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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RADIation After no Axillary Nodal Sampling (RADIANS)
- ClinicalTrials.gov ID
- NCT07723209
- Acronym / sponsor ID
- RADIANS / 25-01450
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 9 Jul 2026 (actual)
- Primary completion
- 31 Jul 2034 (estimated)
- Study completion
- 31 Jul 2034 (estimated)
- First posted
- 23 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early-Stage Breast Cancer Patients | Experimental | Radiation: Partial Breast Irradiation (PBI)Patients in whom a sentinel lymph node biopsy is omitted will receive Partial Breast Irradiation (PBI). |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- Male
- Transgender or non-binary individuals.
- Mastectomy
- Metastatic disease
- History of ipsilateral or contralateral breast cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Partial Breast Irradiation (PBI)Delivered using 3D or 3D/IMRT or IMRT techniques following breast-conserving surgery. | Radiation | Early-Stage Breast Cancer Patients |
Primary outcome
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.
8 secondary outcomes
Rate of Local Recurrence
Time frame: Up to Year 5-post-radiation
Rate of Distant Recurrence
Time frame: Up to Year 5-post-radiation
Breast-Cancer Specific Survival
Time frame: Up to Year 5-post-radiation
Overall Survival
Time frame: Up to Year 5-post-radiation
Rate of Endocrine Therapy Initiation
Time frame: Up to Year 5-post-radiation
Rate of Endocrine Therapy Adherence
Time frame: Up to Year 5-post-radiation
Change in Breast Cancer Treatment Outcome Scale (BCTOS-13) Score
Time frame: Baseline, Year 2 Post-Radiation
Functional Assessment of Chronic Illness Therapy - COmprehensive Score for Financial Toxicity (COST-FACIT)
Time frame: Baseline, Year 2 Post-Radiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No. No plans to share de-identified IPD with other researchers at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Naamit Gerber, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CancerTrials Inbox (212-731-6000, CancerTrials@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Axillary Recurrence (time frame: Up to Year 5-post-radiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.