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:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT05665920
Eligibility Criteria:
Inclusion Criteria:
* Information to the patient and signed informed consent;
* Women aged ≥18 years;
* Breast conserving surgery;
* Invasive adenocarcinoma (except classic invasive lobular carcinoma);
* TNM (Tumor, Nodes, Metastasis) pathologic stage pT1-3 and pN1-3a M0, with indication of lymphatic drainage according to institutional protocol;
* Eastern Cooperative Oncology Group (ECOG) 0 -1;
* Minimum microscopic margin of non-cancerous tissue of 2 mm (excluding deep margin if in the deep fascia);
* No previous breast or mediastinal radiotherapy;
* No hematogenous metastases;
* Ability to carry out long-term follow-up;
Exclusion Criteria:
* Previous local irradiation;
* Concomitant chemotherapy. Concomitance with trastuzumab or hormone blockade will be allowed;
* Histology of metaplastic carcinoma;
* History of another neoplasm: non-melanoma skin cancer, carcinoma in situ of the uterine cervix. Another neoplasm treated with curative intent and without evidence of disease in the last 5 years will be allowed.
* Diagnosis of autoimmune and connective tissue diseases;
* Diagnosis of genetic alterations in cell repair genes (Ex: Fanconi anemia, ataxia teleangiectasia);
* Indication of internal breast irradiation.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05665920
Study Brief:
Protocol Section:
NCT05665920