NCT06998108

Study of BEBT-209 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Patients With HR+/HER2- Locally Advanced or Metastatic Breast Cancer Who Have Progressed After Prior Endocrine Therapy

A 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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: BeBetter Med Inc · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study plans to enroll 330 eligible female patients with locally advanced or metastatic breast cancer. All eligible patients will be randomly assigned to the treatment group or the control group in a 2:1 ratio. The following two factors will be used for stratification: 1) visceral metastasis (yes or no); 2) menopausal status (postmenopausal; premenopausal or perimenopausal). The study consists of a screening period, a treatment period, and a follow-up period. It aims to evaluate the efficacy and safety of BEBT-209 in combination with fulvestrant versus placebo in combination with fulvestrant in patients with HR+/HER2- locally advanced or metastatic breast cancer who have experienced disease progression after prior endocrine therapy.

Conditions

• HR+/HER2- Locally Advanced, Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	BEBT-209 capsules	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.
DRUG	BEBT-209 Placebo capluses	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.
DRUG	Fulvestrant Injection	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.

Timeline

• Start date: 2022-06-09
• Primary completion: 2025-12-31
• Completion: 2026-06-30
• First posted: 2025-05-31
• Last updated: 2025-05-31

Locations

1 site across 1 country: China