Dose Escalated Concomitant Boost Radiotherapy for Early Breast Cancer

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorFondazione Policlinico Universitario Campus Bio-Medico

About this trial

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)

Eligibility criteria

Qualifiers

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

Disqualifiers

Previous chest radiation treatment

Bilateral breast cancer

Neoadjuvant chemotherapy

BMI > 35

Trial design

Treatments tested in this trial

  • hypofractionated radiotherapy with tumor bed boost

Treatment groups

132 Participants
are divided into 1 treatment group