ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer
NCT Number: NCT06570031
Status: ACTIVE_NOT_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Hormone Receptor-positive Breast Cancer|HER2-negative Breast Cancer|Metastatic Breast Cancer|Recurrent Breast Cancer
Interventions: DRUG: ONO-4578|DRUG: letrozole|DRUG: Palbociclib|DRUG: abemaciclib
Sponsor: Ono Pharmaceutical Co. Ltd
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 46
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2021-11-09
Completion Date: 2025-07-31
Locations: Aichi Cancer Center Hospital, Nagoya-shi, Aichi, Japan|Nagoya University Hospital, Nagoya-shi, Aichi, Japan|Chiba Cancer Center, Chiba-shi, Chiba, Japan|National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan|St. Marianna University Hospital, Kawasaki-shi, Kanagawa, Japan|Kanagawa Cancer Center, Yokohama-shi, Kanagawa, Japan|University Hospital Kyoto Prefectural University of Medicine, Kyoto-shi, Kyoto, Japan|Tohoku University Hospital, Sendai-shi, Miyagi, Japan|Osaka International Cancer Institute, Osaka-shi, Osaka, Japan|Saitama Cancer Center, Ina, 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

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.

Primary Outcome Measures: 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 Outcome Measures: 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