Status:
ACTIVE_NOT_RECRUITING
Prone Partial Breast Irradiation (PBI): a Prospective Randomized Trial
Lead Sponsor:
NYU Langone Health
Conditions:
Breast Cancer
Eligibility:
FEMALE
50-90 years
Phase:
NA
Brief Summary
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
Detailed Description
Despite the fact that less extensive experience than that of brachytherapy is available, PBI delivery through an external-beam has many advantages. First of all, it is likely to be more acceptable to ...
Eligibility Criteria
Inclusion
- Post-menopausal women defined as either:
- at least 2 years without menstrual period
- patients older than 50 with serological evidence of post-menopausal status
- hysterectomized patients of any age with FSH confirmation of post- menopausal status
- pT1 breast cancer, excised with negative margins. Criteria for low risk-pTis:
- Screen-detected
- Low to intermediate nuclear grade
- \< 2.5cm in size
- Resected with negative margins at \>3mm)
- clinically N0 or pN0 or sentinel node negative breast cancer
Exclusion
- previous radiation therapy to the ipsilateral breast
- presence of a proportion of DCIS in the core biopsy specimen which is compatible with extensive intraductal component (EIC)
Key Trial Info
Start Date :
October 28 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 7 2026
Estimated Enrollment :
284 Patients enrolled
Trial Details
Trial ID
NCT02276885
Start Date
October 28 2014
End Date
December 7 2026
Last Update
December 30 2025
Active Locations (1)
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1
NYU Langone Medical Center
New York, New York, United States, 10016