Trial Summary
What is the purpose of this trial?The purpose of this study is to test whether a radiotherapy regimen of 8 GY x 3 days over 5 days (every other day) is as safe (well-tolerated) and effective as 6 Gy x 5 over five consecutive days
Eligibility Criteria
This trial is for post-menopausal women with a specific early-stage breast cancer (pT1), who have had the tumor surgically removed with clear margins and no spread to lymph nodes. Women must not have had previous radiation on the same breast or a high proportion of DCIS, which suggests extensive intraductal component.Inclusion Criteria
My breast cancer has not spread to my lymph nodes.
I am a post-menopausal woman, confirmed by lack of periods, age, or tests.
My breast cancer was removed with clear margins.
Exclusion Criteria
I have had radiation therapy on the same side breast before.
The biopsy shows a large amount of a specific type of abnormal cells in the milk ducts.
Participant Groups
The study is comparing two different doses of partial breast irradiation (PBI) radiotherapy in treating breast cancer: one group receives 8 Gy over three sessions every other day for five days, while another gets 6 Gy over five consecutive days. The goal is to see if the higher dose given less frequently is as safe and effective.
2Treatment groups
Experimental Treatment
Group I: PBI Radiotherapy 8 GyExperimental Treatment1 Intervention
Prone partial breast irradiation of 8 Gy x 3 over 5 days, every other day
Group II: PBI Radiotherapy 6 GyExperimental Treatment1 Intervention
Prone partial breast irradiation of 6 Gy x 5 over 5 days, on five consecutive days
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NYU Langone Medical CenterNew York, NY
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Who Is Running the Clinical Trial?
NYU Langone HealthLead Sponsor