Accelerated Partial Irradiation of the Breast: New Altered Fractionation

  • STATUS
    Recruiting
  • End date
    Jun 15, 2026
  • participants needed
    174
  • sponsor
    Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Updated on 26 February 2022
estrogen
carcinoma
carcinoma in situ
lobular carcinoma
estrogen receptor
ductal carcinoma in situ
ductal carcinoma
partial breast irradiation

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.

Description

Breast cancer is the most common tumor among women; although its treatment used to be very aggressive, nowadays is based on the minimum effective treatment.

In non-metastatic patients, the therapeutical strategy is based on surgery, systemic therapy and radiotherapy. Usually in the early stages of the disease, the treatment begins with a conservative surgery followed by adjuvant therapy.

Its been proved that the majority of relapses after conservatory surgery occur near the surgical bed which suggests that the main benefit of radiotherapy treatment lies in its primary effect on residual microscopic disease in the surgical bed. Regarding the radiotherapy used after conservative surgery, its accepted as standard treatment hypofractionated schemes, after they have demonstrated at least the same grade of effectiveness as the classic fractionation in terms of locoregional control, survival, aesthetic results or toxicity.

One of the options of hypofractionated schemes is APBI (Accelerated Partial Breast Irradiation), that by reducing the volume of the radiated breast and an accelerated dose fractionation scheme, can eliminate the residual microscopic disease in the surgical bed. The main advantage of APBI is that can shorten the overall time (total treatment time) by increasing the dose per fraction.

In patients who meet the following criteria: 45 years or 40-44 if there isnt 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, with a free margin of at least 2 mm, as well as with positive and negative estrogen receptor tumors; APBI is currently considered standard treatment.

This radiotherapy modality can be administered using 4 different techniques: interstitial brachytherapy, spherical balloons, intraoperative radiotherapy with electrons or with dedicated kilovoltage (RIO) systems and External Radiotherapy (3D shaped RT or modulated intensity radiotherapy - IMRT-). Each of them have their advantages and disadvantages, without any of them being superior to the others in terms of survival or local control, however, IMRT achieves a more shaped and uniformed dose after conservative surgery.

The aim of this observational study is to evaluate a dose fractionation scheme for APBI (28 Gy in 5 fractions of 5.6 GY, 5 days/week) using external radiotherapy with modulated intensity technique (IMRT), with the possible impact on the quality of life of patients.

Details
Condition Breast Cancer
Clinical Study IdentifierNCT04101656
SponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla
Last Modified on26 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

years or 40-44 if there isnt 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 Criteria

Multicentric and multifocal tumors, except from if its 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
Metastasics 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 thats 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
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