This study is a registry to monitor quality of life and clinical outcomes in patients with clinically localized breast cancer who have received stereotactic accelerated partial breast irradiation via CyberKnife.
Radiotherapy for breast cancer is delivered using several whole breast and partial breast approaches. The optimal approach is unknown. The utilization of partial breast irradiation is growing due to the convenience of fewer fractions versus fifteen- thirty treatments required with conventional or hypofractionated whole breast radiation therapy. Early results with partial breast techniques are promising, showing similar cancer control and toxicity. There is a large body of mature Phase I/II and preliminary Phase III data available exploring the replacement of WBI with an accelerated course of radiation therapy restricted to the region around the tumor bed (accelerated Partial Breast Irradiation, aPBI) using a variety of techniques. For appropriately selected patients treated with modern techniques, the results are encouraging and the techniques have been shown to be safe, tolerable, and highly reproducible with outcomes similar to WBI. Currently, there is limited data assessing the quality of life, cosmetic and oncologic outcomes following stereotactic partial breast irradiation in a large patient population. Our study will be the first essential step in aggregating the outcomes of patients undergoing this type of external beam irradiation in a large patient population.
Study Type
OBSERVATIONAL
Enrollment
200
Five fraction radiation therapy to the lumpectomy cavity
Georgetown University Hospital
Washington D.C., District of Columbia, United States
RECRUITINGIn breast failure
To evaluate the in-breast local failure (Ipsilateral breast events) and patterns of in-breast failure following CK-SAPBI
Time frame: 5 years
Cosmesis
Treatment related Cosmesis based on the Harvard Cosmesis Scale
Time frame: 5 years
Regional Recurrence
Regional recurrence free interval defined as time from end of radiation treatment to the diagnosis of disease in the regional lymph nodes
Time frame: 5 years
Distant Recurrence
Distant disease free interval defined as the time from end of radiation treatment to first diagnosis of distant disease, regardless of the occurrence of any intervening local or regional failure, contralateral breast cancer, or non-breast second primary cancer
Time frame: 5 years
Adverse reactions
Toxicity from treatment based on CTCAE version 4.0
Time frame: 5 years
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