Overview
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)
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.
Eligibility
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