Metastatic Breast Cancer
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and toxicity of Abraxane combined with Gemcitabine in the patients with metastatic breast cancer.
Detailed description
This study is to investigate the efficacy and toxicity of Abraxane combined with Gemcitabine in the patients with metastatic breast cancer.
Interventions
DRUGAbraxane and Gemcitabine
ABX (Abraxane) 125 mg/m2，intravenous infusion，30min，day 1, 8, 15 GEM (Gemcitabine) 800 mg/m2，intravenous infusion，30min，day 1, 8, 15
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
* Female between 18 and 70 years old; * Patients with histologic proved metastatic breast cancer, unsuitable to be treated with surgery; * ECOG (Eastern Cooperative Oncology Group) 0\ 1; * Normal functions with heart, liver,renal and bone marrow:WBC≥3.5×109/L；Hb≥90 g/L；plt≥100×109/L; * Got ICF (Informed Consent Form) before enrollment; * Life expectancy more than 12 weeks
Exclusion criteria
* Pregnant or breast-feeding women or positive serum pregnancy test; * 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; * Participation in any investigational drug study within 4 weeks preceding treatment start; * 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; * Serious uncontrolled intercurrent infections; * Poor compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| number of adverse events | 6 months |
Countries
China
Outcome results
None listed