At a glance
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NCT06998108Phase 3RecruitingUpdate OverdueUpdated 13mo ago · Completion was 6mo agoA Multicenter, Randomized, Controlled, Double-blind Phase III Clinical Study of BEBT-209 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant for the Treatment of HR+/HER2- Locally Advanced or Metastatic Breast Cancer in Patients With Disease Progression After Prior Endocrine Therapy
In Brief
A Phase 3 clinical trial evaluating BEBT-209 capsules, BEBT-209 Placebo capluses, and 1 other intervention for HR+/HER2- Locally Advanced, Metastatic Breast Cancer. Currently recruiting, targeting 330 participants across 1 site.
Signals
Detailed Summary
This study is a randomized, double-blind, multicenter, placebo-controlled Phase III clinical trial designed to evaluate the efficacy and safety of BEBT-209 in combination with fulvestrant in patients with HR+/HER2- locally advanced or metastatic breast cancer.
Study Details
Timeline
Interventions
Oral, 75 mg per dose, twice daily, in a 28-day cycle. Continuous dosing from day 1 to day 21, followed by a rest period from day 22 to day 28.
Oral, 75 mg per dose, twice daily, in a 28-day cycle. Continuous dosing from day 1 to day 21, followed by a rest period from day 22 to day 28.
500 mg intramuscular injection, with a 28-day treatment cycle. Administration on day 1 and day 15 of the first cycle, and then on day 1 of each subsequent cycle.