Health TrialsbyHealthPanel

Radiation After No Axillary Nodal Sampling

ConditionsEarly-stage Breast CancerInvasive Ductal Carcinoma of Female Breast
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40+
SponsorNYU Langone Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Male

Transgender or non-binary individuals.

Mastectomy

Metastatic disease

Trial design

Design model

Single group

Treatments tested in this trial

  • Partial Breast Irradiation (PBI)

    Radiation

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

Treatment groups

105 Participants
are divided into 1 treatment group
Group A: Early-Stage Breast Cancer PatientsExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Up to Year 5-post-radiation

Secondary outcomes

1

Rate of Local Recurrence

Proportion of patients in whom the return of breast cancer to the same area as the original tumor is observed.

Time frame
Up to Year 5-post-radiation
2

Rate of Distant Recurrence

Proportion of patients in whom the return of breast cancer to a different area from the original tumor is observed.

Time frame
Up to Year 5-post-radiation
3

Breast-Cancer Specific Survival

Time from initiation of treatment to death attributed to breast cancer.

Time frame
Up to Year 5-post-radiation
4

Overall Survival

Time from initiation of treatment to death due to any cause.

Time frame
Up to Year 5-post-radiation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

Source ClinicalTrials.gov
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