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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
105
Delivered using 3D or 3D/IMRT or IMRT techniques following breast-conserving surgery.
NYU Langone Health
New York, New York, United States
RECRUITINGRate 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
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
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
Breast-Cancer Specific Survival
Time from initiation of treatment to death attributed to breast cancer.
Time frame: Up to Year 5-post-radiation
Overall Survival
Time from initiation of treatment to death due to any cause.
Time frame: Up to Year 5-post-radiation
Rate of Endocrine Therapy Initiation
Proportion of patients who initiate endocrine therapy.
Time frame: Up to Year 5-post-radiation
Rate of Endocrine Therapy Adherence
Proportion of patients who display adherence to endocrine therapy following initiation.
Time frame: Up to Year 5-post-radiation
Change in Breast Cancer Treatment Outcome Scale (BCTOS-13) Score
BCTOS-13 is a 13-item assessment of aesthetic and functional changes following breast-conserving therapy. Each item is rated on a Likert scale from 1-4; the total score is the average of the item responses and ranges from 1.0 - 4.0. Lower scores indicate a better outcome, meaning the patient perceives less difference between the treated and untreated breast
Time frame: Baseline, Year 2 Post-Radiation
Functional Assessment of Chronic Illness Therapy - COmprehensive Score for Financial Toxicity (COST-FACIT)
OST-FACIT is a patient-reported questionnaire designed to measure the financial distress and hardship caused by medical treatments for chronic illnesses. 11 items are rated on a scale from 0-4; the total score is the sum of responses and ranges from 0-44. Higher scores indicate less financial distress.
Time frame: Baseline, Year 2 Post-Radiation
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