Clinical trial · Interventional
Drug-Drug Interaction Study of Entinostat and Exemestane in Postmenopausal Women With ER+ Breast Cancer
A Phase 1, Two-Cohort, Open-Label, Drug-Drug Interaction Study of Entinostat and Exemestane in Postmenopausal Women With Locally Recurrent or Metastatic ER+ 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)
The purpose of this study is to determine the effect of exemestane on the pharmacokinetics (PK) of entinostat and to determine the effect of entinostat on the PK of exemestane in patients with locally recurrent or metastatic estrogen receptor positive (ER+) breast cancer. Additionally, this study will evaluate the safety and tolerability of entinostat in combination with exemestane, and assess the effectiveness of entinostat in combination with exemestane in terms of best overall response and overall survival.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Estrogen Receptor Positive Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| entinostat | Drug | — | UNRESOLVED |
| exemestane | Drug | Exemestane | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Cohort 1
- description
- Cohort 1 will evaluate exemestane's effect on the PK of entinostat. Each treatment cycle is 28 days.
- interventionNames
- Drug: entinostat
- Drug: exemestane
- type
- ACTIVE_COMPARATOR
- label
- Cohort 2
- description
- Cohort 2 will enroll when Cohort 1 enrollment is complete. Cohort 2 will evaluate entinostat's effect on the PK of exemestane. Each treatment cycle is 28 days.
- interventionNames
- Drug: entinostat
- Drug: exemestane
Primary outcomes (9)
- measure
- Cmax, maximum plasma concentration
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Postmenopausal female patients * Histologically or cytologically confirmed ER+ breast cancer at initial diagnosis and have locally recurrent or metastatic disease that has progressed to where the patient is a candidate to receive exemestane as determined by the Investigator * Patients receiving palliative radiation at the non-target lesions must be clinically stable prior to receiving the first dose of study treatment * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Patient must have acceptable, applicable laboratory requirements * Patients may have a history of brain metastasis provided certain protocol criteria are met * Able to understand and give written informed consent and comply with study procedures Exclusion Criteria: * Rapidly progressive or life-threatening metastases * Inability to swallow oral medications or gastrointestinal (GI) malabsorption syndromes * History of significant GI surgery as determined by Investigator * A medical condition that precludes adequate study treatment or increases patient risk * Currently enrolled in (or completed within 30 days prior to study drug administration) another investigational drug study
References
Publications (0)
Data not yet available