Hypofractionated Regional Nodal Irradiation in Breast Cancer

Running, not enrolling · Not applicable

Conditions studied: Breast Cancer

In brief

This is a prospective clinical trial designed to evaluate the efficacy and safety of hypofractionated regional nodal irradiation in breast cancer patients. After enrollment, participants will be stratified into 2 Groups based on the extent of axillary surgery. Participants will complete activities and assessments at baseline, and after completion of treatment at 1-2 weeks, 3 months, 6 months, 1 year, 2 year, and 3 years following completion of treatment.

Key facts

Study ID

NCT06443359

Run by

Corewell Health East

People needed

56

Starts

2018-11-13

Expected to finish

2027-07-01

Last updated by the study team

2026-04-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female
• Age ≥ 18 years old
• Life expectancy of >5 years
• ECOG (Zubrod) performance status 0-1
• Histologically confirmed invasive carcinoma of the breast, including ductal, lobular, mammary, medullary, and tubular histologies
• Clinical T stage of cT0, cT1, cT2, or cT3
• Clinical N stage of cN0, cN1, or cN2a
• Clinical M stage of cM0Definitive surgery must be performed (either partial mastectomy or mastectomy without immediate reconstruction) with negative surgical margins (defined as no invasive tumor or DCIS on ink).
• Must have pathologic T stage of pT1, pT2, or pT3, or if receiving neoadjuvant chemotherapy, ypT0, ypTis, ypT1, ypT2, or ypT3
• Pathologic N stage of pN0, pN1, pN2a, or pN3a, or if receiving neoadjuvant chemotherapy, ypN0,ypN1, ypN2, or ypN3a) NOTE: any patient with clinically involved but undissected lymph nodes that would require a radiation boost will not be eligible.
• The radiation oncologist is planning to treat the breast/chest wall and ipsilateral regional lymphatics (including the axillary, supraclavicular, and internal mammary chains)
• Patient is able to understand and willing to sign an IRB approved written informed consent document
• All dosimetric constraints outlined in protocol section 3.5 can be met

You may not qualify if…

• Clinical or pathologic T4 disease, including inflammatory breast cancer
• Clinical N stage of cN2b, cN3 disease, pathologic N stage of pN2b, pN3b, or pN3c disease, or if receiving neoadjuvant chemotherapy, ypN2b, ypN3b, or ypN3c disease
• Radiologic evidence of gross residual disease
• History of prior ipsilateral breast cancer (invasive disease or DCIS)
• Active or history of another malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix
• Prior history of radiation therapy to the neck, breast, or thorax. Prior radioactive oral iodine is permitted.
• History of active collagen vascular disease including systemic lupus erythematosis, scleroderoma, or dermatomyositis with an elevated CK level
• Pregnancy, active breast feeding, or refusal or inability to use highly effective means of contraception in participants of child-bearing potential.
• The patient is a prisoner.

Where it is running

• Corewell Health Dearborn Hospital — Dearborn, Michigan, United States
• Corewell Health William Beaumont University Hospital — Royal Oak, Michigan, United States
• Corewell Health Beaumont Troy Hospital — Troy, Michigan, United States

Full record on ClinicalTrials.gov

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