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RECRUITING
NCT07020780
NA

5 fr Ultrahypofractionated WBI and SIB for Breast Cancer With Unfavorable Characteristics

Sponsor: IRCCS San Raffaele

View on ClinicalTrials.gov

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

RADIATION

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