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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT03011060
Eligibility Criteria:
Inclusion Criteria:
1. Pathologically confirmed unilateral invasive carcinoma (all pathological types);
2. No gross or microscopic residual tumor after resection;
3. Clinical stage Ⅰ-stage Ⅲ A, no absolute surgical contraindications;
4. Eastern Cooperative Oncology Group(ECOG) score ≤1;
5. Accepting adjuvant chemotherapy within 15 days after surgery;
6. No peripheral neuropathy;
7. Normal bone marrow and organ functions:
1. Bone marrow function: ANC≥1500/mm3，PLT≥100000/mm3，HGB≥8g/dl
2. Renal function: serum creatinine≤1.5 times the upper limit of normal(ULN), Liver function: total bilirubin ≤1.5 times the upper limit of normal，AST≤2.5 times the upper limit of normal，alanine aminotransferase(ALT)≤2.5 times the upper limit of normal
3. Cardiac function:LVEF≥50%
8. Signed informed consent form.
Exclusion Criteria:
1. Patients with the history of oral fluorouracil chemotherapy or Chinese medicine treatment;
2. Patients with organ dysfunction:
1. Renal function: serum creatinine\>1.5 times the upper limit of normal
2. Liver function: total bilirubin\>1.5 times the upper limit of normal，AST\>1.5 times the upper limit of normal, alanine aminotransferase(ALT)\>1.5 times the upper limit of normal or alkaline phosphatase (ALP) \>2.5 times the upper limit of normal
3. Cardiac function：LVEF\<50%;
3. Human epidermal growth factor receptor-2(HER-2) positive patients who cannot receive Herceptin treatment with a left ventricular ejection fraction(LVEF) less than 55%;
4. Patients allergic to docetaxel, capecitabine, epirubicin and cyclophosphamide;
5. Patients with severe systemic disease and/or uncontrollable infections;
6. Patients with previous malignancies, including contralateral breast cancer;
7. Patients with severe cardiovascular and cerebrovascular disease(i.e. Unstable angina, chronic cardiac failure, uncontrollable high blood pressure of \>150/90 mmhg, myocardial infarction and cerebrovascular accident) history within 6 months before randomization;
8. Pregnant or lactating women.
9. Patients who have cognitive or psychological impairment as well as cannot understand the test program or stand side effects, which will result in a suspension of the trial program and follow-up;
10. Patients without personal freedom or independent civil capacity.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03011060
Study Brief:
Protocol Section:
NCT03011060