Breast Cancer
Conditions
Keywords
tumor bed boost, radiotherapy, hypofractionation
Brief 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)
Detailed 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.
Interventions
RADIATIONhypofractionated radiotherapy with tumor bed boost
hypofractionated radiotherapy with concomitant/simultaneous tumor bed boost
Sponsors
Fondazione Policlinico Universitario Campus Bio-Medico
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breast fibrosis | baseline, each year up to 4 years after radiotherapy | Rate of all grades breast fibrosis evaluated by means of Common Terminology Criteria for Adverse Events (CTCAE) v. 5 scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breast cosmesis | baseline, each year up to 4 years after radiotherapy | Rate of fair and poor cosmesis evaluated by means of European Organisation for Research and Treatment of Cancer (EORTC) Cosmetic Rating System for Breast Cancer |
| Quality of Life (QOL) | baseline, each year up to 4 years after radiotherapy | Quality of Life evaluated by means of European Organization for Research and Treatment-QOL questionnaire (EORTC QLQ-C30) |
Countries
Italy
Contacts
Primary ContactEdy Ippolito, Prof
Outcome results
None listed