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

January 7, 2026 updated by: Washington University School of Medicine

SWIFT RT: Ultra-Hypofractionated vs. Hypofractionated Radiation 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Sub-Investigator:
          • Joanna Yang, M.D.
        • Sub-Investigator:
          • Cynthia X Ma, M.D., Ph.D.
        • Sub-Investigator:
          • Carmen Bergom, M.D., Ph.D.
        • Sub-Investigator:
          • Julie Margenthaler, M.D.
        • Sub-Investigator:
          • Imran Zoberi, M.D.
        • Sub-Investigator:
          • Doug Caruthers, M.S.
        • Contact:
        • Principal Investigator:
          • Maria Thomas, M.D., Ph.D.
        • Sub-Investigator:
          • Jon Hansen, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.
  • Female.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hypofractionated radiation (RT)
Breast/chest wall and nodal radiation (4256 cGy in 16 fractions over 3-4 weeks).
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,
Other Names:
  • RT
Experimental: Ultra-hypofractionated breast/chest wall and regional nodal radiation (SWIFT RT)
Breast/chest wall and nodal radiation (2600 cGy in 5 fractions over 1-2 weeks).
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
Other Names:
  • SWIFT RT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 91 through 5 year follow-up (estimated to be 5 years and 1 month)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Maria Thomas, M.D., Ph.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2024

Primary Completion (Estimated)

April 30, 2034

Study Completion (Estimated)

April 30, 2034

Study Registration Dates

First Submitted

August 14, 2024

First Submitted That Met QC Criteria

August 14, 2024

First Posted (Actual)

August 19, 2024

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202407159

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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