Metronomic Chemotherapy of Capecitabine After Standard Adjuvant Chemotherapy in Operable Triple Negative Breast Cancer
Metronomic Chemotherapy of Capecitabine After Standard Adjuvant Chemotherapy in Operable Triple Negative Breast Cancer
A Multi-center, III Phase,Randomized Controlled Clinical Study of Capecitabine Metronomic
 Chemotherapy After Standard Adjuvant Chemotherapy in Operable Triple Negative Breast Cancer
Capecitabine comes as a tablet to take by mouth. It is usually taken twice a day (in the
 morning and in the evening) for 2 weeks, followed by a 1 week break before repeating the next
 dosage cycle. In this study, capecitabine will be prescribed as dosage of 900mg/m2, and
 maintain for a whole year after the standard treatment in operable triple negative breast
 cancer patients. DFS is set as the primary outcome, OS and DDFS are also observed as the
 secondary outcomes. Statistical analysis are made to see whether this metronomic therapy of
 capecitabine ( 900mg/m2) will bring benefit to any of the iterms above.
Inclusion Criteria:

 -  Female;

 -  aged 18 - 70 years old;

 -  Histological confirmed with unilateral invasive carcinoma (all pathological types are
 applicable);

 -  Newly diagnosed conditions allowing direct surgery without any absolute
 contraindication for surgery;

 -  No mass or microscopic tumor residue after surgery resection;

 -  Initiate adjuvant chemotherapy within 30 days after surgery;

 -  Axillary lymph node positive (including the sentinel lymph node positive and lymph
 node positive after axillary dissection), for example, axillary lymph node negative
 requires that primary tumor size must be greater than 1cm;

 -  Definite reports on ER/PR(progesterone receptor)/Her2 receptor showing all ER/PR/Her2
 negative (specific definitions: immunohistochemical detection of ER <10% tumor cells
 is defined as ER negative, PR <10% positive tumor cells is defined as PR-negative,
 Her2 is 0~1+ or 2+ but determined negative via FISH or CISH detected (no
 amplification) is defined as Her2 negative);

 -  No relevant clinical or imaging evidence of metastasis showing in the preoperative
 examination (M0);

 -  Without peripheral neuropathy;

 -  ECOG performance score is 0 or 1;

 -  Postoperative recovery was good and an interval of at least one week since the surgery
 is necessary;

 -  White blood cell count> 4 × 10^9/l, neutrophil count> 2 × 10^9/l, platelet count> 100
 × 10^9/l and hemoglobin 9g/dl);

 -  ASAT and ALAT <1.5 folds of the upper limit of normal values, alkaline phosphatase
 <2.5 folds of the upper limit of normal values, total bilirubin <1.5 folds of the
 upper limit of normal values;

 -  Serum creatinine <1.5 folds of the upper limit of normal value;

 -  Women at childbearing age should take contraception measures during treatment;

 -  Cardiac function: echocardiographic examination showed LEVF> 50%;

 -  Informed consent form signed.

 Exclusion Criteria:

 -  Bilateral breast cancer or carcinoma in situ (DCIS / LCIS);

 -  Metastasis at any location;

 -  Any tumor > T4a (UICC1987) (accompanied by skin involvement, lump adhesion and
 fixation, inflammatory breast cancer);

 -  Any of ER, PR or Her-2 is positive;

 -  Contralateral breast clinically or radiologically suspected to be malignant but not
 confirmed which needs a biopsy;

 -  Previous neoadjuvant therapy, including chemotherapy, radiotherapy and hormone
 therapy;

 -  Previously suffering from malignant tumors (except for basal cell carcinoma and
 cervical carcinoma in situ), including contralateral breast cancer;

 -  Already enrolled into other clinical trials;

 -  Severe systemic disease and/or uncontrollable infection, unable to be enrolled in this
 study LEVF <50% (echocardiography);

 -  Suffering from severe cardiovascular and cerebrovascular diseases within six months
 before the randomization (such as: unstable angina, chronic heart failure,
 uncontrollable high blood pressure > 150/90mmHg, myocardial infarction or brain
 vascular accident);

 -  Known allergic to taxane and anthracycline agents;

 -  Women at childbearing age refuse to take contraception measures during the treatment
 and 8 weeks after completion of treatment;

 -  Pregnant and breast-feeding women;

 -  Pregnancy test showed positive results before drug administration after enrolling in
 to the study; With mental illness and cognitive impairment, unable to understand trial
 protocol and side effects and complete trial protocol and follow-ups (systematic
 evaluation is required before recruiting into this study);

 -  Without personal freedom and independent civil capacity.