46 results
Primary objective:• Determine if ribociclib plus letrozole gives a >=100% improvement in complete cell cycle arrest (CCCA; defined as Ki67 IHC <1%) as compared to chemotherapy in the surgical specimen*.Secondary objective• Study the…
Primary objective of this study: evaluate the efficacy of each combination arm, as measured by confirmed objective response rate (ORR) by local investigator's assessment per RECIST v1.1secondary objectives: - Safety & tolerability of…
To evaluate the efficacy of each combination arm, as measured by confirmed objective response rate (ORR)
The primary objective is to evaluate the efficacy of IFX-1 treatment as a replacement for glucocorticoids [GC] therapy in subjects with GPA and MPA.Secondary objectives:*To assess safety and tolerability of IFX-1*To compare GC-induced toxicity of…
To assess the efficacy of adding subcutaneous TCZ to csDMARD therapy compared with adding oral prednisone (10 mg daily).
Primary: To compare PFS between ribociclib plus fulvestrant to fulvestrant monotherapy (plus placebo) among men and postmenopausal women with HR+, HER2-negative advanced breast cancer who received no or only one prior endocrine treatment for…