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NCT06902311 · ClinicalTrials.gov registry record · Phase 2
Ultra Hypo-fractionated Adjuvant Whole Breast Radiation Therapy With Simultaneous Integrated Boost for Early-Stage Breast Cancer (H-ASSIST)
A Phase 2 study of Breast Cancer and Early Stage Breast Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
- 1
- Study location
NCT06902311: Recruiting Phase 2 study of Breast Cancer and Early Stage Breast Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT06902311 is a Phase 2 study of Breast Cancer and Early Stage Breast Cancer that is actively recruiting participants, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 90 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06902311, a Phase 2 study of Breast Cancer and Early Stage Breast Cancer, is actively recruiting participants, sponsored by UNC Lineberger Comprehensive Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
- 1
- Study location
Study Summary
This study evaluates the rates of radiation-specific toxicity, quality of life, and oncologic outcomes for early-stage breast cancer and ductal carcinoma in situ treated with 5-fraction whole breast irradiation (WBI) with a simultaneous integrated tumor bed boost (SIB). SIB refers to the technique tumor bed boost given at the same time as standard radiation therapy. The FAST-Forward trial previously showed that a 1-week course of radiotherapy had similar effects to the traditional 3-week course for early-stage breast cancer after surgery. Given these favorable results, a 5-fraction WBI regimen is appealing for many patients who wish to minimize the number of treatment visits while still reducing their risk of recurrence. Generally, tumor bed boosts further decrease the risk of recurrence, but in the setting of 5-fraction WBI, a more traditional sequential boost technique is utilized.
Primary Outcome
The rate of moderate to marked adverse effects in the breast or chest wall at 1 year will be measured using a questionnaire called the Clinician Assessment of Radiation-Specific Toxicity by clinican. This will be compared against historical controls. The questionnaire includes 10 items: 4 Likert-type questions and 6 yes/no questions. Items are rated from 0 to 4, with higher scores indicating more adverse effects. A "yes" response indicates the occurrence of an adverse event.
Conditions Studied
Interventions
- RADIATION Breast Radiotherapy
Study Locations (1)
North Carolina
- University of North Carolina - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2025-03-12 |
| Est. Completion | 2028-02 |
| Phase | Phase 2 |
What NCT06902311 shows while recruiting
NCT06902311 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (97% lower).
The record links to 4 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Breast Radiotherapy is the first listed.
NCT06902311 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT06902311 about?
NCT06902311 is a clinical study titled "Ultra Hypo-fractionated Adjuvant Whole Breast Radiation Therapy With Simultaneous Integrated Boost for Early-Stage Breast Cancer (H-ASSIST)". This study evaluates the rates of radiation-specific toxicity, quality of life, and oncologic outcomes for early-stage breast cancer and ductal carcinoma in situ treated with 5-fraction whole breast irradiation (WBI) with a simultaneous integrated tumor bed boost (SIB). SIB refers to the technique t...
What is the current status of trial NCT06902311?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2025-03-12. Estimated completion is 2028-02.
What conditions does trial NCT06902311 study?
This clinical trial studies the following conditions: Breast Cancer, Early Stage Breast Cancer, Ductal Carcinoma In Situ, DCIS.
What interventions are being tested in trial NCT06902311?
The interventions under investigation include: Breast Radiotherapy (RADIATION).
Who is sponsoring clinical trial NCT06902311?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06902311 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT06902311's enrollment target sits among peer trials
90 613th of 1224 higher than 604 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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