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 @ 6:58 PM
Ignite Modification Date:
2025-12-24 @ 6:58 PM
NCT ID:
NCT05462457
Eligibility Criteria:
Inclusion Criteria:
* signed informed consent form
* female/male patient aged ≥ 18 years
* clinical (c) tumor stage T1-4c, bilateral breast cancer and multifocal tumor allowed
* invasive breast cancer confirmed by core biopsy
* clinically node positive (cN+) (by means of axillary ultrasound or other imaging methods) with ≥ 3 clinically suspicious lymph nodes
* biopsy-proven axillary lymph node involvement
* marking (e.g. with a clip, magnetic seed, carbon suspension) of the clinically suspicious lymph node(s) before the start of NST
* without distant metastases
* indication for NST including chemotherapy
* TAD + ALND planned
* at least 7 lymph nodes (TAD + ALND) planned for histological analysis
Exclusion Criteria:
* cN0 or cN+ with ≤ 2 clinically suspicious lymph nodes
* patients without indication for NST or NST \< 12 weeks
* NST without chemotherapy
* adjuvant/ neoadjuvant therapy already started prior to inclusion in the study
* patients for whom only ALND is planned
* ycN+ (by means of axillary ultrasound or other imaging methods)
* recurrent breast cancer
* larger surgery of the breast (starting from quadrant resection) or the axilla prior to the study
* previous radiotherapy of the breast or axilla
* inflammatory breast cancer
* extramammary breast cancer
* pregnant women
* not able to undergo surgery
* inability to understand the purpose of the clinical study or to comply with study conditions
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05462457
Study Brief:
Protocol Section:
NCT05462457