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Dose Escalated Concomitant Boost Radiotherapy for Early Breast Cancer

RECRUITINGN/ASponsored by Fondazione Policlinico Universitario Campus Bio-Medico
Actively Recruiting
PhaseN/A
SponsorFondazione Policlinico Universitario Campus Bio-Medico
Started2020-03-12
Est. completion2026-03
Eligibility
Age18 Years – 50 Years
SexFEMALE
Healthy vol.Accepted

Summary

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

Age: 18 Years – 50 YearsSex: FEMALEHealthy volunteers accepted
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

Conditions2

Breast CancerCancer

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