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NCT04040569 · ClinicalTrials.gov registry record · Phase 1
A Phase I Dose Escalation Study of Single Fraction Pre-operative Partial Breast (S-PBI) for Early Stage Breast Cancer
A Phase 1 study of Breast Cancer, sponsored by University of Texas Southwestern Medical Center.
- Active
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT04040569: Active Phase 1 study of Breast Cancer, sponsored by University of Texas Southwestern Medical Center.
NCT04040569 is a Phase 1 study of Breast Cancer that is active but no longer recruiting, run by University of Texas Southwestern Medical Center. The registered enrollment target is 45 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04040569, a Phase 1 study of Breast Cancer, is active but no longer recruiting, sponsored by University of Texas Southwestern Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this phase I trial is to evaluate dose-limiting toxicity while dose escalating single-fraction preoperative S-PBI to a presumed radioablative dose over 3 cohorts, starting with 30Gy in 1 fraction and advancing to 34Gy and 38Gy in 1 fraction.
Primary Outcome
The primary objective is to escalate the dose of 1 fraction stereotactic partial breast radiotherapy utilizing the MR Linac, Gammapod or Cyberknife system to an ablative dose in the pre-operative setting to the primary tumor without exceeding the maximum tolerated dose in patients with early stage breast cancer. Done by escalating the dose of SBRT toward the tumorcidal dose of 38 Gy in fraction. Doses will be escalated an additional 3.5-4 Gy per treatment. The phase I portion of the study will b
Conditions Studied
Interventions
- RADIATION Radiomics on MRI
Study Locations (1)
Texas
- University of Texas Southwestern Medical Center - Dallas - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2019-12-25 |
| Est. Completion | 2027-07 |
| Phase | Phase 1 |
What the registry record for NCT04040569 still lists
NCT04040569 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Radiomics on MRI is the first listed.
NCT04040569 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04040569 about?
NCT04040569 is a clinical study titled "A Phase I Dose Escalation Study of Single Fraction Pre-operative Partial Breast (S-PBI) for Early Stage Breast Cancer". The purpose of this phase I trial is to evaluate dose-limiting toxicity while dose escalating single-fraction preoperative S-PBI to a presumed radioablative dose over 3 cohorts, starting with 30Gy in 1 fraction and advancing to 34Gy and 38Gy in 1 fraction.
What is the current status of trial NCT04040569?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2019-12-25. Estimated completion is 2027-07.
What conditions does trial NCT04040569 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT04040569?
The interventions under investigation include: Radiomics on MRI (RADIATION).
Who is sponsoring clinical trial NCT04040569?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04040569 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for 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 NCT04040569's enrollment target sits among peer trials
45 843rd of 1224 higher than 374 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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.
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