Recruitment

Recruitment Status
Unknown status

Inclusion Criteria

No relevant clinical or imaging evidence of metastasis showing in the preoperative examination (M0);
Female;
Without peripheral neuropathy;
...
No relevant clinical or imaging evidence of metastasis showing in the preoperative examination (M0);
Female;
Without peripheral neuropathy;
ECOG performance score is 0 or 1;
Histological confirmed with unilateral invasive carcinoma (all pathological types are applicable);
White blood cell count> 4 × 10^9/l, neutrophil count> 2 × 10^9/l, platelet count> 100 × 10^9/l and hemoglobin 9g/dl);
Serum creatinine <1.5 folds of the upper limit of normal value;
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 mass or microscopic tumor residue after surgery resection;
Cardiac function: echocardiographic examination showed LEVF> 50%;
Informed consent form signed.
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;
aged 18 - 70 years old;
Initiate adjuvant chemotherapy within 30 days after surgery;
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;
Women at childbearing age should take contraception measures during treatment;
Newly diagnosed conditions allowing direct surgery without any absolute contraindication for surgery;
Postoperative recovery was good and an interval of at least one week since the surgery is necessary;

Exclusion Criteria

Known allergic to taxane and anthracycline agents;
Contralateral breast clinically or radiologically suspected to be malignant but not confirmed which needs a biopsy;
Already enrolled into other clinical trials;
...
Known allergic to taxane and anthracycline agents;
Contralateral breast clinically or radiologically suspected to be malignant but not confirmed which needs a biopsy;
Already enrolled into other clinical trials;
Severe systemic disease and/or uncontrollable infection, unable to be enrolled in this study LEVF <50% (echocardiography);
Women at childbearing age refuse to take contraception measures during the treatment and 8 weeks after completion of treatment;
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);
Bilateral breast cancer or carcinoma in situ (DCIS / LCIS);
Any tumor > T4a (UICC1987) (accompanied by skin involvement, lump adhesion and fixation, inflammatory breast cancer);
Previously suffering from malignant tumors (except for basal cell carcinoma and cervical carcinoma in situ), including contralateral breast cancer;
Any of ER, PR or Her-2 is positive;
Previous neoadjuvant therapy, including chemotherapy, radiotherapy and hormone therapy;
Metastasis at any location;
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.
Pregnant and breast-feeding women;

Summary

Conditions
  • Breast Cancer
  • Capecitabine
  • Triple -Negative Breast Cancer
  • Triple Negative Breast Cancer
Type
Observational
Design
  • Observational Model: Case-Control
  • Time Perspective: Prospective

Participation Requirements

Age
Between 18 years and 70 years
Gender
Both males and females

Description

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 aft...

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

No relevant clinical or imaging evidence of metastasis showing in the preoperative examination (M0);
Female;
Without peripheral neuropathy;
...
No relevant clinical or imaging evidence of metastasis showing in the preoperative examination (M0);
Female;
Without peripheral neuropathy;
ECOG performance score is 0 or 1;
Histological confirmed with unilateral invasive carcinoma (all pathological types are applicable);
White blood cell count> 4 × 10^9/l, neutrophil count> 2 × 10^9/l, platelet count> 100 × 10^9/l and hemoglobin 9g/dl);
Serum creatinine <1.5 folds of the upper limit of normal value;
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 mass or microscopic tumor residue after surgery resection;
Cardiac function: echocardiographic examination showed LEVF> 50%;
Informed consent form signed.
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;
aged 18 - 70 years old;
Initiate adjuvant chemotherapy within 30 days after surgery;
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;
Women at childbearing age should take contraception measures during treatment;
Newly diagnosed conditions allowing direct surgery without any absolute contraindication for surgery;
Postoperative recovery was good and an interval of at least one week since the surgery is necessary;

Exclusion Criteria

Known allergic to taxane and anthracycline agents;
Contralateral breast clinically or radiologically suspected to be malignant but not confirmed which needs a biopsy;
Already enrolled into other clinical trials;
...
Known allergic to taxane and anthracycline agents;
Contralateral breast clinically or radiologically suspected to be malignant but not confirmed which needs a biopsy;
Already enrolled into other clinical trials;
Severe systemic disease and/or uncontrollable infection, unable to be enrolled in this study LEVF <50% (echocardiography);
Women at childbearing age refuse to take contraception measures during the treatment and 8 weeks after completion of treatment;
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);
Bilateral breast cancer or carcinoma in situ (DCIS / LCIS);
Any tumor > T4a (UICC1987) (accompanied by skin involvement, lump adhesion and fixation, inflammatory breast cancer);
Previously suffering from malignant tumors (except for basal cell carcinoma and cervical carcinoma in situ), including contralateral breast cancer;
Any of ER, PR or Her-2 is positive;
Previous neoadjuvant therapy, including chemotherapy, radiotherapy and hormone therapy;
Metastasis at any location;
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.
Pregnant and breast-feeding women;

Tracking Information

NCT #
NCT02012634
Collaborators
Roche Pharma AG
Investigators
  • Principal Investigator: Nanlin Li, Doctor Air Force Military Medical University, China
  • Nanlin Li, Doctor Air Force Military Medical University, China