HYPOFRACTIONATED REGIONAL NODAL IRRADIATION IN BREAST CANCER

Launched by WILLIAM BEAUMONT HOSPITALS · May 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a type of radiation treatment called hypofractionated regional nodal irradiation for women with breast cancer. It aims to find out how effective and safe this treatment is for patients after they have had surgery for their cancer. Women who are eligible for the trial are at least 18 years old, have been diagnosed with specific types of invasive breast cancer, and have had surgery with clear margins, meaning no cancer cells were found at the edges of the removed tissue. The trial is currently looking for participants and will involve women who have certain stages of breast cancer and meet other health criteria.

If you decide to participate, you will go through a series of assessments before and after receiving the treatment. These follow-up checks will happen at different times, like 1-2 weeks after treatment, and then at 3 months, 6 months, 1 year, 2 years, and 3 years. It’s important to note that this trial is not for everyone; women with advanced breast cancer or certain other health issues may not qualify. If you are interested in participating, you will need to sign a consent form, which means you understand what the trial involves and agree to take part.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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.

Trial Officials