Partial Breast Irradiation in a Low-risk Population Screened With MRI
This is a pilot study to determine if partial breast irradiation (PBI) limited to the region of the tumor bed following lumpectomy in patients screened with MRI provides historically similar rates of local failure, limited acute skin toxicity, late complications and cosmetic outcome when compared to patients treated with standard 3D-CRT to the whole breast.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Image Guided Partial Breast Irradiation (PBL) In A Low-Risk Population Screened With Magnetic Resonance Imaging (MRI)|
- Rates of toxicity (breast edema/pain, hyperpigmentation, erythema) for patients receiving partial breast irradiation (PBI) compared to historical rates of toxicity of patients receiving whole breast irradiation (WBI) [ Time Frame: During radiation therapy (5-10 days) ] [ Designated as safety issue: Yes ]
- Rates of toxicity (breast edema/pain, hyperpigmentation, erythema) for patients receiving PBI compared to historical rates of toxicity of patients receiving WBI [ Time Frame: Post therapy (until death) ] [ Designated as safety issue: Yes ]
- Survival Rates [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Cosmetic outcomes of breast PBI [ Time Frame: 3 years ] [ Designated as safety issue: No ]Comparison of cosmetic results (appearance, size, shape, texture, scaring) of breast treated with PBI to untreated breast.
|Study Start Date:||June 2009|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Radiation: Partial Breast Irradiation