Clinical trial NCT06570031: ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Hormone Receptor-positive Breast Cancer
HER2-negative Breast Cancer
Metastatic Breast Cancer
Recurrent Breast Cancer
Keywords: Breast Cancer
Hormone Receptor-positive
HER2-negative
Metastatic
Recurrent
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2024-08-26
Enrollment: 46
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Adverse events
timeFrame: Through study completion, an average of 4 year
measure: Serious adverse events
timeFrame: Through study completion, an average of 4 year
measure: Dose-limiting toxicity (Tolerability Confirmation part only)
timeFrame: 28 days
measure: Laboratory abnormality profile of Drugs as measured by incidence and severity of clinical laboratory abnormalities
timeFrame: Through study completion, an average of 4 year
measure: Body temperature
timeFrame: Through study completion, an average of 4 year
measure: Pulse rate
timeFrame: Through study completion, an average of 4 year
measure: Systolic/diastolic blood pressure
timeFrame: Through study completion, an average of 4 year
measure: Saturation of Percutaneous Oxygen (SpO2)
timeFrame: Through study completion, an average of 4 year
measure: Weight
timeFrame: Through study completion, an average of 4 year
measure: Eastern Cooperative Oncology Group Performance Status
timeFrame: Through study completion, an average of 4 year
measure: Chest X-ray
timeFrame: Through study completion, an average of 4 year
measure: CT scan
timeFrame: Through study completion, an average of 4 year
measure: 12-lead electrocardiography (Heart rate)
timeFrame: Through study completion, an average of 4 year
measure: 12-lead electrocardiography (PR interval)
timeFrame: Through study completion, an average of 4 year
measure: 12-lead electrocardiography (RR interval)
timeFrame: Through study completion, an average of 4 year
measure: 12-lead electrocardiography (QRS width)
timeFrame: Through study completion, an average of 4 year
measure: 12-lead electrocardiography (QT interval)
timeFrame: Through study completion, an average of 4 year
Secondary outcomes:
measure: Overall response rate (ORR)
timeFrame: Through study completion, an average of 4 year
measure: Disease control rate (DCR)
timeFrame: Through study completion, an average of 4 year
measure: Clinical benefit rate (CBR)
timeFrame: Through study completion, an average of 4 year
measure: Overall survival (OS)
timeFrame: Through study completion, an average of 4 year
measure: Progression-free survival (PFS)
timeFrame: Through study completion, an average of 4 year
measure: Duration of response (DOR)
timeFrame: Through study completion, an average of 4 year
measure: Time to response (TTR)
timeFrame: Through study completion, an average of 4 year
measure: Best overall response (BOR)
timeFrame: Through study completion, an average of 4 year
measure: Percent change in the sum of diameters of target lesions
timeFrame: Through study completion, an average of 4 year
measure: Maximum percent change in the sum of diameters of target lesions
timeFrame: Through study completion, an average of 4 year
measure: Changes in tumor markers
timeFrame: Through study completion, an average of 4 year
measure: Plasma ONO-4578 concentration
timeFrame: Through study completion, an average of 4 year
Other outcomes:
Locations:
city: Nagoya-shi
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Nagoya-shi
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Chiba-shi
country: Japan
facility: Chiba Cancer Center
state: Chiba
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Kawasaki-shi
country: Japan
facility: St. Marianna University Hospital
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Kyoto-shi
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
state: Kyoto
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital
state: Miyagi
city: Osaka-shi
country: Japan
facility: Osaka International Cancer Institute
state: Osaka
city: Ina
country: Japan
facility: Saitama Cancer Center
state: Saitama
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Koto-ku
country: Japan
facility: The Cancer Institute Hospital Of JFCR
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader
role: STUDY_DIRECTOR
References: