NCT05433480

A Study of BPI-16350 in Combination With Fulvestrant in Patients With HR+ and HER2- Locally Advanced, Recurrent or Metastatic Breast Cancer

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare Fulvestrant Plus BPI-16350 or Plus Placebo in Patients With HR+, HER2- Locally Advanced, Recurrent or Metastatic Breast Cancer With Disease Progression Following Endocrine Therapy

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 274 (actual)
• Sponsor: Betta Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase III clinical trial to evaluate the efficacy and safety of BPI-16350 in combination with Fulvestrant versus placebo combined with Fulvesrant in Patients who have HR positive and HER2 negative locally advanced，recurrent or metastatic breast cancer with disease progression following endocrine therapy.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	BPI-16350	BPI-16350 400 mg, orally once daily
DRUG	placebo	Placebo 400 mg, orally once daily
DRUG	Fulvestrant	Fulvestrant 500 mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 for every cycle until progressive disease

Timeline

• Start date: 2022-05-25
• Primary completion: 2023-12-31
• Completion: 2025-07-31
• First posted: 2022-06-27
• Last updated: 2023-07-27

Locations

64 sites across 1 country: China