Radiation After No Axillary Nodal Sampling

NCT07723209 | Recruiting DMC

• 1 other identifier: 25-01450
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Early-stage Breast Cancer; Invasive Ductal Carcinoma of Female Breast

Outcome Measures

Primary Outcomes (1)

• Rate of Axillary Recurrence

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

  Up to Year 5-post-radiation

Secondary Outcomes (8)

• Rate of Local Recurrence

  Up to Year 5-post-radiation

• Rate of Distant Recurrence

  Up to Year 5-post-radiation

• Breast-Cancer Specific Survival

  Up to Year 5-post-radiation

• Overall Survival

  Up to Year 5-post-radiation

• Rate of Endocrine Therapy Initiation

  Up to Year 5-post-radiation

Study Arms (1)

Early-Stage Breast Cancer Patients

EXPERIMENTAL

Patients in whom a sentinel lymph node biopsy is omitted will receive Partial Breast Irradiation (PBI).

Radiation: Partial Breast Irradiation (PBI)

Interventions

Partial Breast Irradiation (PBI) RADIATION

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

Early-Stage Breast Cancer Patients

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Naamit Gerber, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CancerTrials Inbox

CONTACT

212-731-6000; CancerTrials@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 23, 2026
• Study Start: July 9, 2026
• Primary Completion (Estimated): July 31, 2034
• Study Completion (Estimated): July 31, 2034
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)