drugset / Trial / NCT04481113
Abemaciclib and Niraparib Before Surgery for the Treatment of Hormone Receptor Positive HER2 Negative Breast Cancer
Phase 1
Completed
8 enrolled
OHSU Knight Cancer Institute
Eli Lilly and Company · collabGlaxoSmithKline · collabOregon Health and Science University · collab
NaSingle-groupOpen-labelTreatment
Summary
This phase I trial tests the side effects and best dose of abemaciclib and niraparib in treating patients with breast cancer that is positive for estrogen or progesterone receptors (hormone receptor positive \[HR+\]) and HER2 negative. Abemaciclib may stop the growth of tumor cells by blocking certain proteins called cyclin-dependent kinases, which are needed for cell growth. PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as niraparib, can keep PARP from working so tumor cells can't repair themselves and grow. Giving abemaciclib and niraparib together before surgery may make the tumor smaller.
Timeline
- Start
- 2021-06-07
- Primary completion
- 2023-10-11
- Completion
- 2025-06-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abemaciclib | Small molecule | — | Oral |
| Subject | Niraparib | Small molecule | — | Oral |