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NCT04481113 · ClinicalTrials.gov registry record · Phase 1
Abemaciclib and Niraparib Before Surgery for the Treatment of Hormone Receptor Positive HER2 Negative Breast Cancer
A Phase 1 study, sponsored by OHSU Knight Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT04481113: Completed Phase 1 study, sponsored by OHSU Knight Cancer Institute.
NCT04481113 is a Phase 1 study that has completed, run by OHSU Knight Cancer Institute. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04481113, a Phase 1 study, has completed, sponsored by OHSU Knight Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study 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.
Primary Outcome
Dose-limiting toxicities will specifically be reported for the DLT evaluation period using the MTD-evaluable population.
Interventions
- DRUG Abemaciclib
- DRUG Niraparib Tosylate Monohydrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2021-06-07 |
| Est. Completion | 2025-06-20 |
| Phase | Phase 1 |
What the finished NCT04481113 record still lists
NCT04481113 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Abemaciclib is the first listed.
NCT04481113 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04481113 about?
NCT04481113 is a clinical study titled "Abemaciclib and Niraparib Before Surgery for the Treatment of Hormone Receptor Positive HER2 Negative Breast Cancer". 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 certa...
What is the current status of trial NCT04481113?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2021-06-07. Estimated completion is 2025-06-20.
What interventions are being tested in trial NCT04481113?
The interventions under investigation include: Abemaciclib (DRUG), Niraparib Tosylate Monohydrate (DRUG).
Who is sponsoring clinical trial NCT04481113?
This trial is sponsored by OHSU Knight Cancer Institute, which has 211 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04481113's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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