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Radiation After No Axillary Nodal Sampling

RecruitingNAAges 40 Years - anyFemaleNYU Langone Health
NCT07723209 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a single arm, pilot, prospective study to evaluate the safety of partial breast irradiation in women who undergo breast conserving surgery without sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND). Baseline demographic and clinical information will be collected. All patients will complete the Breast Cancer Treatment Outcome Scale (BCTOS-13) questionnaire and the Functional Assessment of Chronic Illness Therapy-Comprehensive Score for financial Toxicity at baseline and at 2 years. All patients are required to have an axillary ultrasound prior to radiation start if this was not obtained pre-operatively.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Individuals assigned Female at birth, age 40 and older * Breast conserving surgery without SLNB or ALND * All patients should be capable of giving informed consent, * Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. * Histologically confirmed invasive ductal carcinoma * Individuals with pathologic tumor size \<3cm * Patients in whom partial breast is deemed technically not possible due to breast size will be considered screen failures and excluded from the trial. * Clinically and radiologically node-negative (no palpable nodes, negative axillary imaging) * Electrocorticography (ECOG) performance status 0-2 Exclusion Criteria: * Male * Transgender or non-binary individuals. * Mastectomy * Metastatic disease * History of ipsilateral or contralateral breast cancer. * Obstacles to obtaining informed consent or undergoing regular follow-up
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What it tests

  • Partial Breast Irradiation (PBI)
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Where

1 site
NYU Langone Health
New York, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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