Partial Breast Radiation After Breast-Conserving Surgery Without Sentinel Node Biopsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-arm pilot study evaluates the safety of partial breast irradiation in women with early-stage invasive ductal carcinoma who have undergone breast-conserving surgery without SLNB or ALND. Participants will have baseline demographic and clinical data collected and will complete BCTOS-13 and FINANCIAL TOXICITY questionnaires at baseline and 2 years. An axillary ultrasound is required before radiation if not done pre-operatively. Eligible patients are clinically node-negative, have tumor size less than 3 cm, and are suitable for partial breast radiotherapy with ECOG 0-2; male, transgender, or those with mastectomy or metastatic disease are excluded.

Why it matters

Who can join: the full rules

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

Where it's running

• NYU Langone Health
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Naamit Gerber, MD — NYU Langone Health
• Study coordinator: CancerTrials Inbox
• Email: CancerTrials@nyulangone.org
• Phone: 212-731-6000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.