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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: Recruiting Phase 1 study of HER2-positive Breast Cancer and Leptomeningeal Metastasis, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
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 235-participant average among 58 other HER2-positive Breast Cancer trials with a reported enrollment target (83% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
MTD will be determined by testing increasing doses or pertuzumab beginning at 10 mg increasing to 20 mg, 40 mg and 80 mg, along with a fixed dose of 80 mg Trastuzumab.
Conditions Studied
Interventions
- DRUG Trastuzumab
- RADIATION Radiation Therapy
- DRUG Pertuzumab
Study Locations (2)
Florida
- Moffitt Cancer Center - Tampa
Illinois
- Northwestern University - Evanston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2020-12-10 |
| Est. Completion | 2026-08 |
| Phase | Phase 1 |
What NCT04588545 shows while recruiting
NCT04588545 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 235-participant average among 58 other HER2-positive Breast Cancer trials with a reported enrollment target (83% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for HER2-positive Breast Cancer
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 NCT04588545's enrollment target sits among peer trials
39 35th of 58 higher than 24 of 58 other HER2-positive Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HER2-positive Breast Cancer 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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