9 results
Primary Objective:To compare the clinical benefit of abiraterone acetate plus prednisone versus placebo plus prednisone in patients with chemotherapy-naïve castration-resistant prostate cancer (CRPC) who are asymptomatic or mildly symptomatic.…
Primary objective: To estimate the difference in anti-proliferative activity of LEE011 600 mg QD and LEE011 400 mg QD in combination with letrozole 2.5 mg QD vs single agent letrozole 2.5 mg QD as measured by changes in Ki-67 levels from baseline to…
Primary Objective:The primary objective is to compare the radiographic progression-free survival (rPFS) ofapalutamide in combination with abiraterone acetate (AA) plus prednisone or prednisolone(AAP) and AAP in subjects with chemotherapy-naïve mCRPC…
This study aims to investigate the progression-free survival (PFS) according to RECIST 1.1 criteria on matched targeted therapy by STA-analysis (PFS2) in comparison to the PFS recorded on the therapy administered immediately prior to enrolment (PFS1…
Primary Objectives:- To determine the BE of a RS FDC tablet formulation of niraparib and Abiraterone Acetate with respect to niraparib and Abiraterone Acetate co-administered as single agents at steady state under modified fasted conditions in…
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…
The primary objective of the study is to evaluate if treatment with a non-steroidal aromatase inhibitor combined with CDK4/6 inhibition in first line followed at progression by fulvestrant in second line (strategy A) improves progression-free…
To demonstrate superiority of giredestrant over the control treatment in preventing breast cancer recurrence.Secondary objectives• To evaluate the efficacy of giredestrant compared with TPC in terms of overall survival andother measures• To evaluate…
The purpose of this study is to investigate if niraparib added to a standard treatment (consisting of abiraterone acetate plus prednisone) will work better than abiraterone acetate and prednisone alone in treating men with metastatic prostate cancer…