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 @ 3:04 PM
Ignite Modification Date:
2025-12-24 @ 3:04 PM
NCT ID:
NCT06174259
Eligibility Criteria:
Inclusion Criteria:
* Female patients with stage II or III (cT1cN+ or ≥T2 any cN, cM0) breast cancer. - Planned to receive standard neoadjuvant chemotherapy.
* Measurable disease (breast and/or lymph nodes).
* WHO performance status 0-2.
* Being overweight (BMI: 25-29.9 kg/m2) or obese (BMI: ≥30 kg/m2).
* Adequate bone marrow function : white blood cells (WBCs) ≥3.0 x 109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l
* Adequate liver function: bilirubin ≤1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT ≤2.5 x UNL, Alkaline Phosphatase ≤5 x UNL
* Adequate renal function: the calculated creatinine clearance should be ≥50 mL/min
* Patients must be accessible for treatment and follow-up
Exclusion Criteria:
* Serious diseases such as recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias
* Diabetes Mellitus.
* Pregnancy or lactating
* Any metabolic disorders that may affect gluconeogenesis or adaptation to fasting periods.
* Previous malignancy.
* Using weight loss medication.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06174259
Study Brief:
Protocol Section:
NCT06174259