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ACTIVE NOT RECRUITING
NCT06570031
PHASE1

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

Sponsor: Ono Pharmaceutical Co. Ltd

View on ClinicalTrials.gov

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

Key Details

Gender

FEMALE

Age Range

20 Years - Any

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2021-11-09

Completion Date

2026-04-30

Last Updated

2025-07-02

Healthy Volunteers

No

Interventions

DRUG

ONO-4578

Specified dose on specified days

DRUG

letrozole

Specified dose on specified days

DRUG

Palbociclib

Specified dose on specified days

DRUG

abemaciclib

Specified dose on specified days

Locations (13)

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, Japan

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Chiba Cancer Center

Chiba, Chiba, Japan

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

St. Marianna University Hospital

Kawasaki-shi, Kanagawa, Japan

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

University Hospital Kyoto Prefectural University of Medicine

Kyoto, Kyoto, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Osaka International Cancer Institute

Osaka, Osaka, Japan

Saitama Cancer Center

Shinden, Saitama, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

The Cancer Institute Hospital Of JFCR

Koto-ku, Tokyo, Japan

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo, Japan