RecruitingPhase 2NCT06902311

Ultra Hypo-fractionated Adjuvant Whole Breast Radiation Therapy With Simultaneous Integrated Boost for Early-Stage Breast Cancer (H-ASSIST)


Sponsor

UNC Lineberger Comprehensive Cancer Center

Enrollment

90 participants

Start Date

Feb 19, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an accelerated, shorter radiation schedule (ultra hypofractionation) with a simultaneous radiation boost to the tumor site for women with early-stage breast cancer who have had breast-conserving surgery. The goal is to deliver effective radiation in fewer treatment sessions. **You may be eligible if...** - You are a woman aged 50 or older - You have been diagnosed with early-stage invasive breast cancer or ductal carcinoma in situ (DCIS) - You have completed breast-conserving surgery (lumpectomy) with or without lymph node surgery - You are planned for whole breast radiation therapy (3D or IMRT) with a tumor bed boost **You may NOT be eligible if...** - You have had a previous breast reconstruction or implant - You have previously received radiation to the chest area - You have two or more separate breast cancers in the same breast - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONBreast Radiotherapy

The tumor bed boost when given at the same time (called a simultaneous integrated boost, SIB) with whole breast irradiation (WBI).


Locations(1)

University of North Carolina

Chapel Hill, North Carolina, United States

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NCT06902311


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