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NCT Number: NCT07723209

Radiation After No Axillary Nodal Sampling

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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Key information

Conditions

Early-Stage Breast Cancer Breast Diseases Breast Neoplasms Invasive Ductal Carcinoma of Female Breast Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Partial Breast Irradiation (PBI)

Radiation

Delivered using 3D or 3D/IMRT or IMRT techniques following breast-conserving surgery.

Primary outcomes

  1. Rate of Axillary Recurrence

    Time frame: Up to Year 5-post-radiation

    Proportion of patients in whom the return of breast cancer in the lymph nodes of the armpit is observed.

Secondary outcomes

  1. Rate of Local Recurrence

    Time frame: Up to Year 5-post-radiation

    Proportion of patients in whom the return of breast cancer to the same area as the original tumor is observed.

  2. Rate of Distant Recurrence

    Time frame: Up to Year 5-post-radiation

    Proportion of patients in whom the return of breast cancer to a different area from the original tumor is observed.

  3. Breast-Cancer Specific Survival

    Time frame: Up to Year 5-post-radiation

    Time from initiation of treatment to death attributed to breast cancer.

  4. Overall Survival

    Time frame: Up to Year 5-post-radiation

    Time from initiation of treatment to death due to any cause.

  5. Rate of Endocrine Therapy Initiation

    Time frame: Up to Year 5-post-radiation

    Proportion of patients who initiate endocrine therapy.

  6. Rate of Endocrine Therapy Adherence

    Time frame: Up to Year 5-post-radiation

    Proportion of patients who display adherence to endocrine therapy following initiation.

  7. Change in Breast Cancer Treatment Outcome Scale (BCTOS-13) Score

    Time frame: Baseline, Year 2 Post-Radiation

    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

  8. Functional Assessment of Chronic Illness Therapy - COmprehensive Score for Financial Toxicity (COST-FACIT)

    Time frame: Baseline, Year 2 Post-Radiation

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

CancerTrials Inbox

CONTACT

[email protected]

212-731-6000

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

RADIation After no Axillary Nodal Sampling (RADIANS)

Acronym: RADIANS

Important dates

Study start
2026
Primary completion
2034
Study completion
2034
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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