER THE COMBINATION OF PATRITUMAB DERUXTECAN AND PEMBROLIZUMAB ADMINISTERED BEFORE OR AFTER CHEMOTHERAPY IS MORE EFFECTIVE AND SAFER COMPARED TO THE STANDARD COMBINATION OF PEMBROLIZUMAB AND CHEMOTHERAPY FOLLOWED BY SURGERY AND ADJUVANT TREATMENT WITH PEMBROLIZUMAB, IN ORDER TO IMPROVE THE DISEASE-FREE SURVIVAL RATE AND OTHER CLINICAL INDICATORS IN PATIENTS WITH TRIPLE-NEGATIVE BREAST CANCER.
Technical Summary
- PHASE 2, OPEN-LABEL, RANDOMIZED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PATRITUMAB DERUXTECAN PLUS PEMBROLIZUMAB GIVEN BEFORE OR AFTER CARBOPLATIN/PACLITAXEL PLUS PEMBROLIZUMAB COMPARED WITH PEMBROLIZUMAB IN COMBINATION WITH CHEMOTHERAPY, FOLLOWED BY SURGERY AND ADJUVANT PEMBROLIZUMAB, FOR EARLY-STAGE, HIGH-RISK TRIPLE-NEGATIVE OR LOW HORMONE RECEPTOR EXPRESSION/NO HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 EXPRESSION BREAST CANCER (HERTHENA-BREAST03).
- Code EudraCT: 2024-514376-40
- Protocol number: MK-1022-010
- Promoter: Merck Sharp & Dohme, S.A.
- Molecule/Drug: Patritumab deruxtecán más pembrolizumab
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