NCT07021846

Dose Escalated Concomitant Boost Radiotherapy for Early Breast Cancer

Hypofractionated Radiotherapy With Dose Escalated Concomitant Boost for Breast Cancer: a Phase 2 Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The goal of this prospective, single-arm, phase II, non-randomized trial is to evaluate an hypofractionation schedule with high dose simultaneous integrated tumor bed boost in early breast cancer patients. The main question\[s\] it aims to answer are: * evaluate the rate of all grades of radiation-induced fibrosis at 4 years. * evaluate poor/fair cosmesis rate Participants will be treated with hypofractionated radiotherapy (RT) to whole breast with a dose of 40.05 Gy in 15 fractions (2.67 Gy/die) and a concomitant tumor bed dose of 52.5 Gy (3.5 gy/die)

Detailed description

This is a prospective, single-arm, phase II, non-randomized clinical trial that will test an hypofractionated schedule with high dose simultaneous integrated tumor bed boost set on a previous dose finding study. Patients will be treated with hypofractionated RT to whole breast with a dose of 40.05 Gy in 15 fractions (2.67 Gy/die) and a concomitant tumor bed dose of 52.5 Gy (3.5 gy/die). The study population will include early breast cancer patients with younger age (\< or= 50 years) and additional risk factors for local recurrence. The primary objective of the study is to evaluate the rate of radiation-induced fibrosis at 4 years.The expected enrollment is 132 patients in 6 years. Each patient must have a minimum follow-up of 4 years. The secondary objective is to evaluate cosmesis; other objectives are to evaluate quality of life (QoL) and the rate of local control.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	hypofractionated radiotherapy with tumor bed boost	hypofractionated radiotherapy with concomitant/simultaneous tumor bed boost

Timeline

• Start date: 2020-03-12
• Primary completion: 2026-03-01
• Completion: 2030-03-01
• First posted: 2025-06-15
• Last updated: 2025-06-15

Locations

1 site across 1 country: Italy