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)
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
Previous chest radiation treatment
Bilateral breast cancer
Neoadjuvant chemotherapy
BMI > 35
Single group
hypofractionated radiotherapy with tumor bed boost
Radiationhypofractionated radiotherapy with concomitant/simultaneous tumor bed boost
Breast fibrosis
Rate of all grades breast fibrosis evaluated by means of Common Terminology Criteria for Adverse Events (CTCAE) v. 5 scale
Breast cosmesis
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)
Quality of Life evaluated by means of European Organization for Research and Treatment-QOL questionnaire (EORTC QLQ-C30)
Click on the lead sponsor to view all of their trials.
