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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 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.

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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.

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

FieldValue
Enrollment Target 31 participants
Start Date 2021-11-30
Est. Completion 2026-12
Phase Phase 1

What the Registry Record Tells You About NCT04923542

The ClinicalTrials.gov registry entry for NCT04923542 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 212-participant average among 67 other Brain Metastases trials with a reported enrollment target (85% lower). The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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