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.
Willing and able to provide written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
Women greater than or equal to age 65 years
Diagnosis of invasive carcinoma of breast undergoing non-operative management
Previously untreated OR previously treated with primary ET or chemotherapy, with either stable or progressive localized disease.
Active treatment with systemic chemotherapy for breast cancer. Subjects will need to stop any breast cancer chemotherapy agent before enrollment to be included study.
Multicentric tumor.
Clinical or imaging evidence of distant metastases.
Prior ipsilateral breast or thoracic radiation.
Single group
SABR
RadiationRadiation 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.
1-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.
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.
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.
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.
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.
Exploratory Objective-Estimation of Long-term Survival Outcomes
To estimate 2-year and 5-year PFS and OS amongst older women undergoing non-operative management after receiving SABR. Units of Measure include qualitative analysis at 2-years and 5-years post-radiation: 'alive with disease', 'alive without disease', 'deceased with disease', and 'deceased without disease'.
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