Patheon France SAS

Primary objective: To compare the PFS of MK-1026 with that of investigator's choice of chemoimmunotherapy (fludarabine + cyclophosphamide + rituximab [FCR] or bendamustine + rituximab [BR]); Secondary objectives: To compare MK-1026 with that of investigator's choice of chemoimmunotherapy (FCR or BR) in terms of OS, ORR and DOR; To evaluate the safety and tolerability of MK-1026.

Primary objectives: To determine whether amcenestrant once daily (QD) improves invasive breast cancer-free survival (IBCFS) compared with tamoxifen QD as adjuvant therapy in patients with early breast cancer. Secondary objectives: To determine whether amcenestrant once daily (QD) improves invasive disease-free survival (IDFS) compared with tamoxifen QD as adjuvant therapy in patients with early breast cancer; to evaluate distant recurrence-free survival (DRFS) in both treatment groups; to evaluate locoregional recurrence-free survival (LRRFS) in both treatment groups; to evaluate overall survival (OS) in both treatment groups; to evaluate breast cancer-specific survival (BCSS) in both treatment groups; to evaluate overall patient-reported treatment-related adverse reactions, treatment-related symptoms, and quality of life in both treatment groups; to evaluate the safety of both treatment groups; and to characterize the pharmacokinetics (PK) of amcenestrant.

Main purpose To determine serum total iron, transferrin saturation, and the concentrations of maltol and maltol glucuronide in plasma and urine, and to evaluate the iron absorption and pharmacokinetics of maltol in blood and urine. Secondary purpose To determine blood transferrin, total iron binding capacity, ferritin, blood routine indexes and reticulocyte count, and preliminarily evaluate the iron-related pharmacodynamics of maltol iron capsules after single and multiple administrations. To evaluate the safety of single and multiple oral administration of maltol iron capsules in subjects with iron deficiency.