Clinical trial · Interventional
A Study of LY3295668 Erbumine in Participants With Breast Cancer That Has Spread to Other Parts of the Body
A Phase 1b Study of Aurora A Kinase Inhibitor LY3295668 Erbumine in Monotherapy and Combination Therapy in Patients With Metastatic Breast Cancer Post CDK4/6 Inhibitor and Endocrine Therapy
NCT03955939CI-TRIAL-00045342completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The reason for this study is to determine the recommended phase 2 dose of the study drug LY3295668 erbumine in participants with breast cancer that has spread to other parts of the body.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endocrine therapy | Drug | Hormone Therapy | ALIAS |
| LY3295668 Erbumine | Drug | Aurora A Kinase Inhibitor LY3295668 Erbumine | ALIAS |
| Midazolam | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- LY3295668 Erbumine Part A
- description
- LY3295668 erbumine administered orally (Part I). Approximately the first 10 participants enrolled in this arm will be administered midazolam.
- interventionNames
- Drug: LY3295668 Erbumine
- Drug: Midazolam
- type
- EXPERIMENTAL
- label
- LY3295668 Erbumine Part B
- description
- LY3295668 erbumine administered orally (Part I). Approximately the first 10 participants enrolled in this arm will be administered midazolam.
- interventionNames
- Drug: LY3295668 Erbumine
- Drug: Midazolam
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participant must have hormone receptor positive and HER2 negative metastatic breast cancer * Participant must have progressed on at least 1 line of endocrine therapy and 1 cyclin dependent kinase (CDK)4/6 inhibitor * Participant must be able and willing to undergo mandatory tumor biopsy * Participant must have normal organ function * Participant must be able to swallow capsules Exclusion Criteria: * Participant must not have had prior chemotherapy for mBC. Chemotherapy in the adjuvant/neoadjuvant setting is permitted * Participant must not be currently enrolled in a clinical study * Participant must not have another serious medical condition * Participant must not have previously received an aurora kinase inhibitor
References
Publications (0)
Data not yet available
No reference posted for this study.