Node-positive Breast CancerPhase 2SWIFT RTNCT06559540
Ultra-Hypofractionated vs. Hypofractionated Radiation for Node-Positive Breast Cancer
A Phase 2 study testing Hypofractionated radiation and Ultra-hypofractionated breast/chest wall and regional nodal radiation in people with Node-positive Breast Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Node-positive Breast Cancer
- What is being tested?
- Hypofractionated radiation and Ultra-hypofractionated breast/chest wall and regional nodal radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2024to 30 Apr 2034
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Maria Thomas, M.D., Ph.D., 314-362-8615, mariathomas@wustl.edu
Maria Thomas, M.D., Ph.D.
About this study
Official title: 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.
- Conditions
- Node-positive Breast Cancer
- Being tested
- Hypofractionated radiation, Ultra-hypofractionated breast/chest wall and regional nodal radiation
- Keywords
- Breast cancer, Radiation, Hypofractionation, QOL, Cosmesis, Toxicity
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypofractionated radiationRadiation
Also called RT
External beam photon therapy with IMRT or VMAT to the breast/chestwall and regional lymph nodes, including supraclavicular, infraclavicular, axillary, and internal mammary nodes,
Ultra-hypofractionated breast/chest wall and regional nodal radiationRadiation
Also called SWIFT RT
External beam photon therapy with IMRT or VMAT to the breast/chestwall and regional lymph nodes, including supraclavicular, infraclavicular, axillary, and internal mammary nodes
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated radiation (RT) | Active comparator | Breast/chest wall and nodal radiation (4256 cGy in 16 fractions over 3-4 weeks). Receives: Radiation: Hypofractionated radiation |
| Ultra-hypofractionated breast/chest wall and regional nodal radiation (SWIFT RT) | Experimental | Breast/chest wall and nodal radiation (2600 cGy in 5 fractions over 1-2 weeks). Receives: Radiation: Ultra-hypofractionated breast/chest wall and regional nodal radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who are free of serious treatment related late toxicity.
Toxicities of concern may include lymphedema, radiation pneumonitis, brachial plexopathy, rib fracture, cardiac disease, and breast/chest wall fibrosis.
Measured: Day 91 through 5 year follow-up (estimated to be 5 years and 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start27 Aug 2024
- Primary completion30 Apr 2034 (estimated)
- Study completion30 Apr 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Node-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Thomas, M.D., Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559540
- Sponsor's protocol ID
- 202407159
- Acronym
- SWIFT RT
- Status last verified
- Jan 2026
- First submitted
- 14 Aug 2024
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SWIFT RT: Ultra-Hypofractionated vs. Hypofractionated Radiation for Node-Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT06559540
- Acronym / sponsor ID
- SWIFT RT / 202407159
- Conditions
- Node-positive Breast Cancer
- Keywords
- Breast cancer, Radiation, Hypofractionation, QOL, Cosmesis, Toxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- 30 Apr 2034 (estimated)
- Study completion
- 30 Apr 2034 (estimated)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated radiation (RT) | Active comparator | Radiation: Hypofractionated radiationBreast/chest wall and nodal radiation (4256 cGy in 16 fractions over 3-4 weeks). |
| Ultra-hypofractionated breast/chest wall and regional nodal radiation (SWIFT RT) | Experimental | Radiation: Ultra-hypofractionated breast/chest wall and regional nodal radiationBreast/chest wall and nodal radiation (2600 cGy in 5 fractions over 1-2 weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypofractionated radiationAlso: RTExternal beam photon therapy with IMRT or VMAT to the breast/chestwall and regional lymph nodes, including supraclavicular, infraclavicular, axillary, and internal mammary nodes, | Radiation | Hypofractionated radiation (RT) |
| Ultra-hypofractionated breast/chest wall and regional nodal radiationAlso: SWIFT RTExternal 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 (SWIFT RT) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Thomas, M.D., Ph.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hypofractionated radiation and Ultra-hypofractionated breast/chest wall and regional nodal radiation in people with Node-positive Breast Cancer, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Thomas, M.D., Ph.D. (314-362-8615, mariathomas@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.