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NCT04588545 · ClinicalTrials.gov registry record · Phase 1

Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in HER2+ Breast Leptomeningeal Disease

A Phase 1 study of HER2-positive Breast Cancer and Leptomeningeal Metastasis, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Recruiting
Registry status
Phase 1
Development phase
39
Enrollment target
2
Study locations

NCT04588545 is a Phase 1 study of HER2-positive Breast Cancer and Leptomeningeal Metastasis that is actively recruiting participants, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 39 participants, below the 239-participant average among 54 other HER2-positive Breast Cancer trials with a reported enrollment target (84% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT04588545, a Phase 1 study of HER2-positive Breast Cancer and Leptomeningeal Metastasis, is actively recruiting participants, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

RECRUITING
Registry status
Phase 1
Development phase
39 participants
Enrollment target
2
Study locations

Study Summary

The purpose of this study is to find out if radiation therapy followed by intrathecal trastuzumab and pertuzumab is safe and will result in improved survival in HER2 positive breast cancer which has metastasized to the leptomeninges.

Conditions Studied

HER2-positive Breast Cancer Leptomeningeal Metastasis Leptomeningeal Disease

Interventions

  • DRUG Trastuzumab
  • RADIATION Radiation Therapy
  • DRUG Pertuzumab

Study Locations (2)

Florida

  • Moffitt Cancer Center - Tampa

Illinois

  • Northwestern University - Evanston

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2020-12-10
Est. Completion 2026-08
Phase Phase 1

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

502 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04588545

The ClinicalTrials.gov registry entry for NCT04588545 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 239-participant average among 54 other HER2-positive Breast Cancer trials with a reported enrollment target (84% 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 3 conditions, with HER2-positive Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Trastuzumab is the first listed.

NCT04588545 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Florida, Illinois.

Frequently Asked Questions

What is clinical trial NCT04588545 about?

NCT04588545 is a clinical study titled "Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in HER2+ Breast Leptomeningeal Disease". The purpose of this study is to find out if radiation therapy followed by intrathecal trastuzumab and pertuzumab is safe and will result in improved survival in HER2 positive breast cancer which has metastasized to the leptomeninges.

What is the current status of trial NCT04588545?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2020-12-10. Estimated completion is 2026-08.

What conditions does trial NCT04588545 study?

This clinical trial studies the following conditions: HER2-positive Breast Cancer, Leptomeningeal Metastasis, Leptomeningeal Disease.

What interventions are being tested in trial NCT04588545?

The interventions under investigation include: Trastuzumab (DRUG), Radiation Therapy (RADIATION), Pertuzumab (DRUG).

Who is sponsoring clinical trial NCT04588545?

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 NCT04588545 being conducted?

This trial has 2 study locations across Florida, Illinois. 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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.