Actively Recruiting
Dose Escalated Concomitant Boost Radiotherapy for Early Breast Cancer
Led by Fondazione Policlinico Universitario Campus Bio-Medico · Updated on 2025-06-15
132
Participants Needed
1
Research Sites
520 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Dose Escalated Concomitant Boost Radiotherapy for Early Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed breast cancer treated with conservative surgery
- At least 3 surgical clips inserted
- Age between 18 and 50 years
- Presence of at least one risk factor: N1 disease, lymphovascular invasion, extensive intraductal component (>25%), close margins (<4 mm), non-hormone-sensitive disease, or grade 3 tumor
- ECOG performance status less than 2
- Adequate bone marrow function with hemoglobin > 8 g/dl, white blood cell count > 3000/mm3, platelet count > 75000
You will not qualify if you...
- Previous radiation treatment to the chest
- Bilateral breast cancer
- Neoadjuvant chemotherapy
- Body mass index over 35
- Collagen diseases
- Pregnancy or breastfeeding
AI-Screening
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Trial Site Locations
Total: 1 location
1
Università Campus Biomedico
Roma, Italy
Actively Recruiting
Research Team
E
Edy Ippolito, Prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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