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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

NCT06998108 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2025-05-31

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences

    collaborator OTHER

  • BeBetter Med Inc

    lead INDUSTRY

Principal Investigators

  • Binghe Xu, Ph.D · Chinese Academy of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-09
Primary Completion
2025-12-31
Completion
2026-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06998108 on ClinicalTrials.gov