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Radiation Therapy for Node-Positive Breast Cancer

This study is comparing two types of radiation therapy for women with node-positive breast cancer (cancer that has spread to nearby lymph nodes). You would receive either "Hypofractionated radiation" or "Ultra-hypofractionated breast/chest wall and regional nodal radiation." Both involve external beam photon therapy to the breast/chest wall and lymph nodes. The main goal is to see which treatment leads to fewer serious side effects in the long term, measured over five years. To join, you must be a woman aged 18 or older with invasive breast cancer that has spread to your lymph nodes. The study is currently unclear on its recruitment status and plans to enroll 220 participants.

Study design
This is an interventional study comparing two different radiation schedules. It plans to enroll 220 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for serious treatment-related side effects from Day 91 through an estimated 5 years and 1 month after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06559540

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Washington University School of Medicine
~220 participants
Updated 2026-01-09 on ClinicalTrials.gov
What's tested:Hypofractionated radiationUltra-hypofractionated breast/chest wall and regional nodal radiation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of patients who are free of serious treatment related late toxicity.
Measured over Day 91 through 5 year follow-up (estimated to be 5 years and 1 month)

Conditions

Node-positive Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Missouri1

Study leadership

  • Maria Thomas, M.D., Ph.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Maria Thomas, M.D., Ph.D.
[email protected]
314-362-8615
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Proportion of patients who are free of serious treatment related late toxicity.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.