RecruitingPhase 2NCT06559540

Ultra-Hypofractionated vs. Hypofractionated Radiation for Node-Positive Breast Cancer

SWIFT RT: Ultra-Hypofractionated vs. Hypofractionated Radiation for Node-Positive Breast Cancer


Sponsor

Washington University School of Medicine

Enrollment

220 participants

Start Date

Aug 27, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two radiation treatment schedules for women with breast cancer that has spread to nearby lymph nodes — one delivers slightly higher doses over fewer sessions (ultra-hypofractionated) and the other uses a more standard shortened schedule — to see which is more effective with fewer side effects. **You may be eligible if...** - You are a woman aged 18 or older with confirmed breast cancer involving lymph nodes - You have had a lumpectomy or mastectomy with clear surgical margins - Your cancer is stage T1–T3 with node involvement (not stage T4) - Your general health is good (ECOG 0 or 1) - You speak English and can receive treatment at the study site **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have bilateral breast cancer or a prior breast cancer diagnosis - You have lupus, scleroderma, or dermatomyositis - You are pregnant or planning concurrent chemotherapy - Prior radiation would overlap with the planned treatment area 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

RADIATIONHypofractionated 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,

RADIATIONUltra-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


Locations(1)

Washington University School of Medicine

St Louis, Missouri, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06559540


Related Trials