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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
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
...and 3 more locations
Adverse events
Time frame: Through study completion, an average of 4 year
Serious adverse events
Time frame: Through study completion, an average of 4 year
Dose-limiting toxicity (Tolerability Confirmation part only)
Time frame: 28 days
Laboratory abnormality profile of Drugs as measured by incidence and severity of clinical laboratory abnormalities
Time frame: Through study completion, an average of 4 year
Body temperature
Time frame: Through study completion, an average of 4 year
Pulse rate
Time frame: Through study completion, an average of 4 year
Systolic/diastolic blood pressure
Time frame: Through study completion, an average of 4 year
Saturation of Percutaneous Oxygen (SpO2)
Time frame: Through study completion, an average of 4 year
Weight
Time frame: Through study completion, an average of 4 year
Eastern Cooperative Oncology Group Performance Status
Time frame: Through study completion, an average of 4 year
Chest X-ray
Time frame: Through study completion, an average of 4 year
CT scan
Time frame: Through study completion, an average of 4 year
12-lead electrocardiography (Heart rate)
Time frame: Through study completion, an average of 4 year
12-lead electrocardiography (PR interval)
Time frame: Through study completion, an average of 4 year
12-lead electrocardiography (RR interval)
Time frame: Through study completion, an average of 4 year
12-lead electrocardiography (QRS width)
Time frame: Through study completion, an average of 4 year
12-lead electrocardiography (QT interval)
Time frame: Through study completion, an average of 4 year
Overall response rate (ORR)
Time frame: Through study completion, an average of 4 year
Disease control rate (DCR)
Time frame: Through study completion, an average of 4 year
Clinical benefit rate (CBR)
Time frame: Through study completion, an average of 4 year
Overall survival (OS)
Time frame: Through study completion, an average of 4 year
Progression-free survival (PFS)
Time frame: Through study completion, an average of 4 year
Duration of response (DOR)
Time frame: Through study completion, an average of 4 year
Time to response (TTR)
Time frame: Through study completion, an average of 4 year
Best overall response (BOR)
Time frame: Through study completion, an average of 4 year
Percent change in the sum of diameters of target lesions
Time frame: Through study completion, an average of 4 year
Maximum percent change in the sum of diameters of target lesions
Time frame: Through study completion, an average of 4 year
Changes in tumor markers
Time frame: Through study completion, an average of 4 year
Plasma ONO-4578 concentration
Time frame: Through study completion, an average of 4 year
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