OncRef

Clinical Trial: NCT06570031

ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer

Status:

COMPLETED

Phase:

Phase 1

Lead Sponsor:Ono Pharmaceutical Co., Ltd.
Information Provided By:Ono Pharmaceutical Co., Ltd.
Last Update Posted:2026-06-05

Study Overview

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.

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

Conditions

Hormone Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer

Intervention / Treatment

  • Drug: ONO-4578
  • Drug: letrozole
  • Drug: Palbociclib
  • Drug: abemaciclib

Other Study ID Numbers

  • ONO-4578-06

Start Date (Actual)

2021-11-09

Primary Completion Date (Actual)

2026-04-30

Study Completion Date (Actual)

2026-04-30

Enrollment (Actual)

46

Study Type

Interventional

Phase

Phase 1