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 @ 2:54 PM
Ignite Modification Date:
2025-12-24 @ 2:54 PM
NCT ID:
NCT03796559
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years or older at time of consent
* Histologically confirmed cT0-4, N1 breast cancer
* Axillary lymph node metastasis with pathologic confirmation by needle biopsy
* Clip placed in the sampled axillary lymph node before initiation of chemotherapy
* Planned for neo-adjuvant chemotherapy prior to surgical resection
* Eligible for targeted axillary dissection (defined as selective localization and removal of the clipped node and SLND) at the completion of neo-adjuvant chemotherapy
* ECOG performance status 0-2
Exclusion Criteria:
* Distant metastases
* Inflammatory breast cancer
* Prior ipsilateral axillary surgical procedure including SLND or axillary node excision
* Prior history of breast cancer in the ipsilateral breast
* History of lymphoma
* Subject is pregnant
* Previous radiation to the breast or axilla
* Pacemaker or other implantable cardiac device in the ipsilateral chest wall
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03796559
Study Brief:
Protocol Section:
NCT03796559