Study of Multiple Combination Therapies with FWD1802 for Women with ER-positiveHER2-negative Advanced or Metastatic Breast Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of multiple combination therapies with the drug FWD1802 in women who have ER-positiveHER2-negative breast cancer that cannot be removed by surgery and is either locally advanced or has spread to other parts of the body. This phase IbII clinical study is sponsored by Forward Pharmaceuticals Co., Ltd. and aims to understand how these combinations work in this specific breast cancer type. The study involves giving participants FWD1802 orally once daily in 28-day treatment cycles until the disease progresses, side effects become intolerable, or they choose to stop. Participants receive one of several combination treatments FWD1802 with Palbociclib, Ribociclib, Abemaciclib, or Everolimus, each given with or without a hormone therapy called luteinizing hormone-releasing hormone LHRH agonist. Each combination follows a specific dosing schedule, such as Palbociclib and Ribociclib being given daily for 21 days followed by a 7-day break, while Abemaciclib and Everolimus are taken every day. During the study, participants will be closely monitored for side effects, vital signs, and heart function using ECGs. Researchers will assess how well the cancer responds to treatment using standard criteria and study the drugs behavior in the body through blood tests. The study will last approximately 1.5 to 2 years, during which safety events, tumor responses, and other health measures will be tracked to evaluate the treatments impact.

A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC