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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CyberKnife Stereotactic Accelerated Partial Breast Irradiation (CK-SAPBI) | Radiation | Five fraction radiation therapy to the lumpectomy cavity |
|
| Measure | Description | Time Frame |
|---|---|---|
| In breast failure | To evaluate the in-breast local failure (Ipsilateral breast events) and patterns of in-breast failure following CK-SAPBI | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Cosmesis | Treatment related Cosmesis based on the Harvard Cosmesis Scale | 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 |
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Inclusion Criteria:
Additionally, subjects will be considered standard risk and optimal for CK-SAPBI if they meet the following criteria:
Exclusion Criteria:
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Women receiving breast cancer treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olusola Obayomi-Davies, M.D. | Contact | 6104465860 | olusola.obayomi-davies@crozer.org | |
| Michael Repka, M.D. | Contact | 2024443320 | michael.c.repka@gunet.georgetown.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University Hospital | Recruiting | Washington D.C. | District of Columbia | 20008 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 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 | 5 years |
| Adverse reactions | Toxicity from treatment based on CTCAE version 4.0 | 5 years |
| D017437 |
| Skin and Connective Tissue Diseases |