Radiation After No Axillary Nodal Sampling for Early-Stage Breast Cancer

This study is looking at the safety of Partial Breast Irradiation (PBI) for women with early-stage breast cancer (Invasive Ductal Carcinoma of Female Breast) who have had breast-conserving surgery without having their lymph nodes checked. PBI is a type of radiation therapy. The study wants to see how many women develop a recurrence (cancer returning) in their armpit area up to five years after radiation. You may be able to join if you are a woman aged 40 or older, have had breast-conserving surgery without lymph node removal, and are able to give informed consent. This study plans to enroll 105 participants, but its current recruitment status is unclear.

Study design
This is a single-arm, pilot study, meaning all 105 participants will receive the same intervention. It is a prospective study, meaning researchers will follow participants forward in time.
What's involved
You would complete questionnaires about your treatment outcomes and financial impact at the start of the study and again after two years. An ultrasound of your armpit area is required before radiation begins if you haven't had one already.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to five years after radiation to check for armpit recurrence.

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NCT07723209

Radiation After No Axillary Nodal Sampling

Recruiting
NAAges 40+InterventionalTreatment
NYU Langone Health
~105 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:Partial Breast Irradiation (PBI)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of Axillary Recurrence
Measured over Up to Year 5-post-radiation
Early-stage Breast Cancer
Invasive Ductal Carcinoma of Female Breast
1 sites across 1 states
New York1
  • Naamit Gerber, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

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Eligibility criteria

Inclusion

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

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
  • Rate of Axillary RecurrenceUp to Year 5-post-radiation

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