NCT05744687

Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer

Randomized, Double-blind, Placebo-controlled, Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 374 (estimated)
• Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the safety and efficacy of SPH4336 combined with letrozole in first-line treatment of locally advanced or metastatic breast cancer

Conditions

• Locally Advanced or Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	SPH4336 Tablets 400mg	SPH4336 Tablets ：Orally, 400mg once a day; 28 days/cycle Letrozole tablets ：Orally, 2.5mg once a day; 28 days/cycle
DRUG	SPH4336 Tablets Placebo	SPH4336 Tablets Placebo：Orally,28 days/cycle Letrozole tablets ：Orally, 2.5mg once a day; 28 days/cycle

Timeline

• Start date: 2023-04-24
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2023-02-27
• Last updated: 2025-08-17

Locations

9 sites across 1 country: China