Dose Escalated Concomitant Boost Radiotherapy for Early Breast Cancer

Recruiting now · Not applicable

Conditions studied: Breast Cancer

In brief

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)

Key facts

Study ID

NCT07021846

Run by

Fondazione Policlinico Universitario Campus Bio-Medico

People needed

132

Starts

2020-03-12

Expected to finish

2030-03-01

Last updated by the study team

2025-06-15

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

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

Where it is running

• Università Campus Biomedico — Roma, Italy (enrolling)

Full record on ClinicalTrials.gov

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