About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
≥ 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.
Disqualifiers
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.
Trial population
Breast cancer patients that meet the inclusion criteria and none of the exclusion criteria.
Trial design
Case-only
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Evaluate the security in terms of acute toxicity
Adverse effects due to radiotherapy
Secondary outcomes
Dose analysis in critical organs
Measurement of dose in the heart, ipsilateral and contralateral lung, ipsilateral and contralateral breast taking into account the acceptable and optimal dose limit.
Evaluate chronic toxicity
Adverse effects due to radiotherapy
Verify the incidence of locoregional tumor relapses at 2 and 5 years of follow-up
Clinical or imaged based detection of the already treated breast cancer tumor (local relapse) or the ipsilateral regional ganglionic chains: armpit, supraclavicular cavity or internal breast chain (regional relapse).
Verify the disease free survival at 2 and 5 years of follow-up
The disease free survival is the time that passes from the end of the treatment until a control is done or takes place a relapse (local or distant).
Sponsors and contacts
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