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 @ 5:58 PM
Ignite Modification Date:
2025-12-24 @ 5:58 PM
NCT ID:
NCT03251768
Eligibility Criteria:
Inclusion Criteria:
* Age 18-65.
* Diagnosed breast cancer, suitable for TEC or TE .
* ECOG performance status 0 or 1.
* Adjuvant chemotherapy; new adjuvant chemotherapy; newly diagnosed class Ⅳ and prior chemotherapy.
* No obvious abnormal ecg examination.
* TBIL, ALT, AST≤2.5×ULN (≤5×ULN if presence of hepatic metastases).
* Cr, BUN≤2.5×ULN.
* Signed informed consent.
Exclusion Criteria:
* Chemotherapy within past 4 weeks.
* Uncontrolled inflammatory disease,axillary temperature≥38℃.
* Merging other malignant tumor.
* Pregnancy or nursing status.
* Participation in another clinical trial with and investigational product within 3 months prior to study entry.
* Severe diabetes mellitus, or poor blood sugar controller.
* Allergic disease or allergic constitution. History of protein allergy.
* History of drug addiction and alcoholism.
* Hematopoietic stem cell transplantation or organ transplantation.
* Antibiotics were treated within 72 hours before chemotherapy.
* Long-term use of hormones or immunosuppressive agents.
* Severe mental or neurological disease.
* Chronic disease of severe cardiac, kidney and liver.
* Other conditions that would be excluded from this study according to doctors'judgment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03251768
Study Brief:
Protocol Section:
NCT03251768