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Purpose

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

Eligibility

Eligible Ages
Over 40 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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 Criteria

  • 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Early-Stage Breast Cancer Patients 		Patients in whom a sentinel lymph node biopsy is omitted will receive Partial Breast Irradiation (PBI).
  • Radiation: Partial Breast Irradiation (PBI)
    Delivered using 3D or 3D/IMRT or IMRT techniques following breast-conserving surgery.

Recruiting Locations

NYU Langone Health
New York, New York 10016

More Details

Status
Recruiting
Sponsor
NYU Langone Health

Study Contact

CancerTrials Inbox
212-731-6000
CancerTrials@nyulangone.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.