NCT07723209 · NYU Langone Health
Radiation After No Axillary Nodal Sampling
(RADIANS)
What this study is about
This is a single treatment group$1, pilot, forward-looking 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.
View original scientific description
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.
Interventions
RADIATION
Partial Breast Irradiation (PBI)
Delivered using 3D or 3D/IMRT or IMRT techniques following breast-conserving surgery.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Transgender or non-binary individuals.
- Metastatic disease
- History of ipsilateral or contralateral breast cancer.
- Obstacles to obtaining informed consent or undergoing regular follow-up
Where
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 23, 2026 · Source of record for eligibility and locations