Trial Title:
ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer
NCT ID:
NCT06570031
Condition:
Hormone Receptor-positive Breast Cancer
HER2-negative Breast Cancer
Metastatic Breast Cancer
Recurrent Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Recurrence
Letrozole
Palbociclib
Conditions: Keywords:
Breast Cancer
Hormone Receptor-positive
HER2-negative
Metastatic
Recurrent
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ONO-4578
Description:
Specified dose on specified days
Arm group label:
ONO-4578 + letrozole + abemaciclib
Arm group label:
ONO-4578 + letrozole + palbociclib
Intervention type:
Drug
Intervention name:
letrozole
Description:
Specified dose on specified days
Arm group label:
ONO-4578 + letrozole + abemaciclib
Arm group label:
ONO-4578 + letrozole + palbociclib
Intervention type:
Drug
Intervention name:
Palbociclib
Description:
Specified dose on specified days
Arm group label:
ONO-4578 + letrozole + palbociclib
Intervention type:
Drug
Intervention name:
abemaciclib
Description:
Specified dose on specified days
Arm group label:
ONO-4578 + letrozole + abemaciclib
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.
Criteria for 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
Gender:
Female
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Aichi Cancer Center Hospital
Address:
City:
Nagoya-shi
Country:
Japan
Facility:
Name:
Nagoya University Hospital
Address:
City:
Nagoya-shi
Country:
Japan
Facility:
Name:
Chiba Cancer Center
Address:
City:
Chiba-shi
Country:
Japan
Facility:
Name:
National Cancer Center Hospital East
Address:
City:
Kashiwa-shi
Country:
Japan
Facility:
Name:
St. Marianna University Hospital
Address:
City:
Kawasaki-shi
Country:
Japan
Facility:
Name:
Kanagawa Cancer Center
Address:
City:
Yokohama-shi
Country:
Japan
Facility:
Name:
University Hospital Kyoto Prefectural University of Medicine
Address:
City:
Kyoto-shi
Country:
Japan
Facility:
Name:
Tohoku University Hospital
Address:
City:
Sendai-shi
Country:
Japan
Facility:
Name:
Osaka International Cancer Institute
Address:
City:
Osaka-shi
Country:
Japan
Facility:
Name:
Saitama Cancer Center
Address:
City:
Ina
Country:
Japan
Facility:
Name:
National Cancer Center Hospital
Address:
City:
Chuo-ku
Country:
Japan
Facility:
Name:
The Cancer Institute Hospital Of JFCR
Address:
City:
Koto-ku
Country:
Japan
Facility:
Name:
Tokyo Medical University Hospital
Address:
City:
Shinjuku-ku
Country:
Japan
Start date:
November 9, 2021
Completion date:
July 31, 2025
Lead sponsor:
Agency:
Ono Pharmaceutical Co. Ltd
Agency class:
Industry
Source:
Ono Pharmaceutical Co. Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06570031
