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Completed
NCT02276885
Prone Partial Breast Irradiation (PBI): a Prospective Randomized Trial
Conditions: Breast Cancer
Sex: Female
Ages: 50 Years – 90 Years
Healthy volunteers: No
Phase: NA
Enrollment: 284
Sponsor: NYU Langone Health
Location: NYU Langone Medical Center New York New York
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
Eligibility Criteria
Inclusion Criteria:
* Post-menopausal women defined as either:
1. at least 2 years without menstrual period
2. patients older than 50 with serological evidence of post-menopausal status
3. hysterectomized patients of any age with FSH confirmation of post- menopausal status
* pT1 breast cancer, excised with negative margins. Criteria for low risk-pTis:
1. Screen-detected
2. Low to intermediate nuclear grade
3. \< 2.5cm in size
4. Resected with negative margins at \>3mm)
* clinically N0 or pN0 or sentinel node negative breast cancer
Exclusion Criteria:
* 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)
Source: ClinicalTrials.gov (NCT02276885). StuddyBuddy aggregates publicly available trial information.
