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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

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Trial Profile

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 of Trial: Phase II/III

Latest Information Update: 22 Sep 2025

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At a glance

  • Drugs I 022 (Primary) ; Letrozole (Primary)
  • Indications Advanced breast cancer; HER2 negative breast cancer
  • Focus Therapeutic Use
  • Sponsors Shanghai Pharmaceuticals Holding

Most Recent Events

  • 17 Aug 2025 Planned End Date changed from 31 May 2025 to 31 May 2026.
  • 17 Aug 2025 Planned primary completion date changed from 31 May 2025 to 31 May 2026.
  • 20 Dec 2024 Planned End Date changed from 16 Dec 2024 to 31 May 2025.

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