drugset / Trial / NCT04738292
Onapristone and Fulvestrant for ER+ HER2- Metastatic Breast Cancer After Endocrine Therapy and CDK4/6 Inhibitors (The SMILE Study)
NaSingle-groupOpen-labelTreatment
Summary
A phase II single-arm trial of onapristone in combination with fulvestrant for women and men with ER-positive, PgR-positive or negative and HER2-negative locally advanced or metastatic breast cancer after progression on aromatase and CDK4/6 inhibitors. The study will enroll up to 39 participants.
Timeline
- Start
- 2021-10-05
- Primary completion
- 2023-04-03
- Completion
- 2023-05-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fulvestrant | Small molecule | 500 mg | Intramuscular |
| Subject | Onapristone | Other / unclassified | 50 mg | Oral |