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ONO-4578-06: Phase I , Open-label, Non-blind, First-line Endocrine Therapy With ONO-4578 and Standard Treatment Letrozole and CDK4/6 Inhibitors (Palbociclib or Abemaciclib) in Patients With Metastatic or Recurrent Postmenopausal Hormone Receptor-positive HER2-negative Breast Cancer

Trial Profile

ONO-4578-06: Phase I , Open-label, Non-blind, First-line Endocrine Therapy With ONO-4578 and Standard Treatment Letrozole and CDK4/6 Inhibitors (Palbociclib or Abemaciclib) in Patients With Metastatic or Recurrent Postmenopausal Hormone Receptor-positive HER2-negative Breast Cancer

Status: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 10 Jul 2025

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At a glance

  • Drugs ONO 4578 (Primary) ; Abemaciclib; Letrozole; Palbociclib
  • Indications HER2 negative breast cancer
  • Focus Adverse reactions
  • Sponsors Ono Pharmaceutical

Most Recent Events

  • 02 Jul 2025 Planned End Date changed from 31 Jul 2025 to 30 Apr 2026.
  • 02 Jul 2025 Planned primary completion date changed from 31 Jul 2025 to 30 Apr 2026.
  • 28 Aug 2024 New trial record

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