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

PHASE3RecruitingINTERVENTIONAL
Enrollment

330

Participants

Timeline

Start Date

June 9, 2022

Primary Completion Date

December 31, 2025

Study Completion Date

June 30, 2026

Conditions
HR+/HER2- Locally Advanced, Metastatic Breast Cancer
Interventions
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.

Trial Locations (1)

100021

RECRUITING

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Chinese Academy of Medical Sciences

OTHER

lead

BeBetter Med Inc

INDUSTRY