Metastatic Breast Cancer
Conditions
Brief summary
The progression free survival could be prolonged adding pseudomonas aeruginosa to monotherapy capecitabine.
Detailed description
the efficacy of the combination is much better than monotherapy
Interventions
DRUGcapecitabine and pseudomonas aeruginosa combination
capecitabine 1000mg/m2 bid, po. pseudomonas aeruginosa 0.5ml loading dose,1ml qod ih.
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Female between 18 and 70 years old 2. Patients with histologic proved metastatic breast cancer, unsuitable to be treated locally. 3. Patients with Her-2 negative breast cancer(HER-2 negative or one plus by IHC test , if HER-2 two plus by IHC,FISH result should be negative) 4. Disease progression after anthracycline and/or taxane regimen therapy and candidate for capecitabine monotherapy 5. Patients previously treated by capecitabine containing regimen should response to the chemotherapy containing capecitabine and progressed at least 4 months after the last capecitabine treatment 6. Karnofsky score more than 70；ECOG 0\ 2； 7. Normal functions with heart, liver,renal and bone marrow 8. WBC≥4×109/L；Hb≥90 g/L；plt≥100×109/L 9. Got ICF before enrollment
Exclusion criteria
1. Pregnant or breast-feeding women or positive serum pregnancy test 2. Uncontrolled brain metastases. Patients with brain metastases must be locally treated and the disease must be stable for at least one month at the time of enrolling 3. Participation in any investigational drug study within 4 weeks preceding treatment start. 4. Concurrent other malignancy at other sites or previous other cancer within the last 5 years, with the exception of adequately treated in situ carcinoma of cervix uteri or basal or squamous cell carcinoma of the skin or a contralateral breast cancer. 5. Serious uncontrolled intercurrent infections 6. Poor compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate | 1 year |
Countries
China
Outcome results
None listed