clinical trial · NCT06570031
ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer
Ono Pharmaceutical Co., Ltd.·phase1·active not recruiting·n = 46
Hormone Receptor-positive Breast CancerHER2-negative Breast CancerMetastatic Breast CancerRecurrent Breast CancerONO-4578letrozolePalbociclibabemaciclib
brief summary
This is a multicenter, open-label, non-controlled, phase I study to investigate the tolerability and safety of ONO-4578 used in combination with standard-of-care letrozole and a CDK4/6 inhibitor (palbociclib or Abemaciclib) as first-line endocrine therapy in postmenopausal patients with metastatic or recurrent hormone receptor-positive, HER2-negative breast cancer.
started
Nov 9, 2021
primary completion
Apr 30, 2026
completion
Apr 30, 2026
last updated
Jul 2, 2025
official title
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol