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NCT04923542 · ClinicalTrials.gov registry record · Phase 1
Stereotactic Radiation & Abemaciclib in the Management of HR+/HER2- Breast Cancer Brain Metastases
A Phase 1 study of Brain Metastases and HR+ Metastatic Breast Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 2
- Study locations
NCT04923542: Recruiting Phase 1 study of Brain Metastases and HR+ Metastatic Breast Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT04923542 is a Phase 1 study of Brain Metastases and HR+ Metastatic Breast Cancer that is actively recruiting participants, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 31 participants, below the 212-participant average among 67 other Brain Metastases trials with a reported enrollment target (85% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04923542, a Phase 1 study of Brain Metastases and HR+ Metastatic Breast Cancer, is actively recruiting participants, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a single arm study of abemaciclib and endocrine therapy with stereotactic radiosurgery (SRS) among patients with hormone receptor (HR)+/HER2- metastatic breast cancer brain metastases.
Primary Outcome
Intracranial Progression Free Survival: defined as the time from the date of start of treatment to investigator-determined date of progression or death due to any cause, whichever comes first. Progression will be determined by Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) Criteria.
Conditions Studied
Interventions
- DRUG Abemaciclib
- RADIATION Stereotactic Radiosurgery (SRS)
- DRUG Endocrine therapy
Study Locations (2)
Florida
- Moffitt Cancer Center - Tampa
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2021-11-30 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What NCT04923542 shows while recruiting
NCT04923542 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 212-participant average among 67 other Brain Metastases trials with a reported enrollment target (85% lower).
The record links to 2 conditions, with Brain Metastases appearing as the primary indexed condition, and to 3 interventions - of which Abemaciclib is the first listed.
NCT04923542 reports a single indexed study location in Florida, Ohio.
Frequently Asked Questions
What is clinical trial NCT04923542 about?
NCT04923542 is a clinical study titled "Stereotactic Radiation & Abemaciclib in the Management of HR+/HER2- Breast Cancer Brain Metastases". This is a single arm study of abemaciclib and endocrine therapy with stereotactic radiosurgery (SRS) among patients with hormone receptor (HR)+/HER2- metastatic breast cancer brain metastases.
What is the current status of trial NCT04923542?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2021-11-30. Estimated completion is 2026-12.
What conditions does trial NCT04923542 study?
This clinical trial studies the following conditions: Brain Metastases, HR+ Metastatic Breast Cancer.
What interventions are being tested in trial NCT04923542?
The interventions under investigation include: Abemaciclib (DRUG), Stereotactic Radiosurgery (SRS) (RADIATION), Endocrine therapy (DRUG).
Who is sponsoring clinical trial NCT04923542?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04923542 being conducted?
This trial has 2 study locations across Florida, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Brain Metastases
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04923542's enrollment target sits among peer trials
31 42nd of 67 higher than 26 of 67 other Brain Metastases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Brain Metastases 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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