NCT06224244

External Hypofractionated Radiotherapy With Simultaneous Integrated Boost in Early Breast Cancer Patients

A Prospective Phase II Trial of an Accelerated Hypofractionated Radiotherapy Schedule With Risk-adapted Simultaneous Integrated Boost (HF-SIB) in Early Breast Cancer Patients Undergoing Breast Conserving Surgery

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Regina Elena Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a prospective non randomized phase two trial evaluating the feasibility of a ten fraction accelerated hypofractionated radiotherapy schedule with simultaneous integrated boost risk adapted in patients undergoing breast conserving surgery for early breast cancer

Detailed description

Patients enrolled for the study, according to eligibility criteria, undergo breast conserving surgery followed by adjuvant 10-fraction whole breast irradiation with a risk adapted simultaneous-integrated boost dose at the level of the tumour bed according to clinical and pathological risk factors.

Conditions

• Breast Neoplasms
• Breast Cancer

Interventions

Type	Name	Description
RADIATION	Ten-fraction hypofractionated breast radiotherapy with 40 Gy simultaneous integrated bed boost	Patients undergo BCS followed by ten-fraction adjuvant breast irradiation (34Gy) with a risk adapted SIB dose of 40 Gy
RADIATION	Ten-fraction hypofractionated breast radiotherapy with 43 Gy simultaneous integrated bed boost	Patients undergo BCS followed by ten-fraction adjuvant breast irradiation (34Gy) with a risk adapted SIB dose of 43 Gy

Timeline

• Start date: 2022-02-01
• Primary completion: 2025-04-01
• Completion: 2027-04-01
• First posted: 2024-01-25
• Last updated: 2025-07-25

Locations

1 site across 1 country: Italy