mammary cancer
Conditions
Interventions
test team:Capecitabine combined with zoledronic acid (CZ)
Sponsors
Cancer Hospital Affiliated to Harbin Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. female aged 18~70 years old; 2. histologically confirmed recurrence (non resectable) or metastatic breast cancer; 3. pathological immunohistochemistry showed ER-, PR-, Her-2-, or Her-2. If ER-, PR-, but Her-2, FISH test is required, Her-2 gene amplification is negative, Her-2, FISH examination is optional; 4. recurrent or metastatic breast cancer who had not used first-line chemotherapy drugs (accept adjuvant / neoadjuvant therapy, the last treatment time from recurrence or metastasis for more than 6 months); 5. there is at least one measurable target lesion in accordance with the RECIST1.1 standard; 6. ECOG score of 1 or less; 7. all patients should meet the following biochemical values before entering the group: L: blood hemoglobin (Hb) for more than 90 g/L, the number of white blood cell (WBC) = 3.5 * 109/L, neutrophil count (ANC) = 1.5 * 10^9/L, platelet count (PLT) = 100 * 10^9/L; The renal function: the upper limit of normal value than serum creatinine. Liver function: - without liver metastasis, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) is less than 2.5 times the upper limit of the normal value, total bilirubin is less than 1.25 * upper limit of normal; The liver metastasis, AST, ALT, ALP is less than or equal to 5 times the upper limit of normal, the total bilirubin is less than 1.5 * upper limit of normal. 8. the expected survival time over 12 weeks; 9. sign informed consent; 10. patients with good compliance.
Exclusion criteria
Exclusion criteria: 1. pregnant women or lactating women (women of child-bearing age must be negative within 14 days before the first dose, and if they are positive, the pregnancy should be excluded by ultrasonography.); 2. women who were reluctant to adopt effective contraceptives during the study were women of childbearing age; 3. toxicity was not recovered before or during the first four weeks of the study; 4. all medications studied were taken within four weeks before the start of treatment; There are 5. symptoms of central nervous system metastasis. For the stability of asymptomatic brain metastasis and has received radiotherapy, and in addition to brain metastases outside the at least one of the other parts of the evaluation of target lesions may be into the group, but from the last time interval of more than 4 weeks of radiotherapy; 6. in the past five years, there is a history of other malignancies, except for non malignant melanoma and cervical carcinoma in situ that have been cured; 7. have clinical symptoms of cardiovascular, liver, respiratory, renal and blood endocrine systems or neuropsychiatric history; 8. had a history of osteonecrosis, a history of bone metabolism, and a history of bisphosphonate allergy. Oral surgery was performed within three months; 9. uncontrolled infection; 10. any other condition that the researcher considers unsuitable for the test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| size of the lesions; | — |
Contacts
Public ContactLi Cai
Cancer Hospital Affiliated to Harbin Medical University
Outcome results
None listed