drugset / Trial / NCT06016738
OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one endocrine therapy in combination with a CDK4/6 inhibitor.
Timeline
- Start
- 2023-11-16
- Primary completion
- 2026-06-30
- Completion
- 2027-09-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Anastrozole | Other / unclassified | — | — |
| Comparator | Exemestane | Small molecule | — | — |
| Comparator | Fulvestrant | Small molecule | — | — |
| Comparator | Letrozole | Other / unclassified | — | — |
| Subject | Palazestrant | Small molecule | 90 mg | Oral |
| Subject | Palazestrant | Small molecule | 120 mg | Oral |