Bowral

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.

Researchers are assessing how well BGB-43395, a selective CDK4 inhibitor, works by itself or combined with fulvestrant, letrozole, or elacestrant in people with hormone receptor positive (HR+) and HER2-negative breast cancer, as well as other advanced solid tumors. This study is a Phase 1a/1b trial designed to find the best dosing of BGB-43395 and to evaluate its safety, tolerability, and early anti-tumor effects. Participants include those with metastatic or unresectable cancers that depend on CDK4, with specific groups defined for combinations with different drugs and prior treatment histories. The study involves giving BGB-43395 orally in planned doses, either alone or with standard doses of fulvestrant (by injection), letrozole (oral tablet), or elacestrant (oral tablet). Anti-diarrheal medication may also be given as needed. Different parts of the study focus on dose escalation to find the maximum tolerated dose and dose expansion to explore safety and effectiveness in defined patient groups. Participants may receive treatments for up to approximately 60 months, depending on the phase. Participants will be monitored for side effects, drug tolerance, and tumor response over the course of treatment. Researchers will collect data on adverse events, pharmacokinetics, and pharmacodynamics as well as objective tumor responses. Safety and effectiveness are tracked through regular visits involving clinical assessments, lab tests, and questionnaires. The total study duration for each participant can extend up to about five years, allowing for long-term monitoring of treatment effects and safety.