Trials / Active Not Recruiting
Active Not RecruitingNCT06570031
ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer
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
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- Ono Pharmaceutical Co., Ltd. · Industry
- Sex
- Female
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Hormone Receptor-positive Breast Cancer
- HER2-negative Breast Cancer
- Metastatic Breast Cancer
- Recurrent Breast Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ONO-4578 | Specified dose on specified days |
| DRUG | letrozole | Specified dose on specified days |
| DRUG | Palbociclib | Specified dose on specified days |
| DRUG | abemaciclib | Specified dose on specified days |
Timeline
- Start date
- 2021-11-09
- Primary completion
- 2026-04-30
- Completion
- 2026-04-30
- First posted
- 2024-08-26
- Last updated
- 2025-07-02
Locations
13 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT06570031. Inclusion in this directory is not an endorsement.