NCT05860465

Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer

A Phase II/III Study of SPH4336 in Combination With Endocrine Therapy in the Treatment of HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer That Progressed on CDK4/6 Inhibitor Combined With Endocrine Therapy

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 254 (estimated)
• Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study evaluated the safety and efficacy of SPH4336 in combination with endocrine therapy in the treatment of locally advanced or metastatic breast cancer that progressed on CDK4/6 inhibitor combined with endocrine therapy.

Conditions

• Locally Advanced or Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	SPH4336 Tablets	SPH4336 Tablets ：Administered by oral; Letrozole tablets：Administered by oral; Fulvestrant injection：Administered by intravenous infusion
DRUG	SPH4336 Tablets Placebo	SPH4336 Tablets Placebo ：Administered by oral; Letrozole tablets：Administered by oral; Fulvestrant injection：Administered by intravenous infusion

Timeline

• Start date: 2023-09-08
• Primary completion: 2026-12-01
• Completion: 2026-12-30
• First posted: 2023-05-16
• Last updated: 2026-01-14

Locations

22 sites across 1 country: China