Phase III Study of FWD1802 Treatment for Women With ERHER2- Advanced or Metastatic Breast Cancer

What this Trial Is About

Researchers are evaluating FWD1802, a drug being studied for patients with estrogen receptor-positive ER, human epidermal growth factor receptor 2-negative HER2- advanced breast cancer that cannot be removed by surgery or has spread to other parts of the body. This phase III study aims to find the best dose of FWD1802 and assess its safety, tolerability, and effect on tumors, especially in patients whose cancer has specific ESR1 mutations. The study is multicenter, open-label, and includes patients with locally advanced or metastatic breast cancer. The study has three parts Phase I Part A is a dose-escalation phase where up to 27 patients receive increasing doses of FWD1802 tablets, starting with a single dose followed by daily dosing in 28-day cycles. Phase I Part B is a dose-expansion phase exploring 2 to 4 selected dose levels in up to 10 patients per dose to study pharmacokinetics and confirm the recommended dose for Phase II. Phase II focuses on up to 60 patients with ESR1 mutations receiving one or two dose levels to evaluate FWD1802s anti-tumor efficacy and safety. Treatment may continue up to two years or longer if beneficial and agreed upon. Participants will undergo screening including mutation testing and must meet health criteria to join. During treatment, they will receive FWD1802 daily and have blood tests to monitor mutations and drug effects. The study measures safety, drug levels in the body, tumor response, and patient outcomes over about two years. Follow-up includes monitoring for side effects, response to treatment, and disease progression. The trial is designed to gather detailed information about FWD1802s use in this breast cancer type and mutation status.

A Phase I/II Study of FWD1802 in Patients With ER+/HER2- Advanced BC.