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NCT06559540 · ClinicalTrials.gov registry record · Phase 2
Ultra-Hypofractionated vs. Hypofractionated Radiation for Node-Positive Breast Cancer
A Phase 2 study of Node-positive Breast Cancer, sponsored by Washington University School of Medicine.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 220
- Enrollment target
- 1
- Study location
NCT06559540 is a Phase 2 study of Node-positive Breast Cancer that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 220 participants, below the 444-participant average among 4 other Node-positive Breast Cancer trials with a reported enrollment target (50% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06559540, a Phase 2 study of Node-positive Breast Cancer, is actively recruiting participants, sponsored by Washington University School of Medicine.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 220 participants
- Enrollment target
- 1
- Study location
Study Summary
In breast cancer patients with nodal involvement, numerous studies have demonstrated that adjuvant radiation therapy reduces the risk of local recurrence, regional recurrence, and distant metastases, in addition to improving survival. The dose and fractionation for adjuvant breast radiation therapy has evolved over time, as novel schedules have been compared to the current standard of care. Hypofractionated radiation therapy (266 cGy per fraction x 15-16 fractions over 3 weeks) has been shown to result in equivalent oncologic outcomes, as well as equivalent acute and late toxicity, when compared to standard fractionation (200 cGy per fraction x 25 fractions over 5 weeks). Subsequently, hypofractionated breast radiation has become the current standard of care. More recently, ultra-hypofractionated breast radiation (520 cGy per fraction x 5 fractions over 1 week) was shown in a randomized trial to be non-inferior to hypofractionated radiation when treating the breast after lumpectomy. However, the efficacy and toxicity of using ultra-hypofractionated radiation therapy when also treating the regional nodes has not been reported. This is important, as there is greater radiation exposure to several normal tissues, such as the arm/shoulder, brachial plexus, normal lymphatics, heart, and lung, when treating the regional nodes. In this randomized study, the investigators aim to compare the tolerability and efficacy of ultra-hypofractionated breast/chest wall and regional nodal radiation (SWIFT RT) against hypofractionated radiation (RT). The investigators will evaluate acute and late toxicity, oncologic outcomes (including local recurrence, regional recurrence, distant metastasis, and overall survival), cosmesis, and patient-reported quality of life. The investigators will collect blood samples for correlative studies of biomarkers of fibrosis and cardiac toxicity.
Conditions Studied
Interventions
- RADIATION Hypofractionated radiation
- RADIATION Ultra-hypofractionated breast/chest wall and regional nodal radiation
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2024-08-27 |
| Est. Completion | 2034-04-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06559540
The ClinicalTrials.gov registry entry for NCT06559540 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 444-participant average among 4 other Node-positive Breast Cancer trials with a reported enrollment target (50% lower). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Node-positive Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Hypofractionated radiation is the first listed.
NCT06559540 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT06559540 about?
NCT06559540 is a clinical study titled "Ultra-Hypofractionated vs. Hypofractionated Radiation for Node-Positive Breast Cancer". In breast cancer patients with nodal involvement, numerous studies have demonstrated that adjuvant radiation therapy reduces the risk of local recurrence, regional recurrence, and distant metastases, in addition to improving survival. The dose and fractionation for adjuvant breast radiation therapy ...
What is the current status of trial NCT06559540?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 220 participants. The study started on 2024-08-27. Estimated completion is 2034-04-30.
What conditions does trial NCT06559540 study?
This clinical trial studies the following conditions: Node-positive Breast Cancer.
What interventions are being tested in trial NCT06559540?
The interventions under investigation include: Hypofractionated radiation (RADIATION), Ultra-hypofractionated breast/chest wall and regional nodal radiation (RADIATION).
Who is sponsoring clinical trial NCT06559540?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06559540 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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