This phase II study evaluates SABR as non-operative treatment for women aged 65+ with ER-positive, HER2-negative breast cancer ≤5 cm and no lymph node involvement. Eligible patients, including those previously on endocrine therapy, receive 5 SABR treatments, followed by monitoring of quality of life and assessment of treatment-related toxicity.
This is a prospective, phase II study of women with localized breast cancer receiving non-operative management with SABR delivered to the primary tumor. Patients will be screened that are age 65 and over with invasive breast cancer. Those eligible for the trial will have ER-positive and HER2-negative disease measuring ≤5 cm with negative clinical lymph nodes. Patients that were previously on primary ET, with either stable or progressive disease, will be eligible for this study if other inclusion criteria are met. Participants will receive SABR targeting the tumor consisting of 5 total treatments. Participants will then follow-up as per protocol with quality-of-life assessments and treatment-related toxicity evaluation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Radiation therapy will consist of either IMRT or 3D CRT. The modality chosen will be based on the plan with the preferable dosimetric variables and determined by the treating radiation oncology physician. SABR will be prescribed to a total dose of 35 Gy to the GTV over the course of 5 fractions (7 Gy per fraction), ideally treated every other day (excluding weekends). The CTV will be prescribed 30 Gy over 5 fractions, ideally treated every other day.
University of Kansas Medical Center
Kansas City, Kansas, United States
NOT_YET_RECRUITINGUniversity of Kansas Medical Center
Kansas City, Kansas, United States
RECRUITING1-month post-SABR Physical Well-Being
To estimate the change in the score from baseline to 1-month post-SABR on the BREAST-Q: Physical Well-Being Chest Module in older women receiving non-operative management with SABR for localized breast cancer. Conversion Table will be used to convert the raw scale summed score into a score from 0 (worst) to 100 (best). Higher scores reflect a better outcome.
Time frame: 1 month
Patient Reported Outcome
To estimate the change in the score from baseline to 1-month, 6-, and 12-months post-SABR in older women with localized breast cancer undergoing non-operative management using the following BREAST-Q Modules: Satisfaction With Breasts, Adverse Effects of Radiation, Cancer Worry, and Physical-Well Being Chest. Conversion Table will be used to convert the raw scale summed score into a score from 0 (worst) to 100 (best). Higher scores reflect a better outcome.
Time frame: 12 months
Treatment Perception
To capture patient perception about treatment with SABR using the three-item survey "Was it worth it?" (WIWI). Scores will be summed from 3 (lowest) to 9 (highest). Higher scores reflect higher satisfaction.
Time frame: 12 months
Incidence of SABR-Related Adverse Events [Safety and Tolerability]
To describe treatment-related toxicity at 1-month, 6-, and 12-months post-SABR using Common Terminology Criteria for Adverse Events (CTCAE) in older women with localized breast cancer undergoing non-operative management.
Time frame: 12 months
Estimation of Short-term Survival Outcomes
To estimate 1-year progression-free survival (PFS) and overall survival (OS) amongst older women undergoing non-operative management after receiving SABR. Units of Measure include 'alive with disease', 'alive without disease', 'deceased with disease', and 'deceased without disease' at 1-year time interval.
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Time frame: 1 year