Status:
ACTIVE_NOT_RECRUITING
ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer
Lead Sponsor:
Ono Pharmaceutical Co. Ltd
Conditions:
Hormone Receptor-positive Breast Cancer
HER2-negative Breast Cancer
Eligibility:
FEMALE
20+ years
Phase:
PHASE1
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 (palb...
Eligibility Criteria
Inclusion
- Patients with postmenopausal metastatic or recurrent breast cancer
- Patients with ECOG Performance Status 0 to 1
- ER-positive, PgR-positive and HER2-negative patients
Exclusion
- Patients are unable to swallow oral medications
- Patients with severe complication
Key Trial Info
Start Date :
November 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2026
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06570031
Start Date
November 9 2021
End Date
April 30 2026
Last Update
July 2 2025
Active Locations (13)
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1
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan
2
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
3
Chiba Cancer Center
Chiba, Chiba, Japan
4
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan