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

• Status: Recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study evaluates whether sequential neo-adjuvant chemotherapy plus surgery followed by Capecitabine could achieve additional benefits over traditional postoperative chemotherapy. In the study group, patients that do not achieve pathological complete response(pCR) will receive sequential neo-adjuvant chemotherapy followed by Capecitabine. In the control group, patients will be treated with postoperative adjuvant chemotherapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Hospital of Jilin University; The First Hospital of Jilin University
• Collaborators: Baotou Cancer Hospital; First Affiliated Hospital Xi'an Jiaotong University; First Hospital of China Medical University; Qingdao University; The Second Affiliated Hospital of Harbin Medical University
• Treatments: Capecitabine

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.