Breast Cancer Clinical Trial
Official title:
Prospective Observational Study on Outcome of High-precision Hypo-fractionated Radiotherapy in Metastatic Breast Cancer (PRECISE-M)
This study is a prospective observational study on outcomes of high precision hypo-fractionated radiotherapy in breast cancer with distant metastasis.
| Status | Recruiting |
| Enrollment | 400 |
| Est. completion date | December 31, 2033 |
| Est. primary completion date | December 31, 2028 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 19 Years to 100 Years |
| Eligibility | Inclusion Criteria: - histologically confirmed breast cancer - presence of distant metastasis - radiation therapy using IMRT, SBRT, or proton therapy is done or planned - Able and willing to comply with the study protocol Exclusion Criteria: - unable to adhere to the study protocol |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Samsung Medical Center | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Samsung Medical Center |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Local control rate | LC after radiation therapy | 1-year | |
| Secondary | Overall survival rate | 1-year | ||
| Secondary | Disease-free survival | disease-free survival rate after the time of RT | 1-year | |
| Secondary | Treatment-related toxicities | Acute and chronic radiation toxicities according to CTCAE v5.0 | 1-year |
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