drugset / Trial / NCT04872608
A Study of Letrozole, Palbociclib, and Onapristone ER in People With Metastatic Breast Cancer
NaSingle-groupOpen-labelTreatment
Summary
The researchers are doing this study to find out whether the study drug onapristone ER, combined with the standard treatment for your cancer (letrozole and palbociclib), is a safe treatment for people who have metastatic or unresectable ER+/PR+/HER2- breast cancer. The researchers will test different doses of the study drug to find the highest dose that causes few or mild side effects.
Timeline
- Start
- 2021-09-09
- Primary completion
- 2023-04-25
- Completion
- 2023-04-25
Outcome
Outcome not reported
Stopped: “The sponsor closed the study due to discontinuing their onapristone program”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Onapristone | Other / unclassified | 30 mg | — |
| Subject | Onapristone | Other / unclassified | 40 mg | — |
| Subject | Onapristone | Other / unclassified | 50 mg | — |
| Background | Letrozole | Other / unclassified | 2.5 mg | — |
| Background | Palbociclib | Small molecule | — | — |