A Phase II Study of Abraxane Gemcitabine Combination in Patients With Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Albumin-Bound Paclitaxel; Gemcitabine; Paclitaxel

Criteria

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