The purpose of this study is to determine the feasibility of partial breast irradiation in participants with early invasive or non-invasive breast cancer.
* In this study, radiotherapy is given only to a portion of the breast around the tumor bed using external radiation treatments. This approach is called "partial breast irradiation". * Participants will undergo a planning session for the radiation treatments. This planning will be done by CT scan days or weeks before the start of treatment. This planning process is the same as that used to plan conventional radiation therapy treatments. * Radiation therapy will begin 4-12 weeks after the last surgery of the breast in individuals not receiving chemotherapy first. For individuals receiving chemotherapy before radiation therapy, radiation therapy will start 2-6 weeks after ending chemotherapy. * We will be studying three levels of radiation doses to see which is best. The dose the participant receives will depend upon when they are enrolled on the trial. * Participants will receive radiation treatment twice each day for 4 or 5 treatment days, with an overall treatment time of one week.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
324
32 Gy-8 Treatments, 4 Treatment Days
36 Gy- 9 Treatments, 4 1/2 Treatment Days
40 Gy-10 Treatments, 5 Treatment days
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Feasibility and Local Control of Early Breast Cancer Treated by Partial Breast Irradiation Using Different Radiation Doses Determined by Completion.
Feasibility and local control of early breast cancer treated by partial breast irradiation using different radiation doses. Number of patients who completed partial breast irradiation was used to determine feasibility.
Time frame: 10 years
Number of Patients Who Presented With Local Recurrence in the Same Breast Which Received Treatment and Confirmed by Positive Biopsy
Risk of local failure after PBI determined by number of patients who presented with local recurrence in the same breast confirmed by positive biopsy
Time frame: 10 years
Number of Patients Who Presented With Moderate to Severe Composite Toxicity as an Endpoint
Number of patients who presented with moderate to severe composite toxicity as an endpoint
Time frame: 8 years
Number of Patients Who Developed Moderate to Severe Breast Fibrosis After Partial Breast Irradiation
Rate of moderate to severe breast fibrosis determined by number of patients who developed moderate to severe breast fibrosis after partial breast irradiation according to radiation dose level
Time frame: 8 years
Number of Patients Who Had Poor/Fair Cosmetic Outcome After Partial Breast Irradiation
Number of patients who had poor/fair cosmetic outcome after partial breast irradiation. Other participants had excellent/good cosmetic outcomes.
Time frame: 8 years
To Evaluate Patient Satisfaction
A survey asking the patient about her level of satisfaction with her PBI treatment. Patients who are totally satisfied with their appearance.
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Time frame: 8 years