5 fr Ultrahypofractionated WBI and SIB for Breast Cancer With Unfavorable Characteristics
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- Local Relapse Free Survival (LRFS) — 5 years
o demonstrate the non-inferiority of local control (local relapse free survival - LRFS) of the study treatment (delivered in five fractions) compared to the department's standard WBI treatment (delivered in 15 fractions).
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| IRCCS San Raffaele Scientific Institute | Milan | Italy | Recruiting |
More IRCCS San Raffaele trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07020780 on ClinicalTrials.gov ↗ ← All trials in Italy