Type : | Industriel |
Statut : | Ouvert |
Phase : | III |
Étape du traitement : | Traitements combinés |
Date d'ouverture : | 18/06/2021 |
Date clôture : | 21/10/2027 |
Promoteur : | Merck Sharp & Dohme LLC |
Progression du cancer: | Loco-régional et à distance |
Résumé :
The safety and efficacy of pembrolizumab plus the investigator's choice of chemotherapy will be assessed compared to placebo plus the investigator's choice of chemotherapy in the treatment of chemotherapy-candidate hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally recurrent inoperable or metastatic breast cancer.
The primary hypotheses are that the combination of pembrolizumab and chemotherapy is superior to placebo and chemotherapy in regards to Progression-Free Survival (PFS) or overall survival (OS) in participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 and ≥10.
Domaines/spécialités :
- Cancer du sein
Biomarqueurs :
- HER2
- EGFR
- HR
Pathologies :
- Tumeur maligne du sein - Cim10 : C50
Liens externes :