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

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.

Trial Details

NCT ID
NCT06998108
Phase
PHASE3
Sponsor
BeBetter Med Inc
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • BEBT-209 capsules
  • BEBT-209 Placebo capluses
  • Fulvestrant Injection
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723

Key Eligibility Criteria

  • Women aged 18 years or older who are postmenopausal or premenopausal/perimenopausal, and meet one of the following criteria: previous bilateral oop…
  • Patients with histologically confirmed HR+/HER2- breast cancer (based on the most recent test results from either recurrent/metastatic lesion tissu…
  • Evidence of focal recurrence or metastasis, not suitable for curative surgery or radiotherapy, and without clinical indications necessitating chemo…
  • Previous endocrine therapy must meet one of the following criteria: a) progression during or within 12 months after discontinuation of adjuvant end…

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Breast Cancer Trials on Trialify →