Adjuvant Treatment of EC Followed by Taxane +/- Carboplatin in Triple-Negative Breast Cancer

Inclusion Criteria

• Histologically confirmed adenocarcinoma of the breast, completely tumor removal byeither modified radical mastectomy or local excision plus axillary lymph nodedissection (i.e., breast conservation therapy) or sentinel node biopsy. (Tumor-freemargins at least 1 mm for both invasive and noninvasive carcinoma except for lobularcarcinoma in situ (less than 1 mm allowed);

• Tumor specimens are available for estrogen receptor (ER), progesterone receptor (PgR) and Her2 (human epidermal-growth-factor receptor 2) detection, patients shouldbe with triple negative breast cancer. Triple-negative disease is defined as ER <10%positivity, PgR <10% positivity, and negativity for Her2 (IHC (immunohistochemistry) 0-1+ or FISH (fluorescence in situ hybridization) negative);

• Adequate bone marrow function

• Adequate liver and renal function

• Eastern Cooperative Oncology Group (ECOG) Performance Score 0-1;

• Women with potential child-bearing must have a negative pregnancy test (urine orserum) within 7 days of drug administration and agree to use an acceptable method ofbirth control to avoid pregnancy for the duration of the study;

• Written informed consent according to the local ethics committee requirements.

Exclusion Criteria:

• Prior systemic of breast cancer, including chemotherapy;

• Metastatic breast cancer;

• With a history of malignant tumor except uterine cervix cancer in situ or skin basalcell carcinoma;

• Patients with medical conditions that indicate intolerant to adjuvant therapy andrelated treatment, including uncontrolled pulmonary disease, diabetes mellitus,severe infection, active peptic ulcer, coagulation disorder, connective tissuedisease or myelo-suppressive disease;

• Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) oris known to be HIV positive;

• Contraindication for using dexamethasone;

• History of congestive heart failure, uncontrolled or symptomatic angina pectoris,arrhythmia or myocardial infarction; poorly controlled hypertension (systolic BP>180mmHg or diastolic BP>100 mmHg);

• Has peripheral neuropathy no less than grade 1;

• Patient is pregnant or breast feeding;

• Patients with psychiatric disorder or other diseases leading to incompliance to thetherapy;

• Known severe hypersensitivity to any drugs in this study;

• Treatment with any investigational drugs within 30 days before the beginning ofstudy treatment.