Early-stage Breast CancerRADIANSNCT07723209
Radiation After No Axillary Nodal Sampling
A study testing Partial Breast Irradiation (PBI) in people with Early-stage Breast Cancer and Invasive Ductal Carcinoma of Female Breast, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Early-stage Breast Cancer, Invasive Ductal Carcinoma of Female Breast
- What is being tested?
- Partial Breast Irradiation (PBI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2026to 31 Jul 2034
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: 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.
- Being tested
- Partial Breast Irradiation (PBI)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial Breast Irradiation (PBI)Radiation
Delivered using 3D or 3D/IMRT or IMRT techniques following breast-conserving surgery.
| Study group | Role | What they receive |
|---|---|---|
| Early-Stage Breast Cancer Patients | Experimental | Patients in whom a sentinel lymph node biopsy is omitted will receive Partial Breast Irradiation (PBI). Receives: Radiation: Partial Breast Irradiation (PBI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Axillary Recurrence
Proportion of patients in whom the return of breast cancer in the lymph nodes of the armpit is observed.
Measured: Up to Year 5-post-radiation
Secondary outcomes (8)
Rate of Local Recurrence
Proportion of patients in whom the return of breast cancer to the same area as the original tumor is observed.
Measured: 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.
Measured: Up to Year 5-post-radiation
Breast-Cancer Specific Survival
Time from initiation of treatment to death attributed to breast cancer.
Measured: Up to Year 5-post-radiation
Overall Survival
Time from initiation of treatment to death due to any cause.
Measured: Up to Year 5-post-radiation
Rate of Endocrine Therapy Initiation
Proportion of patients who initiate endocrine therapy.
Measured: Up to Year 5-post-radiation
Rate of Endocrine Therapy Adherence
Proportion of patients who display adherence to endocrine therapy following initiation.
Measured: 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
Measured: 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.
Measured: Baseline, Year 2 Post-Radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start9 Jul 2026
- Primary completion31 Jul 2034 (estimated)
- Study completion31 Jul 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-stage Breast CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naamit Gerber, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07723209
- Sponsor's protocol ID
- 25-01450
- Acronym
- RADIANS
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to share de-identified IPD with other researchers at this time.