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 @ 11:17 PM
Ignite Modification Date:
2025-12-24 @ 11:17 PM
NCT ID:
NCT05591456
Eligibility Criteria:
Inclusion Criteria:
* histological diagnosis of breast adenocarcinoma
* prior modified radical mastectomy
* negative resection margins (3 mm)
* pathological stage pT1-pT2, N0-2 (AJCC, 2017)
* no macroscopic evidence of distant metastases at diagnosis
* Age 18-80 years
* Normal hematological and biochemical laboratory tests
* Written informed consent was obtained from all patients
Exclusion Criteria:
* locally advanced disease pT3-pT4, N3
* positive surgical margins
* prior thoracic radiation
* synchronous second primary tumor
* distant metastases
* pregnancy
* presence of a concomitant psychiatric disorder precluding an aware informed consent.
* age \>80 years
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05591456
Study Brief:
Protocol Section:
NCT05591456