RecruitingPhase 3NCT06998108

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


Sponsor

BeBetter Med Inc

Enrollment

330 participants

Start Date

Jun 9, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests BEBT-209 — a new targeted drug — combined with fulvestrant (a hormone-blocking therapy) compared to placebo plus fulvestrant in women with hormone receptor-positive, HER2-negative breast cancer that has spread or come back after prior hormone therapy. **You may be eligible if...** - You are a woman 18 or older with HR+/HER2- breast cancer that has spread or cannot be surgically cured - Your cancer progressed during or after prior hormone therapy - You have not received more than one prior chemotherapy regimen for metastatic disease - Your blood counts, liver, and kidney function are adequate - You have not previously been treated with fulvestrant, everolimus, or CDK4/6 inhibitors **You may NOT be eligible if...** - Your cancer has spread to the brain in an active and uncontrolled way - You have had a recent heart attack, stroke, or severe heart rhythm problem (within 6 months) - You have active HIV, hepatitis B or C - You cannot swallow pills or have conditions affecting gut absorption - You are pregnant, breastfeeding, or have poorly controlled diabetes or high blood pressure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBEBT-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.

DRUGBEBT-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.

DRUGFulvestrant 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.


Locations(1)

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

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06998108