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 @ 5:18 AM
Ignite Modification Date:
2025-12-25 @ 5:18 AM
NCT ID:
NCT03927027
Eligibility Criteria:
Inclusion Criteria:
* Documentation of Disease: cT1-3 patients undergoing axillary surgery who additionally meet one of the following conditions:
* Clinically node negative patients undergoing mastectomy and sentinel lymph node biopsy (SLNB) with possible axillary lymph node dissection (ALND) if SLNB is positive. If ALND is performed during a separate operation, ARM procedure must be repeated. Clinically node negative is defined by i) negative clinical exam and/or ii) negative axillary US and/or iii) negative needle biopsy of sonographically suspicious axillary nodes as applicable to each case.
* Clinically node positive patients as determined by needle biopsy and planned for ALND regardless of type of breast surgery.
* Patients will be staged according to the TNM staging system.
* Prior Treatment: No prior axillary surgery except needle biopsy or concurrent SLNB.
o Prior neoadjuvant chemotherapy is allowed but must be completed at least 2 weeks before registration.
* No prior history of ipsilateral breast cancer (invasive or ductal breast carcinoma in situ \[DCIS\]). Lobular breast carcinoma in situ (LCIS) and benign disease are allowed. (May have neoadjuvant chemotherapy which must be completed 2 weeks before registration).
* No bilateral invasive breast cancer.
* No matted nodes.
* No history of lymphedema of either arm.
* No known allergies blue dyes, including make-up containing blue dye.
* In order to complete the mandatory patient-completed measures, participants must be able to speak and/or read English.
* Female :
Men are excluded from this study because the number of men with breast cancer is insufficient to provide a statistical basis for assessment of effects in this subpopulation of people with breast cancer.
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
* Creatinine: =\< 1.5 x upper limit of normal (ULN).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03927027
Study Brief:
Protocol Section:
NCT03927027