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

Phase 1

Active, not recruiting

Conditions: Hormone Receptor-positive Breast Cancer
HER2-negative Breast Cancer
Metastatic Breast Cancer
Recurrent Breast Cancer

Registration Number: NCT06570031

Lead Sponsor: Ono Pharmaceutical Co. Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Active, not recruiting

Sex: Female

Target Recruitment: 46

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events;Serious adverse events;Dose-limiting toxicity (Tolerability Confirmation part only);Laboratory abnormality profile of Drugs as measured by incidence and severity of clinical laboratory abnormalities;Body temperature;Pulse rate;Systolic/diastolic blood pressure;Saturation of Percutaneous Oxygen (SpO2);Weight;Eastern Cooperative Oncology Group Performance Status;Chest X-ray;CT scan;12-lead electrocardiography (Heart rate);12-lead electrocardiography (PR interval);12-lead electrocardiography (RR interval);12-lead electrocardiography (QRS width);12-lead electrocardiography (QT interval)

Secondary Outcome Measures

Name	Time	Method
Overall response rate (ORR);Disease control rate (DCR);Clinical benefit rate (CBR);Overall survival (OS);Progression-free survival (PFS);Duration of response (DOR);Time to response (TTR);Best overall response (BOR);Percent change in the sum of diameters of target lesions;Maximum percent change in the sum of diameters of target lesions;Changes in tumor markers;Plasma ONO-4578 concentration