RecruitingNCT04101656

Accelerated Partial Irradiation of the Breast: New Altered Fractionation

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Enrollment

174 participants

Start Date

Oct 15, 2019

Study Type

OBSERVATIONAL

Conditions

Breast Cancer

Summary

The aim of this observational study is to evaluate a dose fractionation scheme for APBI using external radiotherapy with modulated intensity technique (IMRT), with the possible impact on the quality of life of patients as it decreases the treatment number of sessions and improves the efficiency and accessibility.

Eligibility

Min Age: 40 Years

Inclusion Criteria4

≥ 45 years or 40-44 if there isn´t any other risk factor
Diagnosed with infiltrating ductal carcinoma (IDC) or ductal carcinoma in situ (DCIS) and that have undergone conservative surgery without ganglionar involvement (pN0) of any histological degree except from invasive lobular carcinoma and with a size ≤ 3 cm.
Disease free margins (R0: \> 2mm).
Positive and negative estrogen receptor tumors.

Exclusion Criteria9

Multicentric and multifocal tumors, except from if it´s focal and the only risk factor.
Patients must not have undergone a neoadjuvant QT therapy.
Patients with BRCA positive mutation will be excluded.
Those patients unable or unsuitable to understand and accept the informed consent.
Metastasic´s affectation evidence.
Extensive lymphovascular invasion, except from if the total resulting size of the focus and breast parenchyma addition is ≤ 3cm.
Breast implants presence in the breast that´s going to be treated.
Contraindicated radiotherapy treatment due to a diagnosis of cutaneous lupus, pregnancy or scleroderma.
Inability to fully know the dosimetric data of the APBI plan.