NCT06559540 · Washington University School of Medicine
Ultra-Hypofractionated vs. Hypofractionated Radiation for Node-Positive Breast Cancer
(SWIFT RT)
What this study is about
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 the usual treatment.
View original scientific description
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.
Interventions
RADIATION
Hypofractionated radiation
External beam photon therapy with IMRT or VMAT to the breast/chestwall and regional lymph nodes, including supraclavicular, infraclavicular, axillary, and internal mammary nodes,
RADIATION
Ultra-hypofractionated breast/chest wall and regional nodal radiation
External beam photon therapy with IMRT or VMAT to the breast/chestwall and regional lymph nodes, including supraclavicular, infraclavicular, axillary, and internal mammary nodes
Primary outcome measures
Proportion of patients who are free of serious treatment related late toxicity.
Time frame: Day 91 through 5 year follow-up (estimated to be 5 years and 1 month)
Toxicities of concern may include lymphedema, radiation pneumonitis, brachial plexopathy, rib fracture, cardiac disease, and breast/chest wall fibrosis.
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
- Histologically confirmed invasive carcinoma of the breast. Metaplastic breast cancer is allowed.
- AJCC 8th Edition Stage: cT1-3 primary tumor. cN1-2 or pN1-2.
- Biopsy-proven involved axillary node(s) (either at baseline and/or at time of surgery).
- Undergone either partial mastectomy (with negative final histologic margins (defined as no tumor on ink, after initial surgery or re-excision)) or mastectomy (with negative histologic margins defined as tumor (either invasive or in situ disease) \> 2 mm from the final margin).
- Nodal surgery with either sentinel lymph node biopsy or axillary lymph node dissection. Effort to recover the original biopsy-proven node should be performed at time of surgery.
- Systemic therapy (chemotherapy and/or endocrine therapy) should be administered as per standard of care and recommendation of medical oncology. Neoadjuvant and/or adjuvant systemic therapy is allowed. Concurrent endocrine therapy, anti-HER2 therapy, and immunotherapy during RT is allowed.
- All radiation therapy must be planned to be delivered at BJH or a Siteman satellite location.
- Age ≥ 18 years at diagnosis.
- ECOG Zubrod performance status 0 or 1.
- English speaker.
- Able to understand and willing to sign IRB-approved written informed consent document.
Exclusion criteria
- Presence of distant metastases.
- Diagnosis of nonepithelial breast malignancies such as sarcoma or lymphoma.
- Diagnosis of bilateral breast cancer.
- AJCC cT4 disease, pT4 disease, or any skin involvement on exam or pathology, including dermal LVSI.
- Presence of palpable or radiographically suspicious supraclavicular, infraclavicular, or internal mammary nodes.
- Prior radiation therapy which would have any overlap with current radiation therapy plan.
- Diagnosis of prior breast cancer or diagnosis of current breast cancer more than one year prior to enrollment.
- Diagnosis of systemic lupus erythematosis, scleroderma, or dermatomyositis.
- Diagnosis of a coexisting medical condition which limits life expectancy to \< 2 years.
- Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational treatment. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.
- Time between last breast cancer surgery to RT simulation is greater than 10 weeks, or time between completion of chemotherapy to RT simulation is greater than 8 weeks, whichever is performed last prior to RT.
- Planning to undergo concurrent chemotherapy.
- Pregnancy, which will be excluded prior to simulation.
Where
- St Louis, Missouri
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?
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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 Jan 9, 2026 · Source of record for eligibility and locations