NCT01550848CompletedPhase 2
A Phase II Study of Abraxane Combined With Gemcitabine in the Patients With Metastatic Breast Cancer
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Fudan University
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- overall response rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
Abraxane and Gemcitabine
Experimental
Abraxane and Gemcitabine
Intervention: Abraxane and Gemcitabine (Drug)
Outcomes
Primary Outcomes
overall response rate
Time Frame: 8 weeks
Secondary Outcomes
- number of adverse events(6 months)
Investigators
Xichun Hu
Principal Investigator
Fudan University
Study Sites (1)
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