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ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer
Sponsor: Ono Pharmaceutical Co. Ltd
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
Conditions
Interventions
ONO-4578
Specified dose on specified days
letrozole
Specified dose on specified days
Palbociclib
Specified dose on specified days
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