Dose Escalated Concomitant Boost Radiotherapy for Early Breast Cancer

Not Applicable

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT07021846
• Lead Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico

Brief 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.

Study Timeline

• Study Start: 2020-03-12
• Status Verified: 2024-09
• Study First Submitted: 2025-05-07
• Study First Submitted QC: 2025-06-11
• Last Update Submitted: 2025-06-11
• Study First Posted: 2025-06-15
• Last Update Posted: 2025-06-15
• Primary Completion: 2026-03
• Study Completion: 2030-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 132

Inclusion Criteria

• histologically proven breast cancer who have undergone conservative surgery
• at least 3 inserted clips
• age: from 18 years old to 50 years
• at least one of the following risk factors: N1 disease, LVI, extensive intraductal component (>25%), close margins (<4 mm), non-hormone-sensitive disease, grading 3
• ECOG performance status < 2
• adequate bone marrow (haemoglobin concentration > 8 g/dl, white blood cell count > 3000/mm3, platelet count > 75000).

Exclusion Criteria

• Previous chest radiation treatment
• Bilateral breast cancer
• Neoadjuvant chemotherapy
• BMI > 35
• Collagen diseases
• Pregnancy or breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Breast fibrosis	baseline, each year up to 4 years after radiotherapy	Rate of all grades breast fibrosis evaluated by means of Common Terminology Criteria for Adverse Events (CTCAE) v. 5 scale

Secondary Outcome Measures

Name	Time	Method
Breast cosmesis	baseline, each year up to 4 years after radiotherapy	Rate of fair and poor cosmesis evaluated by means of European Organisation for Research and Treatment of Cancer (EORTC) Cosmetic Rating System for Breast Cancer
Quality of Life (QOL)	baseline, each year up to 4 years after radiotherapy	Quality of Life evaluated by means of European Organization for Research and Treatment-QOL questionnaire (EORTC QLQ-C30)

Trial Locations

Locations (1)

Università Campus Biomedico; 🇮🇹 Roma, Italy