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 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT03719833
Eligibility Criteria:
Inclusion Criteria:
* Patients must be female
* Patients must be older than 18 years of age and younger than 80 years of age
* Patients must have biopsy-proven breast cancer, histological type-ductal, immunophenotype-Luminal B, HER-2 positive and triple-negative
* Patients with nodal disease (N1-N2) must have fine needle aspiration proven positive node and marked node with titanium clip before onset of neoadjuvant treatment
* Patients treated (oncological and surgical) in Clinical Hospital Centar Rijeka from September 2018 till May 2022
* Patients must be in stage cT1-3 cN0-2 cM0 at the time of diagnosis and cN0 at the time of the surgery
* Patients that are eligible for neoadjuvant oncological treatment, accepting to undergo it and complete it
* Patients who understand, accept and have signed the approved consent form
Exclusion Criteria:
* Patents in T4 stage and/or N3 stage and/or M1 stage at the time of diagnosis
* Patients with inflammatory carcinoma
* Patients with bilateral disease
* Patients with ipsilateral recurrence
* Patients with histological type-lobular and immunophenotype-Luminal A
* Patients that are not eligible for oncological treatment according to protocol, either neoadjuvant or adjuvant, or oncological treatment was interrupted (aborted or completed in another institution)
* Patients that have had previously SLNB or ALND or radiotherapy to the axillary nodes
* Patients that have been or are treated for other malignant disease
* Patients with hypersensitivity or allergy to radiocolloid
* Patients without complete documentation required for this study
* Pregnant patients
* Psychiatric patients
* Male patients
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03719833
Study Brief:
Protocol Section:
NCT03719833