Radiation After No Axillary Nodal Sampling

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT07723209
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Partial Breast Irradiation (PBI) — RADIATION
    Delivered using 3D or 3D/IMRT or IMRT techniques following breast-conserving surgery.

Study Details

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.

Key Dates

First listed
Jul 23, 2026
Start date
Jul 9, 2026
Status verified
Jul 2026
Primary completion
Jul 31, 2034
Completion
Jul 31, 2034

Study Design

Enrollment
105 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Early-Stage Breast Cancer Patients
    Patients in whom a sentinel lymph node biopsy is omitted will receive Partial Breast Irradiation (PBI).

Primary Outcome Measure

Rate of Axillary Recurrence [ Time Frame: Up to Year 5-post-radiation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

Find similar trials in New York, NY

By research site
NYU Langone Health· New York, NY

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