4 results
The primary endpoint is overall survival (OS) in patients with low hENT1 expression. Ifthe hENT1 expression data are available for analysis prior to randomizing 250 patientsthen an interim analysis for sample size re-estimation may be performed.
To compare invasive disease-free survival (iDFS) for ribociclib + ET versus placebo + ET in patients with HR-positive, HER2-negative, EBCwith high risk of recurrence.
The primary objective of the study as a whole (part A-C) is to assess the PK and safety of buccal apomorphine relative to registered apomorphine formulations (subcutaneous, sublingual). Secondary objectives are the characterization of the PK-AE…
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…