Radiation After No Axillary Nodal Sampling (RADIANS)

RADIation After no Axillary Nodal Sampling (RADIANS)

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.

Study Overview

• Status: Recruiting
• Conditions: Early-stage Breast Cancer; Invasive Ductal Carcinoma of Female Breast
• Intervention / Treatment: Radiation: Partial Breast Irradiation (PBI)

• Study Type: Interventional
• Enrollment (Estimated): 105
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: CancerTrials Inbox; Phone Number: 212-731-6000; Email: CancerTrials@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early-Stage Breast Cancer Patients; Patients in whom a sentinel lymph node biopsy is omitted will receive Partial Breast Irradiation (PBI).	Radiation: Partial Breast Irradiation (PBI); Delivered using 3D or 3D/IMRT or IMRT techniques following breast-conserving surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Axillary Recurrence	Proportion of patients in whom the return of breast cancer in the lymph nodes of the armpit is observed.	Up to Year 5-post-radiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Local Recurrence	Proportion of patients in whom the return of breast cancer to the same area as the original tumor is observed.	Up to Year 5-post-radiation
Rate of Distant Recurrence	Proportion of patients in whom the return of breast cancer to a different area from the original tumor is observed.	Up to Year 5-post-radiation
Breast-Cancer Specific Survival	Time from initiation of treatment to death attributed to breast cancer.	Up to Year 5-post-radiation
Overall Survival	Time from initiation of treatment to death due to any cause.	Up to Year 5-post-radiation
Rate of Endocrine Therapy Initiation	Proportion of patients who initiate endocrine therapy.	Up to Year 5-post-radiation
Rate of Endocrine Therapy Adherence	Proportion of patients who display adherence to endocrine therapy following initiation.	Up to Year 5-post-radiation
Change in Breast Cancer Treatment Outcome Scale (BCTOS-13) Score	BCTOS-13 is a 13-item assessment of aesthetic and functional changes following breast-conserving therapy. Each item is rated on a Likert scale from 1-4; the total score is the average of the item responses and ranges from 1.0 - 4.0. Lower scores indicate a better outcome, meaning the patient perceives less difference between the treated and untreated breast	Baseline, Year 2 Post-Radiation
Functional Assessment of Chronic Illness Therapy - COmprehensive Score for Financial Toxicity (COST-FACIT)	OST-FACIT is a patient-reported questionnaire designed to measure the financial distress and hardship caused by medical treatments for chronic illnesses. 11 items are rated on a scale from 0-4; the total score is the sum of responses and ranges from 0-44. Higher scores indicate less financial distress.	Baseline, Year 2 Post-Radiation

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Naamit Gerber, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2026
• Primary Completion (Estimated): July 31, 2034
• Study Completion (Estimated): July 31, 2034

Study Registration Dates

• First Submitted: July 20, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 25-01450

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plans to share de-identified IPD with other researchers at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No