Radiation After No Axillary Nodal Sampling
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Partial Breast Irradiation (PBI).
- Who it may be relevant to
- Registry conditions: Early-stage Breast Cancer, Invasive Ductal Carcinoma of Female Breast. Basic parameters: from 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
RADIation After no Axillary Nodal Sampling (RADIANS)
Overview
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.
Interventions
- Radiation Partial Breast Irradiation (PBI)
Delivered using 3D or 3D/IMRT or IMRT techniques following breast-conserving surgery.
Primary outcome measures
- Rate of Axillary Recurrence [Time frame: Up to Year 5-post-radiation]
Secondary outcome measures (8)
- Rate of Local Recurrence [Time frame: Up to Year 5-post-radiation]
- Rate of Distant Recurrence [Time frame: Up to Year 5-post-radiation]
- Breast-Cancer Specific Survival [Time frame: Up to Year 5-post-radiation]
- Overall Survival [Time frame: Up to Year 5-post-radiation]
- Rate of Endocrine Therapy Initiation [Time frame: Up to Year 5-post-radiation]
- Rate of Endocrine Therapy Adherence [Time frame: Up to Year 5-post-radiation]
- Change in Breast Cancer Treatment Outcome Scale (BCTOS-13) Score [Time frame: Baseline, Year 2 Post-Radiation]
- Functional Assessment of Chronic Illness Therapy - COmprehensive Score for Financial Toxicity (COST-FACIT) [Time frame: Baseline, Year 2 Post-Radiation]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT07723209 · 25-01450