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

NCT06570031 — Phase 1, Completed, 46 participants, Ono Pharmaceutical Co., Ltd.

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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

Registry	NCT06570031
Status	Completed
Phase	Phase 1
Study type	Interventional; non randomized, parallel, masking: none, treatment
Enrollment	46 (Actual)
Sponsor	Ono Pharmaceutical Co., Ltd. (Industry)
Conditions	Hormone Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer
Interventions	ONO-4578, letrozole, Palbociclib, abemaciclib (Drug)
Dates	start 2021-11-09, primary completion 2026-04-30, completion 2026-04-30, first posted 2024-08-26, last updated 2026-06-05
Locations	13 sites in Japan

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
ONO-4578 + letrozole + palbociclib	Experimental	Drug: ONO-4578; Drug: letrozole; Drug: Palbociclib
ONO-4578 + letrozole + abemaciclib	Experimental	Drug: ONO-4578; Drug: letrozole; Drug: abemaciclib

ONO-4578 (Drug): Specified dose on specified days
letrozole (Drug): Specified dose on specified days
Palbociclib (Drug): Specified dose on specified days
abemaciclib (Drug): Specified dose on specified days

+Outcome measures

Primary outcomes

Adverse events [Through study completion, an average of 4 year]
Serious adverse events [Through study completion, an average of 4 year]
Dose-limiting toxicity (Tolerability Confirmation part only) [28 days]
Laboratory abnormality profile of Drugs as measured by incidence and severity of clinical laboratory abnormalities [Through study completion, an average of 4 year]
Body temperature [Through study completion, an average of 4 year]
Pulse rate [Through study completion, an average of 4 year]
Systolic/diastolic blood pressure [Through study completion, an average of 4 year]
Saturation of Percutaneous Oxygen (SpO2) [Through study completion, an average of 4 year]
Weight [Through study completion, an average of 4 year]
Eastern Cooperative Oncology Group Performance Status [Through study completion, an average of 4 year]
Chest X-ray [Through study completion, an average of 4 year]
CT scan [Through study completion, an average of 4 year]
12-lead electrocardiography (Heart rate) [Through study completion, an average of 4 year]
12-lead electrocardiography (PR interval) [Through study completion, an average of 4 year]
12-lead electrocardiography (RR interval) [Through study completion, an average of 4 year]
12-lead electrocardiography (QRS width) [Through study completion, an average of 4 year]
12-lead electrocardiography (QT interval) [Through study completion, an average of 4 year]

Secondary outcomes

Overall response rate (ORR) [Through study completion, an average of 4 year]
Disease control rate (DCR) [Through study completion, an average of 4 year]
Clinical benefit rate (CBR) [Through study completion, an average of 4 year]
Overall survival (OS) [Through study completion, an average of 4 year]
Progression-free survival (PFS) [Through study completion, an average of 4 year]
Duration of response (DOR) [Through study completion, an average of 4 year]
Time to response (TTR) [Through study completion, an average of 4 year]
Best overall response (BOR) [Through study completion, an average of 4 year]
Percent change in the sum of diameters of target lesions [Through study completion, an average of 4 year]
Maximum percent change in the sum of diameters of target lesions [Through study completion, an average of 4 year]
Changes in tumor markers [Through study completion, an average of 4 year]
Plasma ONO-4578 concentration [Through study completion, an average of 4 year]

+Eligibility

Sex: Female, ages: 20 Years to any

Inclusion Criteria:

1. Patients with postmenopausal metastatic or recurrent breast cancer
2. Patients with ECOG Performance Status 0 to 1
3. ER-positive, PgR-positive and HER2-negative patients

Exclusion Criteria:

1. Patients are unable to swallow oral medications
2. Patients with severe complication

+Locations (13)

Facility	City	Country
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

+Investigators

Project Leader, Study director, Ono Pharmaceutical Co., Ltd.