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 @ 9:40 PM
Ignite Modification Date:
2025-12-24 @ 9:40 PM
NCT ID:
NCT02049632
Eligibility Criteria:
Inclusion Criteria:
* Patients with clinically node-negative, invasive breast cancer ≤ 5 cm (T1-T2)
* Histopathology results demonstrate SN micrometastases.
* Patients who undergo mastectomy (protocol change from April 2017 onwards)
* The patient must have given verbal and written consent.
Exclusion Criteria:
* Preoperatively diagnosed lymph node metastases.
* Sentinel node metastases \> 2 mm.
* Metastases beyond the ipsilateral axillary lymph nodes at the time of surgery.
* History of previous breast cancer.
* Pregnancy.
* Bilateral breast cancer where any of the other exclusion criteria applies to either side.
* Medical contraindication for systemic adjuvant therapy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02049632
Study Brief:
Protocol Section:
NCT02049632