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 @ 4:49 AM
Ignite Modification Date:
2025-12-25 @ 4:49 AM
NCT ID:
NCT07077018
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed ER-positive , HER2-negative invasive ductal carcinoma meeting at least one of the following:1)T1c-T2 N1 with histological grade 2 (ER 1-10%) or grade 3. 2)N2-N3 or grade 3 and/or Ki67 ≥40%. 3)T3-T4
* Age 18-75 years at enrollment
* Body mass index (BMI) ≥18.5 kg/m²
* Adequate hematological function:1）White blood cell count\>3.0×10⁹/L.2)Absolute neutrophil count ≥1.5×10⁹/L.3)Platelets ≥100×10⁹/L.
* Adequate organ function:1）Total bilirubin ≤1.5 × upper limit of normal (ULN).2）ALT/AST ≤2.5 × ULN. 3）Alkaline phosphatase ≤5 × ULN.4）Creatinine clearance ≥50 mL/min-1)
* ECOG performance status 0-2
* Willing and able to provide written informed consent
Exclusion Criteria:
* Prior history of any malignancy (including contralateral breast cancer)
* Received any prior neoadjuvant chemotherapy cycle for current diagnosis
* Uncontrolled endocrine disorders:1)Diabetes mellitus requiring insulin or oral hypoglycemics.2)Hyper/hypothyroidism requiring medication
* Active autoimmune disease requiring systemic immunosuppressants
* Current use of antipsychotic medications
* Known hypersensitivity to FMD components (e.g., soy protein, milk protein, nuts)
* Pregnancy or lactation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07077018
Study Brief:
Protocol Section:
NCT07077018