NCT06902311 · UNC Lineberger Comprehensive Cancer Center
Ultra Hypo-fractionated Adjuvant Whole Breast Radiation Therapy With Simultaneous Integrated Boost for Early-Stage Breast Cancer (H-ASSIST)
(H-ASSIST)
What this study is about
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.
View original scientific description
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.
Interventions
RADIATION
Breast Radiotherapy
The tumor bed boost when given at the same time (called a simultaneous integrated boost, SIB) with whole breast irradiation (WBI).
Primary outcome measures
Rate of any moderate-marked adverse effects
Time frame: 1 year
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Willing and able to provide written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- Women ≥ 50 years of age with confirmed de novo invasive carcinoma of breast or ductal carcinoma in situ.
- Subjects with completed breast-conserving surgery (BCS) with or without sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND).
- Subjects planned to receive either SOC whole breast 3D conformal radiation therapy (3D CRT) or SOC whole breast intensity modulated radiation therapy (IMRT) with standard dose tumor bed boost.
- Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial, per the discretion of the treating radiation oncologist.
- Enrollment in another clinical trial is allowed if there is no interference with interventions on this trial per discretion of the Principal Investigator.
Exclusion criteria
- Receipt of concurrent breast reduction involving tissue rearrangement in the lumpectomy cavity (so that boost cannot be accurately targeted).
- Synchronous bilateral breast cancer requiring bilateral radiation therapy.
- Clinical or imaging evidence of distant metastases.
- Prior ipsilateral breast or thoracic radiation.
- Autoimmune conditions
- Collagen Vascular Disease (such as systemic lupus erythematosus, scleroderma, dermatomyositis, among others)
- Patients with pT4 tumors.
- Patients recommended to receive regional nodal irradiation with associated radiation risks
Where
- Chapel Hill, North Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 30, 2026 · Source of record for eligibility and locations