ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer
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
1 other identifier
interventional
46
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2021
Longer than P75 for phase_1
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 9, 2021
CompletedFirst Submitted
Initial submission to the registry
July 31, 2024
CompletedFirst Posted
Study publicly available on registry
August 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2026
CompletedJuly 2, 2025
June 1, 2025
4.5 years
July 31, 2024
June 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (17)
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 (12)
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
- +7 more secondary outcomes
Study Arms (2)
ONO-4578 + letrozole + palbociclib
EXPERIMENTALONO-4578 + letrozole + abemaciclib
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Patients with postmenopausal metastatic or recurrent breast cancer
- Patients with ECOG Performance Status 0 to 1
- ER-positive, PgR-positive and HER2-negative patients
You may not qualify if:
- Patients are unable to swallow oral medications
- Patients with severe complication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Project Leader
Ono Pharmaceutical Co. Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2024
First Posted
August 26, 2024
Study Start
November 9, 2021
Primary Completion
April 30, 2026
Study Completion
April 30, 2026
Last Updated
July 2, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share