Breast cancer
Conditions
Interventions
trial group:Paclitaxel combined with Capecitabine
Sponsors
Shanghai Cancer Center affiliated to Fudan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients over 18 years old; 2. Patients with HER2 negative recurrent or metastatic breast cancer diagnosed by cytology or histology; 3. Patients who have received paclitaxel / docetaxel chemotherapy in the past have relapse during or within 12 months after the adjuvant treatment of paclitaxel / docetaxel chemotherapy, or disease progression during or within 3 months after the advanced treatment of paclitaxel / docetaxel chemotherapy; 4. Patients who have previously received = 1.5 x 10^9 / L, platelet count >= 80 x 10^9 / L, Hb >= 90 g / L, WBC >= 3.0 x 10^9 / L, and no bleeding tendency before enrollment; 9. Patients with sufficient liver and kidney function: total bilirubin (TBIL) <= 1.5 times the upper limit of normal value, if caused by liver metastasis, the above indexes <= 3 times the upper limit of normal value; alanine aminotransferase (ALT), aspartate aminotransferase (AST) <= 3 times the upper limit of normal value, if caused by liver metastasis, the above indexes <= 5 times the upper limit of normal value; renal function examination: serum creatinine (CR) <= 1.5 times the upper limit of normal value Or the calculated creatinine clearance rate was more than or equal to 40 ml / min; 10. The patient and / or legal representative voluntarily agreed to participate in the trial and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who have been treated with paclitaxel for injection (albumin binding) or capecitabine and proved to be drug-resistant; 2. Patients with unstable brain metastasis or meningeal metastasis; 3. According to CTCAE V 5.0, patients with grade 2 or more peripheral neuropathy; 4. Patients with severe cardiovascular diseases such as cerebrovascular accident, myocardial infarction, hypertension, unstable angina pectoris, heart failure (NYHA 2-4) and arrhythmia that cannot be controlled after drug intervention in recent 3 months; 5. Patients with other malignant tumors within 3 years, except the cured basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of any other part; 6. Patients with active infection, HIV and hepatitis requiring systematic treatment; 7. Patients with dementia, mental state change or any mental illness who will hinder understanding or making informed consent or filling in questionnaires; 8. Pregnant or lactating female patients; subjects of childbearing age who refused to accept contraceptive measures; 9. For patients who have received any other trial drug treatment or participated in another intervention clinical trial within 21 days of screening period, the cleaning period of endocrine therapy is 14 days; 10. Laboratory examination with any symptom, treatment or abnormality, which enables the researcher to judge the situation that may interfere with the judgment of the results of this study, interfere with the enrollment of the subjects or is not conducive to the best interests of the subjects; 11. Other conditions considered unsuitable by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| OS;ORR;Safety; | — |
Countries
China
Contacts
Public ContactJian Zhang
Shanghai Tumor Hospital affiliated to Fudan University
Outcome results
None listed