Study Comparing EC-T Verses PCb in the Adjuvant Chemotherapy of Non-triple Negative Breast Cancer

Inclusion Criteria:

1. Female patients aged 18-70 years old;

2. Histologically confirmed unilateral invasive breast cancer (regardless of pathologicaltype)

3. Operable breast cancer at first diagnosis, without any absolute surgicalcontraindication.

4. No gross nor microscopic residual tumor after surgery.

5. HER2-positive with ≥ 1 positive axillary lymph node; or estrogen receptor (ER) and/orprogesterone receptor (PR)-positive and HER2-negative with ≥ 4 positive axillary lymphnode. HER2-positive is defined as an immunohistochemistry (IHC) status of 3+, or apositive in situ hybridization (Fluorescence in situ hybridization (FISH), Chromogenicin situ hybridization (CISH)) test. ER-positive is defined as immunohistochemistryshowing that ≥ 1% of tumor cells were ER positive. PR-positive is defined asimmunohistochemistry showing that ≥ 1% of tumor cells were PR positive.

6. Preoperative examination found no evidence of metastasis in clinical examination norimaging examination.

7. No peripheral neuropathy.

8. Karnofsky score > 70.

9. Good postoperative recovery, at least 1 week has passed since most recent surgery.

10. Has adequate bone marrow function: leukocyte count > 4x10ˆ9 / L, absolute neutrophilcount > 2x10ˆ9 /L; platelet count > 100x10ˆ9 /L, hemoglobin > 9g/dL.

11. Has adequate liver function: alanine aminotransferase (ALT) < 1.5×upper limit ofnormal (ULN), aspartate aminotransferase (AST) < 1.5×ULN, alkaline phosphatase (AKP) < 2.5×ULN, total bilirubin (TBIL) < 1.5×ULN.

12. Has adequate kidney function: serum creatinine < 1.5×ULN.

13. Contraception during treatment for women of childbearing age.

14. Has adequate cardiac function: echocardiography showed left ventricular ejectionfraction (LVEF) > 50%.

15. Participants voluntarily joined the study, has signed informed consent before anytrial related activities are conducted, has good compliance and has agreed tofollow-up.

Exclusion Criteria:

1. Has received previous chemotherapy for late stage disease.

2. Has bilateral breast cancer or bilateral carcinoma in situ.

3. Has metastatic (Stage 4) breast cancer.

4. Has clinical T4 lesion (UICC1987) (with skin involvement, mass adhesion and fixation,and inflammatory breast cancer).

5. Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapyor endocrine therapy).

6. Has previous history of additional malignancy(with the exception of adequately treatedbasal cell carcinoma and cervical carcinoma in situ), including contralateral breastcancer.

7. Is already participating in another clinical trial.

8. Has severe systemic disease and/or uncontrolled infection.

9. Has insufficient cardiac function: echocardiography showed LVEF< 50%.

10. Has suffered from severe cardiovascular and cerebrovascular diseases disease withinthe 6 months previous of randomization (such as unstable angina, chronic heartfailure, uncontrolled hypertension with blood pressure>150/90 mmHg, myocardialinfarction, or cerebrovascular accident.

11. Has known allergy to chemotherapy drugs used in this study.

12. Is pregnant, is breast feeding, or is a woman of childbearing age who cannot practiceeffective contraceptives during treatment and until 8 weeks after the end oftreatment.

13. Has entered the study, but pre-treatment examination showed a positive pregnancy test.

14. Has a history of mental disorders, cognitive impairment, inability to understand thestudy protocol and side effects, inability to complete the study protocol andfollow-up workers (systematic evaluation is required before the patient is enrolledinto the study), or is without independent civil capacity.

15. The researchers judged patients to be unsuitable for the study.