Ultra-Hypofractionated vs. Hypofractionated Radiation for Node-Positive Breast Cancer
SWIFT RT: Ultra-Hypofractionated vs. Hypofractionated Radiation for Node-Positive Breast Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 3 weeks, 5 weeks, 1 week
- Procedures mentioned: Blood draws
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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)."
- "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."
- "The investigators will collect blood samples for correlative studies of biomarkers of fibrosis and cardiac toxicity."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study compares 1 week of radiation with 3 weeks of radiation for breast cancer that has spread to nearby lymph nodes. It is for adult women who have had breast surgery. Researchers will compare side effects, cancer control, breast appearance, and quality of life.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Women age 18 or older at diagnosis who speak English and can understand and sign the consent form.
- Breast cancer confirmed by a tissue test that has grown into nearby breast tissue. Metaplastic breast cancer is allowed.
- Cancer in the study’s stage groups: cT1–3 and cN1–2 or pN1–2. A biopsy must show cancer in underarm lymph nodes.
- Had surgery to remove part or all of the breast, with no cancer at the cut edge. After whole-breast removal, cancer must be more than 2 mm from the edge.
- Had surgery to remove selected underarm lymph nodes or a larger group of nodes.
- Receive chemotherapy and/or hormone treatment as recommended by the cancer doctor. Hormone treatment, anti-HER2 treatment, and immune treatment are allowed during radiation.
- All radiation must be planned at BJH or a Siteman satellite site.
- Able to do usual activities, or limited only in hard physical activity.
Who can't join
- Cancer has spread to distant parts of the body, is in both breasts, or is a breast sarcoma or lymphoma.
- Cancer is stage cT4 or pT4, or involves the skin. Lymph nodes near the collarbone or breastbone feel abnormal or look suspicious on scans.
- Past radiation would overlap the planned treatment area; any past breast cancer; or current breast cancer diagnosed more than 1 year before joining.
- Have lupus, scleroderma, or dermatomyositis—diseases in which the immune system attacks healthy tissue.
- Another health problem limits expected life to less than 2 years, or another cancer could affect how study safety or results are judged.
- Too much time has passed before the radiation planning visit: over 10 weeks after the last breast cancer surgery or over 8 weeks after chemotherapy, based on which treatment ended last.
- Plan to receive chemotherapy during radiation.
- Pregnant. Pregnancy will be ruled out before the radiation planning visit.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (1)
MO
- Washington University School of Medicine · St Louis, MO 63110Maria Thomas, M.D., Ph.D. · Study contact · 314-362-8615 · mariathomas@wustl.eduMaria Thomas, M.D., Ph.D. · Principal investigatorImran Zoberi, M.D. · Sub-investigatorCarmen Bergom, M.D., Ph.D. · Sub-investigatorMore trials in St Louis