Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT04101656
Eligibility Criteria:
Inclusion Criteria:
* ≥ 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT04101656
Study Brief:
Protocol Section:
NCT04101656