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 @ 4:32 AM
Ignite Modification Date:
2025-12-25 @ 4:32 AM
NCT ID:
NCT06261918
Eligibility Criteria:
Inclusion Criteria:
Patients will be treated as per standard. Inclusion criteria depend exclusively on compliance with informed consent, tumor size (only advanced stage tumors will be used for the study) and histological diagnosis. Specifically, patients with the following will be included in the proposed study:
* Histological diagnosis of locally advanced Luminal or HER2+ or Triple negative breast cancer (cT2, T3, T4 N0 or any T N1, N2, N3, M0), clinical stage II to III disease.
* Age \> 18 years
* Regular clinical and instrumental follow up
* Informed consent form signed by enrolled patients - Availability of information from medical records:
1. pre/post NAC blood chemistry tests: blood count, glycemia/glycosylated hemoglobin, lipid profile (triglycerides, total cholesterol, HDL + LDL cholesterol);
2. BMI;
3. possible therapy with oral hypoglycaemic drugs/insulin; statins; diuretics/antihypertensive drugs;
4. Sex hormone hormonal status (pre- or post-menopause);
Exclusion Criteria:
* Prior or synchronous history of systemic malignancy. - History of homo- or contralateral breast cancer.
* Evidence of metastatic (Stage IV) disease.
* Neo-adjuvant treatment with hormonal therapy.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06261918
Study Brief:
Protocol Section:
NCT06261918