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5 fr Ultrahypofractionated WBI and SIB for Breast Cancer With Unfavorable Characteristics
Sponsor: IRCCS San Raffaele
Summary
This is a prospective, randomized, single-center, non-inferiority interventional clinical trial comparing whole breast irradiation (WBI) to a total dose of 26 Gy in 5 fractions with simultaneous integrated boost (SIB) to the tumor bed to a total dose of 30 Gy, and WBI to a total dose of 40.05 Gy in 15 fractions with SIB to the tumor bed to a total dose of 48 Gy (standard treatment), for young or unfavorable breast cancer patients.
Official title: Five Fractions Ultrahypofractionated Whole Breast Radiotherapy and Simultaneous Integrated Boost to the Tumor Bed, for Breast Cancer Patients With Unfavorable Characteristics
Key Details
Gender
FEMALE
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
458
Start Date
2025-07-25
Completion Date
2035-06-30
Last Updated
2025-07-28
Healthy Volunteers
No
Conditions
Interventions
Adjuvant 5 fractions whole breast irradiation with simultaneous integrated boost to the tumor bed
Experimental arm (arm 1-five fractions WBI) patients will be treated to a total dose (TD) of 26 Gy in 5 fractions to whole breast, and a simultaneous integrated boost (SIB) to a TD of 30 Gy to the tumor bed, while arm 2-fifteen-fractions WBI patients with 40 Gy/15 fractions to PTV, and 48 Gy SIB to the tumor bed.
Locations (1)
IRCCS San Raffaele Scientific Institute
Milan, Italy