NCT07723209NARecruiting

Radiation After No Axillary Nodal Sampling

NYU Langone Health

Start Date

7/9/2026

Completion Date

7/31/2034

Summary

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.

Eligibility Criteria

Age Range: 40 years to No maximum

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

Interventions

RADIATION

Partial Breast Irradiation (PBI)

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Conditions

Early-stage Breast CancerInvasive Ductal Carcinoma of Female Breast

Locations

NYU Langone Health

New York, New York 10016

United States