OncoMatch/Clinical Trials/NCT06559540
Ultra-Hypofractionated vs. Hypofractionated Radiation for Node-Positive Breast Cancer
Is NCT06559540 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies non-drug interventions 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 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Disease stage
Required: Stage CN1, CN2, PN1, PN2 (AJCC 8th Edition)
Excluded: Stage PT4
AJCC 8th Edition Stage: cT1-3 primary tumor. cN1-2 or pN1-2. AJCC cT4 disease, pT4 disease, or any skin involvement on exam or pathology, including dermal LVSI [excluded].
Performance status
ECOG ZUBROD 0–1
Prior therapy
Must have received: surgery — breast surgery with negative histologic margins
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).
Must have received: nodal surgery — sentinel lymph node biopsy or axillary lymph node dissection
Nodal surgery with either sentinel lymph node biopsy or axillary lymph node dissection.
Cannot have received: radiation therapy
Prior radiation therapy which would have any overlap with current radiation therapy plan.
Cannot have received: chemotherapy
Planning to undergo concurrent chemotherapy.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Washington University School of Medicine · St Louis, Missouri
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