This phase II trial studies how well radiation therapy works in treating post-menopausal women with early stage breast cancer undergoing surgery. Radiation therapy uses high energy x rays to kill tumor cells. This may be an effective treatment for breast cancer.
PRIMARY OBJECTIVE: I. For select patients with early stage breast cancer undergoing wide local excision followed by single fraction radiation therapy (SFRT), we will evaluate rates of observer-rated toxicity, cosmetic outcomes and patient satisfaction, objective measures of toxicity and quality of life as well as delivery of intended dose. SECONDARY OBJECTIVE: I. Locoregional control reported at five years. OUTLINE: Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained. After completion of study treatment, patients are followed at 1 week, 1 month, 3 months, and then every 6 months for 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Undergo wide local excision breast surgery
Undergo SFRT
Correlative studies
Ancillary studies
Roswell Park Cancer Institute
Buffalo, New York, United States
Number of Patients With Adverse Events as a Measure of Safety and Tolerability
Toxicity will be assessed by the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) v 3.0.
Time frame: Up to 2 years
Quality-of-life Assessments
Will be rated by patients using the POST-B, the Functional Assessment of Chronic Illness Therapy (FACIT), and the Skindex-16.
Time frame: Up to 2 years
Cosmetic Differences in the Treated Breast
Will measure differences in the cosmetic size, shape, or texture of the breast. Cosmesis will be graded according to the Baker Scale. Patient reported cosmesis will also be evaluated using the Ontario Clinical Oncology Breast Cancer Questionnaire.
Time frame: Up to 2 years
Locoregional Control Rate
Locoregional control will be calculated with confidence interval estimates and will be compared to historical control rates.
Time frame: At 5 years
Overall Survival
The overall survival will be analyzed using Kaplan-Meier method.
Time frame: Up to 5 years
Disease Specific Survival
The disease specific survival will be analyzed using Kaplan-Meier method.
Time frame: Up to 5 years
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