Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-negative Breast Cancer | — | UNRESOLVED | — |
| Hormone Receptor-positive Breast Cancer | — | UNRESOLVED | — |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Recurrent Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| abemaciclib | Drug | Abemaciclib | ALIAS |
| letrozole | Drug | Letrozole | ALIAS |
| ONO-4578 | Drug | — | UNRESOLVED |
| Palbociclib | Drug | Palbociclib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ONO-4578 + letrozole + palbociclib
- interventionNames
- Drug: ONO-4578
- Drug: letrozole
- Drug: Palbociclib
- type
- EXPERIMENTAL
- label
- ONO-4578 + letrozole + abemaciclib
- interventionNames
- Drug: ONO-4578
- Drug: letrozole
- Drug: abemaciclib
Primary outcomes (17)
- measure
- Adverse events
- timeFrame
- Through study completion, an average of 4 year
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available