Recruiting

Partial Breast Irradiation

Sponsor:

NYU Langone Health

Code:

NCT07723209

Conditions

Early-stage Breast Cancer

Invasive Ductal Carcinoma of Female Breast

Eligibility Criteria

Sex: Female

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Partial Breast Irradiation (PBI)

Study Details

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

Study ID

NCT07723209

Start date

Jul 9, 2026

Status verified date

Jul, 2026

Completion date

Jul 31, 2034

Anticipated

Primary completion date

Jul 31, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 40+

Healthy Volunteers: Not accepted

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

Enrollment

105 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Early-Stage Breast Cancer Patients

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

Interventions

Partial Breast Irradiation (PBI)

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

CancerTrials Inbox

212-731-6000CancerTrials@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-07-23.