Hypofractionated Regional Nodal Irradiation in Breast Cancer

NCT06443359 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 2018-226
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Breast Cancer

Keywords

lymphedema; hypofractionated; radiation therapy

Outcome Measures

Primary Outcomes (1)

• Number of participants with chronic arm lymphedema

  Chronic arm lymphedema will be assessed at the 3 year follow up. Determination of chronic lymphedema will be based on measurements of arm circumference prior to radiation simulation and through the 3 year follow up visit. Clinically significant lymphedema is defined as a 10% or greater difference in ipsilateral arm, forearm, or both, compared to the contralateral side.

  3 years post radiation therapy

Secondary Outcomes (8)

• Number of participants with recurrence of cancer

  3 years post radiation therapy

• Progress-free survival (months)

  3 years

• Overall survival (months)

  3 years

• Number acute toxicities

  6 months

• Number of chronic toxicities

  1 year

Study Arms (2)

Group 1: sentinel lymph node procedure with or without select removal of clipped lymph nodes

EXPERIMENTAL

Group 1: sentinel lymph node procedure with or without select removal of clipped (clinically involved) lymph nodes. Patients who have more than 5 sentinel lymph nodes removed will be stratified into group 2.

Radiation: hypofractionated radiation

Group 2: axillary lymph node dissection

EXPERIMENTAL

Group 2: axillary lymph node dissection (with or without sentinel lymph node procedure). Patients who have more than 5 sentinel lymph nodes removed will be stratified into group 2.

Radiation: hypofractionated radiation

Interventions

hypofractionated radiation RADIATION

All patients will receive a dose of 42.56 Gy in 16 daily fractions to the whole breast or chest wall and regional lymph nodes. A boost dose of 10 or 12.5 Gy in 4 or 5 daily fractions of 2.5 Gy, respectively, will be administered to either the lumpectomy cavity or mastectomy scar, as appropriate.

Group 1: sentinel lymph node procedure with or without select removal of clipped lymph nodes; Group 2: axillary lymph node dissection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (3)

Corewell Health Dearborn Hospital

Dearborn, Michigan, 48124, United States

Location

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, 48073, United States

Location

Corewell Health Beaumont Troy Hospital

Troy, Michigan, 48085, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Lymphedema

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Study Officials

• Joshua Dilworth, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Radiation Oncology

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 5, 2024
• Study Start: November 13, 2018
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

US (3)