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 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT02003560
Eligibility Criteria:
Inclusion Criteria:
* previous breast conserving surgery within 12 weeks (in case of adjuvant chemotherapy within 28 days after completion of chemotherapy)
* patient age \> 40 years
* ECOG performance status: 0-1
* life expectancy \>5 years
* invasive ductal, papillary, mucinous, medullary or tubular carcinoma
* unifocal tumor
* pathological tumor size \< or = 30 mm
* pathological negative axillary nodal status with axillary dissection or sentinel lymph node biopsy
* surgical clips in the tumor bed
* pathological surgical free margins of at least 2 mm
* written informed consent of patients
Exclusion Criteria:
* Stage III-IV
* multifocal tumor
* extensive intraductal component (EIC)
* ductal or lobular carcinoma in situ (DCIS or LCIS)
* invasive lobular cancer (ILC)
* lymph-vascular invasion (LVI)
* contralateral breast cancer
* history of treatment for previous breast cancer
* lactation or breast feeding women
* Paget-disease of the nipple
* psychiatric disorder
* increased radiosensitivity (e.g. collagen vascular disease)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Study:
NCT02003560
Study Brief:
Protocol Section:
NCT02003560