NotablePrimary and study completion pushed from Sep 2026 to Sep 2027
Eligibility criteria expanded, about 22 words
NotablePrimary and study completion dates: Sep 2025 to Sep 2026v27
NotablePrimary and study completion dates: Sep 2024 to Sep 2025v26
NotablePrimary and study completion dates: Sep 2023 to Sep 2024v25
NotablePrimary and study completion dates: Sep 2022 to Sep 2023
Study sites revised (8)
v24
Show 22 earlier versionsHide 22 earlier versions
NotablePrimary and study completion dates: Sep 2021 to Sep 2022v23
MinorRe-verified, no change to tracked fieldsv22
NotablePrimary and study completion dates: Sep 2020 to Sep 2021v21
NotablePrimary and study completion dates: Sep 2019 to Sep 2020v20
MinorStudy sites: 7 to 8v19
MinorStudy sites: 5 to 7v18
NotablePrimary and study completion dates: Sep 2018 to Sep 2019
Site details revised at 1 of 5 sites
v17
NotablePrimary and study completion dates: Sep 2017 to Sep 2018
Study sites: 6 to 5
v16
NotablePrimary and study completion dates: Sep 2016 to Sep 2017v15
MinorRe-verified, no change to tracked fieldsv14
NotablePrimary and study completion dates: Sep 2015 to Sep 2016
Study sites revised (6)
v13
MinorStudy sites: 5 to 6v12
NotablePrimary and study completion dates: Sep 2014 to Sep 2015
Trial status: Recruiting to Active, Not Recruiting
Site details revised at 5 of 5 sites
v11
MinorRe-verified, no change to tracked fieldsv10
NotablePrimary and study completion dates: Sep 2013 to Sep 2014
Enrollment target: 100 to 110
v9
Minor2 versionsRe-verified since Oct 2, 2012, no change to tracked fieldsv7-v8
NotablePrimary and study completion dates: Sep 2012 to Sep 2013v6
MinorRe-verified, no change to tracked fieldsv5
MinorEligibility criteria shortened, about 8 wordsv4
MinorEligibility criteria expanded, about 12 wordsv3
MinorStudy Status, Referencesv2
MinorStudy First Submitted
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Currently the standard of care is to treat early stage invasive breast cancer or ductal carcinoma in situ (DCIS) with a combination of lumpectomy and radiotherapy, known as "breast-conserving therapy" (BCT). The traditional method of giving radiation therapy after a lumpectomy is to the whole breast.
However the investigators do not know if the whole breast needs to be receive radiation to better control your cancer or only a more limited area of the breast surrounding the tumor. The purpose of this study is to see the side effects of delivering partial breast irradiation (PBI) instead of whole breast irradiation (WBI). PBI is radiation therapy given only to the area of the breast where the cancer was removed. Another purpose of this study is to look long term at the rate at which cancer comes back in the same breast after PBI.
WBI is radiation therapy given 5 days a week for 5 to 7 weeks to the whole breast. Partial breast irradiation radiation therapy (PBI) is much shorter than whole breast irradiation. The investigators propose to deliver the PBI radiation therapy, for a few minutes a day, once a day, five days a week, for 2 weeks.
In this study the investigators will learn about the good and bad effects of PBI radiation therapy. In this study, the investigators will also learn about how the breast looks after surgery and radiation therapy.