Sequential Neo-adjuvant Chemotherapy Followed by Capecitabine Vs. Conventional Adjuvant Chemotherapy in Breast Cancer (NACVCAC)

This is an interventional treatment trial for Breast Neoplasm Female focused on measuring neo-adjuvant chemotherapy, pathological complete response, Neoadjuvant Therapy, Capecitabine, Chemotherapy, Adjuvant Read More

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.