Hormone Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer
Conditions
Keywords
Breast Cancer, Hormone Receptor-positive, HER2-negative, Metastatic, Recurrent
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.
Interventions
DRUGONO-4578
Specified dose on specified days
DRUGletrozole
Specified dose on specified days
DRUGPalbociclib
Specified dose on specified days
DRUGabemaciclib
Specified dose on specified days
Sponsors
Ono Pharmaceutical Co. Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chest X-ray | 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 |
| 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 |
| 12-lead electrocardiography (QT interval) | 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Overall response rate (ORR) | Through study completion, an average of 4 year |
Countries
Japan
Outcome results
None listed