Early-stage Breast Cancer, Breast Carcinoma in Situ, Breast Neoplasms
Conditions
Keywords
Breast Cancer, Early-stage Breast Cancer, Intraoperative Radiotherapy, IORT
Brief summary
This is a prospective, registry study that will enroll all women with early stage breast cancer who will be treated with intraoperative radiotherapy (IORT) during breast-conserving surgery. The purpose of this study is to further validate the long-term effectiveness and safety of this treatment method. We aim to assess short and long-term patient outcomes associated with IORT, including perioperative complications, local and distance disease recurrences, as well as disease-free survival and overall survival.
Detailed description
At Providence Saint John's Health Center, there is the ongoing integration of Intra-Operative Radiation Therapy (IORT) as a standard treatment option among Breast Conserving Therapy (BCT) for individuals with in situ and early stage breast cancer. Currently, approximately 60 women per year are being treated with IORT. No repository of information of patient outcomes with this treatment has been established. This leaves a critical gap in the ability to assess the long-term outcomes of patients treated with IORT. As the practice of using IORT to treat early stage and in situ breast cancer continues to grow at Providence Saint John's Health Center, this registry will provide the data needed to compare patient outcomes with those being treated with the traditional whole breast radiation therapy. In addition, the Providence Health & Services strives to improve patient care and outcomes with excellence whenever possible. The registry will provide the data needed to compare patient outcomes to national and community standards that can inform internal practice patterns and contribute to advancing breast cancer care nationally and internationally.
Interventions
IORT involving 50kV Xrays to a dose of 20 Gy during breast-conserving surgery
Sponsors
Study design
Eligibility
Inclusion criteria
* Clinical stage Tis, T1, or T2(≤ 3cm), N0, M0 (AJCC Classification) * Unifocal Disease * Candidate for breast-conserving surgery * Recommended treatment by multidisciplinary team
Exclusion criteria
* Clinical stage T3-4, N1-3, M1 * Multifocal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Recurrence | 5 years | Presence of recurrent tumor in ipsilateral breast or distant site |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease specific survival | 10 years | survival |
| Overall Survival | 10 years | survival |
Countries
United States